Prescription Drug Information: Acetazolamide (Page 2 of 2)

Congestive Heart Failure

For diuresis in congestive heart failure, the starting dose is usually 250 to 375 mg once daily in the morning (5 mg/kg). If, after an initial response, the patient fails to continue to lose edema fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day.

Acetazolamide tablets yield best diuretic results when given on alternate days, or for two days alternating with a day of rest.

Failures in therapy may be due to overdosage or too frequent dosage. The use of acetazolamide does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction.

Drug-Induced Edema

Recommended dosage is 250 to 375 mg of acetazolamide once a day for one or two days, alternating with a day of rest.

Acute Mountain Sickness

Dosage is 500 mg to 1000 mg daily, in divided doses. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.

Note: The dosage recommendations for glaucoma and epilepsy differ considerably from those for congestive heart failure, since the first two conditions are not dependent upon carbonic anhydrase inhibition in the kidney which requires intermittent dosage if it is to recover from the inhibitory effect of the therapeutic agent.

HOW SUPPLIED

Acetazolamide Tablets USP are supplied as follows:

125 mg – White to off white, round, uncoated tablets, scored in half on one side and debossed with ‘Λ’ on other side.
42
NDC 68071-3550-1 — Bottle of 12

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

Distributed By:
Advagen Pharma Ltd.,
666 Plainsboro Road,
Suite 605
Plainsboro, NJ 08536, USA.

Manufactured by:
Rubicon Research Private Limited
Ambernath, Dist: Thane, 421506 India.

Rev. 05/2021

PRINCIPAL DISPLAY PANEL

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(click image for full-size original)

ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3550(NDC:72888-047)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (ACETAZOLAMIDE) ACETAZOLAMIDE 125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
GELATIN, UNSPECIFIED
GLYCERIN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A
TALC
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code UpArrowhead42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-3550-1 12 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215101 08/19/2021
Labeler — NuCare Pharmaceuticals,Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 repack (68071-3550)

Revised: 12/2023 NuCare Pharmaceuticals,Inc.

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