AcetaZOLAMIDE Tablets USP

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

ACETAZOLAMIDE

Composition:

ACETAZOLAMIDE 250 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 is 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. 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 in hyperchloremia acidosis. It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy. Long-term administration of acetaZOLAMIDE is contraindicated in patients with chronic non-con

Product summary:

AcetaZOLAMIDE is available as round white 250 mg tablet, quadrisected on one side, debossed with "LAN" over "1050" on the other. Bottle of 100     NDC 0527-1050-01 Bottle of 500     NDC 0527-1050-05 Bottle of 1000   NDC 0527-1050-10 Store at controlled room temperature 15°-30° C (59°-86° F)[see USP] Dispense in a well-closed container, as defined in the USP. Rx only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 CIB70454C Rev. 05/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAZOLAMIDE- ACETAZOLAMIDE TABLET
LANNETT COMPANY, INC.
----------
ACETAZOLAMIDE TABLETS USP
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-2yl)-acetamide
and has the following structural formula:
Each tablet, for oral administration, contains 250 mg of
acetaZOLAMIDE. In addition, each tablet
contains the following inactive ingredients: lactose monohydrate,
sodium starch glycolate, corn starch,
and calcium stearate.
CLINICAL PHARMACOLOGY
AcetaZOLAMIDE is a potent carbonic anhydrase inhibitor, effective in
the control of fluid secretion
(e.g., some types of glaucoma), in the treatment of certain convulsive
disorders (e.g., epilepsy), and in
the promotion of diuresis in instances of abnormal fluid retention
(e.g., 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
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 (e.g., epilepsy). Inhibition of carbonic anhydrase in this area
appears to retard abnormal,
paroxysmal, excessive discharge from central nervous system neurons.
The diuretic effect of
acetaZOLAMIDE is due to its action in the kidney on the reversible
rea