Menaven Gel

Heparin Sodium Injection is indicated for: Prophylaxis and treatment of venous thrombosis and pulmonary embolism; Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; Atrial fibrillation with embolization; Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); Prevention of clotting in arterial and cardiac surgery; Prophylaxis and treatment of peripheral arterial embolism. Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. …

• Recommended Adult Dosages: Therapeutic Anticoagulant Effect with Full-Dose Heparin † † Based on 150 lb (68 kg) patient
• Adjust dose based on laboratory monitoring
• Deep Subcutaneous (Intrafat) Injection Use a different site for each injection Initial Dose 5,000 units by intravenous injection, followed by 10,000 to 20,000 units of a concentrated solution, subcutaneously Every 8 hours or Every 12 hours 8,000 to 10,000 units of a concentrated solution 15,000 to 20,000 units of a concentrated solution Intermittent Intravenous Injection Initial dose 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Every 4 to 6 hours 5,000 to 10,000 units, either undiluted or in 50 to 100 mL of 0.9% Sodium Chloride Injection, USP Intravenous Infusion Initial dose 5,000 units by intravenous injection Continuous 20,000 to 40,000 units/24 hours in 1000 mL of 0.9% Sodium Chloride Injection, USP (or in any compatible solution) for infusion Preparation for Administration Confirm the choice of the correct Heparin Sodium Injection vial to ensure that the 1 mL vial is not confused with a “catheter lock flush” vial or other 1 mL vial of incorrect strength [see Warnings and Precautions ]
• Confirm the selection of the correct formulation and strength prior to administration of the drug
• To lessen this risk, the 1 mL vial includes a red cautionary statement
• Read the cautionary statement and confirm that you have selected the correct medication and strength. …

Heparin Sodium Injection, USP preserved with benzyl alcohol is available as follows: 1,000 USP units per mL single-dose vials 5,000 USP units per mL single-dose vials 10,000 USP units per mL single-dose vials 1,000 USP units per mL multiple-dose vials 5,000 USP units per mL multiple-dose vials 10,000 USP units per mL multiple-dose vials 10,000 USP units per 10 mL (1,000 USP units per mL) multiple- …

• There are no adequate and well controlled studies on heparin use
• In pediatric patients
• Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration ]
• Carefully examine all Heparin Sodium Injection vials to confirm choice of the correct strength prior to administration of the drug
• Pediatric patients, including
• Neonates, have died as a result of medication errors in which Heparin Sodium Injection vials have been confused with “catheter lock flush” vials [see Warnings and Precautions ] . …

There are limited adequate and well-controlled studies in patients 65 years and older, however, a higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Warnings and Precautions ( 5.2 )] . Patients over 60 years of age may require lower doses of heparin. Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology ( 12.3 )] .

• Hemorrhage Inform patients that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they are treated with heparin, and that they should report any unusual bleeding or bruising to their physician
• Hemorrhage can occur at virtually any site in patients receiving heparin
• Fatal hemorrhages have occurred [see Warnings and Precautions ]
• Prior to Surgery Advise patients to inform physicians and dentists that they are receiving heparin before any surgery is scheduled [see Warnings and Precautions ]
• Heparin-Induced Thrombocytopenia Inform patients of the risk of heparin-induced thrombocytopenia (HIT). …

The use of Heparin Sodium Injection is contraindicated in patients with the following conditions: History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions ( 5.3 )] ; Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions ( 6.1 )] ; In whom suitable blood coagulation tests, e.g., the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate …

Drugs that interfere with platelet aggregation: May induce bleeding ( 7.2 ) 7.1 Oral Anticoagulants Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or warfarin sodium, a period of at least 5 hours after the last intravenous dose or 24 hours after the last subcutaneous dose should elapse before blood is drawn, if a valid prothrombin time is to be obtained. …

Fatal Medication Errors: Confirm choice of correct strength prior to administration ( 5.1 ) Hemorrhage: Fatal cases have occurred. Use caution in conditions with increased risk of hemorrhage ( 5.2 ) HIT and HITTS: Monitor for signs and symptoms and discontinue if indicative of HIT and HITTS ( 5.3 ) Benzyl Alcohol Toxicity: Do not use benzyl alcohol-preserved drugs in neonates and infants. ( 5.4 ) Monitoring: Blood coagulation tests guide therapy for full-dose heparin. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions ( 5.2 )] Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see Warnings and Precautions ( 5.3 )] Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [ see Warnings and Precautions ( 5.4 ) ] Thrombocytopenia [see Warnings and Precautions ( 5.5 )] Heparin Resistance [see Warnings and Precautions ( 5.7 )] Hypersensitivity [see Warnings and Precautions ( 5.8 )] Hyperkalemia [see Warnings and Precautions ( 5.9 )] Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITTS, injectio …

8.1 Pregnancy Risk Summary There are no available data on Heparin Sodium Injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. …

Bleeding is the chief sign of heparin overdosage. Neutralization of Heparin Effect When clinical circumstances (bleeding) require reversal of the heparin effect, protamine sulfate (1% solution) by slow infusion will neutralize heparin sodium. No more than 50 mg should be administered, very slowly , in any 10-minute period. Each mg of protamine sulfate neutralizes approximately 100 USP heparin units. The amount of protamine required decreases over time as heparin is metabolized. …

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.