Ibuprofen Denk

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Ingredient matches for Ibuprofen Denk

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofen Denk in the following countries:

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International Drug Name Search

Sofradex Ear / Eye Drops

Sofradex Ear/Eye Drops

framycetin sulphate 0.5%

dexamethasone (as dexamethasone sodium metasulphobenzoate) 0.05%

gramicidin 0.005%

Is this leaflet hard to see or read? Phone 01483 505515 for help

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again



• If you have any further questions, ask your doctor or pharmacist



• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours



• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

• 1. What Sofradex Drops are and what they are used for



• 2. Before you use Sofradex Drops



• 3. How to use Sofradex Drops



• 4. Possible side effects



• 5. How to store Sofradex Drops



• 6. Further information

What Sofradex Drops are and what they are used for

What Sofradex Drops are

Sofradex Ear/Eye Drops (called Sofradex Drops in this leaflet) contains three medicines called Framycetin sulphate, Gramicidin and Dexamethasone sodium metasulphobenzoate.

• Framycetin sulphate and Gramicidin belong to a group of medicines called antibiotics. These work by killing the bacteria that is causing the infection



• Dexamethasone sodium metasulphobenzoate. This belongs to a group of medicines called steroids. It works by lowering inflammation

What Sofradex Drops are used for

It is used in the eye(s) for:

• Inflammation in the eye when prevention of bacterial infection is also needed. Signs include sore, red or swollen eyes

It is used in the ear(s) for:

• Inflammation of the ear canal (otitis externa)

Before you use Sofradex Drops

Do not use this medicine and tell your doctor if:

• You are allergic (hypersensitive) to framycetin sulphate, dexamethasone sodium metasulphobenzoate, gramicidin or any of the other ingredients of Sofradex Drops (listed in Section 6 below)
  
  
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, tongue and worsening of redness, itching or swelling of the eye or eyelid
  

If you are using these drops in your eye

• Your eye inflammation is due to an infection caused by a fungus or a virus



• Your eye inflammation is due to an infection called tuberculosis (TB)



• You have pus in your eye(s)



• You have glaucoma



• You have an ulcer in your eye(s) caused by the herpes simplex virus (herpetic keratitis)

If you are using these drops in your ear

• You have a damaged (perforated) ear drum

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Sofradex Drops.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if you are pregnant, might become pregnant, or think you may be
pregnant.

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using any
medicine.

Driving and using machines

You may have blurred eyesight straight after using Sofradex Drops. If this happens, do not drive or use any tools or machines until you can see clearly.

How to use Sofradex Drops

Always use Sofradex Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if
you are not sure.

How to use this medicine

• This medicine can be used in the eye and the ear



• Do not use this medicine for more than 7 days without talking to your doctor

Use in the eye

• Wash your hands



• Remove the cap on the bottle



• Tilt your head back



• Squeeze one or two drops inside the lower lid without touching your eye with the bottle



• Close your eye



• Wipe away any excess drops with a clean tissue



• Always put the cap back on the bottle as soon as you have used it

Use in the ear

• Wash your hands



• Remove the cap on the bottle



• Tilt your head on one side



• Squeeze two or three drops into your ear



• Lie your head with your affected ear facing upwards for a few minutes



• Wipe away any excess drops with a clean tissue



• Always put the cap back on the bottle as soon as you have used it

How much to use

In the eye(s)

• One or two drops in the affected eye six times a day or more if advised by your doctor



• Keep using Sofradex Drops as instructed by your doctor

In the ear(s)

• Two or three drops in the ear three or four times a day



• Keep using Sofradex Drops as instructed by your doctor

If you forget to use Sofradex Drops

If you forget a dose, put some in as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.

If you stop using Sofradex Drops

Keep using these drops until your doctor tells you to stop. Otherwise, you could get an infection or the inflammation could get worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Sofradex Drops can cause side effects, although not everybody gets them

Stop using Sofradex Drops and see a doctor as soon as possible if;

• You get any kind of skin problem, such as a rash or itching around your eyes or irritation burning, stinging, itching or swelling



• Your eyes have problems focussing or develop a blind spot. You may have increased pressure in the eye



• You have difficulty seeing at night or notice that your eyesight is cloudy and fuzzy, or you see halos around lights. These could be signs of cataracts. This may occur after using the medicine for a long time

Talk to your doctor or pharmacist if you get any of the side effects or if you notice any side effects not listed in this leaflet.

How to store Sofradex Drops

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Sofradex Drops after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store below 25°C. Do not refrigerate.

