Heparin

What is Heparin?

• Heparin (Lipo-Hepin; Liquaemin; Panheparin) is an anticoagulant, used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that increase the chance that clots will form.
• Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, possessing anticoagulant properties.
• It is composed of polymers of alternating derivations of α-D-glucosamido (N-sulfated O-sulfated or N-acetylated) and O-sulfated uronic acid (α-L-iduronic acid or β-D-glucuronic acid).

Heparin

Heparin

File:Heparin.gif

Heparin

What are the uses of this medicine?

Heparin (Lipo-Hepin; Liquaemin; Panheparin) is used as:

• Prophylaxis and treatment of venous thrombosis and pulmonary embolism
• Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation
• Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation)
• Prevention of clotting in arterial and cardiac surgery
• Prophylaxis and treatment of peripheral arterial embolism;
• Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

How does this medicine work?

• Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa.
• Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa).
• Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.
• Heparin does not have fibrinolytic activity; therefore, it will not lyse existing clots.
• Heparin is also used to stop the growth of clots that have already formed in the blood vessels, but it cannot be used to decrease the size of clots that have already formed.

Who Should Not Use this medicine ?

This medicine have cannot be used in patients with:

• History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis
• History of thrombocytopenia with pentosan polysulfate
• Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions)
• In whom suitable blood coagulation tests (e.g., whole-blood clotting time, partial thromboplastin time) cannot be performed at appropriate intervals.
• An uncontrollable bleeding state, except when this is due to disseminated intravascular coagulation.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• other anticoagulants such as warfarin (Coumadin)
• antihistamines (in many cough and cold products)
• antithrombin III (Thrombate III)
• aspirin or aspirin-containing products and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• dextran
• digoxin (Digitek, Lanoxin)
• dipyridamole (Persantine, in Aggrenox)
• hydroxychloroquine (Plaquenil)
• indomethacin (Indocin)
• phenylbutazone (Azolid) (not available in the US)
• quinine
• tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin), minocycline (Dynacin, Minocin) and tetracycline (Bristacycline, Sumycin).

Is this medicine FDA approved?

• The discovery of heparin was announced in 1916.
• It is on the World Health Organization's List of Essential Medicines.
• Initial U.S. Approval: 1939
• Enoxaparin (ee nox' a par' in) was the first small molecular weight heparin (average 4,500 daltons) to be approved for use in the United States (1993) and is available in liquid solution in several forms (ampoules, syringes) generically and under the brand name Lovenox.
• Dalteparin (dal' te par' in) (average 5,000 daltons) was approved in the United States in 1994 and is available in liquid solution in single or multidose vials under the brand name Fragmin.
• Tinzaparin (tin" za par' in) (average 4,500-5,500 daltons) was approved for use in the United States in 2000 and has more restricted indications.
• Tinzaparin is available as solution for injection in multidose vials under the brand name Innohep.

How should this medicine be used?

• Periodically monitor platelet counts, hematocrit, and occult blood in stool during the entire course of Heparin Sodium Injection therapy, regardless of the route of administration.

Recommended dosage: Recommended Adult Dosages: As Deep Subcutaneous (Intrafat) Injection:

• Initial Dose:333 units/kg subcutaneously
• Every 12 hours: 250 units/kg subcutaneously

As Intermittent Intravenous Injection:

• Initial Dose:10,000 units, either undiluted or in 50 mL to 100 mL of 0.9% Sodium Chloride Injection, USP
• Every 4 to 6 hours:5,000 units to 10,000 units, either undiluted or in 50 mL to 100 mL of 0.9% Sodium Chloride Injection, USP

As Continuous Intravenous Infusion:

• Initial Dose:5,000 units by intravenous injection
• Continuous:20,000 units to 40,000 units per 24 hours in 1,000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion

Pediatric Use:

• Use preservative-free Heparin Sodium Injection in neonates and infants.
• Initial Dose:75 units/kg to 100 units/kg ( intravenous bolus over 10 minutes)

Maintenance Dose:

• Infants: 25 units/kg/hour to 30 units/kg/hour;
• Infants less than 2 months have the highest requirements (average 28 units/kg/hour)
• Children greater than 1 year of age: 18 units/kg/hour to 20 units/kg/hour;
• Older children may require less heparin, similar to weight-adjusted adult dosage

Cardiovascular Surgery:

• Patients undergoing total body perfusion for open-heart surgery should receive an initial dose of not less than 150 units of heparin sodium per kilogram of body weight.

Low-Dose Prophylaxis of Postoperative Thromboembolism:

• The most widely used dosage has been 5,000 units 2 hours before surgery and 5,000 units every 8 to 12 hours thereafter for 7 days or until the patient is fully ambulatory, whichever is longer.

Extracorporeal Dialysis:

• A dose of 25 units/kg to 30 units/kg followed by an infusion rate of 1,500 units/hour to 2,000 units/hour is suggested.

