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Dosage form: & nbsp
Pills.
Composition:

1 tablet contains:

active substances: triamterene 25,000 mg, hydrochlorothiazide 12,500 mg; Excipients: lactose monohydrate 63,000 mg, potato starch 20,725 mg, povidone K 25 3,900 mg, magnesium stearate 1,300 mg, silicon dioxide colloid 0,975 mg, sodium carboxymethyl starch 2,600 mg.

Description:Yellow, round tablets with a risk on one side and with bevelled edges.
Pharmacotherapeutic group:Diuretic combination.
Pharmacodynamics:
Combined drug. Has a diuretic and hypotensive effect. Contains hydrochlorothiazide - Thiazide diuretic, diuretic effect, which is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium and water ions in the distal nephron: delays excretion of calcium ions, uric acid. Has an antihypertensive effect, which is due to the expansion of arterioles. Does not affect normal blood pressure (BP). The diuretic effect is manifested after 1-2 hours and reaches a maximum - after 4 hours, the duration of the action, depending on the dose, is 10-12 hours. The hypotensive effect develops after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.
Triamterene is a potassium-sparing diuretic, reduces the permeability of cellular membranes of distal tubules for sodium ions and enhances their excretion in the urine without increasing the excretion of potassium ions. The secretion of potassium ions in the distal tubules is reduced. In combination with hydrochlorothiazide, triamterene is able to reduce hypokalemia caused by thiazide diuretics and enhance the diuretic effect of hydrochlorothiazide. The diuretic effect of triamterene after ingestion is noted after 15-20 minutes. The maximum effect is 2-3 hours, the duration of the action is 12 hours.
Pharmacokinetics:
Hydrochlorothiazide is not absorbed from the gastrointestinal tract completely (60-80% of the dose taken internally), however, rather quickly. The connection with blood plasma proteins is 40%, the apparent volume of distribution is 3-4 l / kg. The maximum concentration of hydrochlorothiazide in blood plasma is 2 μg / ml. Half-life is about 3-4 hours. Hydrochlorothiazide not subject to significant metabolism. The primary way of its elimination is renal excretion (filtration and secretion) of the unchanged drug. Hydrochlorothiazide penetrates the placental barrier.Triamterene quickly, but not completely (30-70% of the dose) is absorbed from the gastrointestinal tract. To a moderate extent (67%) it binds to blood plasma proteins. The maximum concentration in the blood plasma is reached after 2-4 hours. It undergoes biotransformation in the liver with the formation of both active and inactive metabolites. The half-life of the unchanged drug is normally 1.5-2 hours (with anuria - 10 h), metabolites - up to 12 h. The main way to remove triamterene - through the intestine, secondary - by the kidneys.

Indications:
- edematous syndrome of various genesis (chronic heart failure, nephrotic syndrome, liver cirrhosis);

- arterial hypertension.
Contraindications:Hypersensitivity to the drug or to sulfonamides, chronic renal failure, anuria, acute glomerulonephritis, severe hepatic insufficiency, precoma and hepatic coma, hyperkalemia, lactation, age under 18 years (efficacy and safety not established), I trimester of pregnancy.
Carefully:With caution - diabetes mellitus, gout, patients with impaired liver function and / or kidneys, deficiency of folic acid (in patients with cirrhosis of the liver).
Dosing and Administration:
Inside, not liquid, squeezed a little water after eating.With edematous syndrome, the initial dose is determined by the severity of water-electrolyte metabolism and is usually 1 tablet 2 times a day after meals, then it is possible to increase the dose to the maximum daily (4 tablets per day): 2 tablets after breakfast and 2 tablets after lunch.
When compensating edema, they switch to maintenance therapy for 1-2 tablets after 1 -2 days.
With arterial hypertension - the initial dose of 1 tablet a day (in the morning, after breakfast), then gradually increase the dose. The maximum daily dose is 4 tablets. In patients with impaired renal function (creatinine clearance - 30-50 ml / min.), The maximum daily dose -1 tablet.
Side effects:

From the digestive system: nausea, vomiting and sometimes diarrhea (when taking the drug before meals), pain and discomfort in the epigastric region, colicky abdominal pain, constipation, dry mouth, thirst, in single cases - hemorrhagic pancreatitis, and in the presence of gallstones - acute cholecystitis.

From the central nervous system: uncoordinated movements, drowsiness, fatigue, headache, nervousness.

