G-Heparin25000 IU/5 ml

G-Heparin is an injectable anticoagulant with the following established uses:

FDA-Approved / Established Indications

• Prophylaxis and treatment of venous thrombosis and pulmonary embolism
• Prevention of postoperative deep vein thrombosis in patients undergoing major abdominal, thoracic, or other surgery
• Atrial fibrillation with embolization
• Diagnosis and treatment of acute and chronic disseminated intravascular coagulation (DIC), under specialist supervision
• Anticoagulation in arterial and cardiac surgery (e.g., cardiopulmonary bypass)
• Maintaining patency of intravenous indwelling catheters and central lines (low-dose flush use)
• Anticoagulation during blood transfusion, extracorporeal circulation, and dialysis procedures

Guideline-Supported / Adjunct Uses

• Bridging anticoagulation in patients transitioning to or from oral anticoagulants (e.g., peri-procedurally)
• Acute coronary syndromes, as an adjunct to other therapies per cardiology guidelines

Use of G-Heparin should always be guided by a physician based on individual risk factors, coagulation status, and monitoring capability.

Each mL of injection contains Heparin Sodium (derived from porcine intestinal mucosa) in strengths typically ranging from 1,000 USP units/mL to 25,000 USP units/mL, depending on the product presentation (multi-dose vial, single-dose vial, or prefilled syringe). Formulations intended for neonates and infants are preservative-free.

G-Heparin is a naturally occurring glycosaminoglycan and a rapid-acting parenteral anticoagulant. It does not dissolve existing clots but prevents the formation of new clots and the extension of existing ones, allowing the body's own fibrinolytic system to work.

G-Heparin is administered by intravenous or subcutaneous injection and is widely used in hospital settings for prevention and treatment of thromboembolic disorders, and as an anticoagulant during surgical and dialysis procedures.

G-Heparin belongs to the class of anticoagulants, specifically the unfractionated heparin group of indirect thrombin inhibitors.

Mechanism of Action

Heparin Sodium acts by binding to antithrombin III (AT-III) and accelerating its natural inhibitory action on activated clotting factors, principally thrombin (Factor IIa) and Factor Xa. This markedly potentiates the inactivation of these enzymes, interrupting the coagulation cascade and preventing the conversion of fibrinogen to fibrin, thereby preventing clot formation.

Pharmacokinetics

Heparin Sodium is not absorbed orally and must be given parenterally. After intravenous administration, anticoagulant effect is immediate; after subcutaneous injection, onset is delayed (20-60 minutes) with variable bioavailability. It is largely metabolized in the liver and reticuloendothelial system and partly excreted unchanged in urine. Its half-life increases with dose (approximately 30-180 minutes) and is prolonged in hepatic or renal impairment.

G-Heparin is given only by intravenous (bolus or continuous infusion) or deep subcutaneous injection; it must never be given intramuscularly due to the risk of hematoma. Concentration and dose must be independently verified before administration because vials of very different strengths look similar, and fatal dosing errors have occurred. Rotate subcutaneous injection sites and avoid massaging the area after injection.

Clinically Significant Interactions

• Oral anticoagulants (e.g., warfarin): Heparin can transiently prolong prothrombin time/INR; blood should be drawn for INR testing at an appropriate interval after a heparin dose (per institutional protocol) during transition therapy.
• Antiplatelet agents (aspirin, clopidogrel, NSAIDs) and other anticoagulants/thrombolytics: Concurrent use with G-Heparin substantially increases the risk of bleeding.
• Glycoprotein IIb/IIIa inhibitors: Additive bleeding risk when combined with G-Heparin.
• Drugs that may partially counteract heparin's effect: Digitalis, tetracyclines, nicotine, and antihistamines have been reported to partially antagonize the anticoagulant effect.
• IV nitroglycerin: May reduce the anticoagulant effect of G-Heparin, with rebound effect when nitroglycerin is stopped.

Always inform the physician of all medications, including herbal supplements, before starting G-Heparin.

Common and serious adverse effects associated with G-Heparin include:

• Bleeding/hemorrhage: The most common risk, ranging from minor bruising to major hemorrhage (e.g., gastrointestinal, retroperitoneal, adrenal).
• Heparin-induced thrombocytopenia (HIT): An immune-mediated drop in platelet count that can paradoxically cause new arterial or venous thrombosis; see Precautions and Warnings.
• Injection-site reactions: Pain, irritation, bruising, or, rarely, skin necrosis at the injection site.
• Hypersensitivity reactions: Chills, fever, urticaria, and rarely anaphylaxis.
• Elevated liver transaminases: Usually transient and reversible.
• Osteoporosis: Associated with prolonged high-dose use.
• Hyperkalemia: Due to suppression of aldosterone secretion, particularly with prolonged use.

