FRAGMIN
DALTEPARIN SODIUM · by PFIZER
Composition
Inj 2500 IU/5000 IU/7500 IU/10000 1U: Dalteparin Sodium 2500 IU (02 m14/5000 111 (02 ml)/7500 IU (0.3ml)/10000 10 (1 ml): solution; Pre-filled syringe.
Indications & Dosage
Pre-operative or post-operative surgical thromboprophylaxis: BY SC INJ: Adult: 2500 IU by SC inj into abdominal wall or lateral part of thigh 1 to 2 hr pre-op, then 2500 IU daily until fully mobile (generally 5-7 days or longer). Prolonged thromboprophylaxis in hip replacement surgery or high risk surgery: BY SC INJ: Adult: 5000 IU by SC Inj on the evening prior to surgery, then 5000 IU each evening for next 5 week. Prevention of clotting in extracorporeal circulation during haemodialysis or haemolittration: BY SC INJ: Adults: If no additional bleeding risk, 30-40 IU/kg by IV bolus then 10-15 IU/kg/hr by IV INF, alternatively if procedure less than 4 hr, as above or 5000 IU by IV bolus. If high bleeding risk, 5-10 IU/kg by IV bolus then4-5 IU/kg/hr by IV INF. Treatment of Deep Venous Thrombosis and/or Pulmonary Embolism: BY SC INJ: Adults: If no additional bleeding risk, 200 IU/ kg by SC inj as a single daily dose: max 18000 IU daily. If high bleeding risk, 100 IU/kg by SC IN twice daily. Give anticoagulants concurrently, use combined treatment for minimum 5 days. Unstable coronary artery disease: BY SC INJ: Adults: 120 IU/kg SC Inj every 12 hr for 5-8 days: max 10000 IU/12 hr, along with low dose Aspirin.
Administration
Administer deep SC only. Vary injection site daily, may be injected in a U-shape to the area surrounding the navel, the upper outer side of the thigh, or the upper outer quadrangle of the buttock. Use thumb and forefinger to lift a fold of skin when injecting dalteparin to the navel area or thigh. Insert needle at a 45 to 90 degree angle the entire length of needle should be inserted. Apply pressure to injection site. Do not massage.
Compatibility
Dalteparin injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.
Stability
Store at 20C-25C (68.F-77F). After first penetration of the rubber stopper, store the multi dose vials at room temperature for up to two weeks. Discard any unused solution after two weeks.
Contraindications
Do not initiate therapy within first few days after MI. PTCA (stenting), CABG acute ischaemic stroke of less than 7 days, hypoprothrombinaemia, severe hepatic impairment, bleeding dis-orders, active bleeding such as peptic ulcer or intracranial haemorrhage.
Precautions
Risk of adrenal suppression leading to hypoaldosteronism and hyperkalaemia, particularly in diabetes, chronic renal failure or metabolic acidosis; monitor serum potassium, spinal or epidural anaesthesia, liver impairment, patients with high bleeding risk. Monitor platelets before and during therapy.
Interactions
Other anticoagulants, antiplatelet agents, aspirin, vit K antagonists, dextran, dipyridamole, indomethacin, suifinpyrazone. probenecid, ethacrynic acid, cylostatics, antihistamines, ascorbic acid, cardiac glycosides, tetracyclines.
Pregnancy
No evidence of risk in humans.
Lactation
Caution advised or effect undetermined.
Side Effects
Bleeding at high doses. Heparin like side-effects.