Sunday, October 7, 2012

etodolac



e-TOE-doe-lak


Oral route(Tablet;Capsule;Tablet, Extended Release)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Etodolac is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .



Commonly used brand name(s)

In the U.S.


  • Lodine

  • Lodine XL

Available Dosage Forms:


  • Tablet

  • Capsule

  • Tablet, Extended Release

Therapeutic Class: Analgesic


Pharmacologic Class: NSAID


Chemical Class: Acetic Acid (class)


Uses For etodolac


Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, etodolac does not cure arthritis and will help you only as long as you continue to take it .


etodolac is available only with your doctor's prescription .


Before Using etodolac


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For etodolac, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to etodolac or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of etodolac capsules and tablets in children below 18 years of age. No studies have also been done on the relationship of etodolac extended-release tablets in children below 6 years of age. Safety and efficacy have not been established in these age groups .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of etodolac in the elderly. However, elderly patients may be more sensitive to the effects of etodolac than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving etodolac .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking etodolac, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using etodolac with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Ketorolac

  • Pentoxifylline

Using etodolac with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abciximab

  • Ardeparin

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Certoparin

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Dipyridamole

  • Enoxaparin

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Lepirudin

  • Methotrexate

  • Nadroparin

  • Nefazodone

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Protein C

  • Reviparin

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Tacrolimus

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Vilazodone

  • Zimeldine

Using etodolac with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acebutolol

  • Acenocoumarol

  • Acetohexamide

  • Alacepril

  • Alprenolol

  • Amiloride

  • Arotinolol

  • Atenolol

  • Azilsartan Medoxomil

  • Azosemide

  • Befunolol

  • Bemetizide

  • Benazepril

  • Bendroflumethiazide

  • Benzthiazide

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bopindolol

  • Bucindolol

  • Bumetanide

  • Bupranolol

  • Buthiazide

  • Candesartan Cilexetil

  • Canrenoate

  • Captopril

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chlorothiazide

  • Chlorpropamide

  • Chlorthalidone

  • Cilazapril

  • Clopamide

  • Cyclopenthiazide

  • Cyclosporine

  • Delapril

  • Desvenlafaxine

  • Dicumarol

  • Dilevalol

  • Duloxetine

  • Enalaprilat

  • Enalapril Maleate

  • Eprosartan

  • Esmolol

  • Ethacrynic Acid

  • Fosinopril

  • Furosemide

  • Gliclazide

  • Glimepiride

  • Glipizide

  • Gliquidone

  • Glyburide

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Imidapril

  • Indapamide

  • Irbesartan

  • Labetalol

  • Landiolol

  • Levobetaxolol

  • Levobunolol

  • Lisinopril

  • Losartan

  • Mepindolol

  • Methyclothiazide

  • Metipranolol

  • Metolazone

  • Metoprolol

  • Milnacipran

  • Moexipril

  • Nadolol

  • Nebivolol

  • Nipradilol

  • Olmesartan Medoxomil

  • Oxprenolol

  • Penbutolol

  • Pentopril

  • Perindopril

  • Phenprocoumon

  • Pindolol

  • Piretanide

  • Polythiazide

  • Propranolol

  • Quinapril

  • Ramipril

  • Sotalol

  • Spirapril

  • Spironolactone

  • Talinolol

  • Tasosartan

  • Telmisartan

  • Temocapril

  • Tertatolol

  • Timolol

  • Tolazamide

  • Tolbutamide

  • Torsemide

  • Trandolapril

  • Triamterene

  • Trichlormethiazide

  • Valsartan

  • Venlafaxine

  • Xipamide

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of etodolac. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anemia or

  • Asthma or

  • Bleeding problems or

  • Blood clots or

  • Edema (fluid retention or body swelling) or

  • Heart attack, history of or

  • Heart disease (e.g., congestive heart failure) or

  • High blood pressure or

  • Kidney disease or

  • Liver disease (e.g., hepatitis) or

  • Stomach or intestinal ulcers or bleeding or

  • Stroke, history of—Use with caution. etodolac may make these conditions worse .

  • Aspirin sensitivity, history of—etodolac should NOT be used in patients with this condition .

  • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—etodolac should NOT be used to relieve pain right before or after the surgery .

Proper Use of etodolac


For safe and effective use of etodolac, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of etodolac may increase the chance of unwanted effects, especially in elderly patients .


When used for severe or continuing arthritis, etodolac must be taken regularly as ordered by your doctor in order for it to help you. etodolac usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of etodolac.


Swallow the extended-release tablet whole. Do not crush, break, or chew it.


Dosing


The dose of etodolac will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of etodolac. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For acute pain:
    • For oral dosage form (capsules or tablets):
      • Adults—200 to 400 milligrams (mg) every 6 to 8 hours. However, the dose usually is not more than 1000 mg per day.

      • Children—Use and dose must be determined by your doctor .



  • For osteoarthritis and rheumatoid arthritis:
    • For oral dosage form (capsules or tablets):
      • Adults—300 mg two or three times a day, or 400 or 500 mg two times a day. If you will be taking etodolac for a long time, your doctor may lower your dose to 600 mg once a day. The dose usually is not more than 1000 mg per day.

      • Children—Use and dose must be determined by your doctor .


    • For oral dosage form (extended-release tablets):
      • Adults—400 mg to 1000 mg once a day.

      • Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor.

      • Children below 6 years of age—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of etodolac, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using etodolac


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .


etodolac may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use etodolac for a long time might also have a higher risk .


etodolac may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .


Serious skin reactions can occur during treatment with etodolac. Check with your doctor right away if you have any of the following symptoms while taking etodolac: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .


Possible warning signs of some serious side effects that can occur during treatment with etodolac may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking etodolac and check with your doctor immediately if you notice any of these warning signs .


etodolac may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .


Using etodolac while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .


