Eptifibatide (Eptifibatide)

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Trade Name: Eptifibatide

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Biosciences

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 2 mg/mL

Storage and handling

EPTIFIBATIDE Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]

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These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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Eptifibatide injection is a platelet aggregation inhibitor indicated for:

Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) n
Treatment of patients undergoing PCI (including intracoronary stenting) n

Before infusion of eptifibatide injection, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.
The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.
ACS or PCI: 180 mcg/kg IV bolus as soon as possible after diagnosis followed by infusion at 2 mcg/kg/min.u00a0u00a0n
PCI: Add a second 180 mcg/kg bolus at 10 minutes. n
In patients with creatinine clearance <50 mL/min, reduce the infusion to 1 mcg/kg/min.u00a0u00a0n

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20 mg/10 mL (2 mg/mL) in a single-dose vial for bolus injection n
75 mg/100 mL (0.75 mg/mL) in a single-dose vial for infusion n

Treatment with eptifibatide is contraindicated in patients with:

Bleeding diathesis or bleeding within the previous 30 days n
Severe uncontrolled hypertension n
Major surgery within the preceding 6 weeks n
Stroke within 30 days or any history of hemorrhagic stroke n
Coadministration of another parenteral GP IIb/IIIa inhibitor n
Dependency on renal dialysis n
Known hypersensitivity to any component of the product n

No data

Eptifibatide can cause serious bleeding. If bleeding cannot be controlled, discontinue eptifibatide immediately. Minimize vascular and other traumas. If heparin is given concomitantly, monitor aPTT or ACT. n
Thrombocytopenia: Discontinue eptifibatide and heparin. Monitor and treat condition appropriately. n

The following serious adverse reaction is also discussed elsewhere in the labeling:
Bleeding and hypotension are the most commonly reported adverse reactions. n
To report SUSPECTED ADVERSE REACTIONS, contact Amneal at 1-855-266-3251 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin and chronic NSAID use increases the risk of bleeding. Concomitant treatment with other inhibitors of platelet receptor GP IIb/IIIa should be avoided.

Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin and chronic NSAID use increases the risk of bleeding. Avoid concomitant use with other glycoprotein (GP) IIb/IIIa inhibitors. n

No data

Geriatric Use:
(8.5)

There has been only limited experience with overdosage of eptifibatide. There were 8 patients in the IMPACT II study, 9 patients in the PURSUIT study and no patients in the ESPRIT study who received bolus doses and/or infusion doses more than double those called for in the protocols. None of these patients experienced an intracranial bleed or other major bleeding.
Eptifibatide was not lethal to rats, rabbits, or monkeys when administered by continuous intravenous infusion for 90 minutes at a total dose of 45 mg/kg (about 2 to 5 times the recommended maximum daily human dose on a body surface area basis). Symptoms of acute toxicity were loss of righting reflex, dyspnea, ptosis and decreased muscle tone in rabbits and petechial hemorrhages in the femoral and abdominal areas of monkeys.
From studies, eptifibatide is not extensively bound to plasma proteins and thus may be cleared from plasma by dialysis.

Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N-(aminoiminomethyl)-N-(3-mercapto-1-oxopropyl)-L-lysylglycyl-L-u03b1-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1u21926)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation.
The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is:
Eptifibatide injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of CHNOS and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of eptifibatide and each 100-mL vial contains 0.75 mg/mL of eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid in water for injection and sodium hydroxide to adjust the pH to 5.35.

No data

No long-term studies in animals have been performed to evaluate the carcinogenic potential of eptifibatide. Eptifibatide was not genotoxic in the Ames test, the mouse lymphoma cell (L 5178Y, TK+/-) forward mutation test, the human lymphocyte chromosome aberration test, or the mouse micronucleus test. Administered by continuous intravenous infusion at total daily doses up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis), eptifibatide had no effect on fertility and reproductive performance of male and female rats.

Eptifibatide was studied in 3 placebo-controlled, randomized studies. PURSUIT evaluated patients with acute coronary syndromes: UA or NSTEMI. Two other studies, ESPRIT and IMPACT II, evaluated patients about to undergo a PCI. Patients underwent primarily balloon angioplasty in IMPACT II and intracoronary stent placement, with or without angioplasty, in ESPRIT.

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Instruct patients to inform the doctor or healthcare provider about any medical conditions, medications and allergies.
Manufactured by:n Hyderabad-500 043, INDIA
Distributed by:n Bridgewater, NJ 08807
Rev. 06-2016-00
LEA-019755-00

No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Eptifibatide (Eptifibatide) which is also known as Eptifibatide and Manufactured by Amneal Biosciences. It is available in strength of 2 mg/mL.

Eptifibatide (Eptifibatide) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.