Riik: Malaisia
keel: inglise
Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CILOSTAZOL
MEDISPEC (M) SDN.BHD
CILOSTAZOL
10 x 10 Tablets
Unison Laboratories Co. Ltd.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CILOSOL 100 Cilostazol (100 mg) 1 WHAT IS IN THIS LEAFLET 1. What Cilosol 100 is used for 2. How Cilosol 100 works 3. Before you use Cilosol 100 4. How to use Cilosol 100 5. While you are using it 6. Side effects 7. Storage and Disposal of Cilosol 100 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CILOSOL 100 IS USED FOR Cilosol 100 is used to treat intermittent claudication (a distinctive type of pain at the legs). It is usually caused by blockage of the blood vessels to the leg, hence the calf muscles are not receiving enough oxygen. The muscle pain or cramping happen whenever you walk some distance but the pain disappears when you rest. Cilosol 100 only works if there is no peripheral tissue death. It is also used for prevention of recurrence of cerebral infarction (lack of oxygen supply to brain tissue), excluding cardiogenic cerebral embolism (an obstruction in brain artery by a plaque or blood clot which originates from the heart). HOW CILOSOL 100 WORKS Cilosol 100 inhibit platelet aggregation and hence inhibit the formation of blood clot or plaque that causing blockage in blood vessels. Cilosol 100 increases blood flow in the occluded ankle, lower limbs and brain by dilating the blood vessels and hence to improve the blood circulation. BEFORE YOU USE CILOSOL 100 _- When you must not use it _ You must not take Cilosol 100 if: • You are allergic (hypersensitive) to Cilostazol or any other ingredients of Cilosol 100 _ _ • You have congestive heart failure of any severity _ _ • You have active pathologic bleeding such as bleeding stomach ulcer and intracranial (bleeding to the brain) _ _ • You have persistent chest pain at rest, or have had a “heart attack” or any heart surgery in the last six months. _ _ • You have severe kidney disease _ _ • You have moderate or severe liver disease. _ _ • You are pregnant. _Pregnancy and breastfeeding _ If you are pregnan Lugege kogu dokumenti
ANTITHROMBOTIC AGENT, PLATELET AGGREGATION INHIBITOR Each tablet contains: CILOSTAZOL 100 MG PRODUCT DESCRIPTION: White, round, flat-faced, bevelled edge tablet with engraved 100 on one side and plain on the other side MECHANISM OF ACTION: _PHARMACOKINETICS_ Absorption Following multiple doses of Cilostazol 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days. The C max of Cilostazol and its primary circulating metabolites increase less than proportionally with increasing doses. However, the AUC for Cilostazol and its metabolites increase approximately proportionately with dose. Biotransformation The apparent elimination half-life of Cilostazol is 10.5 hours. There are two major metabolites, a dehydro-cilostazol and a 4'-trans-hydroxy cilostazol, both of which have similar apparent half-lives. The dehydro metabolite is 4-7 times as active a platelet anti-aggregant as the parent compound and the 4'-trans-hydroxy metabolite is one fifth as active. Plasma concentrations (as measured by AUC) of the dehydro and 4'-trans-hydroxy metabolites are ~41% and ~12% of Cilostazol concentrations. There is no evidence that Cilostazol induces hepatic microsomal enzymes. Elimination Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites. The primary isoenzymes involved in its metabolism are cytochrome P-450 CYP3A4, to a lesser extent, CYP2C19, and to an even lesser extent CYP1A2. The primary route of elimination is urinary (74%) with the remainder excreted in the feces. No measurable amount of unchanged Cilostazol is excreted in the urine, and less than 2% of the dose is excreted as the dehydro-Cilostazol metabolite. Approximately 30% of the dose is excreted in the urine as the 4'-trans-hydroxy metabolite. The remainder is excreted as metabolites, none of which exceed 5% of the total excreted. Distribution Cilostazol is 95-98% protein bound, predominantly to albumin. The dehydro metabolite and 4'-trans-hydroxy metabolite are 97.4% and Lugege kogu dokumenti