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AZOPT: USE IN SPECIFIC POPULATIONS
Pregnancy Category C: Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg / kg per day (20, 62, and 125 times the recommended human ophthalmic dose) produced maternal toxicity at 6 mg / kg per day and a significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than the historic value at 1 and 6 mg / kg. In rats, statistically decreased body weights of fetuses from dams receiving oral doses of 18 mg / kg per day (375 times the recommended human ophthalmic dose) during gestation were proportional to the reduced maternal weight gain, with no statistically significant effects on organ or tissue development. Increases in unossified sternebrae, reduced ossification of the skull, and unossified hyoid that occurred at 6 and 18 mg/kg were not statistically significant. No treatment-related malformations were seen. Following oral administration of 14C-brinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in the fetal tissues and blood.
There are no adequate and well-controlled studies in pregnant women. Azopt (Brinzolamide ophthalmic suspension) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In a study of brinzolamide in lactating rats, decreases in body weight gain in offspring at an oral dose of 15 mg / kg per day (312 times the recommended human ophthalmic dose) were seen during lactation. No other effects were observed. However, following oral administration of 14C-brinzolamide to lactating rats, radioactivity was found in milk at concentrations below those in the blood and plasma.
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 Azopt (Brinzolamide eye drops) 1%, 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.
A three-month controlled clinical study was conducted in which Azopt (Brinzolamide) was dosed only twice a day in pediatric patients 4 weeks to 5 years of age. Patients were not required to discontinue their IOP-lowering medication(s) until initiation of monotherapy with Azopt. IOP-lowering efficacy was not demonstrated in this study in which the mean decrease in elevated IOP was between 0 and 2 mmHg. Five out of 32 patients demonstrated an increase in corneal diameter of one millimeter.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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