Generic drug of Moduretic
Therapeutic class: Cardiology and angiology
active ingredients: Amiloride, Hydrochlorothiazide
laboratory: Ranbaxy Pharma Generic
Box of 90
- Edema of cardiac origin.
- Ascites and oedemas of cirrhotic patients.
Dosage AMILORIDE HYDROCHLOROTH. RPG 5 mg / 50 mg Tablet Box of 90
Reserved for adults.
- Cardiac edema: treatment with amiloride hydrochlorothiazide hydrochloride RPG 5 mg / 50 mg should be started, 1 or 2 tablets daily.
This dosage may be increased but should not exceed 4 tablets per day.
The optimal dosage is determined based on the diuretic response and serum potassium level. Once diuresis is initiated, attempts may be made to reduce the dosage for maintenance treatment and to administer the drug on a batch basis.
- Hypertension: The usual dosage is 1 or 2 tablets a day in one or more doses.
The daily dose may be increased but must not exceed 4 tablets.
When combined with other antihypertensive agents, amiloride hydrochlorothiazide hydrochloride RPG 5 mg / 50 mg may have an additive effect or may potentiate their action, and may require a reduction in dosage.
- Ascites of cirrhotic (see precautions for use): should be started treatment with small doses of amiloride hydrochlorothiazide hydrochloride RPG 5 mg / 50 mg (1 tablet once a day). The dosage can be increased gradually until the onset of effective diuresis. The dosage of amiloride hydrochlorothiazide hydrochloride RPG 5 mg / 50 mg should not exceed 4 tablets per day. The dosage of the maintenance treatment may be lower than that required to trigger diuresis. We can therefore try to reduce daily doses when the weight of the patient has stabilized.
A gradual progression of weight loss is particularly desirable in cirrhotic patients to reduce the risk of side effects induced by diuretic therapy.
CONTRAINDICATED: - Hypersensitivity to amiloride, hydrochlorothiazide. - Hyperkalemia:
Amiloride hydrochlorothiazide hydrochloride RPG 5 mg / 50 mg should not be used when serum potassium is elevated (greater than 5.5 mmol / liter).
- Hepatic encephalopathy.
- Acute or chronic renal failure:
Patients with a creatinine greater than 125 μmol / liter (15 mg / liter) or a total blood urea level exceeding 10 mmol / liter (0.60 g / liter) can not be administered by frequent checks of the level of electrolytes and blood urea. In case of renal insufficiency, potassium retention is increased by the addition of an antikaluretic and can evolve rapidly to hyperkalemia.
- Other antikaluretic therapy and potassium salt intake :
Administration of other antikaluretic agents or potassium supplements is contraindicated in patients treated with amiloride hydrochlorothiazide hydrochloride RPG 5 mg / 50 mg (such association is usually associated with a rapid rise in plasma potassium level).
NOT RECOMMENDED :
- Pregnancy: There is no teratogenesis study available in animals. There is currently no relevant data on the possible malformative or foetotoxic effect of amiloride-hydrochlorothiazide when administered during pregnancy. As a result, the use of amiloride-hydrochlorothiazide is not recommended during pregnancy. However, the discovery of a pregnancy under this association does not justify interruption. In pregnant women, the administration of this combination is not justified in the treatment of edemas and hydrosodeal retention gravidarum, nor in the HTA gravidic, because it can cause fetoplacental ischemia with a risk of fetal hypotrophy, jaundice fetal or neonatal, thrombocytopenia.
- Breast-feeding: Thiazides pass into breast milk, breastfeeding is not recommended.
- Lithium combination (see paragraph interactions) :
This medicine is generally not recommended for combination with lithium.
- Associations discouraged : ciclosporin, tacrolimus; converting enzyme inhibitors (unless there is hypokalemia) except for spironolactone at doses of 12.5 mg to 50 mg / day in the treatment of heart failure; angiotensin II receptor antagonists (unless there is hypokalemia).
Adverse effects Amiloride Hydrochloroth. rpg
- This combination is generally well tolerated and significant adverse effects have not been reported often.
The risk of hyperkalemia (K +> 5.5 mEq / L) in this combination is approximately 1.2% in patients without renal impairment or diabetes mellitus.
- Minor side effects attributed to amiloride hydrochloride have been reported quite often (= 20%) but the cause-effect relationship with the drug has remained uncertain.
- Nausea, anorexia, abdominal pain, abdominal bloating, and mild skin rashes have been reported and are probably due to amiloride.
- The other side effects reported with this combination are usually those encountered during diuresis increases, or thiazide treatments or those related to the underlying disease that justified the treatment.
- Clinical trials do not show that the combination amiloride-hydrochlorothiazide increases the risk of adverse effects compared to each component given alone.
UNDER THIS ASSOCIATION HAVE BEEN REPORTED:
- headache, muscle weakness, fatigue, asthenia, malaise, chest and lumbar pain;
arrhythmia, tachycardia, orthostatic hypotension, angina, signs of digitalis intoxication;
- anorexia, nausea, vomiting, diarrhea, constipation, abdominal pain, gastrointestinal haemorrhage, appetite disturbances, abdominal bloating, thirst, hiccups;
- elevation of serum potassium (> 5.5 mEq / L), gout, dehydration with hypovolemia, hyponatremia justifying dose reduction or discontinuation of treatment;
- rash, pruritus, flushing;
- leg pain, muscle cramps, joint pain;
- dizziness, vertigo, paresthesia, lethargy;
- insomnia, nervousness, confusion, depression, drowsiness;
transient visual disturbances, nasal congestion, dysgeusia;
impotence, dysuria, nocturia, incontinence.
OTHER ADVERSE EFFECTS HAVE BEEN REPORTED WITH EACH OF THE COMPONENTS OF THE ASSOCIATION:
- With amiloride hydrochloride :
. abnormal liver function,
. activation of peptic ulcer probably pre-existing,
. dryness of the mouth,
. aplastic anemia, neutropenia,
. a complete atrioventricular block appeared in a patient already suffering from an incomplete block.
- With hydrochlorothiazide :
. anaphylactic shock, fever,
. necrotizing angiitis,
. cholestatic hepatitis, pancreatitis.
In case of hepatic insufficiency, possibility of occurrence of hepatic encephalopathy (see warnings and contraindications);
. glycosuria, hyperglycemia, hyperuricemia,
. skin and subcutaneous tissues: cases of photosensitivity reaction have been reported,
. hypersialorrhea, urticaria,
. restless leg syndrome,
. respiratory distress, pneumonia,
. transient blurred vision, xanthopsie,
. agranulocytosis, aplastic anemia, haemolytic anemia, leukopenia, purpura, thrombocytopenia.
- Whether the side effects are moderate or severe, reduce the dosage of the combination or discontinue the treatment.