Acetazolamide ER 500mg [Extended Release]

NDC: 16729-331-01

Acetazolamide ER 500 mg Capsules, 100 count — Accord Healthcare

Active ingredient	Acetazolamide 500 mg
Dosage form	Extended-release capsule
Route	Oral
Size	100 capsules
Manufacturer	Accord Healthcare
NDC	16729-331-01

Indications and Usage

Adjunctive treatment of chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering intraocular pressure is desired. Also indicated for prevention or amelioration of symptoms of acute mountain sickness.

Dosage and Administration

For glaucoma, one 500 mg capsule twice daily, usually morning and evening. For acute mountain sickness, 500 mg to 1000 mg daily in divided doses, started 24 to 48 hours before ascent and continued during ascent.

Warnings and Precautions

• Fatal severe sulfonamide reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and fulminant hepatic necrosis can occur
• Concomitant high-dose aspirin may cause anorexia, tachypnea, lethargy, coma, and death
• Monitor for electrolyte imbalance and metabolic acidosis
• Caution in patients with pulmonary obstruction or emphysema

Contraindications

Contraindicated in hypersensitivity to acetazolamide or sulfonamides, depressed sodium or potassium levels, marked kidney or liver disease or dysfunction, adrenal insufficiency, hyperchloremic acidosis, and chronic noncongestive angle-closure glaucoma.

Adverse Reactions

Common adverse reactions include paresthesias, hearing disturbances or tinnitus, loss of appetite, taste alteration, nausea, vomiting, diarrhea, polyuria, and drowsiness; blood dyscrasias and metabolic acidosis may also occur.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F) in well-closed containers.

How Supplied

Orange opaque extended-release capsules, each containing 500 mg of acetazolamide, supplied in bottles of 100.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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