ACETAZOLAMIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Productkenmerken Productkenmerken (SPC)
18-10-2023

Werkstoffen:

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

Beschikbaar vanaf:

Bryant Ranch Prepack

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); 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 tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to 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 i

Product samenvatting:

Acetazolamide Tablets USP are supplied as follows: 250 mg - White color, round standard convex uncoated tablet, debossed "LS721" on one side and scored in quarters on another side. NDC 63629-1195-1 - Bottle of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP using a child-resistant closure. Keep this and all medication out of the reach of children.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

                                ACETAZOLAMIDE- ACETAZOLAMIDE TABLET
BRYANT RANCH PREPACK
----------
ACETAZOLAMIDE TABLETS USP
RX ONLY
DESCRIPTION
Acetazolamide, USP an inhibitor of the enzyme carbonic anhydrase, is a
white to faintly
yellowish white crystalline odorless powder, very slightly soluble in
water, sparingly
soluble in boiling 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:
Molecular Weight: 222.25
Molecular Formula: C
H
N
O
S
Acetazolamide, USP is available as oral tablets containing 125 mg and
250 mg of
acetazolamide respectively and the following inactive ingredients:
lactose monohydrate,
magnesium stearate, maize starch, povidone, sodium starch
glycolate-type A and talc.
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
nonbacteriostatic 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
nonglaucomatous conditions. Evidence seems to indicate that
acetazolamide has utility
4
6
4
3
2
as an adjuvant in the treatment of certain dysfunctions of the central
nervous system
(eg, epilepsy). Inhibition of carbonic anhydrase in this area appears
to retard abnormal,
paroxysmal, excessive discharge from cen
                                
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