Amiloride Hydrochloride and Hydrochlorothiazide (Page 5 of 5)

Amiloride Hydrochloride

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 hyperkalemia occurs, active measures should be taken to reduce the serum potassium levels.

Hydrochlorothiazide

The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

DOSAGE AND ADMINISTRATION

Amiloride hydrochloride and hydrochlorothiazide tablets should be administered with food.

The usual starting dosage is 1 tablet a day. The dosage may be increased to 2 tablets a day, if necessary. More than 2 tablets of amiloride hydrochloride and hydrochlorothiazide daily usually are not needed and there is no controlled experience with such doses.

Hydrochlorothiazide can be given at doses of 12.5 to 50 mg per day when used alone. Patients usually do not require doses of hydrochlorothiazide in excess of 50 mg daily when combined with other antihypertensive agents. The daily dose is usually given as a single dose but may be given in divided doses. Once an initial diuresis has been achieved, dosage adjustment may be necessary. Maintenance therapy may be on an intermittent basis.

HOW SUPPLIED

Product: 50090-0513

NDC: 50090-0513-1 30 TABLET in a BOTTLE

NDC: 50090-0513-0 28 TABLET in a BOTTLE

Amiloride Hydrochloride and Hydrochlorothiazide

Label ImageLabel Image
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0513(NDC:0555-0483)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMILORIDE HYDROCHLORIDE (AMILORIDE) AMILORIDE HYDROCHLORIDE ANHYDROUS 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10 ALUMINUM LAKE
ALUMINUM OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color yellow (light yellow) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 555;483;barr
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-0513-0 28 TABLET in 1 BOTTLE None
2 NDC:50090-0513-1 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071111 12/01/1989
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0513), REPACK (50090-0513)

Revised: 02/2023 A-S Medication Solutions

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