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:

Hikma Pharmaceuticals USA Inc.

INN (Isem Internazzjonali):

ACETAZOLAMIDE SODIUM

Kompożizzjoni:

ACETAZOLAMIDE 500 mg

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. 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 for Injection 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 for Injection 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 sterile intravenous (lyophilized) powder. NDC 0143-9503-01 500 mg Vial Store drug product at 20° to 25°C (68° to 77°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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Contains no preservative. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689.   Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922                                         Revised July 2022 PIN426-WES/3

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ACETAZOLAMIDE- ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HIKMA PHARMACEUTICALS USA 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-2-yl) acetamide and has the following chemical
structure:
M.W.
222.24 C H N O S
Acetazolamide for Injection, USP 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 and, if necessary, hydrochloric acid prior to
lyophilization.
CLINICAL PHARMACOLOGY
Acetazolamide for Injection 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 for Injection 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 for Injection 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
4
6
4
3 2
certain nonglaucomatous conditions. Evidence seems to indicate that
Acetazolamide for
Injection has utility as an adjuvant in the treatment of certain
dysfun