HIPODEHIDRA. 25 mg. 30 tablets

HIPODEHIDRA. 25 mg. 30 tablets
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Hypertension (alone or in combination with other antihypertensive agents)
Swollen syndrome and congestive heart failure
Nephrogenic insipiden (tasteless) diabetes
Idiopathic hypercalciuria and prevent the formation of calcium concretions. 

HIPODEHIDRA. 25 mg. 30 tablets

 
 
CLINICAL DATA
indications
Hypertension ( alone or in combination with other antihypertensive agents )
Swollen syndrome and congestive heart failure
Nephrogenic insipiden ( tasteless ) diabetes
Idiopathic hypercalciuria and prevent the formation of calcium concretions .

Dosage and method of administration
Oral administration.
The dose should be individualized depending on the condition of the patient . Best single dose Hydrochlorothiazide morning while eating .
hypertension
Although the maintenance dose is usually 12,5-25 mg, taken in the morning , early treatment is started at a dose of 25-50 mg once in the morning or in two divided doses . When monotherapy is not effective, it is recommended that a combination therapy with other antihypertensive agents ( such as beta- blockers, calcium channel blockers , vasodilators , reserpine , ACE - inhibitors). The dosage of any anti-hypertensive drugs, including in the combination therapy is typically reduced .
Congestive heart failure and swollen syndrome
Supportive therapy is 25 mg / day , sometimes administered every 2 days , once achieved an improvement of the patient's condition . The initial dose is 25-75 mg, divided into 1-2 doses. Sometimes the initial dose may be as high as 100 mg.
Nephrogenic diabetes insipiden
The initial dose is 100 mg / day, divided into 2-4 doses. Later, the dose can be reduced .
25-50 mg / twice daily.
Use in geriatrics
The initial dose should be Hydrochlorothiazide less ( 12.5 to 25 mg), as compared to younger adults .
children:
The usual daily dose is 1 to 2 mr / kg, in one or two doses , it does not exceed 37,5 mg ( half table . ) Per day for children up to 2 years or 100 mg ( Table 4 . ) Of day for children from 2 to 12 years.
Patients with renal insufficiency
No specific dose thiazide diuretic in patients with mild to moderate renal insufficiency. In patients with creatinine clearance between 30 and 70 ml / min , the dose is half the recommended dosage. Diuretic effect of thiazide diuretics disappears in patients with creatinine clearance less than 30 ml / min ( in patients with serum creatinine concentration below 2,5 mg/100 ml). In the development of severe renal failure occur, Hydrochlorothiazide should be discontinued .
Patients with hepatic impairment
Hydrochlorothiazide is excreted through the kidneys and is not metabolized in the liver. It is particularly important in patients with liver disease to give potassium salts regularly and to monitor the concentrations of serum electrolytes.
Contraindications
Hypersensitivity to Hydrochlorothiazide, sulfonamides or to any of the excipients.
Severe liver or kidney disease (creatinine clearance below 30 ml / min), anuria . Hyponatremia, hypokalemia and hypercalcemia resistant to therapy. Symptomatic hyperuricaemia (patients with a history of gout) . Conditions with increased excretion of potassium. Hypertension in pregnancy .
Special warnings and precautions for use
Patients with renal failure - in these patients the thiazide diuretics may lead to the development of azotemia . In patients with renal insufficiency may occur cumulative effects of Hydrochlorothiazide. If progressive renal failure exacerbated (characterized by elevated levels of non-protein nitrogen) is needed careful consideration of possible discontinuation .
Liver failure - Hydrochlorothiazide should be used with caution in patients with impaired liver function, as the slightest change of water-salt balance can lead to hepatic coma.
Electrolyte imbalance - of patients receiving diuretic therapy should be regularly monitored their serum electrolyte concentration .
Hydrochlorothiazide can cause hypokalemia , hyponatremia , and hypochloremic alkalosis . Symptoms of electrolyte imbalance are dryness of mouth, thirst , seq ^ ^ ^ Oz drowsiness , apathy , anxiety, muscle pain or cramps , hypotension , tachycardia, and gastrointestinal disturbances such as nausea and vomiting.

