Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
ACETAZOLAMIDE SODIUM (UNII: 429ZT169UH) (ACETAZOLAMIDE - UNII:O3FX965V0I)
X-GEN Pharmaceuticals, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
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
NDC 39822-0190-7 500 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: Manufactured for X-GEN Pharmaceuticals, Big Flats, NY 14814. N+ and NOVAPLUS are registered trademarks of Vizient, Inc. Revised April 2016 009742 ACTZ-NP-PI-02
Abbreviated New Drug Application
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 Olvassa el a teljes dokumentumot