Lortuss DM Elixir

Pronunciation: FEN-il-EF-rin/BROME-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Phenylephrine/Brompheniramine/Dextromethorphan
Brand Name: Examples include Alahist DM and Dimetapp DM Cough/Cold

Lortuss DM Elixir is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Lortuss DM Elixir is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Lortuss DM Elixir if:

• you are allergic to any ingredient in Lortuss DM Elixir


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Lortuss DM Elixir:

Some medical conditions may interact with Lortuss DM Elixir. 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 a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Lortuss DM Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Lortuss DM Elixir's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Lortuss DM Elixir


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Lortuss DM Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lortuss DM Elixir 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 Lortuss DM Elixir:

Use Lortuss DM Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Lortuss DM Elixir by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Drink plenty of water while taking Lortuss DM Elixir.


• If you miss a dose of Lortuss DM Elixir, 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 Lortuss DM Elixir.

Important safety information:

• Lortuss DM Elixir may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lortuss DM Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Lortuss DM Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Lortuss DM Elixir without checking with your doctor.


• Lortuss DM Elixir has phenylephrine, brompheniramine, and dextromethorphan in it. Before you start any new medicine, check the label to see if it has phenylephrine, brompheniramine, or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Lortuss DM Elixir for cough with a lot of mucus. Do not use for long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


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


• If your symptoms do not get better within 5 to 7 days, if they get worse, or if they occur along with a fever, check with your doctor.


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


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


• Tell your doctor or dentist that you take Lortuss DM Elixir before you receive any medical or dental care, emergency care, or surgery.


• Use Lortuss DM Elixir with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Lortuss DM Elixir in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Lortuss DM Elixir should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; 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 Lortuss DM Elixir while you are pregnant. Do not take Lortuss DM Elixir in the third trimester of pregnancy. It is not known if Lortuss DM Elixir is found in breast milk. If you are or will be breast-feeding while you use Lortuss DM Elixir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lortuss DM Elixir:

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:

Blurred vision; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; increased sweating; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); chest tightness; difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or sore throat; flushing or redness of the face; hallucinations; mental or mood changes; numbness or tingling; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of the mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; vision changes.

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: Lortuss DM 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 blurred vision; confusion; hallucinations; muscle spasms; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusual eye movements; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Lortuss DM Elixir:

Store Lortuss DM Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lortuss DM Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Lortuss DM Elixir, please talk with your doctor, pharmacist, or other health care provider.


• Lortuss DM Elixir 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 Lortuss DM Elixir. 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 Lortuss DM resources

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

Compare Lortuss DM with other medications

• Cough and Nasal Congestion

Ethezyme Ointment

Pronunciation: pap-ANE/you-REE-ah
Generic Name: Papain/Urea
Brand Name: Examples include Accuzyme and Ethezyme

Ethezyme Ointment is used for:

Removing dead tissue and thinning the pus in lesions such as ulcers, burns, wounds, and carbuncles.

Ethezyme Ointment is a debriding agent. It works by helping the breakdown of dead skin and pus, which helps improve the recovery time of open wounds.

Do NOT use Ethezyme Ointment if:

• you are allergic to any ingredient in Ethezyme Ointment

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

Before using Ethezyme Ointment:

Some medical conditions may interact with Ethezyme Ointment. 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

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

• Medicines containing silver, lead, or mercury because they may decrease Ethezyme Ointment's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ethezyme Ointment 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 Ethezyme Ointment:

Use Ethezyme Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ethezyme Ointment is for external use only.


• Before each use of Ethezyme Ointment, clean the affected area with saline or another mild wound cleansing solution. Do not use hydrogen peroxide.


• Apply Ethezyme Ointment directly to the lesion, cover with appropriate dressing (eg, bandages), and secure into place. Wash the lesion each time the dressing is changed.


• Change wound dressings according to the schedule set by your doctor.


• If irritation occurs, talk with your doctor about changing the dressings more often.


• If you miss a dose of Ethezyme Ointment, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ethezyme Ointment.

Important safety information:

• Ethezyme Ointment is for external use only. Do not get it in the eyes or mouth. If you get Ethezyme Ointment in the eyes, rinse them immediately with a generous amount of cool water.


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

Possible side effects of Ethezyme Ointment:

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:

Mild skin irritation; temporary burning sensation.

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).

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: Ethezyme 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.

Proper storage of Ethezyme Ointment:

Store Ethezyme Ointment in a cool place, between 46 and 59 degrees F (8 and 15 degrees C). Do not refrigerate. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ethezyme Ointment out of the reach of children and away from pets.

General information:

• If you have any questions about Ethezyme Ointment, please talk with your doctor, pharmacist, or other health care provider.


• Ethezyme Ointment 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 Ethezyme Ointment. 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 Ethezyme resources

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

Compare Ethezyme with other medications

• Burns, External
• Dermatologic Lesion
• Wound Cleansing

Idalprem

Idalprem may be available in the countries listed below.

Ingredient matches for Idalprem

Lorazepam

Lorazepam is reported as an ingredient of Idalprem in the following countries:

• Spain

International Drug Name Search

Ishimet

Ishimet may be available in the countries listed below.