Before having any kind of surgery or medical tests, tell your doctor that you are taking etodolac. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .


etodolac Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Abdominal or stomach bloating, burning, cramping, or pain

  • belching

  • bloody or black, tarry stools

  • blurred vision

  • body aches or pain

  • cloudy urine

  • congestion

  • constipation

  • cough or hoarseness

  • decrease in urine output or decrease in urine-concentrating ability

  • diarrhea

  • dizziness

  • dryness or soreness of throat

  • feeling of indigestion

  • fever or chills

  • headache

  • increased bleeding time

  • itching skin

  • loss of appetite

  • lower back or side pain

  • nausea and vomiting

  • nervousness

  • pain in the chest below the breastbone

  • painful or difficult urination

  • pale skin

  • pounding in the ears

  • rash

  • runny nose

  • severe stomach pain

  • slow or fast heartbeat

  • swelling

  • tender, swollen glands in neck

  • trouble in swallowing

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • voice changes

  • vomiting of blood or material that looks like coffee grounds

  • weight loss

Symptoms of overdose
  • Agitation

  • change in consciousness

  • confusion

  • depression

  • difficult or troubled breathing

  • hives

  • hostility

  • irregular, fast or slow, or shallow breathing

  • irritability

  • loss of consciousness

  • muscle twitching

  • pain or discomfort in chest, upper stomach, or throat

  • pale or blue lips, fingernails, or skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • rapid weight gain

  • seizures

  • shortness of breath

  • sleepiness

  • stupor

  • swelling of face, ankles, or hands

  • tightness in chest

  • unusual drowsiness, dullness, or feeling of sluggishness

  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Bloated, full feeling

  • continuing ringing or buzzing or other unexplained noise in ears

  • excess air or gas in stomach or intestines

  • hearing loss

  • lack or loss of strength

  • passing gas

  • sneezing

  • stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: etodolac side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


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More etodolac resources


  • Etodolac Side Effects (in more detail)
  • Etodolac Use in Pregnancy & Breastfeeding
  • Drug Images
  • Etodolac Drug Interactions
  • Etodolac Support Group
  • 17 Reviews for Etodolac - Add your own review/rating


  • Etodolac Prescribing Information (FDA)

  • Etodolac Professional Patient Advice (Wolters Kluwer)

  • Etodolac Monograph (AHFS DI)

  • Etodolac MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lodine Prescribing Information (FDA)

  • Lodine Consumer Overview



Compare etodolac with other medications


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Saturday, October 6, 2012

Hepatitis C Medications


Drugs associated with Hepatitis C

The following drugs and medications are in some way related to, or used in the treatment of Hepatitis C. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Hepatitis C





Drug List:

Friday, October 5, 2012

Fexofenadine Orally Disintegrating Tablets



Pronunciation: FEX-oh-FEN-a-deen
Generic Name: Fexofenadine
Brand Name: Allegra ODT


Fexofenadine Orally Disintegrating Tablets are used for:

Treating seasonal allergy symptoms such as sneezing, runny nose, itchy throat, or itchy, watery eyes. It is also used to treat hives and skin itching. It may also be used for other conditions as determined by your doctor.


Fexofenadine Orally Disintegrating Tablets are an antihistamine. It works by blocking a substance in the body called histamine. This helps to decrease allergy symptoms.


Do NOT use Fexofenadine Orally Disintegrating Tablets if:


  • you are allergic to any ingredient in Fexofenadine Orally Disintegrating Tablets

Contact your doctor or health care provider right away if any of these apply to you.



Before using Fexofenadine Orally Disintegrating Tablets:


Some medical conditions may interact with Fexofenadine Orally Disintegrating Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have kidney problems or trouble urinating

  • if you have phenylketonuria (PKU)

Some MEDICINES MAY INTERACT with Fexofenadine Orally Disintegrating Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Erythromycin or ketoconazole because they may increase the risk of Fexofenadine Orally Disintegrating Tablets's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fexofenadine Orally Disintegrating Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Fexofenadine Orally Disintegrating Tablets:


Use Fexofenadine Orally Disintegrating Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Fexofenadine Orally Disintegrating Tablets by mouth on an empty stomach at least 1 hour before or 2 hours after eating.

  • Do not remove the medicine from the blister pack until you are ready to take it. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Fexofenadine Orally Disintegrating Tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.

  • Do not drink fruit juice at the same time that you take Fexofenadine Orally Disintegrating Tablets. Certain fruit juices (eg, grapefruit, apple, orange) may decrease Fexofenadine Orally Disintegrating Tablets's effectiveness.

  • If you take antacids that contain aluminum or magnesium, do not take them at the same time as Fexofenadine Orally Disintegrating Tablets. Ask your doctor or pharmacist how to take them with Fexofenadine Orally Disintegrating Tablets.

  • If you miss a dose of Fexofenadine Orally Disintegrating Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fexofenadine Orally Disintegrating Tablets.



Important safety information:


  • Fexofenadine Orally Disintegrating Tablets may cause dizziness. It does not usually cause drowsiness when used under normal circumstances at the recommended doses. However, these effects may be worse if you take Fexofenadine Orally Disintegrating Tablets with alcohol or certain medicines. Use Fexofenadine Orally Disintegrating Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.

  • Fexofenadine Orally Disintegrating Tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Fexofenadine Orally Disintegrating Tablets for a few days before the tests.

  • Use Fexofenadine Orally Disintegrating Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

  • Fexofenadine Orally Disintegrating Tablets should be used with extreme caution in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fexofenadine Orally Disintegrating Tablets while you are pregnant. It is not known if Fexofenadine Orally Disintegrating Tablets are found in breast milk. If you are or will be breast-feeding while you use Fexofenadine Orally Disintegrating Tablets, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Fexofenadine Orally Disintegrating Tablets:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Dizziness; headache; stomach upset.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); earache; fever; severe or persistent coughing or vomiting.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Fexofenadine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual or severe dizziness, drowsiness, or dry mouth.


