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Rinalix
INDAPAMIDE Composition
Each tablet contains: Indapamide 2.5 mg Pharmacology
Indapamide is a diuretic with actions similar to those of the thiazide
diuretics. It acts directly on the kidney to increase the excretion of
sodium chloride and water; it also increases the excretion of K+. Indapamide is rapidly and completely absorbed from the gastro-intestinal
tract. A minimum of 70% of a single oral dose is eliminated by the kidneys
and an additional 23% by the gastrointestinal tract, probably including the
biliary route. The half-life of Indapamide in whole blood is approximately
14 hours. Indapamide is strongly and reversibly bound to red blood cells.
Indapamide is not removed by haemodialysis but does not accumulate in
patients with impaired renal function.
Indications
Rinalix is indicated for the treatment of essential hypertension, alone or
in combination with other antihypertensive drugs.
Dosage and Administration
Hypertension: 2.5 mg daily, to be taken in the morning. The action of Indapamide is progressive and the reduction in blood pressure may continue
and not reach a maximum until several months after the initiation of
therapy. A larger dose than 2.5 mg Indapamide is not recommended as there is
no appreciable antihypertensive effect but a diuretic effect may become
apparent.
Contraindications
Anuria, stroke, recent cerebrovascular accident, severe hepatic
insufficiency, known hypersensitivity to indapamide or to other
sulfonamide-derived drugs.
Precautions / Warnings
Hypokalemia, Hyponatremia, and Other Fluid and Electrolyte Imbalances:
Periodic determinations of serum electrolytes should be performed at
appropriate intervals. Patients should be observed for clinical signs of
fluid or electrolyte imbalance, such as hyponatremia, hypochloremic
alkalosis, or hypokalemia.
Hyperuricemia and Gout: Serum concentrations of
uric acid was reported to increase in patients treated with indapamide, and
frank gout may be precipitated in certain patients receiving indapamide.
Serum concentrations of uric acid should therefore be monitored periodically
during treatment. Renal Impairment: Indapamide should be used with caution in patients with
severe renal disease, as reduced plasma volume may exacerbate or precipitate
azotemia. If progressive renal impairment is observed, withholding or
discontinuing diuretic therapy should be considered. Renal function tests
should be performed periodically during treatment with indapamide.
Impaired
Hepatic Function: Indapamide should be used with caution in patients with
impaired hepatic function or progressive liver disease, since minor
alterations of fluid and electrolyte balance may precipitate hepatic coma.
Calcium Excretion: Calcium excretion is decreased by diuretics
pharmacologically related to indapamide. Prolonged treatment with drugs
pharmacologically related to indapamide may in rare instances be associated
with hypercalcemia and hypophosphatemia secondary to physiologic changes in
the parathyroid gland; however, the common complications of
hyperparathyroidism, such as renal lithiasis, bone resorption, and peptic
ulcer, have not been seen. Treatment should be discontinued before tests for
parathyroid function are performed. Like the thiazides, indapamide may
decrease serum PBI (protein-bound iodine) levels without signs of thyroid
disturbance.
Use in Elderly: Plasma potassium and urate concentrations
should be monitored when indapamide is used in elderly. Usage in Pregnancy: Reproduction studies have been performed in animals and
have revealed no evidence of impaired fertility or harm to the fetus due to indapamide. There are, however, no adequate and well-controlled studies in
pregnant women. Moreover, diuretics are known to cross the placental barrier
and appear in cord blood. Therefore the drug should be used during pregnancy
only if clearly needed. There may be hazards associated with this use such
as fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse
reactions that have occurred in the adult.
Nursing Mothers: It is not known
whether this drug is excreted in human milk. Because most drugs are excreted
in human milk, if use of this drug is seemed essential, the patient should
stop nursing.
Adverse Effects
Most adverse effects have been mild and transient. The more common side
effects include hypokalemia, orthostatic hypotension, and allergic reactions
including rash and pruritus. There may be slight increase in serum uric acid
level.
Drug Interactions
*Lithium: In general, diuretics should not be given concomitantly with
lithium because they reduce its renal clearance and add a high risk of
lithium toxicity.
*Fenoxedil, lidoflazine, prenylamine and vincamine, non-antiarrhythmic
drugs inducing wave burst arrhythmia (hypokalemia or even bradycardia and a
preexisting long Q-T interval are predisposing factors).
*Tienilic Acid:
Acute renal failure, (intratubular precipitation of urates related to the
uricosuric effect of tienilic acid and to the state of dehydration due to
other diuretics). Other Antihypertensives: Indapamide may add to or potentiate the action of
other antihypertensive drugs. Norepinephrine: Indapamide, like
the thiazides, may decrease arterial responsiveness to norepinephrine, but
this diminution is not sufficient to preclude effectiveness of the pressor
agent for therapeutic use.
NSAIDs (systemic route): Acute renal
insufficiency in the dehydrated patient (reduction in glomerular filtration
due to the inhibition of vasodilator prostaglandins by the NSAIDS). Hydrate
the patient and monitor renal function at the start of treatment. Metformin: Lactic acidosis due to metformin triggered by possible functional
renal failure related to the diuretics. Do not use metformin when blood
creatinine levels exceed 15 mg/litre (135 micromoles/litre) in men and 12
mg/litre (110 micromoles/litre) in women.
Iodinated contrast media: In cases
of dehydration caused by diuretics, there is an increased risk of acute
renal failure, in particular when high doses of iodinated contrast media are
used. Rehydration before administration of the iodinated product.
Antiarrhythmics inducing wave burst arrhythmia: sotalol, amiodarone,
bepridil and quinidine-type anti-arrhythmic drugs (class la),
Wave burst arrhythmia (hypokalemia and even bradycardia and pre-existing
long Q-T interval are predisposing factors). Prevention and, if necessary, correction of the hypokalemia, monitoring of
the Q-T interval; do not give antiarrhythmic drugs in cases of wave burst
arrhythmia (cardiac pacing). Other hypokalemia drugs: amphotericin B (IV route), glucocorticoids and
mineralocorticoids (systemic route), tetracosactide, stimulant laxatives:
increased risk of hypokalemia (additive effect). Hyperkalemia diuretics (amiloride, canrenone, spironolactone, triamterene). Rational drug combinations which are useful in certain patients do not
exclude the occurrence of hypokalemia or hyperkalemia in particular in
patients with renal failure and diabetes. Digitalis glycosides: Hypokalemia potentiates the toxic effects of digitalis
glycosides. * Inadvisable combinations
Symptoms and Treatment of Overdosage
Symptoms of overdosage include nausea,
vomiting, weakness, gastrointestinal disorders and disturbances of
electrolyte balance. In severe instances, hypotension and depressed
respiration may be observed. If this occurs, support of respiration and
cardiac circulation should be instituted. There is no specific antidote. An evacuation of the stomach is recommended
by emesis and gastric lavage after which the electrolyte and fluid balance
should be evaluated carefully.
Shelf-life
3 years from the date of manufacture.
Description
Pink color, round and deep convex film-coated tablet, 5.5 mm in diameter in
packs of 60's. 15's tablets per blister. Storage
Store at room temperature below 30°C.
Protect from light and moisture.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN |
