ACETAZOLAMIDE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Zydus Pharmaceuticals (USA) Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure 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 patients with chronic non-congestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

Tuoteyhteenveto:

Acetazolamide Extended-release Capsules USP, 500 mg are white to off white pellets filled in size "00el" empty hard gelatin capsules with opaque yellow colored cap imprinted with "XYL" in black ink and opaque white colored body imprinted with "34" in black ink and are supplied as follows: NDC 70710-1591-3 in bottles of 30 capsules with child-resistant closure NDC 70710-1591-9 in bottles of 90 capsules with child-resistant closure NDC 70710-1591-1 in bottles of 100 capsules with child-resistant closure NDC 70710-1591-5 in bottles of 500 capsules NDC 70710-1591-0 in bottles of 1000 capsules NDC 70710-1591-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].   Dispense in a tight container (USP). Call  your  doctor  for  medical  advice  about  side  effects.  You  may  report  side  effects  to  FDA  at  1-800-FDA-1088.   Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 11/23

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ACETAZOLAMIDE- ACETAZOLAMIDE CAPSULE
ZYDUS PHARMACEUTICALS (USA) INC.
----------
ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES, USP
RX ONLY
DESCRIPTION:
Acetazolamide Extended-release Capsules USP are an inhibitor of the
enzyme carbonic anhydrase.
Acetazolamide, USP is a white to faintly yellowish white, crystalline
odorless powder, sparingly soluble in
practically boiling water, slightly soluble in alcohol, very slightly
soluble in water. The chemical name for
acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl) acetamide and
has the following chemical structure:
MW 222.25 C H N O S
Each acetazolamide extended-release capsule, USP intended for oral
administration contains 500 mg of
acetazolamide. In addition, each capsule contains the following
inactive ingredients: gelatin, iron oxide yellow,
microcrystalline cellulose, sodium lauryl sulfate, talc and titanium
dioxide. Each capsule is printed with black
pharmaceutical ink which contains black iron oxide, butyl alcohol,
dehydrated alcohol, isopropyl alcohol,
potassium hydroxide, propylene glycol, shellac and strong ammonia
solution.
Meets USP Dissolution Test 3.
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 case