Hepagusan

Hepagusan

heparin

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Heparin Na.
Description
Each mL contains: Heparin Sodium 5,000 I.U.
Action
Pharmacology: Heparin acts indirectly at multiple sites in both the intrinsic and extrinsic blood clotting systems to po­tentiate the inhibitory action of antithrombin III (heparin cofactor) on several activated coagulation factors, including thrombin (factor IIa) and factors IXa, Xa, XIa, and XIIa, by forming a complex with inducing a conformational change in the antithrombin III molecule. Inhibition of activated factor Xa interferes with thrombin generation and thereby inhibits the various actions of thrombin in coagulation. Heparin also accelerates the formation of an antithrombin III - thrombin complex, thereby inactivating thrombin and preventing the conversion of fibrinogen to fibrin; these actions prevent extension of existing thrombin.
Larger doses of heparin are required to inactivate thrombin than are required to inhibit thrombin formation. Heparin also prevents formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor by thrombin. Heparin has no fibrinolytic activity.
Indications/Uses
Prophylaxis and treatment of venous thrombosis and pulmonary embolism.
Treatment of arterial embolism.
Prevention of coagulation in heart and artery surgery, cerebral thrombosis.
Anticoagulants on blood transfusions, Extracorporeal circulation dialysis, and needs laboratory.
Dosage/Direction for Use
Hemodialysis: Normal dose 7,500-12,500 IU.
Intravenous administration: 5,000-10,000 IU every 4 hours both bolus and con­tinuous infusion in sodium chloride or dextrose. Dosage must be monitored, considering the response varies between individuals. The clotting time must be 2-3 times the control value.
Subcutaneous administration (therapeutic dose): 10,000 IU every 8 hours, after bolus analysis intravenous 5,000 IU.
Low-dose heparin regimen: The recommended dose of 5,000 IU SC every 8 or 12 hours without laboratory control. This regimen is given to all patients who are physically competent above the age of 40 years who will undergo abdominal surgery or thorax. The first injection of heparin (5,000 IU) begins 2 hours before surgery and therapy is continued for 7 days.
Contraindications
Anticoagulant therapy and prophylaxis of thrombo­embolism: Haemorrhagic diatheses.
Ulcers in the G.I. tract.
Severe hypertension (decompensated).
Surgical procedures on CNS.
Suspected brain haemorrhage.
Endocarditis lenta.
Thyroid operation.
Suspected malignant tumor with risk of bleeding.
Known but rarely occurring heparin allergy.
Not to be given intramuscularly for possibility of hematoma.
Additionally in case of anticoagulant therapy: In severe liver, kidney and pancreas disease as well as imminent abortus. Whether Heparin should still be given in these cases depends on a thorough clinical eva­luation of each individual case.
Special Precautions
Heparin sodium injection is not given intramuscularly.
Sodium heparin is used very carefully in patients with ulcerative lesions, menstruation or hemostatic liver disease that is disrupted.
If the coagulation test is too long or bleeding occurs, then heparin sodium should be stopped.
Heparin sodium must be used cautiously in the patients who will undergo surgery, elderly and pregnant wom­en.
Thrombocytopenia is reported in some patients who receive Heparin. Thrombocytopenia mild degree­ severe must be closely monitored.
If Benzyl alcohol is administered in amounts of 100 mmol which significantly exceed those required for preser­vative purposes (0.1 mmol/mL), haemolysis rate, oxygen transport capacity of the erythrocytes as well as res­piratory rate may be adversely affected. Patients suffering from cardiac arrhythmia may be at risk when given Benzyl alcohol in substantially higher doses (8-16 mg per kg BW) than those which may possibly be administered in the course of Heparin therapy in maxi­mal therapeutic doses. For clinical studies on cAMP regulated cell activity it is recommended to use Benzyl alcohol-free Heparin. In case of need, icteric premature and neonate infants should preferably be given Heparin without preservative.
Extra precaution must be exercised when treating old age patient and pregnant women with Heparin. And the same precaution must also be exercised at post-ope­rative treatment and to hypersensitive patients.
Anticoagulant therapy: If heavy bleeding occurs during Heparin therapy pos­sible surgical intervention to stop the bleeding may have to be considered. Otherwise the Heparin dose is to be reduced depending on the extent of bleeding, and in case of need. Heparin therapy may even have to be discontinued or the Heparin action inhibited protamine. To neutralize 5,000 I.U. of heparin about 50 mg of Pro­tamine Hydrochloride or Sulphate are necessary. Be­cause of the possible risk of deep muscle haematoma intramuscular injections should be avoided during Hepa­rin therapy. The same applies also to organ punctures and angiographic procedures. Prevailing thrombopenia may lead Heparin accumulation. Compatibility studies carried out with Heparin Sodium Injection 5,000 I.U./mL have shown compatibility with carrier i.v. Fluids like Sterofundin, Sodium Chloride inj. 0.9%. Dextrose inj. 5% and 10%. These compatibility studies were based on physico-chemical criteria after 24 hours observation period. As matter of principle admixture to any of these carrier solutions should be done shortly prior to starting the infusion.
Adverse Reactions
Anticoagulant therapy and prophylaxis of thrombo­embolism: Heparin may occasionally lead in transient and re­versible hair loss as well as to thrombocytopenia. Both symptoms disappear however upon cessation of therapy.
After long-term therapy over more than 1 year signs of osteoporosis may be observed.
Local or generalized allergic reactions following Heparin medication occur only very seldom.
Additionally in case of anticoagulant therapy: Sporadic side-eftects like headache, nausea, itching and rise of body temperature have been reported. Normally this is no compelling reason to discontinue Heparin therapy.
Prophylaxis of thromboembolism: The occurrence of haematoma formation is very sel­dom as long as the recommended injection technique is adhered to.
Bleeding in the wound can increase especially if thrombin and partial thromboplastin time is long lasting. In such cases the Heparin dose is to be decreased and the time interval of 8 hours prolonged. If required, the Heparin effect can be rapidly neutralized by giving Protamine Hydrochloride or Sulphate.
The Benzyl alcohol added as preservative to the Heparin solution may give rise to allergic skin reactions in isolated cases.
Local irritation: Allergic manifestation caused by Heparin: Haemorrhage manifestation.
Increased transaminase enzyme.
Hypereosinophilia.
Drug Interactions
If sodium heparin is given with dicumarol or warfarin sodium, it takes at least 5 hours (from IV administration last) or 24 hours (from the last SC administration) to check the prothrombin time test valid.
Synergetic effect: Acetyl Salicylic Acid.
Dipirydamole.
Phenylbutazone.
Indometacin.
Sulfinpyrazone.
Probenecid.
Dextran.
Ethacrynic Acid.
Dicumarol.
Cytostatic drugs.
Aspirin.
NSAID.
Octylsalicylic acid.
Hidrochlorokuin.
Counteractive effect: Antihistamines.
Digitalis preparations.
Tetracycline.
Nicotine abuse.
Ascorbic acid.
Storage
Store below 30°C. Do not freeze.
ATC Classification
B01AB01 - heparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.
Presentation/Packing
Inj (vial) 5,000 IU/mL x 5 mL x 10's.
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