Sofradex Drops are sterile when you buy them, so you must not keep them for more than four weeks after opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Sofradex Drops contains

• The eye drops contain the active substances; framycetin sulphate (0.5%w/v), dexamethasone sodium metasulphobenzoate (equivalent to 0.050% w/v of dexamethasone) and gramicidin (0.005%w/v)



• The other ingredients are citric acid, sodium citrate, lithium chloride, phenylethyl alcohol, industrial methylated spirit, polysorbate 80 and purified water

What Sofradex Drops looks like and contents of the pack

Sofradex Drops are clear colourless ear/eye drops. The drops are also available in 5ml, 8ml and 10ml dropper bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Patheon UK Limited

Covingham

Swindon

Wiltshire

SN3 5BZ

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 10/2007

© Sanofi-aventis, 1972 - 2007

SDE 90040

Heparin and Dextrose

Dosage Form: injection
Heparin Sodium in 5% Dextrose Injection

Do not admix with other drugs.

Heparin and Dextrose Description

Heparin Sodium in 5% Dextrose Injection is a sterile, nonpyrogenic solution prepared from heparin sodium (derived from porcine intestinal mucosa and standardized for use as an anticoagulant) and Hydrous Dextrose USP in Water for Injection USP. It is to be administered by intravenous injection. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.

Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) alpha-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-alpha-D-glucose 6-sulfate, (3) beta-D-glucuronic acid, (4) 2-acetamido-2-deoxy-alpha-D-glucose, and (5) alpha-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2) > (1) > (4) > (3) > (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.

(See chart below for quantitative information.)

Structure of Heparin Sodium (representative subunits):	Structure of Hydrous Dextrose USP:

Composition – Each 100 mL Contains:					Concentration of Electrolytes (mEq/liter)			pH	Calculated Osmolarity mOsmol/liter
Solution	Heparin Sodium USP	Hydrous Dextrose USP	Dibasic Sodium Phosphate Heptahydrate USP	Citric Acid Anhydrous USP	Sodium	Phosphate	Citrate
Sodium Metabisulfite NF (antioxidant) <0.07 g Water for Injection USP qs
Heparin Sodium 20,000 units in 5% Dextrose Injection	4,000 units	5 g	0.41 g	0.093 g	38	30	15	5.6 (4.5–7.0)	315
Heparin Sodium 25,000 units in 5% Dextrose Injection	5,000 units	5 g	0.41 g	0.093 g	38	30	15	5.6 (4.5–7.0)	315
Heparin Sodium    25,000 units in 5% Dextrose Injection	10,000 units	5 g	0.41 g	0.093 g	38	30	15	5.6 (4.5–7.0)	315

The formulas of the inactive ingredients are:

Ingredients	Molecular Formula	Molecular Weight
Dibasic Sodium Phosphate Heptahydrate USP	Na2HPO4•7H2O	268.07
Citric Acid Anhydrous USP	CH2(COOH)C(OH)(COOH)CH2COOH	192.12

The EXCEL® Container is Latex-free; PVC-free; and DEHP-free.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector. Refer to the Directions for Use of the container.

Heparin and Dextrose - Clinical Pharmacology

Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Heparin acts at multiple sites in the normal coagulation system. Small amounts of heparin in combination with antithrombin III (heparin cofactor) can inhibit thrombosis by inactivating activated Factor X and inhibiting the conversion of prothrombin to thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.

Bleeding time is usually unaffected by heparin. Clotting time is prolonged by full therapeutic doses of heparin; in most cases it is not measurably affected by low doses of heparin.

Patients over 60 years of age, following similar doses of heparin, may have higher plasma levels of heparin and longer activated partial thromboplastin times (APTTs) compared with patients under 60 years of age.

Peak plasma levels of heparin are achieved 2–4 hours following subcutaneous administration, although there are considerable individual variations. Loglinear plots of heparin plasma concentrations with time for a wide range of dose levels are linear which suggests the absence of zero order processes. Liver and the reticuloendothelial system are the sites of biotransformation. The biphasic elimination curve, a rapidly declining alpha phase (t½ = 10 minutes) and after the age of 40 a slower beta phase, indicates uptake in organs. The absence of a relationship between anticoagulant half-life and concentration half-life may reflect factors such as protein binding of heparin.

Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.

Dextrose provides a source of calories. Dextrose is readily metabolized, may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

Indications and Usage for Heparin and Dextrose

Heparin Sodium in 5% Dextrose Injection is indicated as a continuous intravenous infusion following an initial intravenous therapeutic dose of heparin sodium.

Heparin Sodium Injection is indicated for anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension; for prophylaxis and treatment of pulmonary embolism; in atrial fibrillation with embolization; for treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); for prevention of clotting in arterial and heart surgery; and in prophylaxis and treatment of peripheral arterial embolism.

Contraindications

Heparin sodium should not be used in patients:

With severe thrombocytopenia;

In whom suitable blood coagulation tests – e.g., the whole blood clotting time, partial thromboplastin time, etc., – cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);

With an uncontrollable active bleeding state (see WARNINGS), except when this is due to disseminated intravascular coagulation.

Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Warnings

Heparin is not intended for intramuscular use.

Hypersensitivity

Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations. (See ADVERSE REACTIONS, Hypersensitivity.)

