Amiloride Hydrochloride and Hydrochlorothiazide (Page 5 of 5)

OVERDOSAGE

No data are available in 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 dialyzable.

No specific information is available on the treatment of overdosage with amiloride and hydrochlorothiazide, and no specific antidote is available. Treatment is symptomatic and supportive. Therapy with amiloride and hydrochlorothiazide should be discontinued and the patient observed closely. Suggested measures include induction of emesis and/or gastric lavage.

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 mg 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

Amiloride Hydrochloride and Hydrochlorothiazide Tablets, USP are available containing 5 mg of anhydrous amiloride hydrochloride, USP and 50 mg of hydrochlorothiazide, USP.

The 5 mg/50 mg tablets are light orange, round, scored tablets debossed with M above the score and 577 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0378-0577-01
bottles of 100 tablets
NDC 0378-0577-05
bottles of 500 tablets

Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Protect from light.

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

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 4/2020
AHCTZ:R13

PRINCIPAL DISPLAY PANEL — 5 mg/50 mg

NDC 0378-0577-01

Amiloride HCl and
Hydrochlorothiazide
Tablets, USP

5 mg*/
50 mg

Rx only 100 Tablets

Each tablet contains: Amiloride
Hydrochloride, USP 5 mg*
*(Anhydrous equivalent)
Hydrochlorothiazide, USP 50 mg

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

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Adult Dosage: One or two
tablets daily. See accompanying
prescribing information.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Mylan.com

RM0577A5

Amiloride HCl and Hydrochlorothiazide Tablets 5 mg/50 mg Bottle Label
(click image for full-size original)
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0577
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
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM LAURYL SULFATE
Product Characteristics
Color ORANGE (light orange) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code M;577
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-0577-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-0577-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073209 10/31/1991
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 04/2020 Mylan Pharmaceuticals Inc.

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