Proper storage of Fexofenadine Orally Disintegrating Tablets:

Store Fexofenadine Orally Disintegrating Tablets between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Store in original packaging until just before use. Keep Fexofenadine Orally Disintegrating Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Fexofenadine Orally Disintegrating Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Fexofenadine Orally Disintegrating Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • Carry an identification card at all times that says you are taking Fexofenadine Orally Disintegrating Tablets.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fexofenadine Orally Disintegrating Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fexofenadine resources


  • Fexofenadine Side Effects (in more detail)
  • Fexofenadine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Fexofenadine Drug Interactions
  • Fexofenadine Support Group
  • 25 Reviews for Fexofenadine - Add your own review/rating


Compare Fexofenadine with other medications


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Wednesday, October 3, 2012

Tretin-X Cream


Pronunciation: TRET-i-noin
Generic Name: Tretinoin
Brand Name: Tretin-X


Tretin-X Cream is used for:

Treating acne. It may also be used for other conditions as determined by your doctor.


Tretin-X Cream is a kit that contains tretinoin cream, a cleanser, and a moisturizer. The tretinoin cream works in the skin to reduce the formation of acne and to help acne heal more quickly. The cleanser helps to keep the skin clean, and the moisturizer helps to soothe skin and keep it soft.


Do NOT use Tretin-X Cream if:


  • you are allergic to any ingredient in Tretin-X Cream

Contact your doctor or health care provider right away if this applies to you.



Before using Tretin-X Cream:


Some medical conditions may interact with Tretin-X Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have eczema, an abnormally high white blood cell count, diabetes, or a sunburn

Some MEDICINES MAY INTERACT with Tretin-X Cream. Tell your health care provider if you are using any other medicines, especially any of the following:


  • Topical medicines containing alcohol, resorcinol, sulfur, or salicylic acid because the risk of excessive skin dryness or irritation may occur

Ask your health care provider if Tretin-X Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Tretin-X Cream:


Use Tretin-X Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Tretin-X Cream is for external use only.

  • In the morning, use the foaming cleanser provided in this kit to gently wash your face. Use warm water, and do not scrub. Gently pat your face dry. If your skin feels dry or rough, apply a thin layer of the moisturizer provided in this kit to your face and neck. If you are going to be outside, apply a sunscreen with an SPF of 15 or higher to your face.

  • At bedtime, gently wash your face again with the foaming cleanser provided in this kit. Gently pat your face dry. Wait 30 minutes for skin to dry completely. Apply the cream in this kit to areas of your skin with acne, or as directed by your doctor. Then, gently apply a thin layer of the moisturizer provided in this kit to your entire face and neck.

  • Wash your hands immediately after using Tretin-X Cream.

  • If you miss a dose of Tretin-X Cream, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tretin-X Cream.



Important safety information:


  • Tretin-X Cream is for external use only. Avoid getting Tretin-X Cream in your eyes, nose, or mouth. If you get Tretin-X Cream in your eyes, rinse thoroughly with water.

  • Tretin-X Cream may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tretin-X Cream. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • For the first 2 to 3 weeks of treatment, your skin condition may appear to worsen. This is expected. Do not stop using Tretin-X Cream at this time.

  • Talk with your doctor before you use any other medicines or products on your skin. While you are using Tretin-X Cream, you may use cosmetics.

  • Do not apply Tretin-X Cream to skin that is sunburned. Wait until the burn is fully healed before using Tretin-X Cream.

  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Avoid using other topical medication, cosmetics, or other products that have a strong drying effect. If you have dry skin from using these products, allow your skin to "rest" before using Tretin-X Cream.

  • Do not use Tretin-X Cream for any condition other than that for which it was prescribed.

  • Weather extremes, such as windy or cold weather, may irritate your skin more while you are using Tretin-X Cream.

  • Tretin-X Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Tretin-X Cream should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tretin-X Cream while you are pregnant. It is not known if Tretin-X Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Tretin-X Cream, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Tretin-X Cream:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Increase or decrease of skin pigment (color); redness, peeling, or feeling of warmth; sensitivity to sunlight; skin irritation; stinging at the application site.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe redness, swelling, blistering, or crusting of the skin.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Tretin-X side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include clumsiness; dizziness; excessive redness, peeling, and discomfort; flushing; headache; stomach pain. Tretin-X Cream may be harmful if swallowed.


Proper storage of Tretin-X Cream:

Store Tretin-X Cream at room temperature, between 59 and 80 degrees F (15 and 26 degrees C). Store in a tightly closed container. Store away from heat and light. Keep Tretin-X Cream out of the reach of children and away from pets.


General information:


  • If you have any questions about Tretin-X Cream, please talk with your doctor, pharmacist, or other health care provider.

  • Tretin-X Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tretin-X Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tretin-X resources


  • Tretin-X Side Effects (in more detail)
  • Tretin-X Use in Pregnancy & Breastfeeding
  • Tretin-X Drug Interactions
  • Tretin-X Support Group
  • 1 Review for Tretin-X - Add your own review/rating


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Monday, October 1, 2012

Urso 250


Generic Name: ursodiol (Oral route)

ur-soe-DYE-ol

Commonly used brand name(s)

In the U.S.


  • Actigall

  • Urso

  • Urso 250

  • Urso Forte

Available Dosage Forms:


  • Tablet

  • Capsule

Therapeutic Class: Gastrointestinal Agent


Pharmacologic Class: Bile Acid


Uses For Urso 250


Ursodiol is used in the treatment of gallstone disease. It is taken by mouth to dissolve the gallstones.


Ursodiol is used in patients with gallstones who do not need to have their gallbladders removed or in those in whom surgery should be avoided because of other medical problems. However, ursodiol works only in those patients whose gallstones are made of cholesterol and works best when these stones are small and of the “floating” type.


Ursodiol is also used to help prevent gallstones in patients who are on rapid weight-loss programs.


Ursodiol is also used in patients with cirrhosis of the liver. Cirrhosis causes a patient's liver to have problems and not work properly.


Ursodiol is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ursodiol is used in certain patients with the following medical conditions:


  • Chronic liver disease

  • Liver transplant (to help reduce the risk of rejection)

Before Using Urso 250


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of ursodiol in the pediatric population. Safety and efficacy have not been established .