Ingredient matches for Ishimet

Cimetidine

Cimetidine is reported as an ingredient of Ishimet in the following countries:

• Japan

International Drug Name Search

Zetia

Generic Name: ezetimibe (Oral route)

ez-ET-i-mide

Commonly used brand name(s)

In the U.S.

• Zetia

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihyperlipidemic

Pharmacologic Class: Cholesterol Absorption Inhibitor

Uses For Zetia

Ezetimibe is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels.

This medicine is available only with your doctor's prescription.

Before Using Zetia

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. This medicine should only be used in children 10 years of age or older.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ezetimibe in the elderly with use in other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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 this medicine, 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 this medicine 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.

• Clofibrate


• Gemfibrozil

Using this medicine 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.

• Cholestyramine


• Colestipol


• Cyclosporine


• Fenofibrate

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:

• Liver disease (or history of) or


• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

Proper Use of Zetia

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

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.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

• For tablet dosage form:
  
  • For high cholesterol:
    
    • Adults: 10 milligrams (mg) once daily. May take with or without food.
    
    
    • Children up to 10 years of age—Use is not recommended.
    
    
    • Children 10 years of age and older—10 milligrams (mg) once daily. May take with or without food.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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.

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 Zetia

It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol. Your doctor can then decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. Certain cholesterol medications may cause birth defects or other problems in the baby if taken during pregnancy.

Tell your doctor if you experience any unexplained muscle pain, tenderness, or weakness.

Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Zetia 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.

Frequency not determined

• Abdominal fullness


• black tarry stools


• bleeding gums


• bloating


• blood in urine or stools


• chills


• constipation


• darkened urine


• fast heartbeat


• fever


• gaseous abdominal pain


• general tiredness or weakness


• indigestion


• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs


• loss of appetite


• light-colored stools


• muscle cramps or spasms


• muscular tenderness, wasting or weakness


• nausea


• pains in stomach, side or abdomen, possibly radiating to the back


• pinpoint red spots on skin


• recurrent fever


• severe nausea


• skin rash


• unusual bleeding or bruising


• upper right abdominal pain


• vomiting


• yellow eyes or skin

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

• Fever


• headache


• muscle pain


• runny nose


• sore throat

Less common

• Back pain


• body aches or pain


• chest pain


• chills


• cold or flu-like symptoms


• congestion


• coughing


• diarrhea


• difficulty in moving


• dizziness


• dryness or soreness of throat


• hoarseness


• muscle pain or stiffness


• pain in joints


• pain or tenderness around eyes and cheekbones


• shortness of breath or troubled breathing


• stomach pain


• stuffy nose


• tender, swollen glands in neck


• tightness of chest or wheezing


• trouble in swallowing


• unusual tiredness or weakness


• voice changes

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: Zetia 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 Zetia resources

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

• Zetia Prescribing Information (FDA)


• Zetia Consumer Overview


• Zetia Monograph (AHFS DI)


• Zetia MedFacts Consumer Leaflet (Wolters Kluwer)


• Ezetimibe Professional Patient Advice (Wolters Kluwer)

Compare Zetia with other medications

• High Cholesterol
• High Cholesterol, Familial Heterozygous
• Sitosterolemia

neostigmine

Generic Name: neostigmine (nee o STIG meen)

Brand names: Prostigmin Bromide, Prostigmin

What is neostigmine?

Neostigmine affects chemicals in the body that are involved in the communication between nerve impulses and muscle movement.

Neostigmine is used to treat the symptoms of myasthenia gravis.

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

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

You should not use this medication if you are allergic to neostigmine or pyridostigmine (Mestinon), or if you have a bladder or bowel obstruction, or a serious stomach disorder called peritonitis.

Before taking neostigmine, tell your doctor if you have asthma, kidney disease, slow heartbeats or other heart rhythm disorder, high blood pressure, heart disease, coronary artery disease, an ulcer or other serious stomach disorder, overactive thyroid, or a history of seizures.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it. You may need to take neostigmine at evenly spaced intervals around the clock.

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using neostigmine. You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before taking neostigmine?

You should not use this medication if you are allergic to neostigmine or pyridostigmine (Mestinon), or if you have a bladder or bowel obstruction, or a serious stomach disorder called peritonitis.

To make sure you can safely take neostigmine, tell your doctor if you have any of these other conditions:

• 
  

  asthma;

  
  


• 
  

  kidney disease;

  
  


• 
  

  slow heartbeats or other heart rhythm disorder;

  
  


• 
  

  high blood pressure, heart disease, coronary artery disease;

  
  


• 
  

  an ulcer or other serious stomach disorder;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  a history of seizures.

  
  

FDA pregnancy category C. It is not known whether neostigmine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. You should not take neostigmine during late pregnancy. It is not known whether neostigmine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using neostigmine.

How should I take neostigmine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with food or milk if it upsets your stomach. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it. You may need to take neostigmine at evenly spaced intervals around the clock.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using neostigmine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture, heat, and light.

