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FRUMIL (AMILORIDE, FUROSEMIDE): PRESCRIBING INFORMATION
Frumil tablets containing Furosemide (Frusemide) 40 mg and Amiloride Hydrochloride Anhydrous 5 mg.
Orange tablets with break-line; "Frumil" on reverse side.
Frumil clinical pharmacology
INDICATIONS AND USAGE
Frumil (Amiloride HCl, Furosemide) is indicated for the treatment of cardiac failure, in patients who require diuretics plus potassium supplements, or potassium sparing diuretics.
Patients with hyperkalemia (serum potassium above 5.5 mmol per litre).
Patients with severe hypokalaemia. However, if hypokalaemia develops during treatment it can usually be corrected without interrupting administration of Frumil.
Patients with hypovolaemia or dehydration.
Patients with impaired renal function and a creatinine clearance below 30 mL/min per 1.73 m2 body surface area, acute renal failure or anuria.
Patients with severe hyponatraemia.
Patients with pre-comatose and comatose states associated with hepatic encephalopathy.
Patients on concomitant potassium supplements.
Patients who are pregnant or breastfeeding.
Patients with a hypersensitivity to furosemide (frusemide), amiloride, sulfonamides or sulfonamide derivatives, or any of the excipients of Frumil. Patients allergic to sulfonamides (eg. sulfonamide antibiotics or sulfonylureas) may show cross-sensitivity to furosemide (frusemide).
Hyperkalaemia has been observed in patients receiving amiloride hydrochloride. Furosemide (Frusemide) can cause latent diabetes to become manifest or the insulin requirements of diabetic patients to increase. Patients with prostatic hypertrophy or impairment of micturition are at increased risk of developing acute urinary retention. Serum uric acid levels may rise during treatment with Frumil (Amiloride Hydrochloride, Furosemide) and an acute attack of gout may be precipitated.
Cephaloridine nephrotoxicity may be increased by concomitant administration of patient diuretics such as Amiloride with Furosemide (Frumil).
Frumil drug interactions
Frumil adverse reactions
DOSAGE AND ADMINISTRATION
The initial adult dose is one tablet (40 mg furosemide and 5 mg amiloride hydrochloride) to be taken each morning. This may be increased to two tablets daily if the initial response is unsatisfactory. In this case, it is best to divide the dosage into two daily doses, one to be taken in the morning and the other at noon. The total daily dose of amiloride should not exceed 20 mg. The tablets are to be swallowed whole with sufficient amounts of liquid (approximately half a glass). They are best taken on an empty stomach.
Signs and Symptoms
The clinical picture in acute or chronic overdose depends primarily on the extent and consequences of electrolyte and fluid loss eg. hypovolaemia, dehydration, haemoconcentration,
cardiac arrhythmias (including A-V block and ventricular fibrillation). Symptoms of these disturbances include severe hypotension (progressing to shock), acute renal failure, thrombosis, delirious states, flaccid paralysis, apathy and confusion.
Treatment of over-dosage should be aimed at reversing the dehydration and correcting electrolyte imbalance, particularly hyperkalaemia. Together with the prevention and treatment of serious complications resulting from such disturbances and of other effects on the body, this corrective action may necessitate general and specific intensive medical monitoring and therapeutic measures. Attempts should be made to limit further systemic absorption of the active ingredient. Treatment is symptomatic and supportive. If hyperkalaemia is seen, appropriate measures to reduce it must be instituted.
Contact the Poisons Information Centre for advice on management of overdosage.
HOW SUPPLIED / STORAGE
Calendar packs of 28 tablets (2 x 14 blisters)
Store below 25°C.
Each tablet of Frumil (Amiloride, Furosemide) also contains lactose monohydrate, microcrystalline cellulose, maize starch, sodium starch glycollate, purified talc, silicon dioxide, magnesium stearate, sunset yellow FCF.
Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.
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