Hemorrhage

Hemorrhage can occur at virtually any site in patients receiving heparin. An unexplained fall in hematocrit, fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.

Heparin sodium should be used with extreme caution in disease states in which there is increased danger of hemorrhage. Some of the conditions in which increased danger of hemorrhage exists are:

Cardiovascular – Subacute bacterial endocarditis. Severe hypertension.

Surgical – During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.

Hematologic – Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.

Gastrointestinal – Ulcerative lesions and continuous tube drainage of the stomach or small intestine.

Other – Menstruation, liver disease with impaired hemostasis.

Coagulation Testing

When heparin sodium is administered in therapeutic amounts, its dosage should be regulated by frequent blood coagulation tests. If the coagulation test is unduly prolonged or if hemorrhage occurs, heparin should be discontinued promptly (see OVERDOSAGE).

Thrombocytopenia

Thrombocytopenia has been reported to occur in patients receiving heparin with a reported incidence of up to to 30%. Platelet counts should be obtained at baseline and periodically during heparin administration. Mild thrombocytopenia (count greater than 100,000/mm3) may remain stable or reverse even if heparin is continued. However, thrombocytopenia of any degree should be monitored closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops (seeHeparin-induced Thrombocytopenia (HIT) With or Without Thrombosis), the heparin product should be discontinued, and, if necessary, an alternative anticoagulant administered.

Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis)

HIT is a serious immune-mediated reaction resulting from irreversible aggregation of platelets. HIT may progress to the development of venous and arterial thromboses, a condition referred to as HIT with thrombosis. Thrombotic events may also be the initial presentation for HIT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and fatal outcomes.

Once HIT (with or without thrombosis) is diagnosed or strongly suspected, all heparin sodium sources (including heparin flushes) should be discontinued and an alternative anticoagulant used.  Future use of heparin sodium, especially within 3 to 6 months following the diagnosis of HIT (with or without thrombosis), and while patients test positive for HIT antibodies, should be avoided.

Immune-mediated HIT is diagnosed based on clinical findings supplemented by laboratory tests confirming the presence of antibodies to heparin sodium, or platelet activation induced by heparin sodium. A drop in platelet count greater than 50% from baseline is considered indicative of HIT. Platelet counts begin to fall 5 to 10 days after exposure to heparin sodium in heparin sodium-naïve individuals, and reach a threshold by days 7 to 14. In contrast, “rapid onset” HIT can occur very quickly (within 24 hours following heparin sodium initiation), especially in patients with a recent exposure to heparin sodium (i.e. previous 3 months). Thrombosis development shortly after documenting thrombocytopenia is a characteristic finding in almost half of all patients with HIT.

Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3 or if recurrent thrombosis develops, the heparin product should be promptly discontinued and alternative anticoagulants considered if patients require continued anticoagulation.

Delayed Onset of HIT (With or Without Thrombosis)

Heparin-induced Thrombocytopenia (with or without thrombosis) can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT (with or without thrombosis).

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility of agglomeration.

Excessive administration of potassium-free solutions may result in significant hypokalemia.

Because dosages of this drug are titrated to response (see DOSAGE AND ADMINISTRATION), no additives should be made to Heparin Sodium in 5% Dextrose Injection.

Precautions

General

1. Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) and Delayed Onset of HIT (With or Without Thrombosis): (See WARNINGS .)


2. Heparin Resistance:
   
   Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.


3. Increased Risk to Older Patients, Especially Women:
   
   A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance and electrolyte concentrations during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

Do not use plastic container in series connection.

If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

These solutions are intended for intravenous administration using sterile equipment. It is recommended that any unused heparin solution and intravenous administration apparatus be replaced at least once every 24 hours.

Use only if solution is clear and container and seals are intact.

Laboratory Tests

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration (see DOSAGE AND ADMINISTRATION).

Drug Interactions

Oral Anticoagulants

Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn if a valid prothrombin time is to be obtained.

Platelet Inhibitors

Drugs such as acetylsalicylic acid, dextran, phenylbutazone, ibuprofen, indomethacin, dipyridamole, hydroxychloroquine and others that interfere with platelet-aggregation reactions (the main hemostatic defense of heparinized patients) may induce bleeding and should be used with caution in patients receiving heparin sodium.

Other Interactions

Digitalis, tetracyclines, nicotine, antihistamines, or IV nitroglycerine may partially counteract the anticoagulant action of heparin sodium. Intravenous nitroglycerin administered to heparinized patients may result in a decrease of the partial thromboplastin time with subsequent rebound effect upon discontinuation of nitroglycerin. Careful monitoring of partial thromboplastin time and adjustment of heparin dosage are recommended during coadministration of heparin and intravenous nitroglycerin.

