ACETAZOLAMIDE capsule, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

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

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 Extended-Release Capsules are 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 pa

Tuoteyhteenveto:

Acetazolamide Extended-Release Capsules are available as 500 mg : Size '00' capsules with light green opaque body, imprinted 'HP120' in black ink on light green opaque cap. Contains white to off white pellets. Available in bottles of : Store at controlled room temperature 20° - 25°C (68° - 77°F).[ See USP Controlled Room temperature]. Manufactured by: USV Private Limited Daman - 396210, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 11/2019

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ACETAZOLAMIDE- ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACETAZOLAMIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR
ACETAZOLAMIDE
ACETAZOLAMIDE (ACETAZOLAMIDE) CAPSULE, EXTENDED RELEASE FOR ORAL USE.
INITIAL U.S. APPROVAL:
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 :
Acetazolamide Extended-Release Capsules are extended-release capsules,
for oral
administration, each containing 500 mg of Acetazolamide and the
following inactive
ingredients:
Microcrystalline cellulose, sodium lauryl sulfate, hydroxypropyl
cellulose and talc.
The ingredients in the capsule shell are FD&C green # 3, FDA/E172
black iron oxide,
FDA/E172 yellow iron oxide, titanium dioxide and gelatin.
The ingredients in the imprinting ink are shellac, propylene glycol,
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