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EPTIFIBATIDE
Overview
What is EPTIFIBATIDE?
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-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-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 C
H
N
O
S
and a molecular weight of 831.96. Each 10-mL vial contains 2 mg/mL of Eptifibatide and each 100-mL vial contains either 0.75 mg/mL of Eptifibatide or 2 mg/mL of Eptifibatide. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35.
What does EPTIFIBATIDE look like?
What are the available doses of EPTIFIBATIDE?
What should I talk to my health care provider before I take EPTIFIBATIDE?
How should I use EPTIFIBATIDE?
Eptifibatide Injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
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.
What interacts with EPTIFIBATIDE?
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What are the warnings of EPTIFIBATIDE?
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What are the precautions of EPTIFIBATIDE?
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What are the side effects of EPTIFIBATIDE?
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What should I look out for while using EPTIFIBATIDE?
Treatment with Eptifibatide Injection is contraindicated in patients with:
What might happen if I take too much EPTIFIBATIDE?
There has been only limited experience with overdosage of Eptifibatide Injection. There were 8 patients in the EMPACT II study, 9 patients in the PURSUET study, and no patients in the ESPRET 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.
How should I store and handle EPTIFIBATIDE?
Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Vials should be stored refrigerated at 2°-8°C (36°-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first). Protect from light until administration.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.1 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5960” on the other side, available in bottles of 100 (NDC 0093-5960-01).2 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5961” on the other side, available in bottles of 100 (NDC 0093-5961-01).3 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5963” on the other side, available in bottles of 100 (NDC 0093-5963-01). 4 mg – white to off-white, oval-shaped, unscored, biconvex tablets debossed with “TEVA” on one side and “5964” on the other side, available in bottles of 100 (NDC 0093-5964-01). StorageStore at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa. When administered intravenously, eptifibatide inhibits
platelet aggregation in a dose- and concentration-dependent manner. Platelet aggregation inhibition is reversible following cessation of the eptifibatide infusion; this is thought to result from dissociation of eptifibatide from the platelet.
Non-Clinical Toxicology
Treatment with Eptifibatide Injection is contraindicated in patients with:Caution should be exercised when the following drugs are administered concomitantly with carbidopa and levodopa extended-release tablets.
Symptomatic postural hypotension has occurred when carbidopa and levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with carbidopa and levodopa extended-release tablets is started, dosage adjustment of the antihypertensive drug may be required.
For patients receiving MAO inhibitors (Type A or B), see . Concomitant therapy with selegiline and carbidopa and levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa and levodopa alone (see ).
There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa and levodopa preparations.
Dopamine D receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with carbidopa and levodopa extended-release tablets should be carefully observed for loss of therapeutic response.
Use of carbidopa and levodopa extended-release tablets with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.
Carbidopa and levodopa extended-release tablets iron salts or multivitamins containing iron salts should be coadministered with caution. Iron salts can form chelates with levodopa and carbidopa and consequently reduce the bioavailability of carbidopa and levodopa.
Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
Bleeding is the most common complication encountered during Eptifibatide Injection therapy. Administration of Eptifibatide Injection is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group (TIMI) . Most major bleeding associated with Eptifibatide Injection has been at the arterial access site for cardiac catheterization or from the gastrointestinal or genitourinary tract. Minimize the use of arterial and venous punctures, intramuscular injections, and the use of urinary catheters, nasotracheal intubation, and nasogastric tubes. When obtaining intravenous access, avoid non-compressible sites (e.g., subclavian or jugular veins).
The following serious adverse reaction is also discussed elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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