ACETAZOLAMIDE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For adjunctive treatment of: 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 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 in hyperchloremic 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 Extended-Release Capsules are available as 500 mg: White capsules containing white to off-white pellets, imprinted in black ink (Body:N16; Cap: 548) Available in bottles of 100 Capsules. NDC 50742-233-01. Store at 20° to 25°C [68° to 77°F][See USP controlled room temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals LLC, toll-free at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACETAZOLAMIDE- ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE
INGENUS PHARMACEUTICALS, LLC
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ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES, 500MG
SPL UNCLASSIFIED
ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES
RX ONLY
DESCRIPTION
Acetazolamide Extended-Release Capsules are an inhibitor of the enzyme
carbonic anhydrase.
Acetazolamide 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:
Each acetazolamide extended-release capsule, for oral administration,
contains 500 mg of
acetazolamide and the following inactive ingredients:
Microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized
starch, talc.
The capsule shell contains gelatin, sodium lauryl sulphate and
titanium dioxide. The imprinting ink
contains shellac, potassium hydroxide and black iron oxide.
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
non-bacteriostatic 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 non-glaucomatous conditions. Evidence
seems to indicate that
acetazolamide has utility as an adjuvant in trea