ACETAZOLAMIDE capsule, extended release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Zydus Pharmaceuticals USA Inc.

INN (Isem Internazzjonali):

ACETAZOLAMIDE

Kompożizzjoni:

ACETAZOLAMIDE 500 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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

Sommarju tal-prodott:

Acetazolamide Extended-Release Capsules, 500 mg are white to off-white pellets filled in empty hard gelatin capsules with orange opaque cap imprinted with "EP" in black ink and white opaque body imprinted with "107" in black ink and are supplied as follows: NDC 68382-261-01 in bottle of 100 capsules NDC 68382-261-10 in bottle of 1000 capsules          Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ACETAZOLAMIDE- ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
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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:
MW 222.24 C H N O S
Each acetazolamide extended-release capsule intended for oral
administration contains 500 mg of
acetazolamide. In addition, each capsule contains the following
inactive ingredients: ammonio
methacrylate copolymer dispersion type A and B, FD&C yellow #6,
gelatin, microcrystalline cellulose,
sodium lauryl sulfate, talc and titanium dioxide. The capsule is
printed with black pharmaceutical ink
which contains black iron oxide as a coloring agent.
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