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Drug Catalog - Product Detail

ACETAZOLAMIDE ER CAP 500MG 100CT

NDC Mfr Size Str Form
23155-0120-01 AVET PHARMACEUTICALS 100 500MG CAPSULE
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Description
DESCRIPTION Acetazolamide Extended-Release Capsules are an inhibitor of the enzyme carbonic anhydrase. Acetazolamide 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 : Acetazolamide Extended-Release Capsules are extended-release capsules, for oral administration, each containing 500 mg of Acetazolamide and the following inactive ingredients: Microcrystalline cellulose, sodium lauryl sulfate, hydroxypropyl cellulose and talc. The ingredients in the capsule shell are FD&C green # 3, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide, titanium dioxide and gelatin. The ingredients in the imprinting ink are shellac, propylene glycol, potassium hydroxide and black iron oxide. Image
How Supplied
HOW SUPPLIED Acetazolamide Extended-Release Capsules are available as 500 mg : Size '00' capsules with light green opaque body, imprinted 'HP120' in black ink on light green opaque cap. Contains white to off white pellets. Available in bottles of : 100 NDC 23155-120-01 500 NDC 23155-120-05 Store at controlled room temperature 20° - 25°C (68° - 77°F).[ See USP Controlled Room temperature]. Manufactured by: USV Private Limited Daman - 396210, India Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 11/2019 logo
Indications & Usage
INDICATIONS AND USAGE For adjunctive treatment of: 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 Extended-Release Capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.
Dosage and Administration
DOSAGE AND ADMINISTRATION Glaucoma: The recommended dosage is 1 capsule (500 mg) two times a day. Usually 1 capsule is administered in the morning and 1 capsule in the evening. It may be necessary to adjust the dose, but it has usually been found that dosage in excess of 2 capsules (1 g) does not produce an increased effect. The dosage should be adjusted with careful individual attention both to symptomatology and intraocular tension. In all cases, continuous supervision by a physician is advisable. In those unusual instances where adequate control is not obtained by the twice-a-day administration of Acetazolamide Extended-Release Capsules, the desired control may be established by means of Acetazolamide (tablets or parenteral). Use tablets or parenteral in accordance with the more frequent dosage schedules recommended for these dosage forms, such as 250 mg every four hours, or an initial dose of 500 mg followed by 250 mg or 125 mg every four hours, depending on the case in question. Acute Mountain Sickness: Dosage is 500 mg to 1000 mg daily, in divided doses using tablets or extended-release capsules as appropriate. In circumstances of rapid ascent, such as in rescue or military operations, the higher dose level of 1000 mg is recommended. It is preferable to initiate dosing 24 to 48 hours before ascent and to continue for 48 hours while at high altitude, or longer as necessary to control symptoms.