Amlovas 5 mg N30 Tablet

AMLOVAS, 5 mg, 10 mg tablets

Amlovas composition

 Amlovas 5 mg tablets Active ingredient:  Each tablet contains 5 mg amlodipine, equivalent to 6.94 mg amlodipine besylate. Excipients: microcrystalline cellulose and anhydrous colloidal silicon dioxide, mannitol, sodium  starch glycolate, glycerol dibehenate, magnesium stearate. Amlovas 10 mg tablets Active ingredient:  Each tablet contains 10 mg  amlodipine, equivalent to 13.88 mg amlodipine besylate. Excipients: microcrystalline cellulose and anhydrous colloidal silicon dioxide, mannitol, sodium  starch glycolate, glycerol dibehenate, magnesium stearate.

Indications:

  arterial hypertension; - chronic stable angina; - vasospastic angina (variant angina or Prinzmetal’s angina).

Contraindications:

  hypersensitivity to dihydropyridine derivatives, amlodipine, or any of the excipients; - severe  degree arterial hypotension; - shock (including cardiogenic shock); - obstruction of the outflow tract of the left ventricle (severe aortic valve stenosis); - hemodynamically unstable heart failure after acute myocardial infarction (first 28 days).

Use during pregnancy and lactation:

 Pregnancy There are no adequate and well-controlled studies regarding the use of amlodipine during pregnancy. In animal studies, reproductive toxicity was observed at high doses. Use of amlodipine during pregnancy is recommended only when there is no safer alternative and when the disease itself poses greater risk to the mother and fetus. Lactation It is not known whether amlodipine is excreted into breast milk. A decision on whether to continue/stop breastfeeding should be made considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother. Fertility There are reports of reversible biochemical changes in the head of spermatozoa in some patients treated with calcium channel blockers. Clinical data regarding the possible effect of amlodipine on fertility are insufficient. In a study in mice, additional effects on male fertility were recorded.

How to use Amlovas, dosage

 For arterial hypertension and angina, the usual starting dose is 5 mg once daily; depending on the patient’s individual response, it may be increased up to a maximum dose of 10 mg once daily. Tablets are taken orally with sufficient water, regardless of food intake. In patients with hypertension, amlodipine has been used in combination with a thiazide diuretic, an alpha-blocker, a beta-blocker, or an ACE inhibitor. For angina, amlodipine may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that remains persistent despite adequate doses of nitrates and/or beta-blockers. When Amlovas is prescribed together with thiazide diuretics, beta-adrenoblockers, or ACE inhibitors, no change in the dosing regimen is required. In elderly patients, the usual dosing regimen is recommended, but dose increases should be carried out with caution. Hepatic impairment Dosing recommendations have not been established for patients with mild to moderate hepatic impairment; therefore, dose selection should be made with caution and should start from the lowest range limit. The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. In patients with severe hepatic impairment, amlodipine should be given at the lowest dose and titrated slowly. Renal impairment Changes in the plasma concentration of amlodipine are not related to the severity of renal impairment; therefore, the usual dose is recommended. Amlodipine is not removed by dialysis. Children and adolescents with hypertension aged 6 to 17 years For children and adolescents aged 6 to 17 years, the starting dose for the treatment of hypertension is 2.5 mg amlodipine once daily; if the expected antihypertensive effect is not achieved after 4 weeks, the dose may be increased to 5 mg once daily. Doses greater than 5 mg per day have not been studied in children and adolescents.