The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, and taking concomitant corticosteroids. In patients with swollen syndrome often can occur hyponatremia, particularly in warm days. Chloride deficiency in most cases does not require special treatment and runs smoother .
Hydrochlorothiazide treatment should be discontinued before the pre- study of the function of the parathyroid gland .
Metabolic and endocrine effects - may potentiate the clinical manifestation of latent diabetes. In the treatment of diabetic patients need strict control of blood sugar due to its ability to increase .
Elevated levels of cholesterol and triglycerides are associated with thiazide treatment and can potentiate the clinical manifestations of gout .
Anti-doping test - Hydrochlorothiazide can cause positive doping test.
Others - Hypersensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
Possibly exacerbated systemic lupus erythematosus .
Interaction with other medicinal products and other forms of interaction
Amphotericin B , Carbenoxolone, Corticotrophin ( ACTH ) , corticosteroids and stimulating laxatives : Increased risk of hypokalaemia (additive effect). To monitor serum potassium and , if necessary, corrected. Particular care is needed with concomitant digitalis therapy. Do not use stimulant laxatives .
Nondepolarizing muscle relaxants ( Tubocurarine chloride): the effect of these drugs may be potentiated by Hydrochlorothiazide, causing postural hypotension
Drugs associated with Torsades de pointesi because of the risk of hypokalemia , caution is required in co of Hydrochlorothiazide with other medications associated with Torsades de pointes, some antiarrhythmics , antipsychotics and other (Dofetilide; Cisapride).
Antihypertensive medications (such as beta -blockers, vasodilators, antihypertensives , calcium channel blockers , ACE inhibitors) - taken together with Hydrochlorothiazide intensifies their antihypertensive action. Hemolytic anemia may develop during concomitant therapy with Methyldopa.
Hydrochlorothiazide can interfere with the oral antidiabetics and cause hyperglycemia .
When administered with uricosuric agents (Benzbromarone) he can reduce their effect .
Should not be administered concomitantly with lithium salts , as it reduces the renal clearance of lithium and enhances adverse effects on the heart and nervous system.
Concurrent administration of calcium salts increases the risk of hypercalcaemia ( decreased renal calcium excretion )
Nonsteroidal drugs taken together with HypoDehydra in high doses pose a risk of renal failure ( patient should be hydrated) .
Means that accelerate the metabolism of cholesterol and lipids (Cholestyramine, Colestipol)- can reduce the absorption of thiazide diuretic. Hydrochlorothiazide must be taken 1 hour before , or at 4 to 6 hours after the last administration of these drugs.
Iodinated contrast media : In cases of dehydration caused by diuretics, there is an increased risk of acute renal failure, especially when using high doses of iodinated contrast media . Rehydration is necessary prior to application of the iodine - containing agents.
Cyclosporin - the risk of increased serum creatinine no change in plasma levels of cyclosporine, even in the absence of increased emission of water and sodium ( increased risk of hyperuricemia and gout ) .
Bioavailability of Hydrochlorothiazide may increase in co with anticholinergic agents (Biperidin, Atropin).
Amantadin - may increase the risk of adverse reactions during treatment with amantadin.
Allopurinol - during combination therapy with a thiazide diuretic increases the frequency of allergic reactions to Allopurinol.
Vitamin D increases serum calcium concentration .
Antineoplastic agents (Cyclophosphamid, Methotrexat) - co-administration of thiazide diuretics may increase the myelosuppressive effects of antineoplastic agents.
Pregnancy and lactation
pregnancy
Hydrochlorothiazide crosses the placental barrier. In studies with animals reproductive toxicity was observed . Administered during the second trimester of pregnancy can lead to the development of thrombocytopenia in the newborn child. HypoDehydra should not be used during pregnancy unless clearly necessary.
breastfeeding
Hydrochlorothiazide passes into breast milk and cause side effects in the newborn . Therefore should be discontinued, or Hydrochlorothiazide breastfeeding , which can be replaced with an alternative way of eating.
Effects on ability to drive and use machines