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 or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, stomach cramps, sweating, blurred vision, drooling, and weak or shallow breathing.

Worsening muscle weakness, or no change in your myasthenia gravis symptoms, may also be signs of overdose.

What should I avoid while taking neostigmine?

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase drowsiness caused by neostigmine.

Neostigmine 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. Stop using neostigmine and call your doctor at once if you have any of these serious side effects:

• 
  

  extreme muscle weakness;

  
  


• 
  

  slurred speech, vision problems;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  severe stomach cramps or diarrhea;

  
  


• 
  

  trouble breathing, cough with mucus;

  
  


• 
  

  fast or slow heart rate;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  worsening or no improvement in your symptoms of myasthenia gravis.

  
  

Less serious side effects may include:

• 
  

  headache, drowsiness;

  
  


• 
  

  mild nausea, vomiting, gas;

  
  


• 
  

  urinating more than usual;

  
  


• 
  

  cold sweat, warmth or tingly feeling; or

  
  


• 
  

  mild rash or itching.

  
  

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 neostigmine?

Tell your doctor about all other medicines you use, especially:

• 
  

  atropine (Atreza, Sal-Tropine);

  
  


• 
  

  belladonna (Donnatal, and others);

  
  


• 
  

  benztropine (Cogentin);

  
  


• 
  

  clidinium (Quarzan);

  
  


• 
  

  clozapine (Clozaril, FazaClo);

  
  


• 
  

  dimenhydrinate (Dramamine);

  
  


• 
  

  methscopolamine (Pamine), scopolamine (Transderm Scop);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  an antibiotic such as neomycin (Mycifradin, Neo Fradin, Neo Tab), kanamycin (Kantrex), or streptomycin, tobramycin (Nebcin, Tobi);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  cold medicine, allergy medicine, or sleeping pills that contain an antihistamine such as diphenhydramine (Tylenol PM) or doxylamine (Unisom);

  
  


• 
  

  heart rhythm medication such as quinidine (Quin-G), procainamide (Procan, Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine);

  
  


• 
  

  medicine to treat Alzheimer's dementia, such as donepezil (Aricept), rivastigmine (Exelon), or tacrine (Cognex); or

  
  


• 
  

  a steroid such as betamethasone (Celestone) or dexamethasone (Cortastat, Dexasone, Solurex, DexPak).

  
  

This list is not complete and other drugs may interact with neostigmine. 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 neostigmine resources

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

• neostigmine Injection Advanced Consumer (Micromedex) - Includes Dosage Information


• Neostigmine Professional Patient Advice (Wolters Kluwer)


• Neostigmine MedFacts Consumer Leaflet (Wolters Kluwer)


• Neostigmine Bromide Monograph (AHFS DI)


• neostigmine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare neostigmine with other medications

• Myasthenia Gravis

Where can I get more information?

• Your pharmacist can provide more information about neostigmine.

See also: neostigmine side effects (in more detail)

miglustat

Generic Name: miglustat (mi GLOO stat)

Brand Names: Zavesca

What is miglustat?

Miglustat may reduce the formation of the protein glucosylceramide in the body. Individuals with type 1 Gaucher disease (a hereditary disorder) are missing an enzyme to break down glucosylceramide in the body. Therefore, it may build up in the tissues and cause problems. Untreated Gaucher disease may result in anemia (low level of red blood cells), thrombocytopenia (low level of platelets), bone disease, hepatomegaly (enlargement of the liver), or splenomegaly (enlargement of the spleen).

Miglustat is used in the treatment of mild to moderate type 1 Gaucher disease by people who cannot receive enzyme replacement therapy.

Miglustat may also be used for purposes other than those listed here.

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

Nerve problems such as numbness, tingling, and tremor (shaking) of the hands have been reported by some people taking miglustat. Contact your doctor immediately if you experience new or worsening numbness, tingling, or burning in the hands, arms, legs, or feet or tremor in the hands.

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

Before taking miglustat, tell your doctor if you have kidney problems, any other medical conditions, or if you take any other medicines. You may not be able to take miglustat, or you may require a dosage adjustment or special monitoring during treatment. Miglustat is in the FDA pregnancy category X. This means that miglustat is known to cause birth defects in an unborn baby. Do not take miglustat without first talking to your doctor if you are pregnant or could become pregnant during treatment. Use of birth control is recommended for women during treatment with miglustat. Because miglustat can also affect sperm, birth control is also recommended for men during, and for three months following, treatment with miglustat. It is not known whether miglustat passes into breast milk and if it will affect a nursing baby. Do not take miglustat without first talking to your doctor if you are breast-feeding a baby.

How should I take miglustat?

Take miglustat exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take miglustat at the same time or times each day as directed by your doctor.

Swallow each capsule whole with a full glass of water.

Miglustat can be taken with or without food.

It is important to take miglustat regularly to get the most benefit.

Your doctor may want you to have neurological tests or other medical evaluations during treatment with miglustat to monitor progress and side effects.

Store miglustat at room temperature away from moisture and heat.

