"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
The alpha-1 adrenergic receptor agonist is commonly used by optometrists, ophtha"...
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epider-mal 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 metha-zolamide concomitantly, as anorexia, tachypnea, lethargy, coma and death have been reported with concomitant use of high-dose aspirin and carbonic anhydrase inhibitors.
General: Potassium excretion is increased initially upon administration of methazolamide and in patients with cirrhosis or hepatic insufficiency could precipitate a hepatic coma.
In patients with pulmonary obstruction or emphysema, where alveolar ventilation may be impaired methazolamide should be used with caution because it may precipitate or aggravate acidosis.
Laboratory Tests: To monitor for hematologic reactions common to all sulfonamides, it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating methazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is also recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate methazolamide's carcinogenic potential and its effect on fertility have not been conducted. Methazolamide was not mutagenic in the Ames bacterial test.
Pregnancy: Teratogenic effects. Pregnancy Category C. Methazolamide has been shown to be teratogenic (skeletal anomalies) in rats when given in doses approximately 40 times the human dose. There are no adequate and well controlled studies in pregnant women. Methazolamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from methazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: The safety and effectiveness of methazolamide in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/3/2008
Additional Methazolamide Information
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