Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2021 Publisher: Pharmacy Retailing Pty Ltd, t/a Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand Telephone (09) 9185 100 Email: aspen@aspenpharma.co.nz
MODURETIC is indicated in the treatment of patients with:
MODURETIC, with its combination of amiloride HCl and hydrochlorothiazide, minimises the possibility of the development of excessive potassium loss in patients during vigorous diuresis for prolonged periods. MODURETIC, with its built-in potassium sparing agent, is especially indicated in those conditions where the positive effect on potassium balance is particularly important.
MODURETIC may be used alone, or as an adjunct to other antihypertensive drugs. Since it enhances the action of these agents, the dosage of these antihypertensive drugs may need to be reduced to avoid the risk of an excessive drop in blood pressure.
MODURETIC tablets are available for oral use containing amiloride HCl 5 mg and hydrochlorothiazide 50 mg.
MODURETIC may be started at a dosage of 1 or 2 tablets a day. Dosage may be increased if necessary, but must not exceed four tablets a day. The optimal dosage is determined by the diuretic response and the serum potassium level. Once an initial diuresis has been achieved, reduction in dosage should be attempted for maintenance therapy. Maintenance therapy may be on an intermittent basis.
The usual dosage is one or two tablets given once a day or in divided doses. The dosage may be increased if necessary, but must not exceed four tablets a day.
Treatment should be initiated with a small dose of MODURETIC (1 tablet once a day). If necessary, dosage may be increased gradually until there is effective diuresis. The dosage should not exceed four tablets per day.
Maintenance doses may be lower than those required to initiate diuresis: therefore, reduction in the daily dose should be attempted when the patient’s weight is stabilised. Gradual weight reduction in cirrhotic patients is especially desirable to reduce the likelihood of untoward reactions associated with diuretic therapy.
No data are available with regard to overdosage in humans. The oral LD50 of the combination drug is 189 and 422 mg/kg for female mice and female rats, respectively.
It is not known whether the drug is dialysable.
No specific information is available on the treatment of overdosage with MODURETIC, and no specific antidote is available. Treatment is symptomatic and supportive. Therapy with MODURETIC should be discontinued and the patient observed closely.
In the case of overdose, immediately telephone the New Zealand Poisons Information Centre for advice on 0800 764 766 or 0800 POISON.
No data are available in regard to overdosage in humans.
The oral LD50 of amiloride hydrochloride (calculated as the base) is 56 mg/kg in mice and 36 to 85 mg/kg in rats, depending on the strain.
The most common signs and symptoms to be expected with overdosage are dehydration and electrolyte imbalance. If hyperkalaemia occurs, active measures should be taken to reduce the serum potassium levels.
The oral LD50 of hydrochlorothiazide is greater than 10.0 g/kg in both mice and rats.
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis. If digitalis has been administered, hypokalaemia may accentuate cardiac arrhythmias.
24 months.
Store below 30°C.
Blister pack, PVC/PVdC/Al – 50 tablets.
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