See also: Miglustat dosage (in more detail)

What happens if I miss a dose?

If you miss a dose of miglustat, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a miglustat overdose are not well known but may include dizziness, numbness and tingling, and blood problems.

What should I avoid while taking miglustat?

There are no restrictions on food, beverages, or activity during treatment with miglustat unless otherwise directed by your doctor.

Miglustat side effects

Nerve problems such as numbness, tingling, and tremor (shaking) of the hands have been reported by some people taking miglustat. Contact your doctor immediately if you experience new or worsening numbness, tingling, or burning in the hands, arms, legs, or feet or tremor in the hands. Seek emergency medical attention if you experience a rare but serious allergic reaction to miglustat including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives.

Other less serious side effects may be more likely to occur. Continue to take miglustat and talk to your doctor if you experience:

• 
  

  diarrhea;

  
  


• 
  

  decreased appetite or weight loss;

  
  


• 
  

  gas or abdominal pain;

  
  


• 
  

  constipation;

  
  


• 
  

  muscle cramps or weakness;

  
  


• 
  

  headache;

  
  


• 
  

  dizziness; or

  
  


• 
  

  vision problems.

  
  

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.

Miglustat Dosing Information

Usual Adult Dose for Gaucher Disease:

Initial dose: 100 mg orally 3 times a day at regular intervals

What other drugs will affect miglustat?

Miglustat is not intended for use with imiglucerase (Cerezyme), another treatment for type 1 Gaucher disease.

There are no known interactions between miglustat and other medications. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medications, including vitamins, minerals, and herbal products, during treatment with miglustat.

More miglustat resources

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

• miglustat Advanced Consumer (Micromedex) - Includes Dosage Information


• Miglustat Professional Patient Advice (Wolters Kluwer)


• Miglustat MedFacts Consumer Leaflet (Wolters Kluwer)


• Miglustat Monograph (AHFS DI)


• Zavesca Prescribing Information (FDA)


• Zavesca Consumer Overview

Compare miglustat with other medications

• Gaucher Disease

Where can I get more information?

• Your pharmacist can provide more information about miglustat.

See also: miglustat side effects (in more detail)

Zotex HC Liquid

Pronunciation: dex-klor-fen-EER-a-meen/hye-droe-KOE-done/fen-ill-EF-rin
Generic Name: Dexchlorpheniramine/Hydrocodone/Phenylephrine
Brand Name: Examples include Hydex PD and Zotex HC

Zotex HC Liquid is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Zotex HC Liquid is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex, which reduces a dry cough.

Do NOT use Zotex HC Liquid if:

• you are allergic to any ingredient in Zotex HC Liquid or any other codeine- or morphine-related medicine (eg, codeine)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Zotex HC Liquid:

Some medical conditions may interact with Zotex HC Liquid. 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 a fast, slow, or irregular heartbeat, blood vessel problems, or other heart problems


• if you have a history of adrenal gland problems (eg, adrenal gland tumor); high blood pressure; diabetes; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; or an overactive thyroid


• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus


• if you have or recently have had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures


• if you have a history of stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery


• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Zotex HC Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Zotex HC Liquid's side effects


• Cimetidine, digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased


• Naltrexone because it may decrease Zotex HC Liquid's effectiveness


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Zotex HC Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Zotex HC Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zotex HC Liquid 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 Zotex HC Liquid:

Use Zotex HC Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Zotex HC Liquid by mouth with or without food.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Zotex HC Liquid, 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 Zotex HC Liquid.

Important safety information:

• Zotex HC Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zotex HC Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you take Zotex HC Liquid without checking with your doctor.


• Zotex HC Liquid has dexchlorpheniramine and phenylephrine in it. Before you start any new medicine, check the label to see if it has dexchlorpheniramine or phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


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


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


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


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


• Tell your doctor or dentist that you take Zotex HC Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Zotex HC Liquid with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Zotex HC Liquid in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zotex HC Liquid while you are pregnant. It is not known if Zotex HC Liquid is found in breast milk. Do not breast-feed while taking Zotex HC Liquid.

When used for long periods of time or at high doses, Zotex HC Liquid may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Zotex HC Liquid stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Zotex HC Liquid. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Zotex HC Liquid, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Zotex HC Liquid:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; vision changes.

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: Zotex HC 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Zotex HC Liquid:

Store Zotex HC Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zotex HC Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Zotex HC Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Zotex HC Liquid 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 Zotex HC Liquid. 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 Zotex HC resources

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

Compare Zotex HC with other medications

• Cough and Nasal Congestion

Boots Avert Cold Sore Cream

1. Name Of The Medicinal Product

Action Cold Sore Cream

Boots Avert Cold Sore Cream

TESCO Aciclovir Cold Sore Cream

Sainsbury's Aciclovir Cold Sore Cream

2. Qualitative And Quantitative Composition

Cream, containing 50 mg/g Aciclovir Ph. Eur.

For excipients, see 6.1

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

Action Cold Sore Cream is indicated for:

- treatment of herpes labialis (cold sore) in non-immunocompromised patients.

