Hydrochlorothiazide (Hydrochlorothiazide)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrochlorothiazideHydrochlorothiazide
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    • Dosage form: & nbsppills
    Composition:

    active substance: hydrochlorothiazide - 25 mg, 100 mg;

    Excipients:

    for dosage of 25 mg: lactose monohydrate (sugar milk) - 70 mg, potato starch - 47.4 mg, povidone (polyvinylpyrrolidone low molecular weight medical) - 5 mg, stearic acid - 1.3 mg, talc - 1.3 mg;

    for the dosage of 100 mg: lactose monohydrate (sugar milk) - 56.7 mg, potato starch - 34.2 mg, povidone (polyvinylpyrrolidone low molecular weight medical) - 5.1 mg, stearic acid - 2 mg, talc - 2 mg.

    Description:Tablets are white or almost white, round, flat-cylindrical, with a facet and a risk.
    Pharmacotherapeutic group:Diuretics
    ATX: & nbsp

    C.03.A.A.03   Hydrochlorothiazide

    Pharmacodynamics:
    Thiazide diuretic.
    Reduces the reabsorption of sodium ions at the level of the cortical segment of the Henle loop, without affecting its area passing through the medulla of the kidney.It blocks carbonic anhydrase in the proximal part of the convoluted tubules, strengthens excretion of potassium ions, hydrocarbonates and phosphates in the urine. Increases the excretion of magnesium ions, delays in the body calcium ions and excretion of urates. 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 less than 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 a decrease in the volume of circulating blood (BCC) and changes in the reactivity of the vascular wall, a decrease in the pressor effect of vasoconstrictor (epinephrine, norepinephrine), and an intensification of the depressor effect on the ganglion.
    Thiazides have no effect on normal blood pressure (BP). Antihypertensive effect occurs in 3-4 days,but it may take 3-4 weeks to achieve the optimal therapeutic effect.
    Pharmacokinetics:Absorbed quickly, but incomplete. The maximum concentration in the blood plasma when administered in a dose of 100 mg is achieved after 1.5-2.5 hours. With the appointment of the drug once a day, cumulation is negligible. The connection with plasma proteins is 40-60%. Penetrates through the hematoplacental barrier and into breast milk. The half-life for patients with normal renal function is 6.4 hours, for patients with mild renal insufficiency - 11.5 hours, and for patients with creatinine clearance (CC) of less than 30 ml / min - 20.7 hours. It is not metabolized by the liver. It is excreted by the kidneys: basically unchanged through glomerular filtration and active tubular secretion in the proximal part of the nephron.
    Indications:
    - arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);
    - edematous syndrome of various genesis (chronic heart failure, nephrotic syndrome, premenstrual syndrome, acute glomerulonephritis, chronic renal failure, portal hypertension, treatment with corticosteroids);
    - control polyuria, mainly with nephrogenic diabetes insipidus;
    - prevention of stone formation in the urinary tract in predisposed patients (reduced hypercalciuria).
    Contraindications:
    - hypersensitivity to the drug or other sulfonamides;
    - anuria;
    - severe renal (creatinine clearance (CC) below 30 ml / min) or liver failure;
    - difficultly controlled diabetes mellitus;
    - Addison's disease;
    - refractory hypokalemia, hyponatremia, hypercalcemia;
    - children's age up to 3 years (solid dosage form);
    - patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption (lactose is included in the formulation).
    Carefully:
    Caution should be taken with hypokalemia, hyponatremia, hypercalcemia, in patients with coronary heart disease, cirrhosis of the liver, gout, in the elderly, with the intake of cardiac glycosides.
    Pregnancy and lactation:
    Hydrochlorothiazide penetrates the placental barrier. Contraindicated use of the drug in the first trimester of pregnancy.In the second and third trimesters 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. There is a danger of fetal or neonatal jaundice, thrombocytopenia and other consequences.
    The drug penetrates into breast milk, therefore, if you need to use the drug during lactation, breastfeeding should be discontinued.
    Dosing and Administration:

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

    Adults

    As an antihypertensive agent: the usual initial daily dose is 25-50 mg once, in the form of monotherapy or in combination with other antihypertensive agents. Some patients have enough initial dose of 12.5 mg (both in monotherapy and in combination). It is necessary to use the minimum effective dose, not exceeding 100 mg / day. When combined with other antihypertensive drugs, it may be necessary to reduce the dose of another drug to prevent excessive blood pressure lowering.

    The hypotensive effect is manifested within 3-4 days, but it may take 3-4 weeks to achieve the optimal effect. After the end of therapy, the hypotensive effect persists for one week.

    Ocular syndrome of various origins: the usual initial dose for the treatment of edema is 25-100 mg once a day or once every two days. Depending on the clinical response, 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.

    With premenstrual syndrome, the usual dose is 25 mg per day and is applied from the onset of symptoms before the onset of menstruation.

    In nephrogenic diabetes insipidus, the usual daily dose 50-150 mg (in several steps).

    Elderly patients 12.5 mg 1-2 times a day.

    For the purpose of preventing the formation of stones, 50 mg are prescribed twice a day.

    Children

    Doses should be based on the weight of the child's body. Ordinary pediatric daily doses, 1-2 mg / kg body weight, or 30-60 mg per square meter body surface, are assigned once a day. The total daily dose for children aged 3 to 12 years is 37.5-100 mg per day. After 3-5 days of treatment, it is recommended to take a break for 3-5 days.As maintenance therapy in this dose prescribed 2 times a week. With the use of intermittent course of treatment with admission after 1 -3 days or for 2-3 days followed by a break, the decrease in efficacy is less pronounced and the side effects develop less often.

