Hypothiazide, pills 25mg, 20pcs

Composition

1 tablet contains:

Active ingredient:

hydrochlorothiazide 25 mg;

Auxiliary substances:

magnesium stearate;

talc;

gelatin;

corn starch;

lactose monohydrate.

Pharmacological action

Hypothiazid is a diuretic.

Pharmacodynamics

The primary mechanism of action of thiazide diuretics is to increase diuresis by blocking the reabsorption of sodium and chlorine ions at the beginning of the renal tubules. By doing so, they increase the excretion of sodium and chlorine and, consequently, water. The excretion of other electrolytes, namely potassium and magnesium, also increases.

At maximum therapeutic doses, the natriuretic / diuretic effect of all thiazides is approximately the same. Natriuresis and diuresis occur within 2 hours and reach their maximum after about 4 hours. They also reduce the activity of carbonic anhydrase by increasing the excretion of bicarbonate ion, but this effect is usually weak and does not affect the pH of urine. Hydrochlorothiazide also has antihypertensive properties. Thiazide diuretics do not affect normal blood pressure.

Pharmacokinetics

Hydrochlorothiazide is incompletely, but fairly quickly absorbed from the gastrointestinal tract. This action lasts for 6-12 hours. After oral use of a dose of 100 mg, Cmax in blood plasma is reached in 1.5-2.5 hours.

At the maximum diuretic activity (approximately 4 hours after use), the concentration of hydrochlorothiazide in blood plasma is 2 mcg / ml. Binding to plasma proteins is 40%. It is mainly excreted through the kidneys (filtration and secretion) in unchanged form. T1 / 2 for patients with normal renal function is 6.4 hours, for patients with moderate renal insufficiency-11.5 hours, and for patients with creatinine clearance less than 30 ml / min-20.7 hours.

Hydrochlorothiazide passes through the placental barrier and is excreted in breast milk.

Indications

• hypertension (used as a monotherapy and in combination with other antihypertensive drugs);
• edematous syndrome of different Genesis (congestive heart failure, nephrotic syndrome, premenstrual syndrome, acute glomerulonephritis, chronic renal failure, portal hypertension, treatment with corticosteroids);
• control polyuria, mainly in nephrogenic diabetes insipidus;
• prevention of stone formation in the urinary tract in predisposed patients (reduction of hypercalciuria).

Use during pregnancy and lactation

Hydrochlorothiazide penetrates the placental barrier. It is contraindicated to use the drug in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug can be prescribed only in cases of acute need, when the benefit to the mother exceeds the potential risk to the fetus and / or child. There is a risk of developing jaundice of the fetus or newborn, thrombocytopenia and other consequences.

The drug passes into the mother’s milk; therefore, if the use of the drug is absolutely necessary, then breast-feeding should be discontinued.

Contraindications

• hypersensitivity to the drug or to other sulfonamides;
• anuria;
• severe renal (creatinine clearance less than 30 ml/min) or liver failure;
• difficult to control diabetes mellitus;
• Addison’s disease:
• refractory hypokalemia, hyponatremia, hypercalcemia;
• children under 3 years of age (solid dosage form).

Use with caution in hypokalemia, hyponatremia, hypercalcemia, in patients with CHD, cirrhosis of the liver, gout, in the elderly, in patients suffering from lactose intolerance, when taking cardiac glycosides.

Side effects

Hypokalemia, hypomagnesemia, hypercalcemia and hypochloremic alkalosis:  dry mouth, thirst, irregular heart rate, mood or mental changes, muscle cramps and pains, nausea, vomiting, unusual tiredness or weakness. Hypochloremic alkalosis can cause hepatic encephalopathy or hepatic coma.

Hyponatremia:  confusion, convulsions, lethargy, slow thinking, fatigue, excitability, muscle cramps.

Metabolic events:  hyperglycemia, glucosuria, hyperuricemia with the development of a gout attack. Treatment with thiazides may reduce glucose tolerance, and latent diabetes mellitus may manifest. When using high doses, serum lipids may increase.

From the gastrointestinal tract:  cholecystitis or pancreatitis, cholestatic jaundice, diarrhea, sialadenitis, constipation, anorexia.

From the cardiovascular system:  arrhythmias, orthostatic hypotension, vasculitis.

Nervous system and sensory disorders:  dizziness, blurry vision (temporary), headache, paresthesia.

From the side of hematopoietic organs:  very rarely — leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia.

Hypersensitivity reactions:  urticaria, purpura, necrotic vasculitis, Stevens-Johnson syndrome, respiratory distress syndrome (including pneumonitis and non-cardiogenic pulmonary edema), photosensitivity, anaphylactic reactions up to shock.

Other phenomena:  decreased potency, impaired renal function, interstitial nephritis.

Interaction

Concomitant use of the drug with lithium salts should be avoided (renal clearance of lithium decreases, its toxicity increases).

Use with caution with the following medications:

• antihypertensive drugs (potentiated their effects, you may need a dose adjustment);
• cardiac glycosides (hypokalemia and hypomagnesemia associated with the effect of thiazide diuretics may enhance the toxicity of digitalis);
• amiodarone (its use in conjunction with thiazide diuretics may lead to increased risk of arrhythmias associated with hypokalemia);
• hypoglycemic agents for oral use (reduced their effectiveness may develop hyperglycemia);
• corticosteroids, calcitonin (increase the degree of excretion of potassium);
• NSAIDs (can attenuate the diuretic and hypotensive effect of thiazide);
• non-depolarizing muscle relaxants (their effect may increase);
• by amantadine (amantadine clearance may decrease hydrochlorothiazide, which leads to an increase in the concentration of amantadine plasma and possible toxicity);
• kolestiraminom, which reduces the absorption of hydrochlorothiazide;
• ethanol, barbiturates and narcotic analgesics, which reinforce the effect of orthostatic hypotension.