4.2 Posology And Method Of Administration

Action Cold Sore Cream should be applied five times a day, every four hours, for five or in some cases up to ten days in thin layers on the affected skin, making sure that all lesions are adequately covered.

If lesions have not healed after 10 days treatment, patients should be advised to consult a doctor.

4.3 Contraindications

Action Cold Sore Cream is contra-indicated in patients in case of hypersensitivity to aciclovir or any of the other ingredients of the cream.

4.4 Special Warnings And Precautions For Use

Action Cold Sore Cream should not be applied in the eye or mucosal skin of the mouth or the vagina. Action Cold Sore Cream is for topical use only and should not be swallowed.

Paediatric and geriatric use: no unusual toxicity or paediatric-specific problems have been observed.

In severely immunocompromised patients, oral dosing should be considered. These patients should be encouraged to consult a physician concerning the treatment of any infection.

Action cold sore cream SmPC – PL 15773/0092/IB/011 –December 2006

Action Cold Sore Cream must not be used for the treatment of ocular or genital herpes.

Patients with particularly severe Herpes labialis should be encouraged to seek medical advice.

Cold sore sufferers should be advised to avoid transmitting the virus, particularly when active lesions are present,

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions resulting from administration of other drugs concomitantly with topical aciclovir have been reported.

4.6 Pregnancy And Lactation

There are no adequate and controlled studies to date using aciclovir in pregnant women and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the foetus.

No information is available on levels of aciclovir which may appear in breast milk after topical administration of aciclovir, though systemic availability after topical application is absent or very small.

4.7 Effects On Ability To Drive And Use Machines

Topically applied aciclovir does not affect the ability to drive or use machines.

4.8 Undesirable Effects

Action Cold Sore Cream is usually well tolerated. Undesirable effects that may occur after use of Action Cold Sore Cream are redness, itching, tension, burning or pain of the skin at the site of the application.

4.9 Overdose

Not applicable after topical administration. No measures are required after swallowing of small amounts of the cream.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Aciclovir exerts its antiviral effect on herpes simplex viruses and varicella-zoster virus by interfering with DNA synthesis and inhibiting viral replication. Aciclovir is converted to aciclovir monophosphate principally via virus-coded thymidine kinase. The monophosphate is subsequently phosphorylated to the diphosphate via cellular guanylate kinase and then to the triphosphate via other cellular enzymes (e.g. phosphoglycerate kinase, pyruvate kinase, phosphoenolpyruvate carboxykinase). The formation of the monophosphate seems to be the rate determining step in this process and occurs minimally in uninfected cells.

Aciclovir triphosphate acts as an inhibitor of, and substrate for, the herpes-specified DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes.

5.2 Pharmacokinetic Properties

Action cold sore cream SmPC – PL 15773/0092/IB/011 –December 2006

After oral or intravenous administration, aciclovir is widely distributed in tissues and body fluids. However, after topical application on intact skin no detectable levels of aciclovir in plasma or urine are found. Also, systemic availability after application on affected skin appears to be minimal.

5.3 Preclinical Safety Data

No remarks.

6. Pharmaceutical Particulars

6.1 List Of Excipients

The following excipients are used in Action Cold Sore Cream: purified water, propylene glycol, liquid paraffin, white soft paraffin, cetyl alcohol, dimeticone and arlatone 983 S.

6.2 Incompatibilities

No incompatibilities are reported between topically applied aciclovir and other drugs.

6.3 Shelf Life

The shelf-life is 36 months from the day of manufacture. The shelf-life after first opening is 4 weeks.

The expiry date is printed on the box and tube ('Use by'). Do not use after this date.

6.4 Special Precautions For Storage

Store below 25°C. Do not refrigerate or freeze.

6.5 Nature And Contents Of Container

Action Cold Sore Cream is packed in aluminium tubes containing 2g of cream. The tube is lacquered with epoxy-phenolic resin and closed by a HDPE cap. Single tubes are packed in a carton box.

6.6 Special Precautions For Disposal And Other Handling

Before and after application of the cream, it is advised to wash the hands thoroughly, to avoid contamination of other parts of the body. It may be advisable to use a finger cot or rubber glove. Close the tube carefully after usage.

Action Cold Sore Cream should be applied as early as possible after the start of an infection, ideally during the prodromal period.

7. Marketing Authorisation Holder

ratiopharm GmbH

Graf-Arco-Strasse 3

D-89079 Ulm Germany

8. Marketing Authorisation Number(S)

PL 15773/0092

9. Date Of First Authorisation/Renewal Of The Authorisation

15 January 2002

10. Date Of Revision Of The Text

June 2007

Aquamephyton

Generic Name: phytonadione (fye toe na DYE own)

Brand Names: Mephyton, Vitamin K1

What is Aquamephyton (phytonadione)?

Phytonadione is a man-made form of vitamin K. Phytonadione is important in the production of substances that cause the blood to clot.

Phytonadione is used to treat vitamin K deficiency and to treat certain bleeding or blood clotting problems.

