Amiloride (HCl)

Amiloride is a potassium sparing diuretic. Amiloride (HCl) is antihypertensive agent. Chemically Amiloride (HCl) is identified as N-Amidino-3, 5-diamino-6-chloropyrazinecarboxamide hydrochloride. It reduces the amount of water and sodium retained by the body. Amiloride (HCl) is used to restore normal serum potassium levels in patients who develop hypokalemia and in patients who would be exposed to a particular risk if hypokalemia were to develop. Amiloride (HCl) is mostly used in conjunction with other drugs to lower blood pressure.

Amiloride (HCl) is primarily indicated in conditions like Congestive heart failure, Duodenal ulceration, Edema, Hepatic cirrhosis with ascites, Hypertension, Oedema,Thiazide induced hypokalemia and can also be given in adjunctive therapy as an alternative drug of choice in Cystic fibrosis, NIDDM and Li-induced polyuria.

Amiloride (HCl) is contraindicated in conditions like Acute renal failure,Gout,Hyperkalaemia,Diabetic nephropathy, Concomitant use with Potassium supplementation.

Amiloride HCl is usually well tolerated and, except for hyperkalemia (serum potassium levels greater than 5.5 mEq liter - see WARNINGS ), significant adverse effects have been reported infrequently. Minor adverse reactions were reported relatively frequently (about 20%) but the relationship of many of the reports to amiloride HCl is uncertain and the overall frequency was similar in hydrochlorothiazide treated groups. Nausea/anorexia, abdominal pain, flatulence, and mild skin rash have been reported and probably are related to amiloride. Other adverse experiences that have been reported with amiloride are generally those known to be associated with diuresis, or with the underlying disease being treated. The adverse reactions for amiloride HCl listed in the following table have been arranged into two groups: (1) incidence greater than one percent; and (2) incidence one percent or less. The incidence for group (1) was determined from clinical studies conducted in the United States (837 patients treated with amiloride HCl). The adverse effects listed in group (2) include reports from the same clinical studies and voluntary reports since marketing. The probability of a causal relationship exists between amiloride HCl and these adverse reactions, some of which have been reported only rarely. * Reactions occurring in 3% to 8% of patients treated with amiloride HCl. (Those reactions occurring in less than 3% of the patients are unmarked.) **See WARNINGS . Causal Relationship Unknown Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians. Activation of probable pre-existing peptic ulcer Aplastic anemia Neutropenia Abnormal liver function

Amiloride should be used with caution in patients with diabetes, kidney or liver disease or any drug allergy. Caution must be observed when eating large amounts of food high in potassium such as bananas, baked potatoes, raisins, cooked spinach and other foods. Alcoholic beverages may increase the effects of this drug, causing dizziness or lightheadedness, so limit alcohol intake. Patients should observe caution while driving or performing other activities requiring alertness. Because this drug changes fluid balance, patients may feel dizzy if change from a lying to a standing position too rapidly, avoid this by sitting up a few minutes before rising. Use with caution during pregnancy or lactation.

Drug should not be given to Paediatrics, Pregnant Mothers, Geriatrics, and Neonates.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.

20 to 50 mg (35 (35)) 24 hourly PO — Scraped Dose — No data are available in regard to overdosage in humans. The oral LD 50 of amiloride HCl (calculated as the base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the strain. It is not known whether the drug is dialyzable. The most likely signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. These can be treated by established procedures. Therapy with amiloride HCl should be discontinued and the patient observed closely. There is no specific antidote. Emesis should be induced or gastric lavage performed. Treatment is symptomatic and supportive. If hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels.

( ) — Not recommended in this age group

( ) — Not recommended in this age group

When amiloride HCl is administered concomitantly with an angiotensin-converting enzyme inhibitor, an angiotensin II receptor antagonist, cyclosporine or tacrolimus, the risk of hyperkalemia may be increased. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. (See WARNINGS ). Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Read circulars for lithium preparations before use of such concomitant therapy. In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when amiloride HCl and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained. Since indomethacin and potassium-sparing diuretics, including amiloride HCl, may each be associated with increased serum potassium levels, the potential effects on potassium kinetics and renal function should be considered when these agents are administered concurrently.

Tab Store in a well closed container, Below 40°C.