Eptifibatide apollo

Transcription

1 Eptifibatide apollo Eptifibatide apollo Eptifibatide CAS Number : Molecular Weight : g/mol Molecular Formula : C35H49N11O9S2 Systematic (IUPAC) : N 6 -(aminoiminomethyl)-n 2 - (3-mercapto-1-oxopropyl-L-lysylglycyl-L-a-aspartyl-Ltryptophyl-L -prolyl-l-cysteinamide DRUG DESCRIPTION

2 Eptifibatide is used for: Treating unstable angina (chest pain) or certain types of heart attacks. It may also be used to treat patients undergoing a certain type of procedure (percutaneous coronary intervention [PCI]). It may also be used to treat certain conditions as determined by your doctor that may not be listed in the professional package insert. Eptifibatide is a platelet aggregation inhibitor. It works by preventing blood platelets from sticking together and forming blood clots. Eptifibatide keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. Eptifibatide is used to prevent blood clots or heart attack in people with severe chest pain or other conditions, and in those who are undergoing a procedure called angioplasty (to open blocked arteries). DOSAGE Eptifibatide is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. If you are receiving this injection during an angioplasty procedure, the medicine will be given throughout the entire procedure and for up to 24 hours after the procedure. Eptifibatide is usually given continuously for up to 4 days. Eptifibatide is sometimes given together with aspirin. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

3 Because eptifibatide keeps your blood from coagulating (clotting) to prevent unwanted blood clots, it can also make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop. SIDE EFFECTS Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: *nosebleed or other bleeding that will not stop; *black, bloody, or tarry stools; *coughing up blood or vomit that looks like coffee grounds; *feeling light-headed, fainting; *sudden numbness or weakness, especially on one side of the body; *sudden headache, confusion, problems with vision, speech, or balance; *fever, chills, body aches, flu symptoms; or *pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual. Less serious side effects may also occur, such as: *nausea, stomach pain; *runny or stuffy nose, cough, sore throat; or *mild headache or dizziness. PRECAUTIONS Bleeding: The most common complication is bleeding, including retroperitoneal, pulmonary, and spontaneous GI and/or GU bleeding; watch closely for bleeding,

4 especially the arterial access site for the cardiac catheterization. Use with extreme caution in patients with platelet counts <150,000/mm3, patients with hemorrhagic retinopathy, previous history of GI disease, recent thrombolytic therapy and in chronic dialysis patients. Use caution with administration of other drugs affecting hemostasis. Minimize other procedures including arterial and venous punctures, I.M. injections, nasogastric tubes, etc. Before using Eptifibatide : Some medical conditions may interact with Eptifibatide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: * if you are pregnant, planning to become pregnant, or are breast-feeding * if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement * if you have allergies to medicines, foods, or other substances * if you have kidney problems or high serum creatinine levels, high blood pressure, or low blood platelet levels (eg, thrombocytopenia) Some MEDICINES MAY INTERACT with Eptifibatide. Tell your health care provider if you are taking any other medicines, especially any of the following: * Anticoagulants (eg, warfarin, heparin), aspirin, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), or thrombolytics (eg, alteplase) because risk of bleeding may be increased This may not be a complete list of all interactions that may occur. Ask your health care provider if Eptifibatide may interact with other medicines that you take. Check

5 with your health care provider before you start, stop, or change the dose of any medicine. INTERACTION a blood thinner such as warfarin (Coumadin), heparin, ardeparin (Normiflo), dalteparin (Fragmin), danaparoid (Orgaran), enoxaparin (Lovenox), or tinzaparin (Innohep); or any other medications used to prevent blood clots, such as alteplase (Activase), anistreplase (Eminase), clopidogrel (Plavix), dipyridamole (Persantine), streptokinase (Kabikinase, Streptase), ticlopidine (Ticlid), or urokinase (Abbokinase). If you are using any of these drugs, you may not be able to receive eptifibatide, or you may need dosage adjustments or special tests during treatment. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other "blood thinners" (e.g., warfarin) used in the last 7 days, NSAIDs (e.g., ibuprofen, naproxen), anti-platelet drugs (e.g., dipyridamole, ticlopidine), tipranavir. Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that are similar to this drug. Eptifibatide is often used with other "blood thinners" such as aspirin, clopidogrel, and heparin. Be sure to

