Triampur compositum

General characteristics. Structure:

Active agents: 25 mg of Triamterenum and 12,5 mg of Hydrochlorthiazidum,

excipients: lactoses monohydrate, potato starch, K 25 povidone, silicon dioxide high-disperse, carboxymethyl starch of sodium, magnesium stearate.

Description:

Yellow, round, flat tablets with risky on one party and with slanted edges, smooth surfaces, integral edges and an identical look.

Pharmacological properties:

Pharmacodynamics. The combined drug which effect is caused by properties of the components which are its part; has diuretic and hypotensive effect. Contains Hydrochlorthiazidum - diuretic of average force of action and kaliysberegayushchy diuretic Triamterenum,

Girokhlortiazid - thiazide diuretic which diuretic effect is connected with disturbance of a reabsorption of ions of sodium, chlorine, magnesium, water in distal department of nephron; removal of calcium ions, uric acid detains. Possesses anti-hypertensive action; hypotensive action develops due to expansion of arterioles. Practically does not exert impact on the normal arterial pressure (AP). The diuretic effect is shown in 1-2 hours and reaches a maximum - in 4 h, action duration depending on a dose - 10 - 12 hours. Anti-hypertensive action - is shown is longer (till 24 o'clock).

Triamterenum – kaliysberegayushchy diuretic, reduces permeability of cellular membranes of distal tubules for ions of sodium and strengthens their allocation with urine without increase in allocation of potassium ions. Secretion of potassium ions in distal tubules decreases. In a combination with Hydrochlorthiazidum Triamterenum is capable to reduce the hypopotassemia caused by thiazide diuretics and to strengthen diuretic effect of Hydrochlorthiazidum.

Diuretic action of Triamterenum after intake is noted in 15-20 min. The maximum effect - in 2-3 hour, action duration - 12 hours. Pharmacokinetics

Gidrokhlortiazip is quickly soaked up from digestive tract, absorption makes 80% of the dose accepted inside. Communication with proteins of a blood plasma - 60-80%. Bioavailability makes 70%. The maximum concentration it in plasma after reception of 25 mg of Hydrochlorthiazidum reaches 142 ng/ml in 2-5 hours. In the therapeutic range of doses the average size of the area under a curve "concentration - time" (AUC) increases in direct ratio to increase in a dose. At single purpose of Hydrochlorthiazidum in days cumulation is insignificant.

Gets through a gematoplatsentarny barrier and into breast milk.

Elimination half-life (T 1/2) - from 6 to 8 hours. It is not metabolized. It is removed through kidneys - 95% in an invariable look and about 4% in the form of a hydrolyzate-2 - amine - 4-hloro - t - a benzenedisulfonamida by glomerular filtering and active canalicular secretion in proximal department of nephron. In 60 minutes after intake it is noted in urine and within 24 hours about 50-70% of the entered dose are allocated.

Triamterenum is quickly soaked up from zheludochno - an intestinal path (80% of the accepted dose). About 60% contact proteins of a blood plasma. The maximum concentration in a blood plasma is reached in 2-4 hour. The t 1/2 in a blood plasma makes 4-7 hours. At cirrhosis of T 1/2 can increase by 4 times.

It is metabolized in a liver. The main active metabolite are 4 hydroxytriamterenum, T!/2 who in a blood plasma is made by 2-3 hours.

Triamterenum in an invariable look and in small amounts through kidneys and with bile, an active metabolite - generally kidneys and an insignificant part - together with bile is allocated.

Indications to use:

Arterial hypertension, edematous syndrome of various genesis (heart failure, nephrotic syndrome, cirrhosis).

Route of administration and doses:

Pill is taken inside after food, without chewing and washing down with a small amount of liquid. During treatment it is necessary to use enough liquid.

