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 color, round shape, flat uncoated tablet, debossed “LS720″ on one side and scored in half on another side.

NDC 70756-720-11 — Bottle of 100

250 mg — White color, round standard convex uncoated tablet, debossed “LS721″ on one side and scored in quarters on another side.

NDC 70756-721-11 — Bottle of 100

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

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

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

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Made in India

Revised: March 2020, V-02

Or

Manufactured in India for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Product of Poland

Revised: August 2020, P-01

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 70756-720-11

acetaZOLAMIDE Tablets, USP

125 mg

100 Tablets

Rx only

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Made in India

PRINCIPAL DISPLAY PANEL -- 125 mg Tablet Bottle Label
(click image for full-size original)

NDC 70756-720-11

acetaZOLAMIDE Tablets, USP

125 mg

100 Tablets

Rx only

Manufactured in India for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Product of Poland

125-poland
(click image for full-size original)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 70756-721-11

acetaZOLAMIDE Tablets, USP

250 mg

100 Tablets

Rx only

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Made in India

PRINCIPAL DISPLAY PANEL -- 250 mg Tablet Bottle Label
(click image for full-size original)

NDC 70756-721-11

acetaZOLAMIDE Tablets, USP

250 mg

100 Tablets

Rx only

Manufactured in India for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Product of Poland

250 mg- Poland
(click image for full-size original)
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-720
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
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
WATER
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code LS;720
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-720-11 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214282 11/13/2020
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-721
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (ACETAZOLAMIDE) ACETAZOLAMIDE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
WATER
Product Characteristics
Color WHITE Score 4 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LS;721
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-721-11 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214282 11/13/2020
Labeler — Lifestar Pharma LLC (080268943)
Registrant — Mankind Pharma Limited (915834068)
Establishment
Name Address ID/FEI Operations
Mankind Pharma Limited 916512493 MANUFACTURE (70756-720), MANUFACTURE (70756-721), ANALYSIS (70756-720), ANALYSIS (70756-721), PACK (70756-720), PACK (70756-721)

Revised: 11/2020 Lifestar Pharma LLC

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