GENERIC
Dalteparin Sodium
Indications
Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration, Unstable angina, Prophylaxis of venous thromboembolism during surgical procedures, Venous thromboembolism.
Pharmacology
Dalteparin Na is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate factor Xa inhibition than to prolong aPTT.
Dosage and administration
Intravenous-
Prophylaxis of clotting in extracorporeal circulation in haemodialysis or haemofiltration: 30-40 U/kg IV inj, then 10-15 U/kg/hr as IV infusion.
Subcutaneous-
Venous thromboembolism: 200 U/kg/day as a single or in 2 divided doses in pregnant and high-risk patients. Max: 18,000 U/day.
Prophylaxis of venous thromboembolism during surgical procedures Moderate risk: 2,500 U given 1-2 hr pre-op then 2,500 U once daily for 5-7 days or until the patient is fully ambulant. High risk: 2,500 U given 1-2 hr before and 8-12 hr after the procedure then 5,000 U daily.
Unstable angina: 120 U/kg 12 hrly continued for 5-8 days w/ low-dose aspirin. Max: 10,000 U 12 hrly.
Interactions
Increased risk of haemorrhage with other anticoagulant/ antiplatelet agents (e.g. aspirin/ dipyridamole, glycoprotein IIb/ IIIa receptor antagonists, vit K antagonists, NSAIDs, cytostatics, dextran, thrombolytics, sulfinpyrazone, probenecid, etacrynic acid). Reduced anticoagulant effect with antihistamines, cardiac glycosides, tetracycline and ascorbic acid.
Contraindications
Hypersensitivity. Active major bleeding, severe coagulation disorders; lumbar puncture; sympathetic block; brain, spinal cord, eye or ear surgery; severe hypertension
Side effects
Elevated serum transaminase levels (AST and ALT), allergic reactions (e.g. pruritus, rash, fever, inj site reaction, bullous eruption), pain on inj site. Epidural or spinal haematomas that may result in permanent paralysis, severe haemorrhage, thrombocytopenia.
Pregnancy and lactation
Pregnancy Category B. Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Precautions and warnings
Patient with increased risk of bleeding complications (e.g. following surgery or trauma, haemorrhagic stroke, thrombocytopenia or defective platelet function, uncontrolled HTN, hypertensive or diabetic retinopathy). Increased risk of spinal or epidural haematomas in patient undergoing neuraxial anaesth or spinal puncture esp with post-op use of indwelling epidural catheters. Hepatic and renal impairment. Pregnancy and lactation.
Overdose
Symptoms: Haemorrhagic complications. Management: Administer protamine sulfate by slow IV inj at a dose of 1 mg for every 100 anti-Xa U of dalteparin Na given.
Storage
Store between 20-25°C.
Clinical information is taken from the most complete brand listing (Fragmin); it applies to the active ingredient.
Brands of Dalteparin Sodium
| # | Brand | Company | Form | Strength | Price |
|---|---|---|---|---|---|
| 1 | Fragmin | Janata Traders | SC Injection | 5000 IU/0.2 ml | Not listed |
| 2 | Fragmin | Janata Traders | SC Injection | 7500 IU/0.3 ml | Not listed |
This page is general information and is not medical advice. It does not replace a registered doctor, and it is not a prescription or a recommendation to use any medicine or test. Prices are listed prices and may change. Always follow the advice of your doctor or pharmacist.