Phytonadione may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Aquamephyton (phytonadione)?

Tell your doctor and dentist that you are taking phytonadione before having any type of surgery.

What should I discuss with my healthcare provider before taking Aquamephyton (phytonadione)?

Phytonadione may affect other medical conditions or treatments. Talk to your doctor before taking phytonadione if you have other health problems or conditions, or if you take other medications.

Phytonadione is in the FDA pregnancy category C. This means that it is not known whether phytonadione will be harmful to an unborn baby. Do not take phytonadione without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether phytonadione passes into breast milk and if it will affect a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Aquamephyton (phytonadione)?

Take phytonadione exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each oral dose with a full glass of water.

Injectable forms of phytonadione are usually administered by a healthcare professional. If you are injecting phytonadione at home, your doctor or nurse will give you detailed instructions regarding preparation, administration, and storage of the medication.

Do not take more phytonadione than is prescribed.

It is important to take phytonadione regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with phytonadione to monitor progress and side effects.

Store phytonadione at room temperature away from moisture and heat. Protect phytonadione from light, as light decreases the effectiveness of the medication.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a phytonadione overdose are not known.

What should I avoid while taking Aquamephyton (phytonadione)?

Tell your doctor and dentist that you are taking phytonadione before having any type of surgery.

Aquamephyton (phytonadione) side effects

Seek emergency medical attention or contact your doctor immediately if you experience any serious side effects from phytonadione such as:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  dizziness;

  
  


• 
  

  fast or irregular heartbeats; or

  
  


• 
  

  increased sweating.

  
  

Other less serious side effects may be more likely to occur. Continue to use phytonadione and talk to your doctor if you experience

• 
  

  flushing of the face;

  
  


• 
  

  an unusual taste in the mouth; or

  
  


• 
  

  pain or irritation at the injection site (injectable form).

  
  

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 Aquamephyton (phytonadione)?

Before taking phytonadione, tell your doctor about all other medicines you are taking, especially any of the following:

• 
  

  warfarin (Coumadin);

  
  


• 
  

  mineral oil;

  
  


• 
  

  orlistat (Xenical);

  
  


• 
  

  cholestyramine (Questran, Prevalite);

  
  


• 
  

  a salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others); choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid);

  
  


• a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or


• 
  

  an antibiotic.

  
  

You may not be able to take phytonadione, or you may require a dosage adjustment or special monitoring during treatment.

Medications other than those listed here may also interact with phytonadione. Tell your doctor about all other prescription and over-the-counter medicines that you take, including vitamins, minerals, and herbal products.

More Aquamephyton resources

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

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Apresoline Ampoules 20 mg

1. Name Of The Medicinal Product

Apresoline Ampoules 20 mg

2. Qualitative And Quantitative Composition

The active ingredient is 1-hydralainophthalazine hydrochloride (hydralazine hydrochloride). Each 2 ml ampoule contains 20mg hydralazine hydrochloride.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Ampoules.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of hypertensive emergencies, particularly those associated with pre-eclampsia and toxaemia of pregnancy.

Treatment of hypertension with renal complications.

4.2 Posology And Method Of Administration

Adults:

Initially 5 to 10 mg by slow intravenous injection, to avoid precipitous decreases in arterial pressure with a critical reduction in cerebral or utero-placental perfusion. If necessary a repeat injection can be given after an interval of 20-30 minutes, throughout which blood pressure and heart rate should be monitored. A satisfactory response can be defined as a decrease in diastyloic blood pressure to 90/100 mmHg. The contents of the vial should be reconstituted by dissolving in 1 ml of water for injection BP. This should then be further diluted with 10 ml of Sodium Chloride injection BP 0.9% and be administered by slow intravenous injection. The injection must be given immediately and any remainder discarded. Apresoline may also be given by continuous intravenous infusion, beginning with a flow rate of 200-300µg/min. Maintenance flow rates must be determined individually and are usually within the range 50-150µg/min. The product reconstituted as for direct iv injection may be added via the infusion container to 500 ml of Sodium Chloride Injection BP 0.9% and given by continuous infusion. The addition should be made immediately before administration and the mixture should not be stored. Apresoline for infusion can also be used with 5% sorbitol solution or isotonic inorganic infusion solutions such as Ringers solution.

Children:

Not recommended

Elderly:

Clinical evidence would indicate that no special dosage regime is necessary. Advancing age does not affect either blood concentration or systemic clearance. Renal elimination may however be affected in so far as kidney function diminishes with age.

4.3 Contraindications

Known hypersensitivity to hydralazine of dihydralazine.

Idiopathic systemic lupus erythematosus (SLE) and related diseases.

Severe tachycardia and heart failure with a high cardiac output (e.g. in thyrotoxicosis).

Myocardial insufficiency due to mechanical obstruction (e.g. in the presence of aortic or mitral stenosis or constructive pericarditis).

Isolated right ventricular failure due to pulmonary hypertension (cor pulmonale).

Dissecting aortic aneurysm.