Geriatric


No information is available on the relationship of age to the effects of ursodiol in geriatric patients .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Ascites (accumulation of fluid in the abdominal cavity) or

  • Bleeding varices (veins that enlarge and bleed) or

  • Hepatic encephalopathy (brain disease due to liver failure) or

  • Liver damage (from not having a certain chemical in your liver to break down a substance called lithocholate) or

  • Liver problems—May make these conditions worse .

  • Biliary tract problems or

  • Pancreatitis (inflammation of pancreas)—These conditions may make it necessary to have surgery since treatment with ursodiol would take too long.

Proper Use of ursodiol

This section provides information on the proper use of a number of products that contain ursodiol. It may not be specific to Urso 250. Please read with care.


Take ursodiol with meals for best results, unless otherwise directed by your doctor.


Take ursodiol for the full time of treatment, even if you begin to feel better. If you stop taking this medicine too soon, the gallstones may not dissolve as fast or may not dissolve at all.


It is thought that body weight and the kind of diet the patient follows may affect how fast the stones dissolve and whether new stones will form. However, check with your doctor before going on any diet.


Ursodiol forte tablet can be broken in halves to provide recommended dosage. To break the tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the groove then apply gentle pressure until it breaks apart. Swallow each segment with water. Do not chew .


Half-tablets can be used for up to 28 days when kept in the medicine bottle. Due to the bitter taste, segments should be stored separately .


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (capsules or tablets):
    • For gallstone disease:
      • Adults and children 12 years of age and older—The dose is based on body weight and must be determined by your doctor. The usual dose is 8 to 10 milligrams (mg) per kilogram (kg) (3.6 to 4.5 mg per pound) of body weight a day, divided into two or three doses. Each dose is usually taken with a meal.

      • Children up to 12 years of age—Use and dose must be determined by your doctor.


    • For prevention of gallstones during rapid weight loss:
      • Adults—Oral, 300 mg two times a day.

      • Children up to 12 years of age—Use and dose must be determined by your doctor.


    • For cirrhosis of the liver:
      • Adults—The dose is based on body weight and must be determined by your doctor. The usual dose is 13 to 15 milligrams (mg) per kilogram (kg) (5.85 to 6.75 mg per pound) of body weight a day, divided into two to four doses. Each dose should be taken with a meal.

      • Children up to 12 years of age—Use and dose must be determined by your doctor.



Missed Dose


Call your doctor or pharmacist for instructions.


If you miss a dose of this medicine, take it as soon as possible or double your next dose.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Urso 250


It is important that your doctor check your progress at regular visits. Laboratory tests will have to be done every few months while you are taking this medicine to make sure that the gallstones are dissolving and your liver is working properly.


Do not take aluminum-containing antacids (e.g., ALternaGEL®, Maalox®), cholestyramine (Questran®), colestipol (Colestid®), clofibrate (Atromid-S®), or estrogen or birth control pills while taking ursodiol. To do so may keep ursodiol from working properly. Before using these medicines, check with your doctor first .


Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur. These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor's attention.


Urso 250 Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


More common
  • Bladder pain

  • bloody or cloudy urine

  • difficult, burning, or painful urination

  • dizziness

  • fast heartbeat

  • frequent urge to urinate

  • indigestion

  • lower back or side pain

  • severe nausea

  • shortness of breath

  • skin rash or itching over the entire body

  • stomach pain

  • vomiting

  • weakness

  • wheezing

Less common
  • Black, tarry stools

  • blood in vomit

  • chest pain

  • chills

  • cough

  • fever

  • painful or difficult urination

  • severe or continuing stomach pain

  • sore throat

  • sores, ulcers, or white spots on lips or in mouth

  • swollen glands

  • unusual bleeding or bruising

  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:


  • Diarrhea

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Back pain

  • body aches or pain

  • congestion

  • constipation

  • cough producing mucus

  • difficulty in breathing

  • dryness or soreness of throat

  • ear congestion

  • general feeling of discomfort or illness

  • hair loss

  • headache

  • heartburn

  • loss of appetite

  • loss of voice

  • muscle aches and pains

  • muscle or bone pain

  • muscle stiffness

  • nasal congestion

  • nausea

  • pain, swelling, or redness in joints

  • runny nose

  • shivering

  • sneezing

  • sweating

  • tightness in chest

  • trouble in swallowing

  • trouble sleeping

  • voice changes

Less common or rare
  • Worsening psoriasis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Urso 250 side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Urso 250 resources


  • Urso 250 Side Effects (in more detail)
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  • Drug Images
  • Urso 250 Drug Interactions
  • Urso 250 Support Group
  • 3 Reviews for Urso 250 - Add your own review/rating


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Foltabs plus DHA


Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN


What are Foltabs plus DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.


Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.


Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.


Prenatal vitamins may also be used for purposes not listed in this medication guide.


What is the most important information I should know about prenatal vitamins?


There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.


Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?


Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.


You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.


Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.


Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.


The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.


Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.


What should I avoid while taking prenatal vitamins?


Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.


Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:



  • upset stomach;




  • headache; or




  • unusual or unpleasant taste in your mouth.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect prenatal vitamins?


Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:



  • diuretics (water pills);




  • heart or blood pressure medications;




  • tretinoin (Vesanoid);




  • isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);




  • trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or




  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.



This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Foltabs plus DHA resources


  • Foltabs plus DHA Use in Pregnancy & Breastfeeding
  • Foltabs plus DHA Drug Interactions
  • 0 Reviews for Foltabs plus DHA - Add your own review/rating


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  • CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • CitraNatal Assure Prescribing Information (FDA)

  • CitraNatal Harmony Prescribing Information (FDA)

  • Concept DHA Prescribing Information (FDA)

  • Docosavit Prescribing Information (FDA)

  • Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

  • Folcal DHA Prescribing Information (FDA)

  • Folcaps Care One Prescribing Information (FDA)

  • Gesticare DHA Prescribing Information (FDA)

  • Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • Inatal Advance Prescribing Information (FDA)

  • Inatal Ultra Prescribing Information (FDA)

  • Multi-Nate DHA Prescribing Information (FDA)

  • Multi-Nate DHA Extra Prescribing Information (FDA)

  • MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

  • Natelle One Prescribing Information (FDA)

  • Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

  • OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Paire OB Plus DHA Prescribing Information (FDA)

  • PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

  • PreNexa Prescribing Information (FDA)

  • PreferaOB Prescribing Information (FDA)

  • Prenatal Plus Prescribing Information (FDA)

  • Prenatal Plus Iron Prescribing Information (FDA)

  • Prenate Elite Prescribing Information (FDA)

  • Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

  • Prenate Elite tablets

  • Prenate Essential Prescribing Information (FDA)

  • PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

  • PrimaCare ONE capsules

  • PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Renate DHA Prescribing Information (FDA)

  • Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Se-Natal 19 Prescribing Information (FDA)

  • Tandem DHA Prescribing Information (FDA)

  • Tandem OB Prescribing Information (FDA)

  • TriAdvance Prescribing Information (FDA)

  • Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Triveen-PRx RNF Prescribing Information (FDA)

  • UltimateCare ONE NF Prescribing Information (FDA)

  • Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vinate AZ Prescribing Information (FDA)

  • Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zatean-CH Prescribing Information (FDA)



Compare Foltabs plus DHA with other medications


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Where can I get more information?


  • Your pharmacist can provide more information about prenatal vitamins.


Thursday, September 27, 2012

granisetron


Generic Name: granisetron (oral) (gra NIS e tron)

Brand Names: Granisol, Kytril


What is granisetron?

Granisetron blocks the actions of chemicals in the body that can trigger nausea and vomiting.


Granisetron is used to prevent nausea and vomiting that may be caused by medicine to treat cancer (chemotherapy or radiation).


Granisetron may be used for other purposes not listed in this medication guide.


What is the most important information I should know about granisetron?


You should not use this medication if you are allergic to granisetron or to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

Before taking granisetron, tell your doctor if you have liver disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.


Granisetron is usually started up to 1 hour before chemotherapy. Tell your doctor if you forget to take the medication within the specified amount of time before your procedure.


What should I discuss with my health care provider before taking granisetron?


You should not use this medication if you are allergic to granisetron, to similar medicines such as dolasetron (Anzemet), ondansetron (Zofran), or palonosetron (Aloxi).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take granisetron:


  • liver disease;


  • a heart rhythm disorder;




  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or




  • a personal or family history of Long QT syndrome.




FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether granisetron passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take granisetron?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.


Granisetron is usually started up to 1 hour before chemotherapy. Follow your doctor's instructions.


Measure the liquid form of granisetron with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Store granisetron at room temperature away from moisture and heat.

See also: Granisetron dosage (in more detail)

What happens if I miss a dose?


Tell your doctor if you forget to take your dose within 1 hour before chemotherapy. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include headache.


What should I avoid while taking granisetron?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Granisetron side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;




  • fever, body aches, flu symptoms; or




  • easy bruising or bleeding; unusual weakness.



Less serious side effects may include:



  • headache;




  • stomach pain or upset, loss of appetite;




  • diarrhea or constipation;




  • dizziness; or




  • sleep problems (insomnia);



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Granisetron Dosing Information


Usual Adult Dose for Nausea/Vomiting -- Chemotherapy Induced:

IV: 10 mcg/kg over 5 minutes, beginning 30 minutes before initiation of chemotherapy.

Orally: 2 mg, given up to 1 hour before chemotherapy, or 1 mg twice a day (the first dose is given up to 1 hour before chemotherapy, and the second dose is given 12 hours later).

Granisetron transdermal system: Apply a single patch to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. Granisetron transdermal system is a 52 cm2 patch containing 34.3 mg of granisetron. The patch releases 3.1 mg of granisetron per 24 hours for up to 7 days.

The transdermal system (patch) should be applied to clean, dry, intact healthy skin on the upper outer arm. Granisetron transdermal system should not be placed on skin that is red, irritated or damaged. Each patch is packed in a pouch and should be applied directly after the pouch has been opened. The patch should not be cut into pieces.

Usual Adult Dose for Nausea/Vomiting--Radiation Induced:

2 mg orally given within 1 hour of radiotherapy.

Usual Adult Dose for Nausea/Vomiting -- Postoperative:

Prevention and Treatment
IV: 1 mg undiluted over 30 seconds, given before induction of anesthesia, or immediately before reversal of anesthesia; or give after surgery.

Usual Pediatric Dose for Nausea/Vomiting -- Chemotherapy Induced:

Greater than or equal to 2 to 16 years: 10 mcg/kg IV 30 minutes before start of chemotherapy.

Study (n=80)
Randomized double-blind clinical studies have used granisetron injection in the range of 10 to 40 mcg/kg.


What other drugs will affect granisetron?


There may be other drugs that can interact with granisetron. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More granisetron resources


  • Granisetron Side Effects (in more detail)
  • Granisetron Dosage
  • Granisetron Use in Pregnancy & Breastfeeding
  • Drug Images
  • Granisetron Drug Interactions
  • Granisetron Support Group
  • 6 Reviews for Granisetron - Add your own review/rating


  • granisetron Oral, Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Granisetron MedFacts Consumer Leaflet (Wolters Kluwer)

  • Granisetron Prescribing Information (FDA)

  • Granisetron Hydrochloride Monograph (AHFS DI)

  • Granisol Prescribing Information (FDA)

  • Kytril Prescribing Information (FDA)

  • Kytril Consumer Overview

  • Sancuso Prescribing Information (FDA)

  • Sancuso Advanced Consumer (Micromedex) - Includes Dosage Information

  • Sancuso Consumer Overview

  • Sancuso MedFacts Consumer Leaflet (Wolters Kluwer)



Compare granisetron with other medications


  • Nausea/Vomiting, Chemotherapy Induced
  • Nausea/Vomiting, Postoperative
  • Nausea/Vomiting, Radiation Induced


Where can I get more information?


  • Your pharmacist can provide more information about granisetron.

See also: granisetron side effects (in more detail)


Saturday, September 22, 2012

Lasix




Generic Name: furosemide

Dosage Form: tablet
Lasix®

(furosemide)

Tablets 20, 40, and 80 mg

Warning

Lasix® (furosemide) is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs. (See DOSAGE AND ADMINISTRATION.)