Drug/Laboratory Tests Interactions

Hyperaminotransferasemia

Significant elevations of aminotransferase AST (SGOT) and ALT (SGPT) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin. Since aminotransferase determinations are important in the differential diagnosis of myocardial infarction, liver disease and pulmonary emboli, rises that might be caused by drugs (like heparin) should be interpreted with caution.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals to evaluate the carcinogenic potential, reproduction studies in animals to determine effects on fertility of males and females, and the studies to determine mutagenic potential have not been conducted with Heparin Sodium in 5% Dextrose Injection.

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies on heparin use in pregnant women. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. Heparin sodium does not cross the placenta, based on human and animal studies. Administration of heparin to pregnant animals at doses higher than the maximum human daily dose based on body weight resulted in increased resorptions. Use heparin sodium during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects.

Nursing Mothers

Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing infant. Exercise caution when administering Heparin Sodium to a nursing mother.

Pediatric Use

There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience (see DOSAGE AND ADMINISTRATION, Pediatric Use ).

Geriatric Use

A higher incidence of bleeding has been reported in patients over 60 years of age, especially women (see PRECAUTIONS, General). Clinical studies indicate that lower doses of heparin may be indicated in these patients (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Adverse Reactions

Hemorrhage

Hemorrhage is the chief complication that may result from heparin therapy (see WARNINGS). An overly prolonged clotting time or minor bleeding during therapy can usually be controlled by withdrawing the drug (see OVERDOSAGE). It should be appreciated that gastrointestinal or urinary tract bleeding during anticoagulant therapy may indicate the presence of an underlying occult lesion. Bleeding can occur at any site but certain specific hemorrhagic complications may be difficult to detect:

1. Adrenal hemorrhage, with resultant acute adrenal insufficiency, has occurred during anticoagulant therapy. Therefore, such treatment should be discontinued in patients who develop signs and symptoms of acute adrenal hemorrhage and insufficiency. Initiation of corrective therapy should not depend on laboratory confirmation of the diagnosis, since any delay in an acute situation may result in the patient's death.
   
    


2. Ovarian (corpus luteum) hemorrhage developed in a number of women of reproductive age receiving short- or long-term anticoagulant therapy. This complication if unrecognized may be fatal.
   
    


3. Retroperitoneal hemorrhage.

Thrombocytopenia, Heparin-induced Thrombocytopenia (HIT) (With or Without Thrombosis) and Delayed Onset of HIT (With or Without Thrombosis)

(See WARNINGS.)

Local Irritation

Local irritation, erythema, mild pain, hematoma or ulceration may follow deep subcutaneous (intrafat) injection of heparin sodium. These complications are much more common after intramuscular use, and such use is not recommended.

Hypersensitivity

Generalized hypersensitivity reactions have been reported, with chills, fever, and urticaria as the most usual manifestations, and asthma, rhinitis, lacrimation, headache, nausea and vomiting, and anaphylactoid reactions, including shock, occurring more rarely. Itching and burning, especially on the plantar site of the feet, may occur. (See WARNINGS.)

Certain episodes of painful, ischemic, and cyanosed limbs have in the past been attributed to allergic vasospastic reactions. Whether these are in fact identical to the thrombocytopenia associated complications remains to be determined.

Miscellaneous

Osteoporosis following long-term administration of high-doses of heparin, cutaneous necrosis after systemic administration, suppression of aldosterone synthesis, delayed transient alopecia, priapism, and rebound hyperlipemia on discontinuation of heparin sodium have also been reported.

Significant elevations of aminotransferase AST (SGOT) and ALT (SGPT) levels have occurred in a high percentage of patients (and healthy subjects) who have received heparin.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Overdosage

Symptoms

Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first sign of bleeding. Easy bruising or petechial formations may precede frank bleeding.

Treatment

Neutralization of heparin effect.

When clinical circumstances (bleeding) require reversal of heparinization, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly, in any 10 minute period. Each mg of protamine sulfate neutralizes approximately 100 USP Heparin Units. The amount of protamine required decreases over time as heparin is metabolized. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 1/2 hour after intravenous injection.

Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.

For additional information the labeling of Protamine Sulfate Injection, USP products should be consulted.

Heparin and Dextrose Dosage and Administration

Heparin Sodium in 5% Dextrose Injection is for intravenous use only. Do not use Heparin Sodium in 5% Dextrose Injection as a "catheter lock flush" product.

Heparin Sodium is not effective by oral administration and Heparin Sodium in 5% Dextrose Injection should not be given orally.

This product should not be infused under pressure.

The dosage of heparin sodium should be adjusted according to the patient's coagulation test results. When heparin sodium is administered by continuous intravenous infusion, coagulation tests should be performed approximately every 4 hours during the early stages of therapy. Dosage is considered adequate when the activated partial thromboplastin time (APTT) is 1.5 to 2 times normal or when the whole blood clotting time is elevated approximately 2.5 to 3 times the control value.

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.

