Hydrochlorothiazide - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline - 26.0 mg or 104.0 mg; lactose monohydrate 75.1 mg or 300.4 mg; croscarmellose sodium -1.3 mg or 5.2 mg; silicon dioxide colloid (aerosil) - 1.3 mg or 5.2 mg; calcium stearate - 1.3 mg or 5.2 mg.

Description:Round flat cylindrical tablets white or white with a yellowish tinge color, with a bevel for a dosage of 25 mg, with a facet and a risk on one side for a dosage of 100 mg.

Pharmacotherapeutic group:Diuretics

ATX: & nbsp

C.03.A.A.03 Hydrochlorothiazide

Pharmacodynamics:Thiazide diuretic of average duration of action. Has a diuretic effect, disrupts the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron.Diuretic effect develops after 1-2 hours, reaches a maximum after 4 hours and lasts 6-12 hours. The action decreases with a decrease in the glomerular filtration rate and stops at a value of at least 30 ml / min. In patients with diabetes insipidus has antidiuretic effect (reduces the volume of urine and increases its concentration). It has antihypertensive properties and can be used for this purpose both in monotherapy and for strengthening the antihypertensive effect of other drugs. The hypotensive effect develops due to the expansion of arterioles. Thiazides do not affect normal blood pressure. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect. Thiazide diuretics reduce the excretion of calcium in the urine and thereby reduce the formation of kidney stones.

Pharmacokinetics:It is absorbed from the gastrointestinal tract incompletely (60-80% of the dose taken internally). The connection with plasma proteins is 40%, the apparent volume of distribution is 3-4 l / kg. The maximum concentration in the blood plasma is determined after 2-5 hours.The half-life is 6-15 hours. It is not metabolized by the liver. It is excreted by the kidneys 95% unchanged and about 4% in the form of hydrolyzate-2-amino-4-chloro-t-benzene disulfonamide (reduced in alkaline urine) by glomerular filtration and active tubular secretion in the proximal part of the nephron. Penetrates through the placental barrier and into breast milk.

Indications:

-Arterial hypertension (used both in monotherapy and in combination with other antihypertensive agents);

-current syndrome of various genesis (chronic heart failure, nephrotic syndrome, acute glomerulonephritis, chronic renal failure, portal hypertension, treatment with corticosteroids, premenstrual syndrome);

-control of polyuria, mainly with nephrogenic diabetes insipidus;

-prophylaxis of the formation of stones in the urinary tract (reduction of hypercalciuria).

Contraindications:

-increased sensitivity to the drug or other sulfonamides;

anuria;

-generous renal (creatinine clearance below 30 ml / min) or liver failure;

- difficult-controlled diabetes mellitus;

Addison's disease;

-refractory hypokalemia, hyponatremia, hypercalcemia.

Carefully:

Use with caution in hypokalemia, hyponatremia, hypercalcemia, in patients with coronary heart disease, liver cirrhosis, in elderly patients, in patients suffering from lactose intolerance, with cardiac glycosides, with gout.

Pregnancy and lactation:Hydrochlorothiazide penetrates the placental barrier and into breast milk. Contraindicated use of the drug in the first trimester of pregnancy. In the second and third trimester of pregnancy, the drug can be prescribed only in case of acute necessity, when the benefit to the mother exceeds the potential risk to the fetus and / or the child (there is a risk of jaundice fetus or newborn, thrombocytopenia and other consequences). If it is necessary to prescribe the drug during lactation, breast-feeding should be stopped.

Dosing and Administration:

Inside, after eating. The dosage of the drug is determined individually. With constant a minimum effective dose is established.

Adults

As an antihypertensive agent: the usual initial daily dose of the drug is 25-50 mg once, as a monotherapy or in combination with other antihypertensive drugs. For some patients, an initial dose of 12.5 mg may be sufficient, either as monotherapy or in combination. It is necessary to apply a minimally effective dose, not exceeding 100 mg per day.

If hydrochlorothiazide combined with other antihypertensive drugs, it may be necessary to reduce the dose of another drug in order to prevent an excessive decrease in blood pressure. Hypotensive action occurs after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect. After discontinuation of treatment, the hypotensive effect persists for one week.

Edema syndrome of different etiology: the usual initial daily dose is 25-100 mg once a day or once every two days. Depending on the therapeutic effect, the dose can be reduced to 25-50 mg once a day or once every two days. In some severe cases, doses up to 200 mg per day may be required at the beginning of treatment.

Premenstrual syndrome: The usual dose is 25 mg per day and is applied from the onset of symptoms before the onset of menstruation.

Nephrogenic diabetes insipidus: The usual daily dose is 50-150 mg in several doses.

Children

Doses are set based on the weight of the child's body. A typical pediatric daily dose is 1-2 mg / kg body weight or 30-60 mg per square meter of body surface, is prescribed once a day. The total daily dose for children under 2 years of age is 12.5 - 37.5 mg; at the age of 2 to 12 years - 37.5 - 100 mg.

