ACETAZOLAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAZOLAMIDE (UNII: O3FX965V0I) (ACETAZOLAMIDE - UNII:O3FX965V0I)

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

ACETAZOLAMIDE

Composition:

ACETAZOLAMIDE 125 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent. Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and i

Product summary:

Acetazolamide Tablets USP, 125 mg are available for oral administration as white to off white, round tablet, debossed HP 287 on one side and scored on other side. They are supplied as follows: Bottles of 100 Tablets             NDC 23155-287-01 Bottles of 1000 Tablets           NDC 23155-287-10 Acetazolamide Tablets USP, 250 mg are available for oral administration as white to off white, round tablet, debossed HP 288 on one side and scored in quarters on other side. They are supplied as follows: Bottles of 100 Tablets             NDC 23155-288-01 Bottles of 1000 Tablets           NDC 23155-288-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. 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 MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) 51U000000129US06 Revised: 06/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAZOLAMIDE- ACETAZOLAMIDE TABLET
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
ACETAZOLAMIDE TABLETS USP
RX ONLY
DESCRIPTION
Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a
white to faintly
yellowish white crystalline, odorless powder, weakly acidic, very
slightly soluble in water
and slightly soluble in alcohol. The chemical name for acetazolamide
is _N_-(5-Sulfamoyl-
1,3,4-thiadiazol-2-yl) acetamide and has the following chemical
structure:
Molecular Weight: 222.25
Molecular Formula: C H N O S
Acetazolamide Tablets, USP are available for oral administration each
containing 125 mg
and 250 mg of acetazolamide respectively. Additionally, they contain
the following
inactive ingredients: lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and
sodium starch
glycolate.
CLINICAL PHARMACOLOGY
Acetazolamide is a potent carbonic anhydrase inhibitor, effective in
the control of fluid
secretion (eg, some types of glaucoma), in the treatment of certain
convulsive disorders
(eg, epilepsy), and in the promotion of diuresis in instances of
abnormal fluid retention
(eg, cardiac edema).
Acetazolamide is not a mercurial diuretic. Rather, it is a
nonbacteriostatic sulfonamide
possessing a chemical structure and pharmacological activity
distinctly different from
the bacteriostatic sulfonamides.
Acetazolamide is an enzyme inhibitor that acts specifically on
carbonic anhydrase, the
enzyme that catalyzes the reversible reaction involving the hydration
of carbon dioxide
and the dehydration of carbonic acid. In the eye, this inhibitory
action of acetazolamide
4
6
4
3 2
decreases the secretion of aqueous humor and results in a drop in
intraocular pressure,
a reaction considered desirable in cases of glaucoma and even in
certain
nonglaucomatous conditions. Evidence seems to indicate that
acetazolamide has utility
as an adjuvant in the treatment of certain dysfunctions of the central
nervous system
(eg, epilepsy). Inhibit