Riik: Tansaania
keel: inglise
Allikas: Tanzania Medicinces & Medical Devices Authority
Amlodipine Besylate
Unique Pharmaceutical Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd), INDIA
Selective calcium channel blockers with mainly vas
Amlodipine Besylate
10 mg
Tablets
UNIQUE PHARMACEUTICAL LABORATORIES, INDIA
Physical description: White to off white round flat faced, bevel edged uncoated tablet with break line on one side and plain on other side; Local technical representative: RK Pharmaceuticals (TZ) LIMITED (2050)
Registered/Compliant
2022-09-21
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT AMCARDIA- 10 (Amlodipine Besylate Tablets USP 10mg) 2. CHEMICAL NAME AND STRUCTURE OF THE ACTIVE INGREDIENT: CHEMICAL NAME: AMLODIPINE BESYLATE STRUCTURE: 3. QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablet contains: Amlodipine Besylate USP. Eq. to Amlodipine…….10mg Excipients q.s. .................. White to off White round flat faced, bevel edged uncoated tablet with break line on one side and plain on the other side. 4. CLINICAL AND PHARMACEUTICAL PARTICULARS: 4.1.THERAPEUTIC INDICATIONS: Hypertension Amlodipine besylate is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Chronic stable angina pectoris Amlodipine besylate is indicated for the treatment of chronic stable angina. Amlodipine besylate may be used alone or in combination with other antianginal agents. Vasospastic (Prinzmetal’s) angina Amlodipine besylate is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine besylate may be used as monotherapy or in combination with other antianginal drugs. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS For both hypertension and angina, the usual initial dose is 5 mg amlodipine once daily which may be increased to a maximum dose of 10 mg depending on the individual patient’s response. In hypertensive patients, Amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, amlodipine may be used as monotherapy or in combination with other anti-anginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers. No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors. PEDIATRIC POPULATION Safety and effectiveness of Amlodipine besylate in children have not been establis Lugege kogu dokumenti