Side effects:

From the side of water-electrolyte metabolism and acid-base balance occur more often with prolonged intake in high doses:

-possibly hypokalemia and hypochloremic alkalosis: dry mouth, increased thirst, heart rhythm disturbances, mood and psyche changes, cramps or muscle pain, nausea, vomiting, unusual fatigue and weakness. Hypochloremic alkalosis can cause hepatic encephalopathy or hepatic coma;

Hyponatremia: confusion, convulsions, apathy, slowing down the process of thinking, fatigue, irritability;

-hypomagnesium: arrhythmias;

On the part of the hematopoiesis system: agranulocytosis, thrombocytopenia and hemolytic and aplastic anemia, leukocytopenia;

From the cardiovascular system: arrhythmia, tachycardia, orthostatic hypotension, thrombosis, thromboembolism.

From the genitourinary system: acute interstitial nephritis, vasculitis, hypercreatinemia, in rare cases, a decrease in potency is possible.

From the gastrointestinal tract: cholecystitis or pancreatitis, jaundice, diarrhea, sialadenitis, constipation, anorexia, epigastric pain;

From the nervous system: dizziness, temporary vagueness of vision, headaches, paresthesia, xantopsy;

Metabolic: hyperglycemia, glucosuria, hyperuricemia and exacerbation of gout, hypercalcemia, hyperlipidemia;

Other: allergic reactions

Overdose:

Symptoms: Hypokalemia (adynamia, paralysis, constipation, arrhythmias), drowsiness, lowering of blood pressure dry mouth, oliguria, tachycardia.

Treatment: Rinse the stomach, take Activated carbon, to introduce potassium preparations, infusion of solutions of electrolytes. Symptomatic treatment, there is no specific antidote.

Interaction:

When the drug is combined with glycosides of digitalis, the possibility of manifesting the toxicity of digitalis preparations (for example, increased excitability of the ventricle) associated with hypokalemia and hypomagnesemia may increase. Strengthens the effect of nondepolarizing muscle relaxants.

The combined use of amiodarone with thiazide diuretics can increase the risk of arrhythmias associated with hypokalemia.

The effect of antihypertensive drugs can be enhanced if they are used simultaneously with thiazides.

When combined with corticosteroids or calcitonin, the risk of developing hypokalemia increases.

With simultaneous use reduces the effectiveness of oral hypoglycemic drugs.

Nonsteroidal anti-inflammatory drugs, in particular indomethacin, reduce the antihypertensive effect of thiazides.

Simultaneous use of diflunisal with hydrochlorothiazide causes a significant increase in plasma levels in the plasma and reduces its hyperuricemic effect.

Thiazides can reduce the effect of norepinephrine on blood pressure. Thiazide agents may increase susceptibility to tubocurarine.

Ethanol and phenobarbital, diazepam can increase the antihypertensive effect of thiazide diuretics.

Colestyramine can inhibit the absorption of thiazide diuretics in the gastrointestinal tract (reducing absorption by 85%).

With simultaneous application, it can increase the concentration of lithium salts in the blood to a toxic level. Joint use of these drugs should be avoided.

Special instructions:

Apply with caution in kidney disease and severe impairment of their function. In patients with kidney disease, thiazides can cause azotemia. In patients with impaired renal function, the cumulative effect of the drug may develop. If the progression of kidney disease is not in doubt, it is necessary to suspend or interrupt therapy with diuretics.

Since thiazide diuretics lose their therapeutic effectiveness, if the glomerular filtration rate is less than 39 ml / min, in such patients, the choice drugs are loop diuretics.

Thiazides should be used with caution in patients with impaired liver function or progressive liver disease,since small changes in electrolyte or water balance can cause hepatic coma.

Allergic reactions are more likely in patients with an allergy or bronchial asthma in anamnesis.

The possibility of exacerbation of the course of systemic diseases of connective tissue (systemic lupus erythematosus) is described.

With prolonged use of the drug, it is necessary to regularly monitor the level of blood electrolytes and creatinine clearance. During the period of application of the drug, it is necessary to recommend to patients a diet enriched with potassium. When there are signs of potassium deficiency, as well as with the simultaneous use of cardiac glycosides, glucocorticosteroids and adrenocorticotropic hormone, administration of potassium or potassium-sparing diuretics is indicated.

The antihypertensive effect of the drug can be enhanced in patients after sympathectomy. Calcium excretion is reduced by thiazides. In some patients with prolonged treatment with thiazides, pathological changes in parathyroid glands were observed. The concentration of bilirubin in the serum can be increased by the use of hydrochlorothiazide due to the displacement from the binding sites with albumin. The levels of cholesterol and triglycerides can increase.

For prevention of potassium and magnesium deficiency prescribe a diet with a high content of microelements, potassium-sparing diuretics, potassium and magnesium salts.

Regular monitoring of the content of potassium, glucose, uric acid, lipids, creatinine is necessary in the blood plasma.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Tablets of 25 mg and 100 mg.

Packaging:For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. 2 contour mesh packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:5 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N001621 / 01

Date of registration:31.08.2007 / 24.10.2013

Expiration Date:Unlimited

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp16.04.2017

Illustrated instructions

Instructions

Hydrochlorothiazide (Hydrochlorothiazide)