Apo-Triaside - instructions for use, dose, side effects, contraindications

Active substanceHydrochlorothiazide + TriamtereneHydrochlorothiazide + Triamterene

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Apo-Triazid

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Apothec Inc. Canada

Triamtel

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VALENTA PHARM, PAO Russia

Dosage form: & nbsp

pills

Composition:

1 tablet contains:

active substances: hydrochlorothiazide 25 mg, triamterene 50 mg

Excipients: lactose monohydrate - 196.1 mg, magnesium stearate 4.0 mg, silicon dioxide colloid (aerosil) 0.6 mg, croscarmellose sodium 24.6 mg, dye yellow (E110) 0.3 mg.

Description:

Round flat pills of light orange color with bevelled edges. On the surface of the tablets, blotches of a darker color are allowed. One side with the risk and engraving of "ARO" over "50-25", the other side - smooth.

Pharmacotherapeutic group:Diuretic combination

ATX: & nbsp

C.03.E.A.01 Hydrochlorothiazide in combination with potassium-sparing drugs

Pharmacodynamics:

Combined drug. Has a diuretic and antihypertensive effect.

Contains hydrochlorothiazide - Thiazide diuretic, the diuretic effect of which is associated with a violation of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron: delays the excretion of calcium ions, uric acid. Has antihypertensive properties; the hypotensive effect develops due to the expansion of arterioles. Does not affect normal blood pressure.The diuretic effect of hydrochlorothiazide occurs in 1-2 hours, reaches a maximum after 4 hours and lasts for 6-12 hours. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

Triamterene - 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 absorbed from the gastrointestinal tract incompletely (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 taken is absorbed from the gastrointestinal tract. Moderately (67%) binds to blood plasma proteins. The maximum concentration in the blood plasma is reached after 2-4 hours. Biotransformed in the liver with the formation of both active and inactive metabolites. The half-life of the drug is normally 1,5-2 hours (with anuria - 10 hours), metabolites - up to 12 hours. The main way to remove triamterene with bile through the intestine, secondary - the kidneys.

Indications:

- Ocular syndrome of various genesis (chronic heart failure, nephrotic syndrome, liver cirrhosis);

- arterial hypertension.

Contraindications:Hypersensitivity to the drug (including sulfanilamides), chronic renal failure, anuria, acute glomerulonephritis, severe hepatic insufficiency, precoma, hepatic coma, hyperkalemia,severe renal dysfunction (creatinine clearance less than 30 ml / min), lactation period, age under 18 years (efficacy and safety not established), pregnancy, lactase deficiency, lactose intolerance, glucose-galactose malabsorption (the drug contains lactose).

Carefully:Caution should be used in patients with impaired renal and / or liver function, urolithiasis, gout, diabetes mellitus, and suspected folic acid deficiency in the body (eg, liver cirrhosis due to chronic alcohol abuse), patients under the age of 18 years efficacy and safety not established), with the risk of acidosis.

Pregnancy and lactation:

Apo-Triaside is contraindicated in pregnancy.

If you need to use Apo-Triaside during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Inside, not liquid, after eating, with plenty of water.

Edema 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 the dose may be increased: 2 tablets after breakfast and 1 tablet after lunch.When compensating edema, they switch to maintenance therapy for 1-2 tablets after 1-2 days.

Arterial hypertension: 1 tablet inside, not liquid, squeezed small _; amount of water, after breakfast. Then the dose can be increased. In patients with impaired renal function (creatinine clearance is 30-50 ml / min.).

The maximum daily dose of 4 tablets.

Side effects:

From the digestive system: sialadenitis, nausea, vomiting, diarrhea, pain and discomfort in the epigastric region, colic pain in the abdomen, constipation, dryness of the oral mucosa, thirst, pancreatitis, cholestatic jaundice, acute cholecystitis.

From the central nervous system: dizziness, headache, paresthesia, anorexia, depression, sleep disorders, increased excitability.

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

From the side of metabolism: a decrease in glucose tolerance, exacerbation of gout, hypochloremic alkalosis.

From the side of the organ of vision: visual impairment, worsening of already existing myopia or a decrease in the production of tear fluid, xantopsy.

From the skin and subcutaneous tissue: skin rash (including hemorrhagic), itching, anaphylactoid reactions, skin redness, photosensitivity reactions, urticaria, vasculitis, exacerbation of systemic lupus erythematosus, toxic epidermal necrolysis.

From the hematopoietic and lymphatic system: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, oppression of bone marrow hematopoiesis.

From the cardiovascular system: heart palpitations, marked decrease in ad, orthostatic hypotension, heart rhythm disturbances, thrombosis, embolism.

From the respiratory system: Respiratory distress syndrome (including pneumonia and pulmonary edema).

From the urinary system: nephrolithiasis, interstitial nephritis.