Doses of drug are selected the doctor individually for each patient. Hypostases:

In an initiation of treatment appoint 2 - 4 tablets of drug (in the morning and at noon). Further doses are appointed depending on organism dehydration degree. A maintenance dose - 1 pill a day which is taken every day in the morning, or on 2 tablets every other day (on 1 tablet in the morning and at noon). If necessary it is possible to increase this maintenance dose to 4 tablets a day (on 2 tablets in the morning and at noon). Arterial giperteiziya:

The initial dose of drug makes 2 tablets in the morning and 2 tablets at noon. At additional reception of other antihypertensives or 2 tablets of Triampur compositum a day are sufficient for performing long therapy (on 1 tablet in the morning and at noon).

The accompanying therapy at treatment of heart failure cordial glycosides: doses of drug select depending on data of inspection of the patient: appoint 2 tablets a day, if necessary, increase a dose as much as possible to 4 tablets a day (on 1 tablet or as much as possible on 2 tablets in the morning and at noon). At reduced function of kidneys (creatinine of serum of 1,5 - 1,8 mg/dl or clearance of creatinine (30 - 50ml/mines) the daily dose making 1 tablet should not be exceeded.

Features of use:

At prolonged treatment it is necessary to control periodically in blood the content of potassium, sodium, chlorine, urea, creatinine, glucose, uric acid, a picture of peripheral blood (in case of suspicion on a lack of folic acid), especially at simultaneous treatment by cardiac glycosides, adrenal hormones or purgatives.

At suspicion on deficit of folic acid (a lack of vitamin B, for example, at alcoholic cirrhosis) it is necessary to control a pattern of peripheral blood regularly.

Before a research of function of epithelial body and not less than three days before carrying out a glucose tolerance test treatment by drug is interrupted, otherwise results of researches can be distorted. Treatment is carried out under constant medical control.

It is impossible to accept 2 doses of drug at the same time if administration of drug is missed. It is necessary to avoid potentially dangerous types of activity requiring special attention and speed of psychomotor reactions (against the background of decrease in the ABP delay of speed of response is possible. It is especially strongly expressed in an initiation of treatment, at increase in a dose and replacement of one drug with another, and also at the simultaneous use with alcohol).

At the patients carrying contact lenses during treatment products of the lacrimal liquid can decrease.

Side effects:

From the alimentary system: nausea, vomiting and sometimes diarrhea (at administration of drug before food), pains and discomfort in zpigastralny area, kolikoobrazny abdominal pains, a lock, dryness in a mouth. thirst, in isolated cases - hemorrhagic pancreatitis, and in the presence of gallstones - acute cholecystitis.

From the central nervous system: in-coordinate movements, drowsiness, feeling of fatigue, headache, nervousness,

From a musculoskeletal system: muscle tensions, muscular weakness, spasms of gastrocnemius muscles.

From cardiovascular system: heartbeat, decrease in the ABP, disturbance of a cordial rhythm and disturbance of regulation of blood circulation with dizzinesses, an oglushyonnost of consciousness or tendency to faints. Due to the big loss of liquid and reduction of volume of the circulating blood against the background of use of drug in high doses and plentiful release of urine can be noted a thromboembolism, in rare instances - spasms, confusion of consciousness, a vascular collapse and an acute renal failure.

From a metabolism: temporary increase in concentration of the nitrogen-containing substances emitted with urine (urea, creatinine), in blood (generally in an initiation of treatment), disturbances of water and electrolytic balance, generally reduction of content of sodium, magnesium, chlorides in blood, decrease or increase in content of potassium (at prolonged continuous use of drug), a hypercalcemia, decrease in tolerance to glucose. Increase in content of uric acid in blood is possible on the basis of what at some especially predisposed patients gout attacks can be provoked, formation of urinary stones can be noted. At sensitive patients depending on the accepted total dose of drug increase in maintenance of lipids in blood can be observed. Due to the increase in concentration of sugar in blood latent can be shown or be aggravated already existing diabetes mellitus form. Medicine can promote accumulation of nonvolatile acids in blood (metabolic acidosis).

From organs of sight: vision disorders, deterioration in already available short-sightedness or reduction of products of the lacrimal liquid.

