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Eptifibatide (Eptifibatide)

Trade Name : Eptifibatide

Baxter Healthcare Corporation

INJECTION

Strength 75 mg/100mL

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

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Eptifibatide (Eptifibatide) which is also known as Eptifibatide and Manufactured by Baxter Healthcare Corporation. It is available in strength of 75 mg/100mL per ml. Read more

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.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • Eptifibatide injection is a platelet aggregation inhibitor indicated for:
  • Eptifibatide injection in GALAXY container is for intravenous infusion only, not for intravenous bolus use. 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.
  • Eptifibatide injection in GALAXY container is for intravenous infusion only, not for intravenous bolus use.ACS or PCI: 180 mcg/kg IV bolus as soon as possible after diagnosis followed by infusion at 2 mcg/kg/min. , n PCI: Add a second 180 mcg/kg bolus at 10 minutes. () In patients with creatinine clearance less than 50 mL/min, reduce the infusion to 1 mcg/kg/min.u00a0u00a0, )
  • No data
  • Treatment with eptifibatide is contraindicated in patients with:
  • No data
  • The following serious adverse reaction is also discussed elsewhere in the labeling:
  • Bleeding and hypotension are the most commonly reported adverse reactions.n n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or .
  • 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.
  • u2022
  • (7.1)
  • No data
  • u2022
  • 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 infusion with an empirical formula of CHNOS and a molecular weight of 831.96. Eptifibatide injection is a refrigerated, premixed, sterile, non-pyrogenic single-dose solution packaged in the GALAXY container (PL 2501 plastic). Each 100 mL container consists of either 0.75 mg/mL of eptifibatide or 2 mg/mL of eptifibatide. Each container, of either strength, also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35.
  • The GALAXY container is fabricated from a specially designed multilayered plastic (PL 2501). Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
  • 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.
  • No data
  • Instruct patients to inform the doctor or healthcare provider about any medical conditions, medications, and allergies.
  • Baxter and Galaxy are registered trademarks of Baxter International Inc.
  • Arrayn- Baxter Logo
  • Baxter Healthcare Corporationn
  • 07-19-00-759
  • Made in USA.
  • NDC 0338-9558-10n- Eptifibatide Injectionn- 75 mg per 100 mLn- (0.75 mg / mL)n- For Intravenous Infusion Only. Not for Intravenous Bolus Use.n- GALAXYSingle Dose ContainerDiscard unused portion
  • Code 2G3476Sterile Nonpyrogenic
  • Each mL contains 0.75 mg Eptifibatide; 5.25 mg citric acid, USP; andWater for Injection, USP. pH adjusted with sodium hydroxide to 5.35.
  • Dosage: See prescribing information.
  • Caution: Do not add supplemental medication or additives.
  • Rx only
  • Use carton to protect contents from light until administration.
  • ____________________________________________________________PL 2501 Plastic
  • Baxter Logo
  • Baxter and Galaxy are registered trademarks of Baxter International Inc.n , Deerfield, IL 60015 USAMade in USA
  • 07-34-75-959
  • Bar Code Position Only
  • NDC 0338-9558-10
  • Eptifibatide Injectionn- 75 mg per 100 mL
  • Rx Only
  • USE CARTON TO PROTECT CONTENTSFROM LIGHT UNTIL ADMINISTRATION
  • 1 GALAXY Single Dose ContainerDiscard unused portion
  • Baxter LogoDeerfield, IL 60015 USA
  • For Intravenous Infusion Only. Not for Intravenous Bolus Use.n n
  • 75 mg per 100 mLn
  • NDC 0338-9558-10
  • Eptifibatide Injectionn- 75 mg per 100 mLn
  • For Intravenous Infusion Only.Not For Intravenous Bolus Use.
