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:

Nostrum Laboratories, 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 p

Sommarju tal-prodott:

Acetazolamide Extended-release Capsules are available as 500 mg: White to off-white Beads filled into capsule, size 00, yellow opaque/white opaque with black imprint on cap, "NA" above "500" Available in bottles of: Store at controlled room temperature 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ACETAZOLAMIDE- ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE
NOSTRUM LABORATORIES, INC.
----------
ACETAZOLAMIDE EXTENDED-RELEASE CAPSULES
RX ONLY
Revised June 2022
DESCRIPTION
Acetazolamide extended-release capsules are an inhibitor of the enzyme
carbonic
anhydrase.
Acetazolamide, USP 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
Acetazolamide extended-release capsules are for oral administration,
each containing
500 mg of acetazolamide and the following inactive ingredients:
Silicified microcrystalline cellulose, hypromellose, oleic
acid,ethylcellulose, medium chain
triglycerides, ammonium hydroxide and talc.
The ingredients in the capsule shell are yellow iron oxide, gelatin
and titanium dioxide.
The ingredients in the imprinting ink are black iron oxide, D&C yellow
# 10 aluminum
lake, FD&C blue # 1/brilliant blue FCF aluminum lake, FD&C blue # 2
/indigo carmine
aluminum lake, FD&C red # 40/allura red AC aluminum lake, propylene
glycol and shellac
glaze.
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
4 6 4
3 2
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