From the side of the locomotive system: muscle tension, muscle weakness, cramps calf muscles.

From the cardiovascular system: palpitations, decreased blood pressure, cardiac arrhythmias and impaired blood circulation regulation with dizziness, confusion, or a tendency to faint. In connection with a large loss of fluid and a decrease in the volume of circulating blood, when using the drug in high doses and / or abundant urine release, thrombi may develop, embolism develop, in rare cases convulsions, confusion, vascular collapse, and acute renal failure.

From the side of metabolism: a temporary increase in the concentration of nitrogen-containing substances released by the kidneys (urea, Creatinine) in the blood (mainly at the beginning of treatment), disorders of fluid and electrolyte balance, mainly reduction of sodium, magnesium, chloride in blood, a reduction or an increase in the potassium content (with prolonged continuous use of the drug), hypercalcemia, reduced tolerance to glucose. It is possible to increase the content of uric acid in the blood, on the basis of which, in some particularly predisposed patients, gout attacks can be triggered, and the formation of urinary stones can be noted.In sensitive patients, depending on the accepted total dose of the drug, an increase in the lipid content in the blood can be observed. In connection with the increase in the concentration of glucose in the blood, the already existing form of diabetes mellitus may become latent or aggravate. The drug can promote the accumulation of nonvolatile acids in the blood (metabolic acidosis).

On the part of the organs of vision: visual impairment, worsening of already existing myopia or a decrease in the production of tear fluid.

On the part of the hematopoiesis system: aplastic anemia, leukopenia, thrombocytopenia, agranulocytosis, megaloblastic anemia with a previous folate deficiency in the body, hemolysis resulting from the appearance of autoantibodies to the active substance hydrochlorothiazide in the blood with the simultaneous use of methyldopa.

Allergic reactions: reddening of the skin, skin itching, urticaria, systemic lupus erythematosus, photoallergic exanthema, fever, hypersensitivity reactions (anaphylactoid reactions), severe inflammation of the blood vessels and non-bacterial inflammation of the kidney tissue (aseptic interstitial nephritis).In a few cases, a sudden development of pulmonary edema with symptoms of shock was described. The reason for this is probably the allergic reaction of patients to the active substance hydrochlorothiazide.

Other: icteric skin color, mucous membranes and sclera.

Overdose:Symptoms: marked decrease in blood pressure.
Treatment: symptomatic.
Interaction:
Medicines that bind intensively to blood proteins (indirect anticoagulants, clofibrate, non-steroidal anti-inflammatory drugs) increase the diuretic effect of the drug.
The hypotensive effect is enhanced by vasodilators, barbiturates, phenothiazines, tricyclic antidepressants, ethanol.
Triampur enhances the neurotoxicity of salicylates, weakens the effect of oral hypoglycemic drugs, norepinephrine, epinephrine and antidotal drugs, increases the effects (including side effects) of cardiac glycosides, cardiotoxic and neurotoxic effects of lithium, the effect of curare-like muscle relaxants, reduces the excretion of quinidine.
With the simultaneous administration of methyldopa, the risk of hemolysis increases. Kolestyramine reduces the absorption of Triampur.
Chlorpropamide with simultaneous reception with Triampur can lead to severe hypokalemia.
When combined with non-steroidal anti-inflammatory drugs, it is possible to develop acute renal failure.
Special instructions:
With prolonged treatment, it is necessary to periodically monitor the blood levels of potassium, sodium, chlorine, urea, creatinine, glucose, uric acid, a picture of peripheral blood (with a suspicion of a lack of folic acid). At the beginning of treatment, the drug should avoid potentially dangerous activities requiring increased attention and speed of psychomotor reactions (against a background of lowering blood pressure - slowing the reaction rate).
Do not take two doses of the drug at the same time, if you missed taking the drug.
Effect on the ability to drive transp. cf. and fur:

Form release / dosage:
Tablets 12.5 mg + 25 mg.
Packaging:
50 tablets per vial of colorless glass with polyethylene stopper of white color from PE of low density with relief
the inscription "AWD". 1 bottle per cardboard pack together with instructions for use.
Storage conditions:
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Shelf life:
5 years.Do not use after the expiry date printed on the package.
Terms of leave from pharmacies:On prescription
Registration number:П N015340 / 01
Date of registration:12.12.2008
The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
Manufacturer: & nbsp
Representation: & nbspTeva Teva Israel
Information update date: & nbsp23.09.2015
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