From system of a hemopoiesis: aplastic anemia, leukopenia, thrombocytopenia, agranulocytosis. megaloblastny anemia at the previous deficit of folic acid in an organism, the hemolysis resulting from emergence in blood of autoantibodies to active agent to Hydrochlorthiazidum at simultaneous use Methyldopums, Allergic reactions: erubescence, itch, urticaria, system lupus erythematosus, photoallergic dieback, fever, hypersensitivity reactions (anaphylactoid reactions), heavy inflammations of blood vessels and not bacterial inflammations of tissue of kidneys (aseptic intersticial nephrite). In isolated cases suddenly developing was described swelled a lung. Probably allergic reaction of patients to active agent Hydrochlorthiazidum is the reason of it. Other: icteric coloring of skin, mucous membranes and scleras.

Interaction with other medicines:

• hypotensive action amplifies at simultaneous use with others hypotensive, diuretic, vasodilating, sedatives (for example, barbiturates), the drugs oppressing function of the central nervous system means (fenotiazina), tricyclic antidepressants or ethanol.
• At a concomitant use of inhibitors of the angiotensin-converting enzyme (ACE) in an initiation of treatment perhaps sharp decrease in the ABP.
• Hypotensive and diuretic action of Hydrochlorthiazidum can weaken under the influence of nonsteroid antiinflammatory and antirheumatic drugs, for example, of salicylates, indometacin).
• At simultaneous use with non-steroidal anti-inflammatory drugs (indometacin) development of an acute renal failure is possible.
• Strengthens a neurotoxicity of salicylates.
• Strengthens kardio-and neurotoxic effect of drugs of lithium.
• Colestyraminum and колестипол (the means applied at a giperlipoproteinemiya of II and type) reduce absorption of Hydrochlorthiazidum from a GIT.
• At co-administration from metildopy hemolysis is possible.
• The hyperpotassemia can be observed at a concomitant use of salts of potassium, at treatment by kaliysberegayushchy medicines or certain hypotensive drugs (angiotensin-converting enzyme inhibitors).
• The concomitant use with glucocorticoids or laxatives to means can lead to a hypopotassemia.
• Chlorproramidum can lead to the expressed hypopotassemia.
• Strengthens action of kurarepodobny muscle relaxants
• Strengthens action and collateral influence of cardiac glycosides with deficit of potassium and/or magnesium in an organism,
• Weakens action of peroral hypoglycemic means,  Norepinephrinum, Epinephrinum and antigouty means,
• Reduces removal of quinidine from an organism.
• Strengthens influence of tsitostatik on marrow
• Expressiveness of decrease  in a potentiality increases at a concomitant use of beta adrenoblockers.

Contraindications:

Hypersensitivity to active agents or to streptocides, a chronic renal failure (clearance of creatinine less than 30 ml/min., serum creatinine more than 1.8 mg/dl), an anury, an acute glomerulonephritis, heavy abnormal liver functions (a prekoma and a hepatic coma), disturbances of water and electrolytic balance (a hyperpotassemia, a hypercalcemia or a hypopotassemia, a hyponatremia), a hypovolemia, pregnancy, the lactation period (in case of need purposes of drug to resolve an issue of the breastfeeding termination).

With care drug should be used at an impaired renal function and/or a liver, an urolithiasis, gout, a diabetes mellitus and at suspicion on deficit of folic acid of an organism (for example, at the cirrhosis caused by a chronic alcohol abuse), age up to 18 years (efficiency and safety is not established), risk of development of acidosis.

Overdose:

Symptoms: frequent desires to an urination, weakness, fatigue, confusion of consciousness, paresthesia, the expressed decrease in the ABP, disturbance of a heart rhythm and sometimes - spasms.

Treatment: the gastric lavage and symptomatic therapy is shown.

Storage conditions:

List B. At a temperature not above 30 °C. To store in the place, unavailable to children! Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

50 tablets in a bottle of colourless glass with a polyethylene stopper. To 1 bottle in a cardboard pack together with the application instruction.