4.4 Special Warnings And Precautions For Use

Warnings

The overall 'hyperdynamic' state of the circulation induced by hydralazine may accentuate certain clinical conditions. Myocardial stimulation may provoke or aggravate angina pectoris. Patients with suspected or confirmed coronary artery disease should therefore be given Apresoline only under beta-blocker cover or in combination with other suitable sympatholytic agents. It is important that the beta-blocker medication should be commenced a few days before the start of treatment with Apresoline.

Patients who have survived a myocardial infarction should not receive Apresoline until a post-infarction stabilisation phase has been achieved.

Prolonged treatment with hydralazine may provoke a systemic lupus erythematosus (SLE)-like syndrome. First symptoms are likely to be similar to rheumatoid arthritis (arthralgia, sometimes associated with fever, anaemia, leucopenia, thrombocytopenia and rash) and are reversible after withdrawal of the drug. In its more severe form it resembles acute SLE (similar manifestations as the milder form plus pleurisy, pleural effusions and pericarditis), and in rare cases renal and ocular involvement have been reported. Early detection and a timely diagnosis with appropriate therapy (i.e. treatment discontinuation and possibly long-term treatment with corticosteroids may be required to reverse these changes) are of utmost importance in this life-threatening illness to prevent more sever complications, which may sometimes be fatal.

Since such reactions tend to occur more frequently the higher the dose and the longer its duration, and since they are more common in slow acetylators, it is recommended that for maintenance therapy the lowest effective dose should be used. If 100 mg daily fails to elicit an adequate clinical effect, the patient's acetylator status should be evaluated. Slow acetylators and women run greater risk of developing the LE like syndrome and every effort should therefore be made to keep the dosage below 100 mg daily and a careful watch kept for signs and symptoms suggestive of this syndrome. If such symptoms do develop the drug should be gradually withdrawn. Rapid acetylators often respond inadequately even to doses of 100 mg daily and therefore the dose can be raised with only a slightly increased risk of an LE-like syndrome.

During long term treatment with Apresoline it is advisable to determine the antinuclear factors and conduct urine analysis at intervals of approximately 6 months. Microhaematuria and / or proteinuria, in particular together with positive titres of ANF, may be initial signs of immune-complex glomerulonephritis associated with the SLE like syndrome. If overt clinical signs or symptoms develop, the drug should be withdrawn immediately.

Skin rash, febrile reactions and change in blood count occur rarely and drug should be withdrawn. Peripheral neuritis in the form of paraesthesia has been reported, and may respond to pyridoxine administration or drug withdrawal.

In high (cyto-) toxic concentrations, hydralazine induces gene mutations in single cell organisms and in mammalian cells in vitro. No unequivocally mutagenic effects have been detected in vivo in a great number of test systems.

Hydralazine in lifetime carcinogenicity studies, caused, towards the end of the experiments, small but statistically significant increases in lung tumours in mice and in hepatic and testicular tumours in rats. These tumours also occur spontaneously with fairly high frequency in aged rodents.

With due consideration of these animals and in-vitro toxicological findings, hydralazine in therapeutic doses does not appear to bear risk that would necessitate a limitation of its administration. Many years of clinical experience have not suggested that human cancer is associated with hydralazine use.

Precautions

In patients with renal impairment (creatine clearance < 30 ml/min or serum creatinine concentration > 2.5 mg / 100 ml or 221 µmol / l) and in patients with hepatic dysfunction the dose or interval between doses should be adjusted according to clinical response, in order to avoid accumulation of the 'apparent' active substance.

Apresoline should be used with caution in patients with coronary artery disease (since it may increase angina) or cerebrovascular disease.

When undergoing surgery, patients treated with Apresoline may show a fall in blood pressure, in which case one should not use adrenaline to correct the hypotension, since it enhances the cardiac-accelerating effects of hydralazine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potentiation of effects: Concurrent therapy with other antihypertensives (vasodilators, calcium antagonists, ACE inhibitors, diuretics), anaesthetics, tricyclic antidepressants, major tranquillisers, nitrates or drugs exerting central depressant actions (including alcohol).

Administration of Apresoline shortly before or after diazoxide may give rise to marked hypotension.

MAO inhibitors should be used with caution in patients receiving Apresoline.

Concurrent administration of Apresoline with beta-blockers subject to a strong first pass effect (e.g. propranolol) may increase their bioavailability. Download adjustment of these drugs may be required when they are given concomitantly with Apresoline.

There is potential for the hypotensive effect of hydralazine to be antagonised when used concomitantly with oestrogens or non-steroidal anti-inflammatory drugs.

4.6 Pregnancy And Lactation

Use of Apresoline in pregnancy, before the third trimester should be avoided but the drug maybe employed in later pregnancy if there is no safer alternative or when the disease itself carries serious risks for the mother or child e.g. pre-eclampsia and /or eclampsia.

No serious adverse effects in human pregnancy have been reported to date with Apresoline, although experience in the third trimester is extensive.

Hydralazine passes into breast milk but reports available so far have not shown adverse effects on the infant. Mothers in whom use of Apresoline proves unavoidable may breast feed their infant provided that the infant is observed for possible adverse effects.

