2010/06/13

DALTEPARIN SODIUM

Pharmacological action

Anticoagulant of direct action. It is a low molecular weight heparin (average molecular weight of 4000-6000 daltons), isolated from the mucosa of the small intestine of pig. Binds antithrombin plasma, as a consequence is the suppression of some clotting factors, primarily, a factor Xa; significantly inhibited the formation of thrombin. Renders poorly marked effect on the adhesion of platelets. Slightly increases the APTT and thrombin time.


Pharmacokinetics

Pharmacokinetic parameters of dalteparin sodium did not vary according to the administered dose. After sc injection of bioavailability is about 90%.

T 1 / 2 after i / v injection of 2 h, after s / c - 3-4 hours is derived mainly by the kidneys.

In patients with severe impaired renal function T 1 / 2 increases.


Statement

Acute deep vein thrombosis, prevention of blood clotting in the extracorporeal circulation during long-term hemodialysis or hemofiltration in patients with acute or chronic renal failure, prevention of thromboembolic complications in pre-and postoperative period; unstable angina or myocardial infarction (without pathological tooth Q).


Dosage regimen

Dose was set individually, depending on indications, clinical situation and applied treatment regimens. Enter in / jet or drip, and n / k.

Not intended for the / m injection.


Side effect

On the part of the hemopoietic system and blood coagulation system: rarely - thrombocytopenia, bleeding (when used in high doses).

On the part of the digestive system: in some cases - increase in liver transaminases.

Local reactions: the formation of subcutaneous hematoma at the injection site, rarely - necrosis of the skin.


Contraindications

Serious breaches of the blood coagulation system, stomach ulcer and duodenal ulcer in acute, bacterial endocarditis, trauma central nervous system, organs of vision, hearing, and oral surgery on these organs, the simultaneous application of local anesthesia (for the treatment of acute deep vein thrombosis) and unstable angina, increased sensitivity to dalteparin sodium.


Application of pregnancy and breastfeeding

There are no adequate and strictly controlled studies of safety during pregnancy and lactation (breastfeeding) was carried out. A small clinical experience with dalteparin sodium during pregnancy indicates the absence of any negative effect on pregnancy and child health.

Unknown is allocated whether dalteparin sodium in breast milk.


Cautions

With careful use dalteparin sodium in patients with thrombocytopenia or platelet defects, marked disturbances of liver function, uncontrolled hypertension, hypertensive or diabetic retinopathy, with hypersensitivity to heparin or low molecular weight heparin in history; patients in the early postoperative period.

Increasing doses of dalteparin sodium in order to increase the APTT may lead to overdose and bleeding. For laboratory monitoring of treatment dalteparin sodium should use tests to determine anti-Xa activity.

In an emergency hemodialysis requires a more careful control of the activity level of anti-Xa because of the narrow range of therapeutic doses for these patients.

In patients with transmural myocardial infarction, developed in the presence of unstable angina and myocardial infarction without pathological Q wave in the case of thrombolytic therapy cancellation dalteparin sodium is optional. However, in such a situation increases the risk of bleeding.


Drug Interactions

With the simultaneous use of antihistamines, cardiac glycosides, tetracycline, ascorbic acid reduced the effectiveness of dalteparin sodium.

With the simultaneous use of NSAIDs, antagonists of vitamin K, dipyridamole, dextran, sulfinpirazon, probenecid, ethacrynic acid, cytotoxic drugs (for i / v injection) increases the effects of dalteparin sodium.