When an oral anticoagulant of the coumarin or similar type is to be begun in patients already receiving heparin sodium, baseline and subsequent tests of prothrombin activity must be determined at a time when heparin activity is too low to affect the prothrombin time. This is about 5 hours after the last IV bolus and 24 hours after the last subcutaneous dose. If continuous IV heparin infusion is used, prothrombin time can usually be measured at any time.

In converting from heparin to an oral anticoagulant, the dose of the oral anticoagulant should be the usual initial amount and thereafter prothrombin time should be determined at the usual intervals. To ensure continuous anticoagulation, it is advisable to continue full heparin therapy for several days after the prothrombin time has reached the therapeutic range. Heparin therapy may then be discontinued without tapering.

Although dosage must be adjusted for the individual patient according to the results of suitable laboratory tests, the following dosage schedules may be used as guidelines:

Method of Administration	Frequency	Recommended Dose*
* Based on 150-lb. (68-kg) patient.
	Initial dose	5,000 units by IV injection
Continuous Intravenous infusion	Continuous	20,000 – 40,000 units/24 hours

Pediatric Use

There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience. In general, the following dosage schedule may be used as a guideline in pediatric patients:

Initial Dose                  75 to 100 units/kg (IV bolus over 10 minutes)

Maintenance Dose      Infants: 25 to 30 units/kg/hour;

                                            Infants < 2 months have the highest 

                                            requirements (average 28 units/kg/hour)

                                    Children > 1 year of age: 18 to 20 units/kg/hour;

                                          Older children may require less heparin,         

                                          similar to weight-adjusted adult dosage

Monitoring                    Adjust heparin to maintain aPTT of 60 to

                                          85 seconds, assuming this reflects an

                                          anti-Factor Xa level of 0.35 to 0.70.

Geriatric Use

Patients over 60 years of age may require lower doses of heparin. (See PRECAUTIONS.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Heparin and Dextrose Supplied

Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in EXCEL® containers packaged 24 per case.

	NDC	Cat. No.	Size
Heparin Sodium 20,000 Units in 5% Dextrose Injection
	0264-9567-10	P5671	500 mL
Heparin Sodium 25,000 Units in 5% Dextrose Injection
	0264-9577-10	P5771	500 mL
Heparin Sodium 25,000 Units in 5% Dextrose Injection
	0264-9587-20	P5872	250 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Rx only

Revised: September 2011

EXCEL is a registered trademark of B. Braun Medical Inc.

Directions for Use of EXCEL® Container

Do not admix with other drugs.

Caution: Do not use plastic container in series connection.

To Open

Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired.

NOTE:	Before use, perform the following checks:
	Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date.
	Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used.
	Use only if solution is clear and container and seals are intact.

Preparation for Administration

1. Remove plastic protector from sterile set port at bottom of container.


2. Attach administration set. Refer to complete directions accompanying set.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

1-800-227-2862

www.bbraun.com

Made in USA

Y36-002-774   LD-239-2

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

HEPARIN SODIUM

20,000 UNITS (40 UNITS/ML)

in 5% Dextrose Injection

REF P5671

NDC 0264-9567-10

500 mL

EXCEL® CONTAINER

Each 100 mL contains: Heparin Sodium USP

(porcine intestinal mucosa) 4,000 USP Heparin units

Hydrous Dextrose USP 5 g

Dibasic Sodium Phosphate•7H2O USP 0.41 g

Citric Acid Anhydrous USP 0.093 g

Sodium Metabisulfite NF (antioxidant) <0.07 g

Water for Injection USP qs

pH: 5.6 (4.5-7.0)

Calc. Osmolarity: 315 mOsmol/liter

Electrolytes (mEq/liter):         Sodium 38

Phosphate (HPO

WARNING: Do not admix with other drugs.

Sterile, nonpyrogenic. Single dose container.


Do not use in series connection.

For intravenous use only. Use only if solution is clear and

container and seals are intact.

Recommended Storage: Room temperature (25ºC). Avoid

excessive heat. Protect from freezing. See Package Insert.


Rx only


EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA      


LD-305-1   Y94-003-121

Do not remove overwrap until ready for use. After removing the overwrap, check

for minute leaks by squeezing container firmly. If leaks are found, discard solution

as sterility may be impaired.

EXP

LOT

PRINCIPAL DISPLAY PANEL - 500 mL Container Label

HEPARIN SODIUM

25,000 UNITS   50 UNITS/ML

in 5% Dextrose Injection

REF P5771

NDC 0264-9577-10


500 mL

EXCEL® CONTAINER

Each 100 mL contains: Heparin Sodium USP

(porcine intestinal mucosa) 5,000 USP Heparin units

Hydrous Dextrose USP 5 g

Dibasic Sodium Phosphate•7H2O USP 0.41 g

Citric Acid Anhydrous USP 0.093 g

Sodium Metabisulfite NF (antioxidant) <0.07 g

Water for Injection USP qs


pH: 5.6 (4.5-7.0)

Calc. Osmolarity: 315 mOsmol/liter

Electrolytes (mEq/liter):    Sodium 38

Phosphate (HPO

) 30       Citrate 15

WARNING: Do not admix with other drugs.

