Composition

Each ampoule contains heparin calcium 5000 or 12000 I.U.

Pharmalogical Actions

Heparin calcium (Cal-Heparine®)inhibits the reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo.

Small amounts of heparin calcium can inhibit thrombosis by inactivating the activated factor-X and inhibiting the conversion of prothrombin into thrombin. In the already developed thrombosis, larger amounts of heparin calcium can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen into fibrin. It also inhibits the activation of fibrin stabilizing factor.

Indications

Preventive

Postoperative venous thrombosis and pulmonary embolism ( low dose regimen)
Clotting in arterial and heart surgery
Thromboembolic accidents, e.g., occlusive arterial disease of the lower extremities, myocardial infarction and some arrhythmias.

Curative

Thrombophlebitis
Pulmonary embolism
Cerebral thrombosis
Myocardial infarction
Atrial fibrillation with embolization
Peripheral arterial embolism or thrombosis

Cal-Heparine® is also employed as an anticoagulant in blood transfusion, dialysis procedure and blood sampling.

Contraindications

Abortion
Bacterial endocarditis
C.N.S. trauma
During Vitamin K antagonist therapy
Any active bleeding
Postoperative period following brain or spinal cord surgery.

Haemorrhagic states or tendencies due to:

Clotting factors deficiencies, e.g., thrombocytopenia, hypofibrinogenemia, hemophilia and permeability disorders
Vascular permeability disorders, e.g., purpura.

Precautions

Severe hypertension
Hypersensitivity to heparin
Consumption coagulopathy
Antiplatelet or dextran therapy
During menstruation
Heparin resistance
Gastric ulcers
Pediatric use
Increased risk in the hepatin elderly over 60 years of age.

Pregnancy: Although calcium does not cross the placental barrier and has no teratogenic effect, it should not be given to a pregnant woman unless mandatory.

Warnings

Heparin should not be given intramuscularly.
Ensure thorough mixing of Cal-Heparine® with infusion solution before administration.
When heparin is given with dicumarol or coumarins, a period of at least 5 hours after the last I.V.dose or 24 hours after the last S.C.dose should elapse before shifting to oral anticoagulants to avoid haemorrhagic risks.

Drug Interaction

Platelet inhibitors: Acetylsalicylic acid, dextran, phenylbutazone, ibuprofen, indomethacin, dipyridamole, hydroxychloroquine and other drugs interfering with platelet aggregation reactions should be used with caution in patients receiving heparin calcium so as not to induce bleeding.

Other Interactions: Digitalis, tetracyclines, nicotine and antihistamines may partially counteract the anticoagulant action of heparin.

Laboratory test interactions: Significant elevations of aminotransferases (SGOT and SGPT) levels may occur in patients and healthy subjects who have received heparin.

Side Effects

Haemorrhage, hepersensitivity or local irritation may occur with heparin therapy.

Antitode

The anticoagulant activity of heparin can be neutralized by slow I.V. infusion of protamine sulfate 1% solution.

Each 1 mg of protamine sulfate neutralizes approximately 100 I.U heparin (max. 50mg protamine sulfate).

Dosage and Administration

Prophylactic dose:

Injection of one ampoule (5000 I.U) S.C. two hours before operation; then every 8 hours following surgery, for 7 to 10 days or complete ambulation.

Therapeutic dose:

The dosage of Cal-Heparine® should be adjusted to each case according to the results of activated partial thromboplastin time (APTT) and coagulation tests.

The dose is considered adequate when APTT is 1.5 to 2 times the normal or when coagulation time is approximately 2.5 to 3 times the control value.

When Cal-Heparine® is given by deep subcutaneous or intermittent I.V. injection, a coagulation test should be performed before each injection during the early stages of treatment and dialy thereafter.

When Cal-Heparine® is administered by continuous I.V. infusion, a coagulation test should be carried out approximately every 4 to 6 hours in the early stages of therapy.

How Supplied

Box of 1 or 3 ampoules, containing 5000 I.U
Box of 3 ampoules, containing 12000 I.U

Keep all medicaments out of reach of children

Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: B01AB01