Medicinal Products

ALTIZIDE SPIRONOLACTONE RPG 25 mg / 15 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Altizide, Spironolactone
laboratory: Ranbaxy Pharma Generic

Compressed
Box of 30
All forms

Indication

· Hypertension.

· Edema of renal, cardiac and hepatic origin.

Dosage ALTIZIDE SPIRONOLACTONE RPG 25 mg / 15 mg Tablet Box of 30

Hypertension:

1/2 to 1 tablet a day. The treatment is initiated at a dose of half a tablet a day; in case of ineffectiveness, after 6 to 8 weeks of treatment, the dosage is increased to 1 tablet / day.

Edema of cardiac and renal origin:

· Attack treatment: 3 to 4 tablets a day. These doses will then be lowered depending on the patient's response.

· Maintenance treatment: 1 to 2 tablets daily.

Edema of hepatic origin:

· Attack treatment: 4 to 6 tablets a day.

· Maintenance treatment: 1 to 2 tablets daily.

In the case of oedemas, these doses will be adapted to the response obtained (diuresis, weight) and the electrolyte balance of the patient.

Against indications

This medicine MUST NEVER BE USED in case of:

· Severe or acute renal failure including: anuria, fast-evolving renal dysfunction;

· Hyperkalemia;

· Terminal stage of liver failure;

· Hypersensitivity to sulfonamides;

· Hypersensitivity to spironolactone;

· Combinations with other potassium diuretics, potassium salts (except in cases of hypokalemia) (see section 4.5). See also Interactions with other medicinal products and other forms of interaction .

This drug is generally not recommended in cirrhotic patients, when the serum is less than 125 mmol / l and in subjects who may have acidosis.

Side effects Altizide Spironolactone Rpg

Linked to spironolactone

These side effects have been observed in adults:

gynecomastia may occur during the use of spironolactone: its development seems to be related to both the dosage used and the duration of therapy; it is usually reversible when stopping the administration of spironolactone; however, in rare cases it can persist.

Other rare and generally reversible adverse effects at discontinuation of therapy have been encountered, these are:

· Impotence in humans,

· Menstrual disorders in women,

· Digestive intolerance,

· skin rash,

· Sleepiness,

· Cramps of the lower limbs.

Biologically

Under spironolactone, serum potassium may increase moderately. More marked hyperkalemias are reported in patients with renal insufficiency and in patients receiving potassium supplementation or ACE inhibitors: although the vast majority of these hyperkalaemias are asymptomatic, they must be rapidly corrected. In cases of hyperkalemia, treatment with spironolactone will be discontinued.

These disorders are usually reversible upon discontinuation of treatment.

Linked to altizide

The biological or clinical adverse effects are most dose-dependent and can be reduced by finding the lowest effective dose, especially in high blood pressure.

Thiazide and related diuretics may result in:

Biologically :

· Potassium depletion with hypokalemia, especially in case of intensive diuresis, and particularly severe in some at-risk populations (section Warnings and precautions for use ).

Hyponatremia with hypovolemia leading to dehydration and orthostatic hypotension. The concomitant loss of chlorine ions may secondarily cause a compensatory metabolic alkalosis: the incidence and the amplitude of this effect are small.

Elevated serum uric acid and blood glucose levels during treatment: the use of these diuretics will be carefully discussed in gouty and diabetic subjects.

· Hematologic disorders, much rarer, thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, haemolytic anemia.

· An exceptional hypercalcemia.

Clinically :

· In case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (section Contraindications and section Warnings and precautions for use ),

· Hypersensitivity reactions, mainly dermatological, in subjects predisposed to allergic and asthmatic manifestations,

· Cases of photosensitivity reaction (uncommon) have been reported (see Warnings and Precautions section ).

· Maculopapular eruptions, purpura, possible aggravation of pre-existing systemic acute lupus erythematosus,

· Nausea, constipation, dizziness, asthenia, paresthesia, headache, rarely seen and usually giving way to a reduction in dosage.

· Exceptionally: pancreatitis.

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