Lasix Description


Lasix® is a diuretic which is an anthranilic acid derivative. Lasix tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: lactose monohydrate NF, magnesium stearate NF, starch NF, talc USP, and colloidal silicon dioxide NF. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Lasix is available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids.


The CAS Registry Number is 54-31-9.


The structural formula is as follows:




Lasix - Clinical Pharmacology


Investigations into the mode of action of Lasix have utilized micropuncture studies in rats, stop flow experiments in dogs and various clearance studies in both humans and experimental animals. It has been demonstrated that Lasix inhibits primarily the absorption of sodium and chloride not only in the proximal and distal tubules but also in the loop of Henle. The high degree of efficacy is largely due to the unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone.


Recent evidence suggests that furosemide glucuronide is the only or at least the major biotransformation product of furosemide in man. Furosemide is extensively bound to plasma proteins, mainly to albumin. Plasma concentrations ranging from 1 to 400 μg/mL are 91 to 99% bound in healthy individuals. The unbound fraction averages 2.3 to 4.1% at therapeutic concentrations.


The onset of diuresis following oral administration is within 1 hour. The peak effect occurs within the first or second hour. The duration of diuretic effect is 6 to 8 hours.


In fasted normal men, the mean bioavailability of furosemide from Lasix Tablets and Lasix Oral Solution is 64% and 60%, respectively, of that from an intravenous injection of the drug. Although furosemide is more rapidly absorbed from the oral solution (50 minutes) than from the tablet (87 minutes), peak plasma levels and area under the plasma concentration-time curves do not differ significantly. Peak plasma concentrations increase with increasing dose but times-to-peak do not differ among doses. The terminal half-life of furosemide is approximately 2 hours.


Significantly more furosemide is excreted in urine following the IV injection than after the tablet or oral solution. There are no significant differences between the two oral formulations in the amount of unchanged drug excreted in urine.



Geriatric Population


Furosemide binding to albumin may be reduced in elderly patients. Furosemide is predominantly excreted unchanged in the urine. The renal clearance of furosemide after intravenous administration in older healthy male subjects (60–70 years of age) is statistically significantly smaller than in younger healthy male subjects (20–35 years of age). The initial diuretic effect of furosemide in older subjects is decreased relative to younger subjects. (See PRECAUTIONS: Geriatric Use.)



Indications and Usage for Lasix



Edema


Lasix is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Lasix is particularly useful when an agent with greater diuretic potential is desired.



Hypertension


Oral Lasix may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with Lasix alone.



Contraindications


Lasix is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.



Warnings


In patients with hepatic cirrhosis and ascites, Lasix therapy is best initiated in the hospital. In hepatic coma and in states of electrolyte depletion, therapy should not be instituted until the basic condition is improved. Sudden alterations of fluid and electrolyte balance in patients with cirrhosis may precipitate hepatic coma; therefore, strict observation is necessary during the period of diuresis. Supplemental potassium chloride and, if required, an aldosterone antagonist are helpful in preventing hypokalemia and metabolic alkalosis.


If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, Lasix should be discontinued.


Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that Lasix ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg Lasix per minute has been used). (See PRECAUTIONS: Drug Interactions)



Precautions



General


Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. As with any effective diuretic, electrolyte depletion may occur during Lasix therapy, especially in patients receiving higher doses and a restricted salt intake. Hypokalemia may develop with Lasix, especially with brisk diuresis, inadequate oral electrolyte intake, when cirrhosis is present, or during concomitant use of corticosteroids, ACTH, licorice in large amounts, or prolonged use of laxatives. Digitalis therapy may exaggerate metabolic effects of hypokalemia, especially myocardial effects.


All patients receiving Lasix therapy should be observed for these signs or symptoms of fluid or electrolyte imbalance (hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia or hypocalcemia): dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, arrhythmia, or gastrointestinal disturbances such as nausea and vomiting. Increases in blood glucose and alterations in glucose tolerance tests (with abnormalities of the fasting and 2-hour postprandial sugar) have been observed, and rarely, precipitation of diabetes mellitus has been reported.


In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. Thus, these patients require careful monitoring, especially during the initial stages of treatment.


In patients at high risk for radiocontrast nephropathy Lasix can lead to a higher incidence of deterioration in renal function after receiving radiocontrast compared to high-risk patients who received only intravenous hydration prior to receiving radiocontrast.


In patients with hypoproteinemia (e.g., associated with nephrotic syndrome) the effect of Lasix may be weakened and its ototoxicity potentiated.


Asymptomatic hyperuricemia can occur and gout may rarely be precipitated.


Patients allergic to sulfonamides may also be allergic to Lasix. The possibility exists of exacerbation or activation of systemic lupus erythematosus.


As with many other drugs, patients should be observed regularly for the possible occurrence of blood dyscrasias, liver or kidney damage, or other idiosyncratic reactions.



Information for Patients


Patients receiving Lasix should be advised that they may experience symptoms from excessive fluid and/or electrolyte losses. The postural hypotension that sometimes occurs can usually be managed by getting up slowly. Potassium supplements and/or dietary measures may be needed to control or avoid hypokalemia.


Patients with diabetes mellitus should be told that furosemide may increase blood glucose levels and thereby affect urine glucose tests. The skin of some patients may be more sensitive to the effects of sunlight while taking furosemide.


Hypertensive patients should avoid medications that may increase blood pressure, including over-the-counter products for appetite suppression and cold symptoms.



Laboratory Tests


Serum electrolytes (particularly potassium), CO2, creatinine and BUN should be determined frequently during the first few months of Lasix therapy and periodically thereafter. Serum and urine electrolyte determinations are particularly important when the patient is vomiting profusely or receiving parenteral fluids. Abnormalities should be corrected or the drug temporarily withdrawn. Other medications may also influence serum electrolytes.


Reversible elevations of BUN may occur and are associated with dehydration, which should be avoided, particularly in patients with renal insufficiency.


