Expiration date: 02/2025
Composition
One tablet contains
active substance:
1.5 mg / 5 mg tablets: indapamide 1.5 mg and amlodipine besilate 6,935 mg, (equivalent to 5 mg amlodipine)
1.5 mg / 10 mg tablets: indapamide 1.5 mg and amlodipine besilate 13.87 mg, (equivalent to 10 mg amlodipine)
excipients: hypromellose 4000, lactose monohydrate, magnesium stearate, povidone K 30, silicon colloidal anhydrous dioxide, calcium hydrophosphate dihydrate, microcrystalline cellulose, sodium croscarmellose, corn starch pre-gelatinized
shell: gylcerin, hypermallus, iron oxide red (E 172), macrogol 6000, magnesium stearate, titanium dioxide (E 171), purified water
Description
Two-layer round-shaped tablets, film-coated, white, with an engraved symbol on one side of the tablet (for a dosage of 1.5 mg/5 mg);
Two-layer tablets round, film-coated, pink, with an engraved symbol on one side of the tablet (for a dosage of 1.5 mg/10 mg).
Pharmacotherapeutic group
Blockers of" slow " calcium channels. "Slow" calcium channel blockers in combination with diuretics. Amlodipine and diuretics.
Code ATX C08GA02
Pharmacological properties
Pharmacokinetics
Indapamid:
Indapamide 1.5 mg is represented by slow release, which is based on a special matrix carrier, providing a gradual controlled release of indapamide.
Absorption:
The released indapamide is rapidly and completely absorbed in the gastrointestinal tract.
Eating slightly increases the absorption of the drug, without affecting the completeness of the absorption of the active substance.
The maximum concentration in the blood plasma is achieved after 12 hours after ingestion of a single dose. In repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between doses of the drug are smoothed. There is an individual variability of drug absorption parameters.
Distribution:
About 79 % of the drug binds to plasma proteins.
The half-life is 14-24 hours (average 18 hours).
The equilibrium concentration is achieved after 7 days of drug administration.
When re - taking the drug is not observed its cumulation.
Breeding:
Indapamide is excreted in the form of inactive metabolites, mainly by the kidneys (70% of the administered dose) and through the intestine (22 %).
Amlodipine:
Amlodipine presents a quick release.
Absorption, distribution, plasma protein binding:
After oral administration of therapeutic doses, amlodipine is well absorbed, reaching a maximum concentration in the blood 6-12 hours after taking the drug. Absolute bioavailability is 64-80%. The volume of distribution is approximately 21 l/kg. In vitro studies have shown that approximately 97.5% of circulating amlodipine is bound to proteins of blood plasma.
Eating has no effect on the bioavailability of amlodipine.
Biotransformation / excretion
The final half-life of the blood plasma is about 35-50 hours, which allows you to take the drug once a day. Amlodipine is actively metabolized in the liver with the formation of inactive metabolites: 10% unchanged, 60% of metabolites excreted in the urine.
Indications for use
- in the treatment of essential hypertension in patients taking indapamide and amlodipine in the same doses as in a fixed combination.
Dosage and administration
The drug is recommended to take in the morning before meals, 1 time per day. The tablet should be swallowed whole, without chewing, drinking water.
The combination drug in fixed doses is not suitable for initial therapy. If a dosage change is required, titration should be carried out with individual components.
The duration of treatment is determined by the attending physician.
