Fragmin

What is it?

An anticoagulant preparation which is a low molecular weight heparin produced as a solution in ampoules for injection and which contain 2500 iu or 10,000iu of dalteparin sodium per ml. FRAGMIN PRE- FILLED SINGLE DOSE SYRINGES contain 12500iu or 25000iu of dalteparin sodium per ml, available containing 0.2ml of solution. Also, available as graduated syringes containing 10,000iu per ml and multidose vials containing 25,000iu per ml.

Medical Uses

Prevention of thrombosis during and after surgery, especially hip replacement, clotting in extracorporeal circulation during dialysis treatment. Treatment of deep vein thrombosis, pulmonary embolism, coronary artery disease which is not stable (along with low doses of aspirin).

Dosage

Dependent upon condition being treated (i. e. surgery or dialysis) and if patient is at high or low risk of bleeding (dialysis). Surgery, 2500iu to 5000iu usually given by subcutaneous injection into abdominal wall or thigh, before and after surgical procedure, generally continuing for 5 days to 1 week (sometimes longer) or until person is mobile. Hip surgery, post-operative treatment is usually for 5 weeks until person is mobile. Haemodialysis (dosages dependent upon bleeding risk and according to body weight) , given by intravenous bolus. Deep vein thrombosis and pulmonary embolism, dosages dependent upon bleeding risk and according to body weight, given by subcutaneous injection up to maximum daily dose of 18,000iu, usually as single or two doses each day, along with anticoagulants. Coronary artery disease which is not stabilised, 120iu per kg of body weight by subcutaneous injection twice daily (every 12 hours) to a maximum single dose of 10,000iu, continuing for 5 to 8 days.

Special Care

Breast-feeding, liver disease, undergoing spinal or epidural anaesthesia, those at high risk of bleeding - monitor blood platelets. Risk of suppression of adrenal gland function causing hypoaldosteronism (symptoms associated with low levels of the adrenal gland hormone, aldosterone, which regulates sodium and potassium levels in blood and body tissues) and raised potassium levels (hyperkalaemia), especially in diabetic patients and those with metabolic acidosis or chronic renal failure. Blood potassium and electrolyte levels must be monitored during treatment.

Avoid Use

Children, patients with active duodenal ulcer, subacute endocarditis, brain haemorrhage, undergoing surgery of central nervous system, ears or eyes, previous heparin-induced bleeding disorder (thrombocytopenia) as a result of immune response. Pregnant women should not be treated with Fragmin multi-dose vial.

Possible Drug and Food Interactions

Cardiac glycosides, other anticoagulant and antiplatelet drugs, indomethaein, tetracyclines, probencid, antihistamines, dextran, sulphinpyrazone, aspirin, ethacrynic acid, vitamin K antagonists, cytostatics, dipyradamole, cardiac glycosides.

Known Side Effects

Bleeding, if dose is high, thrombocytopenia (types 1 and 11), short-lived rise in liver enzymes, hypoaldosteronism causing hyperkalaemia, especially in high-risk patients (see Special care), those taking potassium-sparing drugs or long-term use (in excess of 7 days), allergic reactions.