Report any unusual bleeding, bruising, or signs of allergic reaction to a physician immediately.

Pregnancy: G-Heparin does not cross the placenta and is generally the anticoagulant of choice when anticoagulation is required during pregnancy; however, it should be used only if clearly needed, with the potential benefit weighed against potential risk, and only under close physician supervision. Preservative-free formulations are preferred in pregnancy.

Lactation: G-Heparin is a large molecule that is not expected to pass into breast milk in clinically significant amounts and is generally considered compatible with breastfeeding, but a physician should be consulted before use while breastfeeding, particularly regarding formulation choice (preservative-free preferred).

Boxed Warning

Heparin-Induced Thrombocytopenia (HIT): G-Heparin can cause a serious immune-mediated reaction (HIT) that may progress to life-threatening arterial and venous thrombosis. Platelet counts should be monitored regularly, especially between days 4 and 14 of therapy; G-Heparin must be discontinued immediately if HIT is suspected or confirmed.

Medication errors: Vials of G-Heparin are available in multiple, visually similar concentrations. Fatal hemorrhages, particularly in pediatric patients, have resulted from mix-ups between concentrated vials and dilute catheter-lock/flush solutions. The prescribed concentration and dose must always be independently verified before administration.

Other Precautions

• Bleeding risk: Use with caution in patients over 60 years old (especially women), and in those with conditions predisposing to bleeding (e.g., severe hypertension, recent surgery, subacute bacterial endocarditis, peptic ulcer disease).
• Renal or hepatic impairment: May alter heparin clearance; use with caution and monitor closely.
• Benzyl alcohol toxicity: Multi-dose formulations containing benzyl alcohol should be avoided in neonates and infants due to risk of a fatal "gasping syndrome"; use preservative-free formulations in this population.
• Regular monitoring of aPTT (for therapeutic dosing), platelet count, and hematocrit is required throughout therapy.
• Heparin resistance may occur in fever, extensive thrombosis, infection, myocardial infarction, cancer, or postoperative states, requiring dose adjustment.

Overdosage of G-Heparin primarily manifests as bleeding, ranging from minor oozing to major hemorrhage. If overdose or excessive bleeding is suspected, seek immediate medical attention or contact emergency services. Protamine sulfate is a specific reversal (antidote) agent that can neutralize the anticoagulant effect of G-Heparin and is administered only under direct medical supervision in a clinical setting; it must not be self-administered. Do not attempt to manage a suspected overdose at home.

Store at room temperature, generally between 20°C and 25°C (68°F to 77°F), protected from light and excessive heat. Do not freeze. Keep out of reach of children. Discard any unused portion of single-dose vials; follow institutional protocol for multi-dose vial storage and expiry after opening.

Elderly (over 60 years): More susceptible to bleeding complications with G-Heparin; lower doses may be required, and close monitoring is recommended.

Renal/Hepatic impairment: Clearance of G-Heparin may be altered; use with caution and monitor coagulation parameters closely.

Neonates and infants: Only preservative-free G-Heparin should be used; dosing must be individualized and closely monitored by a specialist. See Pediatric Uses.

Pregnant and breastfeeding women: See Pregnancy and Lactation section.

Duration of G-Heparin therapy depends on the indication: short courses (a few days) for surgical prophylaxis or bridging, and longer courses (typically 5-10 days or more) for treatment of venous thromboembolism, often transitioning to an oral anticoagulant for continued treatment. The treating physician determines the exact duration based on clinical response and coagulation monitoring.

Anticoagulant; Unfractionated heparin.

Heparin Sodium binds to antithrombin III, greatly enhancing its ability to inactivate thrombin (Factor IIa) and activated Factor Xa, thereby blocking the coagulation cascade and preventing new clot formation without lysing existing clots.

Category C

G-Heparin may be used in neonates, infants, and children for anticoagulation (e.g., catheter patency, thromboembolic disease) under close specialist supervision, using only preservative-free formulations to avoid benzyl alcohol toxicity. Formal controlled efficacy studies in children are limited, and dosing (typically 75-100 units/kg loading dose, then 18-30 units/kg/hour maintenance, adjusted by aPTT) is based on clinical experience and extrapolation from adult data. Safety and efficacy for indications beyond these established uses have not been fully established in pediatric patients.