Expiration date: 05/2025

Composition and form of issue:

1 tablet contains amlodipine 5 or 10 mg, in a contour 10 PCs., in a box of 2, 3 or 10 packages.

Pharmacological action:

Blocks the flow of calcium ions through cell membranes in smooth muscle cells of the myocardium and vessels. It has a direct relaxing effect on the smooth muscles of blood vessels, expands peripheral arterioles, which leads to a decrease in OPSS, reduces the load on the heart and reduces the need for myocardium in oxygen, dilates the coronary arteries, increasing the flow of oxygen to the myocardium.

Pharmacokinetics:

After ingestion quickly and almost completely (90%) is absorbed from the gastrointestinal tract. Bioavailability is 60-65%, Cmax in plasma is achieved in 6-12 h, the equilibrium concentration - in 7-8 days. The volume of distribution is approximately 20 l/kg, binding to plasma proteins more than 95%, and penetrates the GEB and breast milk. Metabolized mainly in the liver with formation of active metabolites, T1/2 — 35-45 hours Excreted by the kidneys (10% — unchanged and 60% as metabolites), and jelchew through the intestines.

Indications:

Arterial hypertension (monotherapy or in combination with tiazidnami dioretikami, ACE inhibitors or alpha - and beta-blockers), angina (stable and unstable, including prinzmetals or variant), dilated (non-ischemic) cardiomyopathy with severe chronic heart failure.

Contraindications:

Hypersensitivity, hypotension.

Use during pregnancy and breast-feeding:

It is possible only if the expected effect of therapy exceeds the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Side effect:

From the nervous system and sensory organs: dizziness, headache, drowsiness, fatigue rarely — mood changes, asthenia, convulsions, myalgia, visual impairment, paresthesia.

From the cardiovascular system and blood (hematopoiesis, hemostasis): heartbeat, tides.

From the digestive tract: nausea, abdominal pain, dyspeptic symptoms rarely — hyperplasia of the gums, increased levels of hepatic transaminases, jaundice.

With the genitourinary system: frequent urination, edema, impotence.

From the skin: allergic reactions (skin rash, itching), rarely — erythema multiforme.

Other: rarely-shortness of breath, gynecomastia.

Dosage and administration:

Inside, the initial dose of 5 mg / day, if necessary, the daily dose can be increased to 10 mg. the Maximum daily dose of 10 mg.

Overdose:

Symptoms: severe hypotension.

Treatment: maintenance of the cardiovascular system, monitoring of the heart and lungs, elevated position of the limbs, control of BCC and diuresis, the use of vasoconstrictors, the introduction of calcium gluconate (b/V).

Precautionary measures:

With caution should be prescribed to patients with impaired liver function, aortic stenosis, chronic heart failure.

Special instruction:

It is necessary to refrain from using the drug in pediatric practice, since the safety and efficacy of its use in children are not determined.