Amlodipine-Astrapharm
Release Forms:
Composition:
- active substance: amlodipine;
- 1 tablet contains amlodipine besylate in terms of 100% substance 5 mg or 10 mg;
- excipients: calcium hydrogen phosphate, microcrystalline cellulose, magnesium stearate, corn starch.
Dosage form. Tablets.
Basic physical and chemical properties: tablets of white color, flat-cylindrical shape, edges of surfaces are beveled, on the one hand – risk.
10 tablets in a blister, 2, 3, or 10 blisters in a box.
Indications:
- Arterial hypertension.
- Chronic stable angina.
- Vasospastic angina (Princemetal angina).
Contraindications:
- Hypersensitivity to dihydropyridines, amlodipine, or any other component of the drug.
- Severe hypotension.
- Shock (including cardiogenic shock).
- Obstruction of the excretory tract of the left ventricle (eg, severe aortic stenosis).
- Hemodynamically unstable heart failure after acute myocardial infarction.
Method of application and dose:
Adults.
Typically, for the treatment of hypertension and angina, the recommended starting dose is 5 mg amlodipine once daily. Depending on the patient’s response to therapy, the dose may be increased to a maximum dose of 10 mg once daily.
In patients with angina, the drug can be used as monotherapy or in combination with other antianginal drugs with resistance to nitrates and/or adequate doses of β-blockers.
There is an experience in the use of the drug in combination with thiazide diuretics, α-blockers, β-blockers or angiotensin-converting enzyme inhibitors in patients with hypertension.
There is no need to adjust the dose of the drug when used concomitantly with thiazide diuretics, β-blockers and angiotensin-converting enzyme inhibitors.
Children from 6 years with arterial hypertension.
The recommended starting dose for this category of patients is 2.5 mg once daily. If the required blood pressure is not reached within 4 weeks, the dose can be increased to 5 mg per day. The use of the drug in doses above 5 mg for this category of patients has not been studied.
Elderly patients.
No dose adjustment is required for this category of patients. Dose escalation should be performed with caution.
Patients with impaired renal function.
It is recommended to use the usual doses of the drug, as changes in the concentration of amlodipine in blood plasma are not associated with the severity of the renal failure. Amlodipine is not removed by dialysis.
Use in patients with impaired liver function.
Doses for use in patients with mild to the moderate hepatic impairment have not been established, so dose selection should be done with caution and start with the lowest dose (see sections “Features of use” and “Pharmacological properties. Pharmacokinetics”).