ACETAZOLAMIDE capsule, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Alembic Pharmaceuticals Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 extended-release capsules

Rezumat produs:

Acetazolamide extended-release capsules are available as:  500 mg: Orange opaque cap and orange opaque body, size ‘00’ capsule having imprinting ‘A’ on cap and ‘247’ on body with black ink, filled with white to off-white pellets.  NDC 62332-349-31                Bottle of 100 capsules NDC 62332-349-91                Bottle of 1000 capsules Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Alembic Pharmaceuticals Limited at 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India  Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 06/2022

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ACETAZOLAMIDE - ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE
ALEMBIC PHARMACEUTICALS INC.
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ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES
RX ONLY
REVISED: 06/2022
DESCRIPTION:
Acetazolamide extended-release capsules are an inhibitor of the enzyme
carbonic
anhydrase.
Acetazolamide is a white to faintly yellowish white crystalline,
odorless powder, sparingly
soluble in practically boiling water, 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 222.25 C H N40 S
Acetazolamide are extended-release capsules, for oral administration,
each containing
500 mg of acetazolamide and the following inactive ingredients:
Microcrystalline cellulose, sodium lauryl sulfate and talc.
The ingredients in the capsule shell are D&C Red No. 28, D&C Yellow
No. 10, FD&C Red
No. 40, gelatin and titanium dioxide.
The ingredients in the imprinting ink are shellac, propylene glycol,
potassium hydroxide
and iron oxide black.
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
4
6
3 2
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. Evi