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 100’s (NDC #60429-275-01).

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

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

Dist. by:
Par Pharmaceutical
Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:
Par Formulations Private Limited,
9/215, Pudupakkam, Kelambakkam-603 103.
Made in India

Mfg. Lic. No.: TN00002121
OS117-01-74-01

Issued: 07/2021

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

PRINCIPAL DISPLAY PANEL 5MG 100’S

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AMILORIDE HYDROCHLORIDE
amiloride hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-275(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
CELLULOSE, MICROCRYSTALLINE
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:60429-275-01 100 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 — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (60429-275), repack (60429-275)

Revised: 03/2022 Golden State Medical Supply, Inc.

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