Drugplain

Methazolamide 50 mg/1

Methazolamide · TABLET · Bryant Ranch Prepack

2 Recalls on Record
Plain English

Methazolamide is a tablet containing methazolamide at 50 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Methazolamide
Generic Name
Methazolamide
NDC Code (Product)
63629-1987
Manufacturer
Bryant Ranch Prepack
Strength
50 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040001
Marketing Start
11/06/2014

Recall History

2 Recalls on Record
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: METHAZOLAMIDE, Tablet, 50 mg may have potentially been mislabeled as the following drug: BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD39573_1, EXP: 5/13/2014.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective40 reports
fatigue36 reports
dizziness29 reports
headache28 reports
dyspnoea26 reports
off label use24 reports
blood pressure increased22 reports
asthenia21 reports
anxiety20 reports
death20 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Methazolamide Tablets are indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.

Dosage & Administration

DOSAGE AND ADMINISTRATION The effective therapeutic dose administered varies from 50 mg to 100 mg two or three times daily. The drug may be used concomitantly with miotic and osmotic agents.

Warnings

WARNINGS Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Hypersensitivity reactions may recur when a sulfonamide is readministered, irrespective of the route of administration. If hypersensitivity or other serious reactions occur, the use of this drug should be discontinued. Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma, and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors.

Contraindications

CONTRAINDICATIONS Methazolamide therapy is contraindicated in situations in which sodium and/or potassium serum levels are depressed, in cases of marked kidney or liver disease or dysfunction, in adrenal gland failure, and in hyperchloremic acidosis. In patients with cirrhosis, use may precipitate the development of hepatic encephalopathy. Long-term administration of methazolamide is contraindicated in patients with angle-closure glaucoma, since organic closure of the angle may occur in spite of lowered intraocular pressure.

Drug Interactions

Drug Interactions Methazolamide should be used with caution in patients on steroid therapy because of the potential for developing hypokalemia. Caution is advised for patients receiving high-dose aspirin and methazolamide concomitantly, as anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors (see WARNINGS ).

Adverse Reactions

ADVERSE REACTIONS Adverse reactions, occurring most often early in therapy, include paresthesias, particularly a “tingling” feeling in the extremities; hearing dysfunction or tinnitus; fatigue; malaise; loss of appetite; taste alteration; gastrointestinal disturbances such as nausea, vomiting, and diarrhea; polyuria; and occasional instances of drowsiness and confusion. Metabolic acidosis and electrolyte imbalance may occur. Transient myopia has been reported. This condition invariably subsides upon diminution or discontinuance of the medication. Other occasional adverse reactions include urticaria, melena, hematuria, glycosuria, hepatic insufficiency, flaccid paralysis, photosensitivity, convulsions, and, rarely, crystalluria and renal calculi. Also see PRECAUTIONS: Information for Patients for possible reactions common to sulfonamide derivatives. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC at 1-800-206-7821 or F

Frequently Asked Questions

What is Methazolamide used for?

Methazolamide contains Methazolamide. It is a tablet taken oral. Consult your doctor for specific uses.

Is Methazolamide a controlled substance?

Methazolamide is not classified as a controlled substance by the DEA.

What is the generic name for Methazolamide?

The generic name for Methazolamide is Methazolamide. There are 3 other brand versions of Methazolamide.

What is the NDC code for Methazolamide 50 mg/1?

The NDC (National Drug Code) for Methazolamide 50 mg/1 is 63629-1987, listed by Bryant Ranch Prepack.