Normodipine Tablet 5mg #30

Form

tableti

Dosage mg

5

Pack

30

International Nonproprietary Name - amlodipine Clinical-pharmacological group: Cardiovascular system → Antihypertensives → Calcium channel blockers Composition: Each tablet contains: Active substance: 5 mg amlodipine (in the form of 6.944 mg amlodipine besylate) or 10 mg amlodipine (in the form of 13.889 mg amlodipine besylate) in each tablet. Excipients: magnesium stearate, sodium carboxymethyl starch (type A), anhydrous calcium hydrogen phosphate, microcrystalline cellulose. Description 5 mg tablets: White or almost white, biconvex, oblong-oval tablets with the engraving "5" on one side; 10 mg tablets: White or almost white, biconvex, oblong-oval tablets with the engraving "10" on one side and a score line on the other side. Pharmacotherapeutic group Selective calcium channel blockers with predominant action on blood vessels. Dihydropyridine derivatives. Indications for use - Arterial hypertension. - Chronic stable angina. - Vasospastic angina (Prinzmetal's angina). Method of administration and dosage Adults For both hypertension and angina, the usual starting dose is 5 mg once daily. Depending on the patient's individual response to treatment, this dose can be increased to a maximum dose of 10 mg per day. In patients with arterial hypertension, Normodipine is used in combination with thiazide diuretics, alpha-blockers, beta-blockers, or angiotensin-converting enzyme inhibitors. In patients with angina who do not respond to adequate doses of nitrates and/or beta-blockers, Normodipine can be used as monotherapy or in combination with other antianginal agents. When co-administered with thiazide diuretics, beta-blockers, and inhibitors, dose adjustment is not necessary. Special patient populations Elderly When used at similar doses, Normodipine is equally well tolerated by both young and elderly patients. For elderly patients, the usual treatment regimen is recommended, but dose increases should be done with caution (see sections "Precautions" and "Pharmacokinetics"). Hepatic impairment Recommended doses for patients with mild or moderate hepatic impairment have not been established. Dose selection should be done with caution, and treatment should be initiated with the lowest recommended dose (see sections "Precautions" and "Pharmacokinetics"). The pharmacokinetics of amlodipine in individuals with severe hepatic impairment have not been studied. Treatment of patients with severe hepatic impairment should begin with the minimum dose of amlodipine, and dose titration should be gradual. Renal impairment Changes in amlodipine concentration in blood plasma are not correlated with the degree of renal impairment, so the use of usual doses is recommended in these patients. Amlodipine is not removed by hemodialysis. Pediatric patients Children and adolescents aged 6 to 17 years with arterial hypertension The recommended starting dose for the treatment of arterial hypertension in patients aged 6 to 17 years is 2.5 mg per day; if blood pressure control is not achieved after 4 weeks of drug use, the dose can be increased to 5 mg per day. Doses exceeding 5 mg per day for the treatment of pediatric patients have not been studied (see sections "Pharmacodynamics" and "Pharmacokinetics"). This medicinal product is not manufactured in 2.5 mg dosage. Children under 6 years of age No data is available. Contraindications Amlodipine is contraindicated in patients with the following conditions: - Hypersensitivity to amlodipine, dihydropyridines, or any other components of the preparation listed in the "Composition" section; - Severe arterial hypotension; - Shock (including cardiogenic shock)