Indapen
Producer: Polpharma/Medana Pharma S. A. (Polfarm / Medan of Pharm S.A.) Poland
Code of automatic telephone exchange: C03BA11
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: индапамид 2,5 mg
Other ingredients: cellulose microcrystallic, кросповидон, magnesium stearate, gipromelloza, stearic acid, titanium dioxide.
Pharmacological properties:
Pharmacodynamics. Indapamid — tiazidopodobny diuretic with hypotensive action. The vascular mechanism of action is caused by reduction of contractility of unstriated muscles of vessels due to influence on transmembrane ion exchange (reduction of intracellular transport of calcium) and stimulation of synthesis of E2 prostaglandin having vasodilating action and, respectively, acting hypotensively. Indapamid reduces the ABP gradually. The hypotensive effect of an indapamid is more expressed, than diuretic. Hypotensive action is shown at the raised ABP.
Indapamid reduces a hypertrophy of a left ventricle. Drug is easily dissolved in fats, quickly soaked up by walls of vessels, reabsorbirutsya easily in proximal tubules of kidneys and is slowly removed with urine. Practically does not influence the lipidic status (the general XC, XC LPNP and TG) and does not break glucose metabolism, even patients with intolerance have glucose, patients with a diabetes mellitus and AG.
Pharmacokinetics. After oral administration индапамид it is quickly and completely soaked up in a GIT. Cmax of an indapamid in a blood plasma are reached in 1–2 h after oral administration. Food does not influence drug absorption speed. Indapamid contacts proteins of a blood plasma for 71–79%. T½ makes about 15 h. Steady concentration of active ingredient are reached in 4 days of intake of 2,5 mg/days Indapamid is metabolized in a liver. 60–70% of the accepted dose are removed with urine in the form of metabolites and only 5–7% — in not changed look. 20–30% of the accepted dose are removed with a stake.
Indications to use:
Arterial hypertension.
Route of administration and doses:
Indapen is intended for oral administration.
The recommended scheme of a drug dosing Indapen — 1 tablet (2,5 mg) of 1 times a day, in the morning.
Features of use:
With abnormal liver functions tiazidopodobny diuretics can cause development of hepatic encephalopathy in patients. At emergence of symptoms of hepatic encephalopathy use of an indapamid needs to be stopped immediately.
During treatment periodic control of potassium concentrations, sodium and uric acid in a blood plasma is necessary. Determination of level of elekrolit at patients with disturbance of water and electrolytic balance is especially important. At use of an indapamid need of control of concentration of uric acid for a blood plasma of patients with gout is caused by a possibility of increase in its level that can lead to an exacerbation of a disease. Due to a possibility of increase in level of glucose in blood at treatment indapamidy control of level of glucose at patients with a diabetes mellitus is necessary.
It is impossible to accept индапамид together with other drugs raising калийурез.
Tiazida and tiazidopodobny diuretics are effective only at normal function of kidneys or at its minimum disturbances (concentration of creatinine <25 mg/l, 220 µmol/l).
Use of drug for treatment of athletes can become the reason of false positive results at a drug test.
As индапамид reduces the level of the iodine connected with protein in a blood plasma (perhaps, in view of the direct competition for protein-binding), patients cannot accept drug with dysfunctions of a thyroid gland.
Period of pregnancy and feeding by a breast. During pregnancy Indapen it is possible to accept only in urgent cases. Before purpose of drug Indapen it is necessary to weigh potential advantage and possible risk both for mother, and for a fruit. Indapamid is allocated with breast milk therefore during administration of drug feeding by a breast is not recommended.
Children. There is no sufficient experience of use of drug for children.
Influence on ability to manage vehicles and to work with mechanisms. At administration of drug Indapen there can be symptoms connected with arterial hypotension, in this case ability to control of vehicles and work with mechanisms can worsen.
Side effects:
The adynamy, dryness in a mouth, a headache and/or dizziness, nausea, a lock, spotty and papular rash, a purpura, an aggravation of symptoms of a system lupus erythematosus, allergic reactions, orthostatic hypotension, increase in concentration of uric acid, paresthesia, a hypopotassemia and a hyponatremia, a hypomagnesiemia, the increased concentration of glucose and lipids, increase in activity of enzymes of a liver are possible. In isolated cases hematologic changes (thrombocytopenia, a leukopenia, an agranulocytosis, aplastic anemia or hemolitic anemia), it was very seldom reported about a hypercalcemia. Patients with a liver failure have a potential risk of development of hepatic encephalopathy. Very seldom noted pancreatitis.
Interaction with other medicines:
Indapen it is impossible to accept together with astemizoly, galofantriny, pentamidine, terfenadiny, Vincaminum and erythromycin (in/in).
It is necessary to observe extra care at simultaneous use of Indapen with such medicines as:
• Baclofenum: hypertensive action amplifies;
• APF inhibitors: risk of decrease in the ABP and development of OPN at use of APF against the background of deficit of sodium (especially at patients with narrowing of a renal artery);
• Metforminum: can promote development of lactoacidosis;
• the radiopaque substances containing iodine: in case of the dehydration caused by use of diuretics the risk of developing of a renal failure, especially in that case when a large amount of contrast medium was used increases;
• calcium salts: risk of increase in concentration of calcium in a blood plasma that is connected with reduction of allocation of the last kidneys;
• cyclosporine: risk of increase in concentration of creatinine in a blood plasma;
• the drugs reducing potassium concentrations (Amphotericinum of V, GKS for system use, prolonged use of purgatives): risk of a hypopotassemia;
• neuroleptics and tricyclic antidepressants: strengthening of hypotensive action and orthostatic hypotension;
• digitalis drugs: the decrease in potassium concentrations caused indapamidy can increase toxicity of cardiac glycosides;
• antiarrhytmic drugs (quinidine, Disopyramidum, Amiodaronum, bretylium): can cause tachycardia as torsades de pointes (trembling/blinking);
• lithium salts: risk of increase in concentration of lithium that it is connected with allocation reduction by kidneys;
• NPVP: decrease in hypotensive action of an indapamid is possible.
Contraindications:
Hypersensitivity to the indapamid and other sulfonamides and/or other substances which are a part of drug. Heavy renal failure (anury). Hepatic encephalopathy and heavy abnormal liver functions. Hypopotassemia (mmol/l <3,5).
Overdose:
Acute intoxication indapamidy can be followed by nausea, vomiting, an adynamy, an abdominal pain, disturbances of water and electrolytic balance, arterial hypotension and the subsequent oppression of respiratory function.
Treatment: in an initial stage of intoxication at patients who are in consciousness it is necessary to wash out a stomach, to cause vomiting or to use the probe. It is necessary to recover water and electrolytic balance; it is necessary to support functions of respiratory and cardiovascular systems.
Storage conditions:
In the dry and protected from light place at a temperature not above 25 °C.
Issue conditions:
According to the recipe
Packaging:
The tab. п / about 2,5 mg, No. 20, No. 30, No. 60.