国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate)
Alkaloid AD-Skopje
amlodipine (amlodipine besilate)
5mg
tablets
Prescription
ALKADIPIN ® 5 and 10 mg tablets Module 1.3.1.1 Summary of product characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ALKADIPIN 5 mg tablets ALKADIPIN 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALKADIPIN 5 mg tablets Each tablet contains 6,934 mg of amlodipine besilate equivalent to 5 mg amlodipine. ALKADIPIN 10 mg tablets Each tablet contains 13,869 mg of amlodipine besilate equivalent to 10 mg amlodipine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _*_ Tablets _ _ ALKADIPIN 5 mg tablets Round, biconvex and white tablets with bisection line on one side. The tablet can be divided into two equal halves. ALKADIPIN 10 mg tablets Round, biconvex and white tablets with bisection line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension; Chronic stable angina pectoris; Vasospastic (Prinzmetal's) angina. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION IN ADULTS_ _ For both hypertension and angina the usual initial dose is 5mg 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, ALKADIPIN may be used as monotherapy or in combination with other antianginal ALKADIPIN ® 5 and 10 mg tablets Module 1.3.1.1 Summary of product characteristics 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. USE IN CHILDREN Children with hypertension from 6 years to 17 years of age. The recommended antihypertensive oral dose in paediatric patients ages 6-17 y 完全なドキュメントを読む