Sterile, nonpyrogenic. Single dose container.


Do not use in series connection. For intravenous use only.

Use only if solution is clear and container and seals are

intact.

Recommended Storage:

Room temperature (25ºC). Avoid excessive heat.

Protect from freezing. See Package Insert.

Rx only


EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA    LD-307-1    Y94-003-123

Do not remove overwrap until ready for use. After removing the overwrap, check for

minute leaks by squeezing container firmly. If leaks are found, discard solution as

sterility may be impaired.

EXP

LOT

PRINCIPAL DISPLAY PANEL - 250 mL Container Label

HEPARIN SODIUM

25,000 UNITS  100 UNITS/ML
in 5% Dextrose Injection

REF P5872

NDC 0264-9587-20


250 mL

EXCEL® CONTAINER

Each 100 mL contains:

Heparin Sodium USP (porcine intestinal

mucosa) 10,000 USP Heparin units;

Hydrous Dextrose USP 5 g; Dibasic Sodium

Phosphate•7H2O USP 0.41 g; Citric Acid

Anhydrous USP 0.093 g; Sodium

Metabisulfite NF (antioxidant) <0.07 g

Water for Injection USP qs

pH: 5.6 (4.5-7.0)

Calculated Osmolarity: 315 mOsmol/liter

Electrolytes (mEq/liter):   Sodium 38

Phosphate (HPO

WARNING: Do not admix with other drugs.

Sterile, nonpyrogenic. Single dose container.

Do not use in series connection. For

intravenous use only. Use only if solution is

clear and container and seals are intact.

Recommended Storage: Room temperature

(25ºC). Avoid excessive heat. Protect from

freezing. See Package Insert.

     

Rx only



EXCEL is a registered trademark of B. Braun Medical Inc.

B. Braun Medical Inc.

Irvine, CA 92614-5895 USA

Made in USA    

Y94-003-125   LD-309-1

Do not remove overwrap until ready for use. After

removing the overwrap, check for minute leaks

by squeezing container firmly. If leaks are found,

discard solution as sterility may be impaired.

EXP

LOT

HEPARIN SODIUM IN DEXTROSE  heparin sodium and dextrose  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0264-9567 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HEPARIN SODIUM (HEPARIN) HEPARIN 4000 [USP'U]  in 100 mL DEXTROSE (DEXTROSE) DEXTROSE 5 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM PHOSPHATE, DIBASIC 0.41 g  in 100 mL ANHYDROUS CITRIC ACID 0.093 g  in 100 mL SODIUM METABISULFITE 0.07 g  in 100 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0264-9567-10 24 CONTAINER In 1 CASE contains a CONTAINER 1 500 mL In 1 CONTAINER This package is contained within the CASE (0264-9567-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019952	07/20/1992

HEPARIN SODIUM IN DEXTROSE  heparin sodium and dextrose  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0264-9577 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HEPARIN SODIUM (HEPARIN) HEPARIN 5000 [USP'U]  in 100 mL DEXTROSE (DEXTROSE) DEXTROSE 5 g  in 100 mL

Inactive Ingredients Ingredient Name Strength WATER   SODIUM PHOSPHATE, DIBASIC 0.41 g  in 100 mL ANHYDROUS CITRIC ACID 0.093 g  in 100 mL SODIUM METABISULFITE 0.07 g  in 100 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Triderm

triamcinolone acetonide

Dosage Form: cream
Triderm Cream (Triamcinolone Acetonide 0.1%)

Triderm 1oz

NDC 0316-0170-01

Triderm Cream (Triamcinolone Acetonide Cream USP) 0.1%

Each g contains 1mg Triamcinolone Acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate

1ounce (28.4g)

Del-Ray Dermatologicals

Johnson City, TN 37604

Usual Dosage: Apply to the affected area 2 or 3 time daily. See Package Insert.

See Crimp of tube for Expiration Date and Lot number

Store at 59-86oF

Caution: Federal law prohibits dispensing without prescription.

For External Use Only.

Not for Opthalmic Use.

Keep out of reach of children

Triderm Patient Package Insert

Triderm Cream Patient Package Insert (Triamcinolone Acetonide Cream USP 0.1%)

Triderm Prescribing Information

DESCRIPTION:

The topical corticosteroids constitute a class of primarily synthetic steroids used as anit-inflammitory and antipruritic agents. Triamcinolone Acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1,4-diene-3, 20-dione, 9-flouro-11, 21-dihydroxy-16,17-[(1-methylethylidene) bis(oxy)]-(IIβ16a). Its structural formula is:

Each gram of Triderm CREAM (Triamcinolone Acetonide Cream USP) 0.1% contains 1 mg Triamcinolone Acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate.

CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.


The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE

Triamcinolone Acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Triamcinolone Acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.


Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS-Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician

4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

∙ Urinary free cortisol test

∙ ACTH stimulation test

Carinogensis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenaI (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.


ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

∙Burning

∙Itching

∙Irritation

∙Dryness

∙Foliculities

∙Hypertrichosis

∙Acneiform eruptions

∙Hypopigmentation

∙Perioral dermatitis

∙Allergic contact dermatitis

∙Maceration of the skin

∙Secondary infection

∙Skin Atrophy

∙Striae

∙Miliaria


OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systems effects (See PRECAUTIONS).


DOSAGE AND ADMINISTRATION

Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.


Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.


HOW SUPPLIED:

Triderm (Triamcinolone Acetonide Cream USP) 0.1% is supplied in 3 ounce (85.2g) and 1 ounce (28.4g) tubes


CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.


DEL-RAY DERMATOLOGICALS

P.O.Box 1425

Johnson City, Tennessee 37604

PRINTED IN USA

REVISED 11/03

Triderm Cream 3oz Label

NDC 0316-0170-03

Triderm Cream (Triamcinolone Acetonide Cream USP) 0.1%


Each g contains 1mg Triamcinolone Acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate


3ounce (85.2g)


Distributed by

Del-Ray Dermatologicals

Manufactured by

Crown Laboratories, Inc

Johnson City, TN 37604


Usual Dosage: Apply to the affected area 2 or 3 time daily. See Insert.


See Crimp of tube for Expiration Date and Batch number

Store at 59-86oF


Caution: Federal law prohibits dispensing without prescription.


For External Use Only.


Not for Opthalmic Use.


Keep out of reach of children

Triderm Cream 3g pouch

NDC 0316-0170-02

Triderm Cream (Triamcinolone Acetonide Cream USP) 0.1%


Each g contains 1mg Triamcinolone Acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate


0.1ounce (3g)


Distributed by:

Del-Ray Dermatologicals

Johnson City, TN 37604

www.delrayderm.com

Manufactured by:

Crown Laboratories, Inc

Johnson City, TN 37604


Usual Dosage: Apply to the affected area 2 or 3 time daily.


Store at controlled room temperature 15o-30oC (59o-86oF)


Caution: Federal law prohibits dispensing without prescription.


For External Use Only.


Not for Opthalmic Use.


Keep out of reach of children

1oz Triderm label

Triderm  triamcinolone acetonide  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0316-0170 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Triamcinolone Acetonide (Triamcinolone) Triamcinolone Acetonide 1 mg  in 1 g

Inactive Ingredients Ingredient Name Strength WATER   MINERAL OIL   PROPYLENE GLYCOL   SORBITOL   CETYL PALMITATE   SORBIC ACID   POTASSIUM SORBATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0316-0170-01 28.4 g In 1 TUBE None 2 0316-0170-03 85.2 g In 1 TUBE None 3 0316-0170-30 3 g In 1 POUCH None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088042	03/19/1984

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Operations
Crown Laboratories		079035945	manufacture

Revised: 09/2011Crown Laboratories

More Triderm resources

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

• Triderm Advanced Consumer (Micromedex) - Includes Dosage Information


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Adalimumab

Pronunciation: A-da-LIM-ue-mab
Generic Name: Adalimumab
Brand Name: Humira

Patients who use Adalimumab have an increased risk of developing serious and sometimes fatal infections (eg, bacterial, viral, or fungal infections; tuberculosis [TB],). Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).

TB may be caused by a new infection or by reactivation of a previous infection. Patients should receive a TB skin test before using Adalimumab. Patients who test positive for TB should begin treatment for TB before starting Adalimumab. All patients should also be monitored for signs of TB while using Adalimumab, even if their TB test is negative.

Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle aches or weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores; diarrhea or stomach pain; increased or painful urination).

Adalimumab is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Talk with your doctor for more information.

A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has been reported in patients using TNF blockers, including Adalimumab. These cases have been fatal. Most of these cases occurred in teenagers or young adults, and most of these patients had Crohn disease or ulcerative colitis. Patients who developed this cancer were usually using Adalimumab along with certain other medicines (azathioprine, 6-mercaptopurine). Tell your doctor if you have or have ever had any type of cancer.

Adalimumab is used for:

Treating a variety of moderate to severe inflammatory conditions (eg, rheumatoid arthritis, juvenile idiopathic arthritis [JIA], psoriatic arthritis, ankylosing spondylitis). It is also used to treat certain patients with moderate to severe Crohn disease and certain patients with chronic plaque psoriasis. It may be used alone or in combination with other medicine. It may also be used for other conditions as determined by your doctor.

Adalimumab is a TNF blocker. It works by blocking a protein (TNF-alpha) found in the body that causes inflammation.

