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QUALITATIVE AND QUANTITATIVE COMPOSITION     

Excipients:

See section 6.1 for excipients.

Spironolactone - 25 mg

Hydrochlorothiazide - 25 mg

4. CLINICAL FEATURES

4.1. Therapeutic indications

• Conjunctive heart failure, liver cirrhosis with ascites and / or edema, nephrotic syndrome and other edematous conditions,

• essential hypertension,

• in patients with digital field; it is used when other diuretics are insufficient or unsuitable to achieve the electrolyte balance

.

4.2 Posology and method of administration

Posology / frequency and duration of administration:

Edema (congestive heart failure, liver cirrhosis or nephrotic syndrome): The ALDACTAZIDE® isgeneral dose of 100 daily for each of spironolactone and hydrochlorothiazide, which can be taken in a single dose or in divided doses. mg. However, 25 mg to 200 mg dose can be adjusted according to the response of the patient.

With the ALDACTAZIDE® use of, diuresis occurs immediately and continues for 2-3 days after discontinuation of the drug due to the prolonged effect of the spironolactone compound.

Essential hypertension: Although the dosage varies depending on the results of each component titer; The daily optimum dose for spironolactone and hydrochlorothiazide for many patients is 50 to 100 mg, which can be taken in a single dose or in divided doses.

Since spironolactone is sufficient to reduce the negative effect of hydrochlorothiazide on potassium, the ALDACTAZINEduring long-term treatment of hypertension or many types of edema ® use of potassium supplements withis not recommended.  

Method of administration: It

should be taken orally.

ALDACTAZIDE®is recommended to be taken once a day with meals.

Additional information on special populations:

Renal insufficiency: Acute renal failure, marked disruption in the mechanism of kidney excretion should not be used.

Hepatic impairment: It should not be used in case of acute and severe hepatic impairment.

Pediatric population:

ALDACTAZIDE children® in Although there are no clinical studies using, the daily dose can be given in divided doses of 3 mg of spironolate per kilogram of body weight.

Efficacy and safety have not been proven in pediatric patients.

Geriatric population: It

is recommended to start treatment with the lowest dose and the dose may be gradually increased to obtain maximum benefit. Care must be taken in serious liver and kidney disorders that may alter drug metabolism and excretion.

4.3. Contraindications

ALDACTAZIDE®

• Anuria,

• Acute renal failure,

• Significant impairment in the mechanism of excretion of the kidneys,

• Hyperkalemia,

• Acute or severe liver failure,

• Addison's disease,

• Spironolactone, thiazide diuretics, sulfonamide derivative drugs or ALDACTAZIDE® other auxiliary substances contained in

is contraindicated.

4.4. Special Warnings and Precautions

in® potassium-sparing diuretics during use ALDACTAZIDE inhibitors, angiotensin II antagonists, aldosterone antagonists, potassium supplements, salt substitution rich diet or potassium potassium should not be applied since they may cause severe hyperkalemia. Excessive ALDACTAZIDE potassium intake may cause hyperkalemia in the patient using. Spironolactone, when used in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) such as ACE inhibitors or indomethacin, may cause severe hyperkalemia, even if diuretic is present. ALDACTAZIDE Particular attention should be paid to the use ofwith said drugs.

If hypokalamia is suspected (paresthesia, muscle weakness, fatigue, bardikardi, shock), an electrocardiogram (ECG) should be performed. However, since mild hypercalamia cannot be detected by ECG changes, serum potassium levels should also be checked.

If hyperkalemia develops, ALDACTAZIDE should be discontinued immediately and, if necessary, measures should be taken to reduce serum potassium to normal level (such as calcium chloride solution, intravenous administration of sodium bicarbonate solution and / or oral or parenteral administration of glucose with fast acting insulin preparations). These applications should be repeated if necessary. Cationic modifying resins such as sodium polystyrene sulfonates should be administered orally or rectally. Dialysis may be required for ongoing hyperkalamia.

In cases where spironolactone is used in combination with ammonium chloride or cholestramine, edil hyperkalemic metabolic acidosis, has been reported in patients.

ALDACTAZIDE in patients with hepatic impairment as minor changes in fluid and electrolyte balance may cause hepatic coma® should be used with caution.

Hyperkalemia may occur in patients with renal dysfunction or excessive potassium intake and may lead to fatal cardiac disorders.

ALDACTAZIDE because thiazides may cause the ascites in patients with severe renal failure® should be used with caution in this patient group. The effect of accumulation of the drug can be seen in patients with renal insufficiency.

Thiazides may increase or potentiate the effect of other antihypertensive drugs.

Patients with or without a history of allergy or bronchial asthma may develop allergies to thiazides.

It has been reported that sulfonamide derivatives, including thiazides, activate or exacerbate systemic lupus erythematosus.

ALDACTAZIDE may cause a temporary increase of BUN. When treatment is terminated, it returns to its normal level. BUN may continue to increase if there is already a renal failure.

Some decompensated hepatic cirrhosis patients have been reported to have reversible hyperchloromic metabolic acidosis, usually accompanied by hyperkalamin, even if they have normal renal function.

Dry mouth, thirst, characterized by lethargy and drowsiness, dilüzyonal hyponatremia can be detected with low serum levels of sodium, ALDACTAZIDE be® seen when used togetherand other diuretics. Dilutional hyponatremia may occur in patients with edema in hot weather. The reduction of water instead of sodium supplementation is a more suitable treatment, except in cases such as life-threatening hyponatremia.

Low-salt syndrome, manifested by confusion similar to that seen in hepatic comararely ALDACTAZIDE® , canbe seen duringuse. This syndrome is different from dilusion hyponatremia because it does not occur with obvious fluid involvement. ALDACTAZIDE for treatment® should be discontinued and sodium should be given.

Thiazides may cause hyperuricemia and the formation of gout attacks in some patients. It has also been shown to increase the excretion of magnesium in the urine that may cause hypomagnesemia. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

Thiazides can aggravate diabetes and change the need for insulin. Diabetes, which is hidden during thiazide treatment, may become apparent.

Thiazides may reduce urinary calcium excretion. Thiazides may cause intermittent and very mild serum calcium increase. Significant hypercalcemia may be indicative of latent hyperparathyroidism. Thiazide uptake should be discontinued before performing parathyroid function tests. Pathologic alterations in hypercalcemia and hypophosphatemia and parathyroid glands can be seen during long-term thiazide treatment.

Gynecomastia development can be seen with the use of spironolactone,ALDACTAZIDE  in®. return to normal upon discontinuation of treatment However, it was observed that gynecomastia did not disappear.