Urine and blood glucose should be checked periodically in diabetics receiving Lasix, even in those suspected of latent diabetes.


Lasix may lower serum levels of calcium (rarely cases of tetany have been reported) and magnesium. Accordingly, serum levels of these electrolytes should be determined periodically.


In premature infants Lasix may precipitate nephrocalcinosis/nephrolithiasis, therefore renal function must be monitored and renal ultrasonography performed. (See PRECAUTIONS: Pediatric Use)



Drug Interactions


Lasix may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.


Lasix should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Lasix, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.


There is a risk of ototoxic effects if cisplatin and Lasix are given concomitantly. In addition, nephrotoxicity of nephrotoxic drugs such as cisplatin may be enhanced if Lasix is not given in lower doses and with positive fluid balance when used to achieve forced diuresis during cisplatin treatment.


Lasix has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.


Lithium generally should not be given with diuretics because they reduce lithium's renal clearance and add a high risk of lithium toxicity.


Lasix combined with angiotensin converting enzyme inhibitors or angiotensin II receptor blockers may lead to severe hypotension and deterioration in renal function, including renal failure. An interruption or reduction in the dosage of Lasix, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers may be necessary.


Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.


Lasix may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.


Simultaneous administration of sucralfate and Lasix tablets may reduce the natriuretic and antihypertensive effects of Lasix. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Lasix is achieved. The intake of Lasix and sucralfate should be separated by at least two hours.


In isolated cases, intravenous administration of Lasix within 24 hours of taking chloral hydrate may lead to flushing, sweating attacks, restlessness, nausea, increase in blood pressure and tachycardia. Use of Lasix concomitantly with chloral hydrate is, therefore, not recommended.


Phenytoin interferes directly with renal action of Lasix. There is evidence that treatment with phenytoin leads to decrease intestinal absorption of Lasix, and consequently to lower peak serum furosemide concentrations.


Methotrexate and other drugs that, like Lasix, undergo significant renal tubular secretion may reduce the effect of Lasix. Conversely, Lasix may decrease renal elimination of other drugs that undergo tubular secretion. High-dose treatment of both Lasix and these other drugs may result in elevated serum levels of these drugs and may potentiate their toxicity as well as the toxicity of Lasix.


Lasix can increase the risk of cephalosporin-induced nephrotoxicity even in the setting of minor or transient renal impairment.


Concomitant use of cyclosporine and Lasix is associated with increased risk of gouty arthritis secondary to Lasix-induced hyperurecemia and cyclosporine impairment of renal urate excretion.


One study in six subjects demonstrated that the combination of furosemide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when furosemide was used in conjunction with NSAIDs.


Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Lasix (furosemide) in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and Lasix should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Lasix is achieved.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Furosemide was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. A small but significantly increased incidence of mammary gland carcinomas occurred in female mice at a dose 17.5 times the maximum human dose of 600 mg. There were marginal increases in uncommon tumors in male rats at a dose of 15 mg/kg (slightly greater than the maximum human dose) but not at 30 mg/kg.


Furosemide was devoid of mutagenic activity in various strains of Salmonella typhimurium when tested in the presence or absence of an in vitro metabolic activation system, and questionably positive for gene mutation in mouse lymphoma cells in the presence of rat liver S9 at the highest dose tested. Furosemide did not induce sister chromatid exchange in human cells in vitro, but other studies on chromosomal aberrations in human cells in vitro gave conflicting results. In Chinese hamster cells it induced chromosomal damage but was questionably positive for sister chromatid exchange. Studies on the induction by furosemide of chromosomal aberrations in mice were inconclusive. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae.


Lasix (furosemide) produced no impairment of fertility in male or female rats, at 100 mg/kg/day (the maximum effective diuretic dose in the rat and 8 times the maximal human dose of 600 mg/day).



Pregnancy



PREGNANCY CATEGORY C - Furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits at 2, 4 and 8 times the maximal recommended human dose. There are no adequate and well-controlled studies in pregnant women. Lasix should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.


Treatment during pregnancy requires monitoring of fetal growth because of the potential for higher birth weights.


The effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits.


Furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (2 times the maximal recommended human dose of 600 mg/day). In another study, a dose of 50 mg/kg (4 times the maximal recommended human dose of 600 mg/day) also caused maternal deaths and abortions when administered to rabbits between Days 12 and 17 of gestation. In a third study, none of the pregnant rabbits survived a dose of 100 mg/kg. Data from the above studies indicate fetal lethality that can precede maternal deaths.


The results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses derived from the treated dams as compared with the incidence in fetuses from the control group.



Nursing Mothers


Because it appears in breast milk, caution should be exercised when Lasix is administered to a nursing mother.


Lasix may inhibit lactation.



Pediatric Use


In premature infants Lasix may precipitate nephrocalcinosis/nephrolithiasis.


Nephrocalcinosis/nephrolithiasis has also been observed in children under 4 years of age with no history of prematurity who have been treated chronically with Lasix. Monitor renal function, and renal ultrasonography should be considered, in pediatric patients receiving Lasix.


If Lasix is administered to premature infants during the first weeks of life, it may increase the risk of persistence of patent ductus arteriosus



Geriatric Use


Controlled clinical studies of Lasix did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.


This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function. (See PRECAUTIONS: General and DOSAGE AND ADMINISTRATION.)



Adverse Reactions


Adverse reactions are categorized below by organ system and listed by decreasing severity.