Do NOT use Adalimumab if:

• you are allergic to any ingredient in Adalimumab


• you have a severe infection (eg, sepsis) or any other active infection


• you are using abatacept or anakinra

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

Before using Adalimumab:

Some medical conditions may interact with Adalimumab. 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, including rubber or latex


• if you have a history of an infection that keeps coming back, TB infection, or positive TB skin test


• if you have a history of hepatitis B infection or other liver problems; heart problems (eg, heart failure); high cholesterol; high blood pressure; diabetes; cancer (eg, lymphoma); blood problems; bone marrow problems; an autoimmune disorder (eg, lupus); other immune system problems (eg, weakened immune system); or numbness, tingling, or other nervous system problems (eg, multiple sclerosis [MS], Guillain-Barré syndrome, seizures)


• if you have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery


• if you have an infection, open cuts or sores on your body, flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection


• if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB


• if you live or have lived in certain parts of the country (eg, Ohio or Mississippi river valleys) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common


• if you are using another TNF blocker (eg, certolizumab, etanercept, infliximab) or have recently received treatment with one of these medicines


• if you take medicine that may weaken your immune system (eg, 6-mercaptopurine, azathioprine, cyclosporine)

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

• Abatacept, anakinra, corticosteroids (eg, prednisone), methotrexate, or tocilizumab because the risk of serious infection may be increased

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

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

• Adalimumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Adalimumab refilled.


• Adalimumab is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Adalimumab. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Adalimumab if it contains particles, is cloudy or discolored, or if the syringe or pen is cracked or damaged.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.


• Rotate injection sites. New injections should be given at least 1 inch from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard, or where you have scars or stretch marks.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Adalimumab, use it as soon as you remember. Then go back to your regular dosing schedule.

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

Important safety information:

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


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


• Adalimumab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Before you use Adalimumab, discuss your vaccination history with your doctor to be sure that you are up to date on vaccines.


• Adalimumab may increase the risk of developing blood cancer (eg, leukemia, lymphoma) or other types of cancer. This may be fatal in some cases. Discuss any questions or concerns with your doctor. Tell your doctor if you have ever had cancer. Contact your doctor right away if you develop any unusual symptoms, such as unusual bruising, unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness or weakness, unexplained cough or shortness of breath, persistent unexplained itching, or unexplained weight loss.


• New or worsening nervous system problems (eg, multiple sclerosis, Guillain-Barré syndrome, seizures) have occurred with TNF blockers. Tell your doctor if you have a condition that affects your nervous system. Discuss any questions or concerns with your doctor.


• Some patients who use Adalimumab have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches).


• Severe liver problems have occurred with TNF blockers. Contact your doctor right away if you develop symptoms of liver problems (eg, dark urine; loss of appetite; pale stools, unusual stomach pain, tiredness, or vomiting; yellowing of the skin or eyes).


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


• Adalimumab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Adalimumab. Talk with your doctor before you receive any vaccine.


• Adalimumab may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Adalimumab.


• Lab tests, including TB, liver function, and complete blood cell counts, may be performed while you use Adalimumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Adalimumab with caution in the ELDERLY; they may be more sensitive to its effects, especially an increased risk of infection and certain types of cancer.


• Caution is advised when using Adalimumab in CHILDREN; they may be at increased risk of developing certain types of cancer with Adalimumab, which may be fatal.


• Adalimumab should be used with extreme caution in CHILDREN younger than 4 years; 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 Adalimumab while you are pregnant. It is not known if Adalimumab is found in breast milk. Do not breast-feed while using Adalimumab.

Possible side effects of Adalimumab:

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:

Back pain; headache; mild pain, redness, or swelling at the injection site; mild stomach pain; nausea; runny or stuff nose.

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; unusual hoarseness); black, tarry, or bloody stools; blood in the urine; burning, numbness, or tingling; butterfly-shaped rash on the nose and cheeks; change in the appearance of a mole; chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; muscle pain or weakness; new or worsening joint pain; open sore that does not heal; persistent pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; persistent cough; flu-like symptoms; warm, red, or painful skin; increased or painful urination); swelling of the ankles, hands, or feet; tremor; unexplained weight loss or weight gain; unusual bruising or bleeding; unusual lumps; unusual skin growth or other skin changes; unusual tiredness or weakness; unusually pale skin; vision changes; vomit that looks like coffee grounds.

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: Adalimumab 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 Adalimumab:

Store Adalimumab in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Store in the original container until ready to use. If you need to take Adalimumab with you, such as when traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use after the expiration date on the dose tray label or prefilled syringe. Do not use Adalimumab if it has ever been frozen. Keep Adalimumab out of the reach of children and away from pets.

General information:

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


• Adalimumab 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 Adalimumab. 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 Adalimumab resources

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

• Adalimumab Professional Patient Advice (Wolters Kluwer)


• Adalimumab Monograph (AHFS DI)


• adalimumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Humira Prescribing Information (FDA)


• Humira Consumer Overview

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