6 check with your doctor or pharmacist regarding which medicines you need to take after leaving the hospital. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of milligrams a day). Consult your doctor or pharmacist for more details. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. PHARMALOGY Mechanism of Action 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 ex vivo platelet aggregation in a dose- and concentrationdependent manner. Platelet aggregation inhibition is reversible following cessation of the eptifibatide infusion; this is thought to result from dissociation of eptifibatide from the platelet. Patients in clinical studies were older (range years) than those in the clinical pharmacology studies. Elderly patients with coronary artery disease demonstrated higher plasma levels and lower total body clearance of eptifibatide when given the same dose as younger patients. Limited data are available on lighter weight ( < 50 kg) patients over 75 years of age.eptifibatide was studied in three placebo-controlled, randomized studies. PURSUIT evaluated patients with acute coronary syndromes: unstable angina (UA) or

7 non-st-segment elevation MI (NSTEMI). Two other studies, ESPRIT and IMPACT II, evaluated patients about to undergo a percutaneous coronary intervention (PCI). Patients underwent primarily balloon angioplasty in IMPACT II and intracoronary stent placement, with or without angioplasty, in ESPRIT. CONSUMER INFORMATION USES: Eptifibatide is a type of "blood thinner" used to prevent blood clots that can cause a heart attack or other serious blood flow problems. It is used before certain procedures used to open up the blood vessels in the heart (e.g., balloon angioplasty, coronary stent placement, percutaneous coronary intervention-pci, coronary artery bypass graft-cabg). It is also used with other medications (e.g., nitrates, beta blockers) to stop or prevent a heart attack in people with continuing chest pain when the above procedures cannot be done. It is usually used with heparin and aspirin. HOW TO USE: Follow all instructions for preparation and usage on the product package. If you have questions about using this medication properly, consult your pharmacist. Do not shake the medication. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid. If you have certain heart procedures to open up the blood vessels in your heart (e.g., stent, PCI), you will need to lie very still after your procedure with your head up slightly. The tube for your procedure is usually placed near the groin. Keep the leg (or other limb nearest the tube) straight to prevent bleeding from the tube area. Pressure will be applied to the area (e.g., with a sandbag,

8 special pressure dressing/device). You will not be allowed out of bed for several hours after the procedure. SIDE EFFECTS: Dizziness or minor bleeding/irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. PRECAUTIONS: Before using eptifibatide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. MISSED DOSE: If your dose is stopped or interrupted, contact the doctor immediately to establish a new dosing schedule/rate.storage: Store in the refrigerator between degrees F (2-8 degrees C). Do not freeze. This medication may be stored for up to 2 months at room temperature at 77 degrees F (25 degrees C) away from light and moisture. If the medication is stored at room temperature, cross out the manufacturer's expiration date if it is longer than 2 months away, then write in a new discard date 2 months from the present date. Discard any unused liquid. Keep all medicines away from children and pets. Type biotech Description Synthetic cyclic hexapeptide that binds to platelet receptor glycoprotein and inhibits platelet aggregation. Categories Anticoagulants Antiplatelet Agents Platelet Aggregation Inhibitors

9 Pharmacology Indication For treatment of myocardial infarction and acute coronary syndrome. Pharmacodynamics Eptifibatide is an anti-coagulant that selectively blocks the platelet glycoprotein IIb/IIIa receptor. Eptifibatide is a cyclic heptapeptide derived from a protein found in the venom of the southeastern pygmy rattlesnake (Sistrurus miliarus barbouri). It belongs to the class of the so called arginin-glycin-aspartat-mimetics and reversibly binds to platelets. Mechanism of Action Eptifibatide inhibits platelet aggregation by reversibly binding to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets, thus preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands. Inhibition of platelet aggregation occurs in a dose- and concentration-dependent manner. Metabolism No major metabolites have been detected in human plasma. Deamidated eptifibatide and other, more polar metabolites have been detected in urine. Toxicity 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) Affected Organisms Humans and other mammals

10 apollo asia Division apollo Pharmaceuticals INDIA [P] Ltd asia Division Mr.Vipin Saxena CEO DIRECT: Wireline Purchase HELPDESK: Wireline Sales HELPDESK: Wireless 24x7 HELPDESK: Blackberry Pin : 32E6500D 32E C58 apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in Chat: MSN Hotmail:VipinrSaxena Skype NAME:VipinrSaxena Rocketmail:VipinrSaxena

11 Google mail:vipinrsaxena BlackBerry:28415C58 Regd. Office :- 1104, Maker Chamber V, Nariman Point Mumbai, INDIA Pin: Industrial Office D-62, OIC India Oshiwara Industrial Centre, New Link Road, Goregoan West, Mumbai, INDIA Pin: Manufacturing Unit Address: Plot No. 117A, Village: Chamble Near MonaTona Limited.Wada, Maharashtra, PIN : INDIA apollo@hotmail.co.in Sales@apollopharma.in Export@apollopharma.in purchase@apollopharma.in

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