Gastrointestinal System Reactions


  1. hepatic encephalopathy in patients with hepatocellular insufficiency

  2. pancreatitis

  3. jaundice (intrahepatic cholestatic jaundice)

  4. increased liver enzymes

  5. anorexia

  6. oral and gastric irritation

  7. cramping

  8. diarrhea

  9. constipation

  10. nausea

  11. vomiting

Systemic Hypersensitivity Reactions


  1. Severe anaphylactic or anaphylactoid reactions (e.g. with shock)

  2. systemic vasculitis

  3. interstitial nephritis

  4. necrotizing angiitis

Central Nervous System Reactions


  1. tinnitus and hearing loss

  2. paresthesias

  3. vertigo

  4. dizziness

  5. headache

  6. blurred vision

  7. xanthopsia

Hematologic Reactions


  1. aplastic anemia

  2. thrombocytopenia

  3. agranulocytosis

  4. hemolytic anemia

  5. leukopenia

  6. anemia

  7. eosinophilia

Dermatologic-Hypersensitivity Reactions


  1. toxic epidermal necrolysis

  2. Stevens-Johnson Syndrome

  3. erythema multiforme

  4. drug rash with eosinophilia and systemic symptoms

  5. acute generalized exanthematous pustulosis

  6. exfoliative dermatitis

  7. bullous pemphigoid

  8. purpura

  9. photosensitivity

  10. rash

  11. pruritis

  12. urticaria

Cardiovascular Reaction


  1. Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.

  2. Increase in cholesterol and triglyceride serum levels

Other Reactions


  1. hyperglycemia

  2. glycosuria

  3. hyperuricemia

  4. muscle spasm

  5. weakness

  6. restlessness

  7. urinary bladder spasm

  8. thrombophlebitis

  9. fever

Whenever adverse reactions are moderate or severe, Lasix dosage should be reduced or therapy withdrawn.



Overdosage


The principal signs and symptoms of overdose with Lasix are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action.


The acute toxicity of Lasix has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats.


The concentration of Lasix in biological fluids associated with toxicity or death is not known.


Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy).


Hemodialysis does not accelerate furosemide elimination.



Lasix Dosage and Administration



Edema


Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.


Adults

The usual initial dose of Lasix is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). The dose of Lasix may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.


Edema may be most efficiently and safely mobilized by giving Lasix on 2 to 4 consecutive days each week.


When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests.)


Geriatric patients

In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).


Pediatric patients

The usual initial dose of oral Lasix in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.



Hypertension


Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.


Adults

The usual initial dose of Lasix for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.


Changes in blood pressure must be carefully monitored when Lasix is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when Lasix is added to the regimen. As the blood pressure falls under the potentiating effect of Lasix, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.


Geriatric patients

In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).



How is Lasix Supplied


Lasix (furosemide) Tablets 20 mg are supplied as white, oval, monogrammed tablets in Bottles of 100 (NDC 0039-0067-10), and 1000 (NDC 0039-0067-70). The 20 mg tablets are imprinted with "Lasix®" on one side.


Lasix Tablets 40 mg are supplied as white, round, monogrammed, scored tablets in Bottles of 100 (NDC 0039-0060-13), 500 (NDC 0039-0060-50), and 1000 (NDC 0039-0060-70). The 40 mg tablets are imprinted with "Lasix® 40" on one side.


Lasix Tablets 80 mg are supplied as white, round, monogrammed, facetted edge tablets in Bottles of 50 (NDC 0039-0066-05) and 500 (NDC 0039-0066-50). The 80 mg tablets are imprinted with "Lasix® 80" on one side.



Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.


Tested by USP Dissolution Test 2


Store at 25° C (77° F); excursions permitted to 15 – 30° C (59 – 86° F). [See USP Controlled Room Temperature.]



Revised August 2011


sanofi-aventis U.S. LLC

Bridgewater, NJ 08807


© 2011 sanofi-aventis U.S. LLC



PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label


NDC 0039-0067-10


Lasix®


furosemide


Tablets


100 Tablets


20mg


sanofi aventis




PRINCIPAL DISPLAY PANEL - 40 mg Bottle Label


NDC 0039-0060-13


Lasix®


furosemide


Tablets


100 Tablets


40mg


sanofi aventis




PRINCIPAL DISPLAY PANEL - 80 mg Bottle Label


NDC 0039-0066-05


Lasix®


furosemide


Tablets


50 Tablets


80mg


sanofi aventis










Lasix 
furosemide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0039-0067
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
furosemide (furosemide)furosemide20 mg












Inactive Ingredients
Ingredient NameStrength
lactose monohydrate 
magnesium stearate 
talc 
silicon dioxide 


















Product Characteristics
ColorWHITEScoreno score
ShapeOVAL (ellipsoidal)Size8mm
FlavorImprint CodeLasix
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10039-0067-10100 TABLET In 1 BOTTLENone
20039-0067-701000 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01627307/01/1966







Lasix 
furosemide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0039-0060
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
furosemide (furosemide)furosemide40 mg












Inactive Ingredients
Ingredient NameStrength
lactose monohydrate 
magnesium stearate 
talc 
silicon dioxide 


















Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize8mm
FlavorImprint CodeLasix;40
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
10039-0060-13100 TABLET In 1 BOTTLENone
20039-0060-50500 TABLET In 1 BOTTLENone
30039-0060-701000 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01627307/01/1966







Lasix 
furosemide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0039-0066
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
furosemide (furosemide)furosemide80 mg












Inactive Ingredients
Ingredient NameStrength
lactose monohydrate 
magnesium stearate 
talc 
silicon dioxide 


















Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeLasix;80
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10039-0066-0550 TABLET In 1 BOTTLENone
20039-0066-50500 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01627307/01/1966


Labeler - Sanofi-Aventis U.S. LLC (824676584)









Establishment
NameAddressID/FEIOperations
Sanofi-Aventis Canada Inc.251046934MANUFACTURE
Revised: 09/2011Sanofi-Aventis U.S. LLC

More Lasix resources


  • Lasix Side Effects (in more detail)
  • Lasix Dosage
  • Lasix Use in Pregnancy & Breastfeeding
  • Drug Images
  • Lasix Drug Interactions
  • Lasix Support Group
  • 12 Reviews for Lasix - Add your own review/rating


  • Lasix Monograph (AHFS DI)

  • Lasix Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lasix MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lasix Consumer Overview

  • Furosemide Professional Patient Advice (Wolters Kluwer)

  • Furosemide MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Lasix with other medications


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  • Edema
  • Heart Failure
  • High Blood Pressure
  • Hypercalcemia
  • Nonobstructive Oliguria
  • Oliguria
  • Pulmonary Edema
  • Renal Failure
  • Renal Transplant