Arifam (indapamide) tablets with modified release 1.5 mg/5 mg. №30

active ingredients: indapamide, amlodipine;

1 tablet contains 1.5 mg of indapamide and 6.935 mg of amlodipine besilate, which corresponds to 5 mg of amlodipine, or 13.87 mg of amlodipine besylate, which corresponds to 10 mg of amlodipine;

excipients: hypromelose 4000 (E 464), lactose monohydrate, magnesium stearate (E 572), povidone (E 1201), colloidal anhydrous silicon dioxide, calcium hydrogen phosphate, microcrystalline cellulose (E 460), croscarmellose sodium (E 468), corn starch pregelatinized; film coat: glycerin (E 422), hypromelose (E 464), macrogol 6000, magnesium stearate (E 572), titanium dioxide (E 171), iron oxide red (E 172) (Arifam® 1.5 mg / 10 mg) .

Modified release tablets.

Basic physical and chemical properties:

Arifam® 1.5 mg/5 mg: white, round, film-coated tablet, debossed with ” ” on one side.

Calcium channel blockers and diuretics. Amlodipine and diuretics. Code ATX C08G A02.

Mechanism of action

Indapamide is a derivative of sulfonamides with an indole ring, pharmacologically related to thiazide diuretics, acting by inhibiting sodium reabsorption in the cortical segment of the kidneys. This increases the urinary excretion of sodium and chloride and, to a lesser extent, potassium and magnesium, thus increasing urine output and providing an antihypertensive effect.

Amlodipine is an inhibitor of the entry of calcium ions of the dihydropyridine group (a blocker of slow calcium channels or an antagonist of calcium ions), which prevents the transmembrane entry of calcium ions to the smooth muscles of the myocardium and blood vessels. The mechanism of antihypertensive action of amlodipine is the ability to relax vascular smooth muscle.

Pharmacodynamic effects

Phase II and III clinical studies have shown that when indapamide is used as monotherapy, the antihypertensive effect lasts 24 hours. This effect is manifested in doses in which the diuretic properties are minimal. The antihypertensive effect of indapamide is associated with an improvement in arterial elasticity, a decrease in arteriole resistance and a decrease in total peripheral vascular resistance. Indapamide reduces left ventricular hypertrophy.

When the recommended dose is exceeded, the therapeutic effect of thiazide and thiazide-like diuretics does not increase, while the number of side effects increases. In the absence of the effect of treatment, the dose should not be increased.

Also, during short-, medium- and long-term studies in patients with arterial hypertension, it was demonstrated that indapamide:

• does not affect the metabolism of lipids (triglycerides, low and high density lipoproteins);
• does not affect the metabolism of carbohydrates, even in diabetic patients with arterial hypertension.

In patients with arterial hypertension, taking amlodipine once a day provides a clinically significant decrease in blood pressure within 24 hours in both the supine and standing positions. Due to the slow onset of action of amlodipine, its use does not lead to acute hypotension. Amlodipine has not been associated with any metabolic side effects or changes in plasma lipid levels, so it can be used in patients with asthma, gout and diabetics.