Clotin®

Therapeutic Area:

Generic Name:

Heparin

Dosage Form:

5,000 unit ampoule

Drug Dose

Therapeutic Indications:

Anticoagulation: Prophylaxis and treatment of thromboembolic disorders (eg, venous thromboembolism, pulmonary embolism) and thromboembolic complications associated with atrial fibrillation; prevention of clotting in arterial and cardiac surgery; as an anticoagulant for blood transfusions, extracorporeal circulation, and dialysis procedures.

Mechanism of Action:

Potentiates the action of antithrombin III and thereby inactivates thrombin (as well as other coagulation factors IXa, Xa, XIa, XIIa, and plasmin) and prevents the conversion of fibrinogen to fibrin; heparin also stimulates release of lipoprotein lipase (lipoprotein lipase hydrolyzes triglycerides to glycerol and free fatty acids)

Method of Administration:

Atrial fibrillation (to prevent stroke and systemic embolism):

IV: Initial bolus of 60 to 80 units/kg (maximum: 5,000 units), followed by a continuous infusion of 12 to 18 units/kg/hour (maximum: 1,000 units/hour)

Hemodialysis, anticoagulation of circuit:

IV: Initial: Bolus 1,000 units or 2,000 units at the beginning of hemodialysis, followed by a continuous infusion of 500 units/hour; stop the infusion 60 minutes before the end of hemodialysis

Notes

Contraindications:

Hypersensitivity to heparin or any component of the formulation (unless a life-threatening situation necessitates use and use of an alternative anticoagulant is not possible); severe thrombocytopenia; history of heparin-induced thrombocytopenia; history of heparin-induced thrombocytopenia with thrombosis; uncontrolled active bleeding; not for use when appropriate blood coagulation tests cannot be obtained at appropriate intervals (applies to full-dose heparin only).

Interactions:

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the anticoagulant effect of Heparin. Management: Decrease the dose of heparin or agents with antiplatelet properties if coadministration is required. Risk D: Consider therapy modification

Apixaban: May enhance the anticoagulant effect of Anticoagulants. Refer to separate drug interaction content and to full drug monograph content regarding use of apixaban with vitamin K antagonists (eg, warfarin, acenocoumarol) during anticoagulant transition and bridging periods. Risk X: Avoid combination

Streptokinase: May enhance the anticoagulant effect of Heparin. Risk X: Avoid combination

Pregnancy and Lactation:

Heparin does not cross the placenta

Heparin is not present in breast milk

Warning and Precaution:

  • Bleeding: May occur, including fatal events. Use with caution in patients with an increased risk of bleeding, including subacute bacterial endocarditis; congenital or acquired bleeding disorders; active ulcerative or angiodysplastic GI diseases; continuous GI tube drainage; severe uncontrolled hypertension; history of hemorrhagic stroke.
  • Heparin resistance: Dose requirements >35,000 units/24 hours to maintain a therapeutic aPTT may occur in patients with antithrombin deficiency, increased heparin clearance, elevations in heparinbinding proteins, and elevations in factor VIII and/or fibrinogen; frequently encountered in patients with fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer, and in postsurgical patients; measurement of anticoagulant effects using anti-Factor Xa levels may be of benefit.
  • Hyperkalemia: Monitor for hyperkalemia; can cause hyperkalemia by suppressing aldosterone production.
  • Hypersensitivity reactions: May occur; in patients with a documented hypersensitivity reaction, heparin should only be considered in life-threatening situations when use of an alternative anticoagulant is not possible. Some products are derived from animal tissue and may be contraindicated in patients with animal allergies (ie, pork); consult individual prescribing information.
  • Osteoporosis: May occur with prolonged use (>6 months) due to a reduction in bone mineral density. • Thrombocytopenia: Heparin-induced thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets, may occur. Patients who develop HIT may be at risk of developing a new thrombus (heparin-induced thrombocytopenia with thrombosis [HITT]).

Adverse Reactions:

>10%: Hematologic & oncologic: Thrombocytopenia (≤30%)

1% to 10%: Hematologic & oncologic: Heparin-induced thrombocytopenia (1% to 2%)

Storage:

Store below 30°C and protect from freezing.