Amiloride Hydrochloride (Page 3 of 3)

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

Amiloride HCl should be administered with food.

Amiloride HCl, one 5 mg tablet daily, should be added to the usual antihypertensive or diuretic dosage of a kaliuretic diuretic. The dosage may be increased to 10 mg per day, if necessary. More than two 5 mg tablets of amiloride HCl daily usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

In treating patients with congestive heart failure after an initial diuresis has been achieved, potassium loss may also decrease and the need for amiloride HCl should be re-evaluated. Dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

If it is necessary to use amiloride HCl alone (see INDICATIONS), the starting dosage should be one 5 mg tablet daily. This dosage may be increased to 10 mg per day, if necessary. More than two 5 mg tablets usually are not needed, and there is little controlled experience with such doses. If persistent hypokalemia is documented with 10 mg, the dose can be increased to 15 mg, then 20 mg, with careful monitoring of electrolytes.

HOW SUPPLIED

Each yellow compressed tablet contains 5 mg of anhydrous Amiloride HCl and is debossed “Par 117”. They are available in bottles of 1000’s (NDC #63629-2114-1).

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container as defined in the USP.

Amiloride Hcl Anhydrous 5 mg Tab, #1000

AMILORIDE HYDROCHLORIDE amiloride hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2114(NDC:49884-117) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMILORIDE HYDROCHLORIDE ANHYDROUS (AMILORIDE) AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 FD&C YELLOW NO. 6 DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code Par;117 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63629-2114-1 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070346 01/22/1986

Labeler — Bryant Ranch Prepack (171714327)

Registrant — Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Operations
Bryant Ranch Prepack		171714327	REPACK (63629-2114), RELABEL (63629-2114)

Revised: 04/2022 Bryant Ranch Prepack