ACETAZOLAMIDE- acetazolamide injection, powder, lyophilized, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

X-GEN Pharmaceuticals, Inc.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 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 g

제품 요약:

NDC 39822-0191-9 500 mg Vial Store drug product at controlled room temperature 20° to 25°C (68° to 77°F).  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. Manufactured for: X-GEN Pharmaceuticals, Inc. Big Flats, NY 14814 PREMIERProTM Rx is a trademark of Premier, Inc., used under license. March 2013 ACTZ-PRPI-00 011823

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ACETAZOLAMIDE- ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
X-GEN PHARMACEUTICALS, INC.
----------
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 structural formula:
S TRUCTURE
Acetazolamide is available for intravenous use, and is supplied as a
sterile powder requiring
reconstitution. Each vial contains 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 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 (e.g., epilepsy). Inhibition of carbonic anhydrase in this area
appears to