  • UNVARNISHED AREA FOR ON-LINEPRINTING OF LOT & EXP
  • *UPC-ABar Code Placement
  • 303389558101
  • Each mL contains 0.75 mg Eptifibatide; 5.25 mg citric acid, USP; and Water for Injection, USP. pH adjusted with sodium hydroxide to 5.35.
  • Dosage: See prescribing information.
  • Caution: Do not add supplemental medication or additives.
  • Rx only
  • Use carton to protect contents from light until administration.
  • Baxter and Galaxy are registered trademarks of Baxter International Inc.n , Deerfield, IL 60015 USA
  • 07-01-75-957
  • For Intravenous Infusion Only.Not For Intravenous Bolus Use.n n
  • 75 mg per 100 mL
  • For Intravenous Infusion Only. Not For Intravenous Bolus Use.n n
  • 75 mg per 100 mL
  • For Intravenous Infusion Only.Not For Intravenous Bolus Use.n n
  • 75 mg per 100 mL
  • Eptifibatide Injection75 mg per 100 mL (0.75 mg / mL)
  • Contains: 12 x 100 mL GALAXY Single-Dose ContainersNDC 0338-9558-10Code: 2G3475n
  • Rx OnlyBaxter Logon- Baxter Healthcare Corporation
  • Eptifibatide Injection75 mg per 100 mL (0.75 mg / mL)
  • Contains: 12 x 100 mL GALAXY Single-Dose ContainersNDC 0338-9558-10Code: 2G3475n
  • Rx OnlyBaxter Logon- Baxter Healthcare Corporation
  • This is the level of packaging where Serialization occurs
  • NDC 0338-9559-20n- Eptifibatide Injectionn- 200 mg per 100 mLn- (2 mg / mL)n- For Intravenous Infusion Only. Not for Intravenous Bolus Use.n- GALAXYSingle Dose ContainerDiscard unused portion
  • Code 2G3477Sterile Nonpyrogenic
  • Each mL contains: 2 mg Eptifibatide, 5.25 mg citric acid, USP; and Water for Injection, USP. pH adjusted with sodium hydroxide to 5.35.
  • Dosage: See prescribing information.
  • Caution: Do not add supplemental medication or additives.
  • Rx only
  • Use carton to protect contents from light until administration.
  • ____________________________________________________________PL 2501 Plastic
  • Baxter Logo
  • Baxter and Galaxy are registered trademarks of Baxter International Inc.n , Deerfield, IL 60015 USAMade in USA
  • 07-34-75-959
  • Bar Code Position Only
  • NDC 0338-9559-20
  • Eptifibatide Injectionn- 200 mg per 100 mL
  • Rx Only
  • USE CARTON TO PROTECT CONTENTSFROM LIGHT UNTIL ADMINISTRATION
  • 1 GALAXY Single Dose ContainerDiscard unused portion
  • Baxter LogoDeerfield, IL 60015 USA
  • For Intravenous Infusion Only. Not for Intravenous Bolus Use.n n
  • 200 mg per 100 mLn
  • NDC 0338-9559-20
  • Eptifibatide Injectionn- 200 mg per 100 mLn
  • For Intravenous Infusion Only.Not For Intravenous Bolus Use.
  • UNVARNISHED AREA FOR ON-LINEPRINTING OF LOT & EXP
  • *UPC-ABar Code Placement
  • 303389559207
  • Each mL contains 2 mg Eptifibatide, 5.25 mg citric acid, USP; and Water for Injection, USP. pH adjusted with sodium hydroxide to 5.35.
  • Dosage: See prescribing information.
  • Caution: Do not add supplemental medication or additives.
  • Rx only
  • Use carton to protect contents from light until administration.
  • Baxter and Galaxy are registered trademarks of Baxter International Inc.n , Deerfield, IL 60015 USA
  • 07-01-75-958
  • For Intravenous Infusion Only.Not For Intravenous Bolus Use.n n
  • 200 mg per 100 mL
  • For Intravenous Infusion Only. Not For Intravenous Bolus Use.n n
  • 200 mg per 100 mL
  • For Intravenous Infusion Only.Not For Intravenous Bolus Use.n n
  • 200 mg per 100 mL
  • Eptifibatide Injection200 mg per 100 mL (2 mg / mL)
  • Contains: 12 x 100 mL GALAXY Single-Dose ContainersNDC 0338-9559-20Code: 2G3477n
  • Rx OnlyBaxter Logon- Baxter Healthcare Corporation
  • Eptifibatide Injection200 mg per 100 mL (2 mg / mL)
  • Contains: 12 x 100 mL GALAXY Single-Dose ContainersNDC 0338-9559-20Code: 2G3477n
  • Rx OnlyBaxter Logon- Baxter Healthcare Corporation
  • This is the level of packaging where Serialization occurs

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