"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
For topical ophthalmic use only; not for injection. There is evidence that mydriatics may produce a transient elevation of intraocular pressure in patients with open-angle glaucoma. This preparation rarely may cause CNS disturbances which may be particularly dangerous in infants, children, or the aged. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse have been reported with the use of anticholinergic drugs.
Patients with hypertension, hyperthyroidism, diabetes, or cardiac disease (i.e., arrhythmias or chronic ischemic heart disease) should be monitored after instillation. The elderly and others in whom glaucoma or increased intraocular pressure may be encountered following administration of PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) Solution should also be monitored closely. To avoid inducing angle-closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been performed to evaluate the carcinogenic, mutagenic or impairment of fertility potential of PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) .
Pregnancy Category C: Animal reproduction studies have not been conducted with PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) . It is also not known whether PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) can cause fetal harm when administered to a pregnant woman or can affect reproduction capability. PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established. PAREMYD® (hydroxyamphetamine hydrobromide, tropicamide) may rarely cause CNS disturbances which may be dangerous in infants and children. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs. (See WARNINGS.) Keep this and all medications out of the reach of children.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Last reviewed on RxList: 2/20/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Paremyd Information
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