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Dalteparin Sodium information from DrugsUpdate  

See Available Brands of Dalteparin Sodium in India

P - Caution when used during pregnancy
L - Caution when used during lactation
LI - Lab *

Dalteparin is a low molecular weight heparin. It is marketed as Fragmin by Pfizer Inc. Like other low molecular weight heparins, dalteparin is used for prophylaxis or treatment of deep vein thrombosis and pulmonary embolism. Dalteparin is the only low molecular weight heparin shown to be safe in critically ill people with renal failure. Heparins are cleared by the kidneys, but studies have shown that dalteparin does not accumulate even if kidney function is reduced.

Pharmacodynamics

Pharmacokinetics

Dalteparin sodium is a low molecular weight heparin analogue which inhibits factor Xa more than factor IIa (thrombin).


Absorption Almost completely absorbed from the GI tract (oral); peak plasma concentrations after 4 hr.


Excretion Via kidneys; prolonged in renal impairment. Elimination half-life: 2 hr (IV), 3-5 hr (SC).

Dalteparin Sodium Indications / Dalteparin Sodium Uses

Information Not Available

Dalteparin Sodium Adverse Reactions / Dalteparin Sodium Side Effects

Hypersensitivity reactions; thrombocytopenia; inj site pain and tenderness; ecchymoses; haematoma. Prolonged use may lead to alopecia and osteoporosis Potentially Fatal: Severe haemorrhage.

Precautions

Warnings Spinal/Epidural hematomas Risk of spinal/epidural hematoma, which can result in long-term or permanent paralysis, is increased in patients receiving neuraxial anesthesia or spinal puncture who are anticoagulated with LMWHs or heparinoids. Other risk factors include indwelling epidural catheters, repeated/traumatic epidural/spinal puncture, or use of other drugs affecting hemostasis (eg, NSAIDs, platelet inhibitors, anticoagulants). Frequently monitor for signs or symptoms of neurological impairment. Monitor Periodic routine CBC, including platelet count, blood chemistry, and stool occult blood tests, is recommended; anticoagulant effect can be monitored by using anti-factor Xa in patients with severe renal function impairment or if abnormal coagulation parameters or bleeding occur. Thrombocytopenia Use very cautiously in patients with history of heparin-induced thrombocytopenia. Interchangeability with Heparin Cannot be exchanged on a unit-per-unit basis with other types of heparin. Bleeding risk Avoid use in patients at risk for bleeding (eg, severe hypertension, severe liver or kidney disease, platelet defects, recent GI bleeding) or shortly after brain, spinal, or ophthalmological surgery. Benzyl Alcohol The multiple-dose vial of dalteparin contains benzyl alcohol as a preservative, which has been associated with fatal ?gasping syndrome? in premature infants. Over Dosage Symptoms Hemorrhagic complications.

Special Precautions

Preexisting thrombocytopenia, recent childbirth, DM, subacute bacterial endocarditis, pericarditis, recent lumbar puncture, vasculitis. Monitor coagulation time. Hepatic or renal dysfunction; high doses; osteoporosis; familial antithrombin III deficiency; elderly; children; platelet count and stool occult blood test recommended during treatment; GI ulceration. Pregnancy and lactation.

Other Drug Interactions

Increased risk of hyperkalaemia when used with potassium sparing drugs such as ACE inhibitors. Potentially Fatal: Oral anticoagulants, platelet inhibitors and NSAIDs may increase risk of haemorrhage.

Other Interactions

Information Not Available

Dosage

Intravenous Prevention of clotting in extracorporeal circulation in haemodialysis or haemofiltration Adult: 30-40 units/kg via IV inj, followed by an IV infusion of 10-15 units/kg/hr. A single dose of 5000 units may be given for haemodialysis or haemofiltration session lasting <4 hr. For patients at high risk of bleeding complications or who are in acute renal failure: 5-10 units/kg via IV inj followed by an infusion of 4-5 units/kg/hr. Subcutaneous Pulmonary embolism Adult: 200 units/kg daily as a single dose or in 2 divided doses in high-risk patients. Max: 18,000 units daily. Subcutaneous Deep vein thrombosis Adult: 200 units/kg daily as a single dose or in 2 divided doses in high-risk patients. Max: 18,000 units daily. Subcutaneous Prophylaxis of venous thromboembolism during surgical procedures Adult: High-risk thrombosis: 2500 units given 1-2 hr before and 8-12 hr after the procedure followed by 5000 units daily. May continue dosage for up to 5 wk following hip replacement therapy. Moderate-risk thrombosis: 2500 units given 1-2 hr before the procedure followed by 2500 units once daily for 5-7 days or until the patient is fully ambulant. Subcutaneous Unstable angina Adult: 120 units/kg every 12 hr continued for 5-8 days with concomitant low-dose of aspirin. Max: 10,000 units every 12 hr. Max Dosage: 10,000 u every 12 hrs.

Food(before/after)

Information Not Available

List of Contraindications

Dalteparin Sodium and Pregnancy

Caution when used during 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).

Dalteparin Sodium and Lactation

Caution when used during lactation

Dalteparin Sodium and Children

Safety and efficacy not established

Dalteparin Sodium and Geriatic

Information Not Available

Dalteparin Sodium and Other Contraindications

Hypersensitivity. Active major bleeding, severe coagulation disorders; lumbar puncture; sympathetic block; brain, spinal cord, eye or ear surgery; severe hypertension.

Storage

Intravenous Store below 25 ℃ Subcutaneous Store below 25 ℃

Lab interference

Intravenous Store below 25 ℃ Subcutaneous Store below 25 ℃

Dalteparin Sodium brands in India:

Dalpin Fragmin Fragmin-GS

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