Laboratory research: hyperglycemia, glucosuria, hyperuricemia, hyponatremia, hypomagnesemia, hypochloraemia, hyponatremia, hypo- or hyperkalemia, hypercalcemia, hypercholesterolemia, hypertriglyceridemia.

Other: increased fatigue, fever.

Overdose:

Symptoms: marked reduction in blood pressure.

Treatment: symptomatic.

Interaction:

- Hypotensive effect is enhanced by simultaneous application to other hypotensive, diuretic, vasodilating, sedatives (for example, barbiturates), drugs depressing the central nervous system (phenothiazines), tricyclic antidepressants or ethanol-containing drugs.

- With simultaneous reception inhibitors of angiotensin-converting enzyme (ACE) at the beginning of treatment, a sharp drop in blood pressure is possible.

- The hypotensive and diuretic effect of hydrochlorothiazide may weaken under the influence of non-steroidal anti-inflammatory (NSAIDs) and antirheumatic drugs, for example, salicylates, indomethacin).

- When used simultaneously with indomethacin possible the development of acute renal failure.

- Enhances neurotoxicity salicylates.

- Strengthens cardio-and neurotoxic action lithium preparations.

- Kolestyramine and Colestypol (drugs used in hyperlipoproteinemia II a type) reduce the absorption of hydrochlorothiazide from the gastrointestinal tract.

- With simultaneous appointment with methyldopa hemolysis is possible.

- Hyperkalemia can occur with simultaneous admission potassium salts, in the treatment of potassium-sparing drugs (eg, veroshpirona) or certain antihypertensive drugs (angiotensin-converting enzyme inhibitors).

- Simultaneous reception with glucocorticoids or laxatives can lead to hypokalemia.

- Chloropropamide can lead to severe hypokalemia.

- Strengthens the action curare-like muscle relaxants

- Strengthens the action and side effect cardiac glycosides in the presence of a deficiency of potassium and / or magnesium in the body.

- Weakens the action hypoglycemic agents, taken inside and antipropassage preparations, and norepinephrine (norepinephrine), epinephrine (adrenaline).

- Reduces excretion quinidine from the body.

- Strengthens the influence cytostatics on the bone marrow.

- The severity of the decrease in potency increases with simultaneous admission beta-blockers.

- With simultaneous admission with vitamin D and calcium preparations, there may be hypercalcemia.

- With a simultaneous appointment with cyclosporine, the risk of developing hyperkalemia increases.

- With simultaneous use with theophylline, hypokalemia can occur.

- Do not use simultaneously with tacrolimus because of the high risk of developing hyperkalemia.

- Progesterone enhances the action of Apo-Triaside.

- With the simultaneous administration of apo-triazide with fluconazole, an increase in the concentration of fluconazole is possible.

Special instructions:

In case of long-term treatment, the content of potassium, sodium, chlorine, urea, creatinine, glucose, uric acid, peripheral blood should be monitored periodically, in case of suspected folate deficiency, especially with simultaneous treatment with cardiac glycosides, hormones of the adrenal cortex or laxatives means.

If you suspect a deficiency of folic acid (a lack of vitamin B, for example, with alcoholic cirrhosis of the liver), you should regularly monitor the picture of peripheral blood.

Before the study of parathyroid function and at least three days before the sample with a sugar load treatment with the drug is interrupted, otherwise the results of the research may be distorted. The treatment is carried out under constant medical supervision.

Do not take 2 doses of the drug at the same time, if you missed taking the drug.

In patients wearing contact lenses, the production of tear fluid may decrease during treatment.

Use in Pediatrics

Do not apply until age 18. Efficiency and safety is not established.

Effect on the ability to drive transp. cf. and fur:It is necessary to avoid potentially dangerous activities requiring increased attention and speed of psychomotor reactions (against the background of a decrease in blood pressure, the reaction speed may be slowed down). This is especially pronounced at the beginning of treatment, with increasing doses and replacing one drug with another, and also with simultaneous use of alcohol.

Form release / dosage:

Tablets, 25 mg hydrochlorothiazide + 50 mg triamterene.

Packaging:

50 tablets in bottles of high-density polyethylene.

1 bottle per cardboard pack together with instructions for use.

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

By 5 contour mesh packages in a cardboard bundle together with instructions for use.

For hospitals:

1000 tablets per bottle of high-density polyethylene.

90 bottles in a cardboard box together with instructions for use (the number of instructions corresponds to the number of bottles).

Storage conditions:

Store at a temperature of 15 to 25 ° C, in a dry place protected from light.

Keep out of the reach of children.

Shelf life:4 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011657 / 01

Date of registration:07.11.2011

Expiration Date:Unlimited

The owner of the registration certificate:Apothec Inc.Apothec Inc. Canada

Manufacturer: & nbsp

APOTEX, Inc. Canada

Representation: & nbspVECTOR-MEDICA CJSC VECTOR-MEDICA CJSC Russia

Information update date: & nbsp10.09.2017

Illustrated instructions

Instructions

Apo-Triazid (Triazide-Apo)