Effect of the drug on laboratory test data

Thiazides can reduce plasma levels of protein-bound iodine.

Thiazides should be discontinued before parathyroid function tests are performed. The concentration of bilirubin in the blood serum may be increased.

How to take, course of use and dosage

Inside, after eating.

The dosage should be selected individually. With constant medical monitoring, the minimum effective dose is set.

Due to the increased loss of potassium and magnesium ions during treatment (the level of potassium in the serum may decrease below 3.0 mmol/l), it becomes necessary to replace potassium and magnesium.

For adults. As an antihypertensive agent, the usual starting daily dose is 25-50 mg once, as monotherapy or in combination with other antihypertensive agents. For some patients, an initial dose of 12.5 mg is sufficient, either as monotherapy or in combination. It is necessary to use the minimum effective dose, not exceeding 100 mg / day. If Hypothiazid® when 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.

The antihypertensive effect manifests itself within 3-4 days, but it may take up to 3-4 weeks to achieve the optimal effect. After the end of treatment, the hypotensive effect persists for 1 week.

Edematous syndrome of various origins. The usual initial dose in the treatment of edema is 25-100 mg of the drug once a day or once every 2 days. Depending on the clinical response, the dose can be reduced to 25-50 mg once a day or once every 2 days. In some severe cases, doses of up to 200 mg/day may be required at the beginning of treatment.

In premenstrual syndrome, the usual dose is 25 mg / day and is used between the onset of symptoms and the onset of menstruation.

For nephrogenic diabetes insipidus, the usual daily dose of 50-150 mg (in several doses) is recommended.

For children. Doses should be determined based on the child’s body weight. The usual pediatric daily dose is 1-2 mg / kg or 30-60 mg / m2 of body surface area, administered once a day. The total daily dose for children aged 3-12 years is 37.5-100 mg.

Overdose

The most prominent manifestation of an overdose of hydrochlorothiazide is acute loss of fluid and electrolytes, which is expressed in the following signs and symptoms: :

Cardiovascular diseases:  tachycardia, decreased heart rate HELL, shock.

Neuromuscular:  weakness, confusion, dizziness and spasms of the calf muscles, paresthesia, impaired consciousness, fatigue.

Gastrointestinal problems:  nausea, vomiting, thirst.

Kidney diseases:  polyuria, oliguria, or anuria (due to hemoconcentration).

Laboratory parameters: hypokalemia, hyponatremia, hypochloremia, alkalosis, elevated blood urea nitrogen (especially in patients with renal insufficiency).

Treatment: there is no specific antidote for an overdose of hydrochlorothiazide.

Induction of vomiting, gastric lavage may be ways to remove the drug.

Absorption of the drug can be reduced by prescribing activated carbon. In the event of a decline BCC and electrolytes (potassium, sodium) should be replaced for AD or shock.

The water-electrolyte balance (especially serum potassium) and renal function should be monitored until normal values are established.

Special instructions

Long term treatment should be carefully monitored for clinical symptoms of violations of water-electrolyte balance, primarily in patients at high risk: patients with diseases of the cardiovascular system and the liver; in the case of severe vomiting or the appearance of such signs of violations of water-electrolyte balance, as dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, complaints from the gastrointestinal tract.

Hypokalemia can be avoided by using potassium-containing medications or foods rich in potassium (fruits, vegetables), especially in the case of increased potassium loss (increased diuresis, prolonged treatment) or simultaneous treatment with digitalis glycosides or corticosteroids.

Thiazides have been shown to increase urinary magnesium excretion; this can lead to hypomagnesemia.

With reduced renal function, monitoring of creatinine clearance is necessary. In patients with impaired renal function, the drug may cause azotemia, and cumulative effects may also develop. If renal impairment is apparent, discontinuation of the drug should be considered when oliguria occurs.

Patients with impaired liver function or with progressive liver diseases should be treated with caution, since a small change in the water-electrolyte balance, as well as the level of ammonium in the serum, can cause a hepatic coma.

In the case of severe cerebral and coronary sclerosis, the use of the drug requires special caution.

Treatment with thiazide medications may impair glucose tolerance. During a long course of treatment for manifest and latent diabetes mellitus, systematic monitoring of carbohydrate metabolism is necessary; it may be necessary to change the dose of hypoglycemic drugs. Increased monitoring of patients with impaired uric acid metabolism is required.

Alcohol, barbiturates, narcotic analgesics enhance the orthostatic hypotensive effect of thiazide diuretics.

With long-term therapy, in rare cases, a pathological change in the parathyroid glands was observed, accompanied by hypercalcemia and hypophosphatemia. Thiazides can reduce the amount of iodine binding to serum proteins without showing signs of thyroid dysfunction.

In patients suffering from lactose intolerance, gastrointestinal complaints may occur due to the presence of lactose in the tablets: Hypothiazide® 25 mg tablets contain 63 mg of lactose, Hypothiazide® 100 mg — 39 mg of lactose.

Influence on the ability to drive a car and perform work that requires increased attention. In the initial stage of using the drug (the duration of this period is determined individually), it is forbidden to drive a car and perform work that requires increased attention.

Form of production

Tablets

Storage conditions

Store in a place protected from light and out of reach of children at a temperature of 15° to 25°C.

Shelf life

5 years

Active ingredient

Hydrochlorothiazide

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Heart Failure, Hypertension