"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"...
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits at daily oral doses up to 10 mg/kg body weight (5 mg/kg in teratogenicity studies), and have revealed no evidence of impaired fertility or harm to the fetus due to dipivefrin HCI. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy 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 PROPINE® (dipivefrin) ophthalmic solution is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Propine Information
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