HypoDehydra does not affect the ability to drive and use
Undesirable effects
Most often dose-related and resolved with discontinuation or dose reduction. Some patients may experience the following side effects:
Common (> 1 /100, < 1/10)
Metabolism and nutrition - hypokalemia .
Uncommon (> 1/ 1000 , <1 /100)
Metabolism and nutrition , hyponatremia, hypomagnesemia , and hyperuricemia ;
Cardiac disorders , hypotension, especially after alcohol , anesthetics or sedatives .
Gastrointestinal disorders , loss of appetite , nausea, vomiting Skin and subcutaneous tissue urticaria, other skin rashes, including erythema multiforme ;
Reproductive system and breast disorders - impotence.
Rare (> 1/ 10 000 , <1/ 1000 )
Blood and lymphatic system - thrombocytopenia ;
Metabolism and nutrition - hypercalcemia, hyperglycemia ,
glyukozouriya ;
Nervous system - headaches, dizziness , vertigo, paraesthesia ,
depression, sleep problems ;
Cardiac disorders - cardiac arrhythmias ;
Hepatobiliary disorders - intrahepatic cholestasis or jaundice Skin and subcutaneous tissue disorders - photosensitisation .
Very rare ( <1/ 10, 000)
Blood and Lymphatic System - leukopenia , agranulocytosis, suppress bone marrow function and hemolytic anemia Immune system disorders - Hypersensitivity reactions , Metabolism and Nutrition - hypochloremic alkalosis ;
Respiratory, thoracic and mediastinal disorders - respiratory diseases (including pneumonia and pulmonary edema) ;
Gastrointestinal disorders - pancreatitis ;
Skin and subcutaneous tissue disorders - necrotizing vasculitis , acute toxic epidermolysis lupus erythematosus .
overdose
symptoms
The most common symptoms reported with overdose with Hydrochlorothiazide were dry mouth , thirst, weakness, lethargy , restlessness, drowsiness, muscle pain and cramps , hypotension, oliguria , tachycardia , nausea, vomiting.
treatment
Symptomatic and supportive. Should be taken to reduce the absorption and removal of the product ( to induce vomiting, gastric lavage with medicinal charcoal , magnesium sulfate) . It is correct electrolyte imbalance , hypotension. Necessity - Oxygen or artificial ventilation. There is no specific antidote . Not clear possibility of separation Hydrochlorothiazide by hemodialysis.
Pharmacological Properties
Pharmacodynamic properties
Pharmacotherapeutic group : thiazide diuretic.
Hydrochlorothiazide is a thiazide diuretic with a sulfonamide structure and moderately expressed natriuretic effect. Decreased reabsorption of sodium and chloride ions in the distal and collecting tubules of the nephron . As a result of this action the diuresis increased by separating the sodium and chloride ions in equimolar quantities and the corresponding quantity of water. The diuretic action occurs equally in alkaline and acidic urine. The presence of the group in the composition sulfamic determines weak inhibitory action on the enzyme carbonic anhydrase. Hydrochlorothiazide increases the release and potassium, magnesium and bicarbonate ions , but in the body causes a retention of calcium ions. Contributes for the reduction of elevated blood pressure as a result of fluid loss and the release of large amounts of sodium ions from the cell membranes of the arterioles , leading to a reduction in the peripheral resistance of blood vessels , plasma volume , reducing the preload of the heart, the stroke volume , renal plasma and glomerular filtration. In patients with diabetes insipidus polyuria decreased by partially defined mechanism of action. Increases the plasma concentration of uric acid.
pharmacokinetics
Hydrochlorothiazide is well absorbed after oral administration. The diuretic effect occurs rapidly , 1-2 hours after administration , reaches a maximum after 4 and continues until 12:00 . The plasma half-life ranged from 2 to 15 hours , such as in kidney and heart failure is almost doubled . The volume of distribution is 3 - 41/kg. Crosses the placental barrier. Broadcast in breast milk. Hydrochlorothiazide is not metabolized . Completely excreted unchanged in the urine by filtration and excretion. Full transmission is completed in 36 to 48 hours, with 70% being excreted in the urine within 24 hours.
Expiration date
3 years
Special precautions for storage
At temperatures below 25 ° C
Packaging Data
Each blister contains 10 tablets. In a cardboard box ima.Z blister and package leaflet .
Special instructions for use
no
 
 
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