ACETAZOLAMIDE injection, powder, lyophilized, for solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

ACETAZOLAMIDE SODIUM (UNII: 429ZT169UH) (ACETAZOLAMIDE - UNII:O3FX965V0I)

Disponibbli minn:

Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.

INN (Isem Internazzjonali):

ACETAZOLAMIDE SODIUM

Kompożizzjoni:

ACETAZOLAMIDE 500 mg in 5 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 is 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 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 noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

Sommarju tal-prodott:

Acetazolamide for Injection, USP (lyophilized) powder is supplied as follows: Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Reconstituted solution should be stored in refrigerator at 2° to 8°C (36° to 46°F). Use within 12 hours of reconstitution. Contains no preservative. Discard unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Manufactured by: Emcure Pharmaceuticals Ltd., Sanand, Ahmedabad – 382110, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ08816 1.866.901.DRUG (3784) Revised: 07/2022 OR Manufactured by: Stelis Biopharma Limited, Bengaluru, Karnataka - 561203, INDIA. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 07/2023

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ACETAZOLAMIDE- ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HERITAGE PHARMACEUTICALS LABS INC. D/B/A AVET PHARMACEUTICALS LABS
INC.
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ACETAZOLAMIDE FOR INJECTION USP
FOR INTRAVENOUS USE
RX ONLY
DESCRIPTION
Acetazolamide, an inhibitor of the enzyme carbonic anhydrase, 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-2yl)-acetamide and has the following chemical
structure:
MW 222.25 C H N O S
Acetazolamide is available for intravenous use, and is supplied as a
sterile powder
requiring reconstitution. Each vial contains an amount of
acetazolamide sodium
equivalent to 500 mg of acetazolamide. The bulk solution is adjusted
to pH 9.6 using
sodium hydroxide NF and, if necessary, hydrochloric acid NF prior to
lyophilization.
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
as an adjuvant in the treatment of certain dysfunctions of the central
nervous system
(