देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
Prasugrel Hydrochloride 5.49mg eqv Prasugrel
ELI LILLY (SINGAPORE) PTE LTD
B01AC22
5mg/tablet
TABLET, FILM COATED
Prasugrel Hydrochloride 5.49mg eqv Prasugrel 5 mg
ORAL
Prescription Only
Eli Lilly and Company
ACTIVE
2010-05-05
Page 1 of 18 NAME OF THE MEDICINE Effient (prasugrel hydrochloride) The active ingredient is prasugrel hydrochloride. DESCRIPTION Effient, an adenosine diphosphate (ADP) receptor antagonist of the thienopyridine class, is a potent inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Chemically, prasugrel hydrochloride is (±)-2-[2-acetyloxy-6,7-dihydrothieno[3,2-_c_]pyridin-5(_4_H)-yl]-1-cyclopropyl-2- (2-fluorophenyl)ethanone hydrochloride. The empirical formula is C 20 H 20 FNO 3 S•HCl which corresponds to a molecular weight of 409.90. The chemical structure is: The CAS number for prasugrel hydrochloride is 389574-19-0. It is a white to light brown solid. Prasugrel hydrochloride is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Effient is available for oral administration as a 5 mg or 10 mg double-arrow shaped, film-coated, not scored tablet, debossed on each side. Each beige 10 mg tablet is manufactured with 10.98 mg prasugrel hydrochloride, equivalent to 10 mg of prasugrel and each yellow 5 mg tablet with 5.49 mg prasugrel hydrochloride, equivalent to 5 mg of prasugrel. Other ingredients include mannitol, hypromellose, croscarmellose sodium, cellulose - microcrystalline, and vegetable magnesium stearate. The colour coatings contain lactose, hypromellose, titanium dioxide, glycerol triacetate, iron oxide yellow CI77492, and iron oxide red CI77491. PHARMACOLOGY पूरा दस्तावेज़ पढ़ें
Page 1 of 18 NAME OF THE MEDICINE Effient (prasugrel hydrochloride) The active ingredient is prasugrel hydrochloride. DESCRIPTION Effient, an adenosine diphosphate (ADP) receptor antagonist of the thienopyridine class, is a potent inhibitor of platelet activation and aggregation mediated by the P2Y 12 ADP receptor. Chemically, prasugrel hydrochloride is (±)-2-[2-acetyloxy-6,7-dihydrothieno[3,2-_c_]pyridin-5(_4_H)-yl]-1-cyclopropyl-2- (2-fluorophenyl)ethanone hydrochloride. The empirical formula is C 20 H 20 FNO 3 S•HCl which corresponds to a molecular weight of 409.90. The chemical structure is: The CAS number for prasugrel hydrochloride is 389574-19-0. It is a white to light brown solid. Prasugrel hydrochloride is soluble at pH 2, slightly soluble at pH 3 to 4, and practically insoluble at pH 6 to 7.5. It also dissolves freely in methanol and is slightly soluble in 1- and 2-propanol and acetone. It is practically insoluble in diethyl ether and ethyl acetate. Effient is available for oral administration as a 5 mg or 10 mg double-arrow shaped, film-coated, not scored tablet, debossed on each side. Each beige 10 mg tablet is manufactured with 10.98 mg prasugrel hydrochloride, equivalent to 10 mg of prasugrel and each yellow 5 mg tablet with 5.49 mg prasugrel hydrochloride, equivalent to 5 mg of prasugrel. Other ingredients include mannitol, hypromellose, croscarmellose sodium, cellulose - microcrystalline, and vegetable magnesium stearate. The colour coatings contain lactose, hypromellose, titanium dioxide, glycerol triacetate, iron oxide yellow CI77492, and iron oxide red CI77491. PHARMACOLOGY MECHANISM OF ACTION Effient is an inhibitor of platelet activation and aggregation through the irreversible binding of its active metabolite to the P2Y 12 class of ADP receptors on platelets. A variety of drugs that inhibit platelet function have been shown to decrease morbid events in people with established atherosclerotic disease. Since platelets participate in the initiation and/or evolution of thrombotic complication पूरा दस्तावेज़ पढ़ें