Source: Health Products and Food Branch (CA) Revision Year: 2014
NOVAMILOR (amiloride hydrochloride and hydrochlorothiazide) is not indicated for initial therapy. If the fixed drug combination represents the dosage determined through titration on the individual drugs, then the fixed combination may be more convenient to the patient. If it becomes necessary to adjust the dosage during maintenance treatment, the individual drugs should be used.
NOVAMILOR is indicated in the maintenance therapy of patients with edema of cardiac origin or with arterial hypertension who are hypokalemic or in whom normal potassium levels are clinically important (i.e., patients with cardiac arrhythmias, digitalized patients and those in whom adequate intake of dietary potassium is not possible).
NOVAMILOR is also indicated in the maintenance of patients with hepatic cirrhosis with ascites and edema. In these patients, satisfactory diuresis with diminished potassium loss and decreased risk of metabolic alkalosis may be attained with use of amiloride hydrochloride alone. Kaliureticdiuretic agents may be added to the treatment regimen in resistant cases in order to obtain satisfactory diuresis and maintain a more balanced serum electrolyte pattern. As with all forms of therapy for ascites of hepatic cirrhosis, the primary objective is gradual weight loss and avoidance of electrolyte imbalance (see PRECAUTIONS).
Patients should be titrated with the individual drugs in order to establish optimum dosage.
Maintenance doses may be lower than those required to initiate diuresis; therefore, reduction in the daily dosage should be attempted when the patient’s weight is stabilized. In cirrhotic patients, gradual weight reduction is especially desirable to reduce the likelihood of untoward reactions associated with diuretic therapy.
The usual maintenance dose of NOVAMILOR (amiloride hydrochloride and hydrochlorothiazide) is 1 tablet given once a day. The dosage should not exceed 4 tablets a day in single or divided doses.
The usual maintenance dose of NOVAMILOR is 1 or 2 tablets given once a day or in divided doses. The dosage should not exceed 4 tablets a day. Therapy may be on an intermittent basis.
The usual maintenance dosage is 1 or 2 tablets given once a day or in divided doses. The dosage should not exceed 4 tablets a day.
There is no data available concerning overdosage with the combination of amiloride hydrochloride and hydrochlorothiazide or with amiloride hydrochloride alone in humans.
Electrolyte imbalance and dehydration are the most common signs and symptoms to be expected from overdosage with NOVAMILOR (amiloride hydrochloride and hydrochlorothiazide). It is therefore necessary to monitor serum electrolyte levels carefully. Special attention should be given to potassium levels.
Digitalized patients are particularly prone to cardiac arrhythmias which can be caused by abnormal potassium levels.
No specific antidote is available for NOVAMILOR. Treatment is symptomatic and supportive, and the induction of emesis and/or gastric lavage is suggested. If overdosage occurs, NOVAMILOR therapy should be discontinued immediately and the patient should be observed closely.
It is not known whether the drug is dialyzable.
Store between 15 and 30°C. Unit dose strips should be stored between 15°C and 25°C and protected from high humidity.
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