4.7 Effects On Ability To Drive And Use Machines

Apresoline may impair the patient's reactions especially at the start of the treatment. The patient should be warned of the hazard when driving or operating machinery.

4.8 Undesirable Effects

Some of the adverse effects listed below e.g. tachycardia, palpitations, angina symptoms, flushing, headache, dizziness, nasal congestion and gastro-intestinal disturbances are commonly seen at the start of treatment, especially if the dose is raised quickly. However such effects generally subside in the further course of treatment.

(The following frequency estimates are used: frequent > 10 %, occasional 1-10% rare 0.001-1% isolated cases < 0.001%)

Cardiovascular system:

Frequently: tachycardia, palpitations.

Occasionally: flushing, hypotension, anginal symptoms.

Rarely: oedema, heart failure.

Isolated cases: paradoxical pressor responses.

Central and peripheral nervous system:

Frequently: headache.

Rarely: dizziness.

Isolated cases: peripheral neuritis, polyneuritis, paraesthesia (these unwanted effects may be reversed by administering pyridoxine).

Musculo-skeletal system:

Occasionally: arthralgia, joint swelling, myalgia.

Skin and appendages:

Rarely: rash.

Urogenital system:

Rarely: proteinuria, increased plasma creatinine, haematuria sometimes in association with glomerulonephritis.

Isolated cases: acute renal failure, urinary retention.

Gastrointestinal tract:

Occasionally: gastrointestinal disturbances, diarrhoea, nausea, vomiting. Rarely: jaundice, liver enlargement, abnormal liver function sometimes in association with hepatitis.

Isolated cases: paralytic ileus.

Blood:

Rarely: anaemia, leucopenia, neutropenia, thrombocytopenia with or without purpura.

Isolated cases: haemolytic anaemia, leucocytosis, lymphadenopathy, pancytopenia, splenomegaly, agranulocytosis.

Psychiatric reactions:

Rarely: agitation, anorexia, anxiety.

Isolated cases: depression, hallucinations.

Sense organs:

Rarely: increased lacrimination, conjunctivitis, nasal congestion.

Hypersensitivity reactions:

Occasionally: SLE-like syndrome (sometimes resulting in a fatal outcome see section 4.4 Special warnings and precautions for use)

Rarely: hypersensitivity reactions such as pruritus, urticaria, vasculitis, eosinophilia, hepatitis.

Respiratory tract:

Rarely: dyspnoea, pleural pain.

Miscellaneous:

Rarely: fever, weight decrease, malaise.

Isolated cases: exophthalmos.

4.9 Overdose

Signs and symptoms

Symptoms include hypotension, tachycardia, myocardial ischaemia dysrhythmias and coma.

Treatment

Supportive measures including intravenous fluids are also indicated. If hypotension is present, an attempt should be made to raise the blood pressure without increasing the tachycardia. Adrenaline should therefore be avoided.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group

Hydralazine is a peripheral vasodilator.

Mechanism of action

Hydralazine is a direct acting vasodilator which exerts its effects principally on the arterioles. Its precise mode of action is not known. Administration of hydralazine produces a fall in peripheral resistance and a decrease in arterial blood pressure, effects which induce reflux sympathetic cardiovascular responses. The concomitant use of a beta-blocker will reduce these reflex effects and enhance the anti-hypertensive effect. The use of hydralazine can result in sodium and fluid retention, producing oedema and reduced urinary volume. These effects can be prevented by concomitant administration of a diuretic.

5.2 Pharmacokinetic Properties

Absorption

None stated

Distribution

Apresoline is rapidly distributed in the body and displays a particular affinity for the blood-vessel walls. Plasma protein binding is of the order of 90%.

Biotransformation

None stated

Elimination

Plasma half-life averages 2-3 hours but is prolonged up to 16 hours in severe renal failure (creatinine clearance less than 20 ml / min) and shortened to approximately 45 minutes in rapid acetylators.

Characteristics in patients

None stated

5.3 Preclinical Safety Data

Hydralazine has been found to be teratogenic in mice producing a small incidence of cleft palate and certain other bony malformations, in oral doses ranging from 20-120 mg / kg i.e. 20-30 times the maximum human daily dose. It was not teratogenic in rats or rabbits.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hydrochloric acid

6.2 Incompatibilities

Dextrose infusion solutions are not compatible because contact between hydralazine and glucose causes hydralazine to be rapidly broken down.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

The ampoules should be protected from light and stored below 30ºC. Single use only. Use immediately after reconstitution.

Medicines should be kept out of reach of children.

6.5 Nature And Contents Of Container

Colourless Type I glass 2 ml ampoule. Five ampoules are packed in a cupboard printed carton.

6.6 Special Precautions For Disposal And Other Handling

None.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Waymade plc

Trading as Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex

SS14 3FR

United Kingdom.

8. Marketing Authorisation Number(S)

PL 06464/1239

9. Date Of First Authorisation/Renewal Of The Authorisation

15 November 2001

10. Date Of Revision Of The Text

November 2009