Amlovas 10 mg N30 Tablet

AMLOVAS, 5 mg, 10 mg tablets

Amlovas composition

 Amlovas 5 mg tablets Active ingredient:  1 tablet contains 6.94 mg of amlodipine besylate equivalent to 5 mg amlodipine  . Excipients: microcrystalline cellulose and anhydrous colloidal silicon dioxide, mannitol, sodium  starch glycolate, glycerol dibehenate, magnesium stearate. Amlovas 10 mg tablets Active ingredient:  1 tablet contains 13.88 mg of amlodipine besylate equivalent to 10 mg  amlodipine. 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  arterial hypotension; - shock (including cardiogenic shock); - obstruction of the outflow tract of the left ventricle (severe aortic valve stenosis); - hemodynamically non-stable 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. The use of amlodipine during pregnancy is recommended only when there is no safer alternative and when the disease itself carries greater risk for both the mother and the fetus. Lactation It is not known whether amlodipine is excreted into breast milk. The decision 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 on the possible effect of amlodipine on fertility are insufficient. In a mouse study, additional effects on male fertility were recorded.

How to use Amlovas and 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 a sufficient amount of 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 agents in patients with angina that remains refractory to treatment with adequate doses of nitrates and/or beta-blockers. When Amlovas is prescribed together with thiazide diuretics, beta-adrenergic blockers, or ACE inhibitors, no change in the dosing regimen is required. In elderly patients, the usual dosing regimen is recommended, but increasing the dose should be done with caution. Hepatic impairment Dosing recommendations have not been established for patients with mild to moderate hepatic impairment; therefore, dose selection should be done with caution and should start from the lowest range of the dosing interval. 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 eliminated by dialysis. Hypertensive children and adolescents 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 of 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.