Administration:

• Heparin comes as a solution (liquid) to be injected intravenously (into a vein) or deeply under the skin and as a dilute (less concentrated) solution to be injected into intravenous catheters.
• Heparin should not be injected into a muscle.
• Heparin is sometimes injected one to six times a day and sometimes given as a slow, continuous injection into the vein.
• When heparin is used to prevent blood clots from forming in intravenous catheters, it is usually used when the catheter is first put in place, and every time that blood is drawn out of the catheter or medication is given through the catheter.
• If you will be injecting heparin yourself, follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Use heparin exactly as directed.
• Do not use more or less of it or use it more often than prescribed by your doctor.
• Your doctor may increase or decrease your dose during your heparin treatment.
• If you will be injecting heparin yourself, be sure you know how much medication you should use.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As heparin sodium 1,000 UPS units or 5,000 USP units; 9 mg sodium chloride; 9.45 mg benzyl alcohol added as preservative.
• Each mL of the 10,000 USP units per mL preparations contains: heparin sodium 10,000 USP units; 9.45 mg benzyl alcohol added as preservative.

• The preservative-free product contains (per mL): 1,000 USP units of heparin sodium and 9 mg sodium chloride.

This medicine is available in fallowing brand namesː

• Lipo-Hepin; Liquaemin; Panheparin

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• fatigue
• headache
• indigestion
• nausea
• bleeding
• ecchymoses
• rash
• urticaria
• alopecia
• priapism
• rebound hyperlipemia

heparin sodium may cause some serious side effects which may include:

• Hemorrhage
• Heparin-Induced Thrombocytopenia and Thrombosis
• Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
• Heparin Resistance
• Hypersensitivity
• Thrombocytopenia
• Elevations of serum aminotransferases
• Osteoporosis

What special precautions should I follow?

• Heparin Sodium Injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred due to medication errors. Carefully examine all Heparin Sodium Injection vials to confirm the correct vial choice prior to administration of the drug.
• Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. Use caution in conditions with increased risk of hemorrhage.
• Heparin-induced thrombocytopenia (HIT) is a serious antibody-mediated reaction resulting from irreversible aggregation of platelets. Monitor for signs and symptoms and discontinue if indicative of HIT and heparin-induced thrombocytopenia and thrombosis (HITT).
• Use preservative-free Heparin Sodium Injection in neonates and infants. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low-birth weight infants treated with benzyl alcohol-preserved formulation in infusion solutions, including Heparin Sodium Injection.
• Thrombocytopenia in patients receiving heparin has been reported. Monitor thrombocytopenia of any degree closely. If the count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant.
• Periodically monitor platelet counts, hematocrit, and occult blood in stool during the entire course of heparin therapy, regardless of the route of administration.
• Resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer, in postsurgical patients, and patients with antithrombin III deficiency. Adjustment of heparin doses based on anti-Factor Xa levels may be warranted.
• Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations.
• Heparin Sodium Injection is derived from animal tissue, it should be used with caution in patients with a history of allergy.
• Advise patients to inform physicians and dentists that they are receiving heparin before any surgery is scheduled.
• Because of the risk of hemorrhage, advise patients to inform their physicians and dentists of all medications they are taking, including non-prescription medications, and before starting any new medication.
• The low molecular weight heparins are associated with serum enzyme elevations during therapy that are usually asymptomatic and resolve rapidly upon stopping; the low molecular weight heparins have not been implicated in cases of acute, clinically apparent, idiosyncratic liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Bleeding
• blood in urine
• black, tarry stools
• easy bruising
• unusual bleeding
• red blood in stools
• vomit that is bloody or looks like coffee grounds

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• 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.
• Because fatal reactions often resembling anaphylaxis have been reported with protamine, it should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.

Can this medicine be used in pregnancy?

• There are no available data on heparin sodium use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.
• Consider the benefits and risks of Heparin Sodium Injection to a pregnant woman and possible risks to the fetus when prescribing Heparin Sodium Injection to a pregnant woman.
• If available, preservative-free Heparin Sodium Injection is recommended when heparin therapy is needed during pregnancy.

Can this medicine be used in children?

• There are no adequate and well controlled studies on heparin use in pediatric patients.
• Pediatric dosing recommendations are based on clinical experience.
• Use preservative-free Heparin Sodium Injection in neonates and infants.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• HEPARIN SODIUM

Inactive ingredients:

• SODIUM CHLORIDE
• BENZYL ALCOHOL
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE
• WATER

Who manufactures and distributes this medicine?

• Pfizer Labs

Mfd. for:

• SAGENT Pharmaceuticals
• Schaumburg, IL 60195 (USA)
• Made in India

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Use only if solution is clear and the seal is intact.
• Do not use if solution is discolored or contains a precipitate.

• Dailymed label info on Heparin
• FDA Heparin

Heparin Resources
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