    Side effects:

    Violations of the electrolyte balance:

    - hypokalemia, hypomagnesemia, hypercalcemia and hypochloraemic alkalosis: dry mouth, thirst, irregular heart rhythm, changes in mood or psyche, cramps and muscle pains, nausea, vomiting, unusual fatigue or weakness. Hypochloremic alkalosis can cause hepatic encephalopathy or hepatic coma;

    - hyponatremia: confusion, convulsions, lethargy, slowing down of the thinking process, fatigue, excitability, muscle cramps.

    Metabolic phenomena: hyperglycemia, glucosuria, hyperuricemia with the development of an attack of gout.

    Treatment with thiazides can reduce glucose tolerance, as a consequence of which latent diabetes mellitus can manifest itself. When using high doses, serum lipid levels may increase.

    From the central and peripheral nervous system: dizziness, transient visual impairment, headache, paresthesia.

    From the digestive system: cholecystitis, pancreatitis, cholestatic jaundice, diarrhea, sialadenitis, constipation, anorexia.

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

    From the genitourinary system: impaired renal function, interstitial nephritis, in rare cases, a possible decrease in potency.

    On the part of the hematopoiesis system: very rarely - leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia.

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

    Overdose:
    Symptoms: decrease in blood pressure, tachycardia, shock, weakness, confusion, dizziness and cramping of the calf muscles, paresthesia, disturbance of consciousness, fatigue; nausea, vomiting, thirst; polyuria, oliguria or anuria (due to hemoconcentration); hypokalemia (adynamia,paralysis, constipation, arrhythmia), hyponatremia, hypochloraemia, alkalosis, increased urea concentration in the blood (especially in patients with renal insufficiency).
    Treatment: there is no specific antidote. Gastric lavage, reception of activated charcoal, in the event of a decrease in blood pressure or shock, the volume of circulating blood and electrolytes should be reimbursed (potassium, sodium). It is necessary to monitor the water-electrolyte balance (especially the level of potassium in the serum) and the function of the kidneys.
    Interaction:
    It should avoid simultaneous use of the drug with lithium salts (renal clearance of lithium decreases, its toxicity increases).
    With caution it is necessary to use with antihypertensive agents (strengthening their action, dosage correction may be required); cardiac glycosides (hypokalemia and hypomagnesemia with thiazide diuretics may increase the toxicity of cardiac glycosides); amiodarone (risk of arrhythmias associated with hypokalemia); hypoglycemic agents for oral administration (their effectiveness decreases, the risk of developing hyperglycemia); corticosteroids,calcitonin (increased hypokalemia); non-steroidal anti-inflammatory drugs (weaken the diuretic and hypotensive effect of thiazides); Nondepolarizing muscle relaxants (their effect may be increased); amantadine (clearance of amantadine may decrease, which leads to an increase in the concentration of amantadine in the plasma and possible toxicity); colestyramine (reduces the absorption of hydrochlorothiazide); ethanol, barbiturates and narcotic analgesics, which increase the risk of developing orthostatic hypotension. Thiazides can reduce the concentration of protein-bound iodine in the blood plasma.
    Special instructions:
    With long-term treatment, it is necessary to closely monitor the clinical symptoms of water-electrolyte imbalance, primarily in patients at high risk: patients with cardiovascular disease and impaired liver function.
    Hypokalemia can be avoided by the use of potassium-containing drugs or foods rich in potassium (fruits, vegetables), especially in case of increased potassium loss (severe diuresis, prolonged treatment) or simultaneous treatment with cardiac glycosides or corticosteroid drugs.Increases the excretion of magnesium in the urine, which can lead to hypomagnesemia. With reduced renal function, CC control is necessary. In renal patients, the drug can accumulate and cause the development of azotemia. With the development of oliguria should consider the possibility of discontinuing the drug. With mild and moderate hepatic insufficiency or progressive liver disease hydrochlorothiazide prescribe with caution, because a small change in the water-electrolyte balance and accumulation of ammonium in the serum can cause hepatic coma.
    In the case of severe cerebral and coronary sclerosis, the administration of the drug requires special care.
    May interfere with glucose tolerance. During a long course of treatment with manifest and latent diabetes, systematic control of carbohydrate metabolism is necessary; it may be necessary to correct the dose of hypoglycemic agents. During the treatment period, periodic monitoring of the concentration of uric acid is necessary. Alcohol, barbiturates, narcotic analgesics strengthen the orthostatic hypotensive effect of thiazide diuretics.With prolonged therapy, in rare cases, a pathological change in the function of the parathyroid glands was observed, accompanied by hypercalcemia and hypophosphatemia. It can affect the results of laboratory studies of the function of parathyroid glands, so the drug should be discarded before determining the function of the parathyroid glands.
    Hydrochlorothiazide can reduce the amount of iodine that binds to whey proteins, without manifesting signs of thyroid dysfunction.
    Effect on the ability to drive transp. cf. and fur:
    At the beginning of therapy with the drug (the duration of this period is determined individually), it is recommended to refrain from driving vehicles and performing work that requires a high concentration of attention and speed of psychomotor reactions (due to the possible development of dizziness and drowsiness), and further caution should be exercised.
    Form release / dosage:
    Tablets 25 mg, 100 mg.
    Packaging:For 10 or 20 tablets in a contour mesh package. 1, 2, 3, 4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.
    Storage conditions:In a dry, dark place at a temperature of 15 to 25 ° C.Keep out of the reach of children.
    Shelf life:
    2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000726
    Date of registration:21.06.2010 / 11.09.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.04.2017
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