May 28, 2017
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Iopidine Eye

"The US Food and Drug Administration (FDA) today approved a first-of-its-kind intraocular lens (IOL) for cataract treatment that provides vision at near, intermediate, and far distances as a multifocal IOL does, but with less of a halo and glare p"...

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Iopidine Eye




PATIENT INFORMATION

Do not touch dropper tip to any surface as this may contaminate the contents.

The preservative in IOPIDINE 0.5% Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of IOPIDINE 0.5% Ophthalmic Solution but may be reinserted 15 minutes after instillation.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No significant change in tumor incidence or type was observed following two years of oral administration of apraclonidine HCl to rats and mice at dosages of 1.0 and 0.6 mg/kg, up to 20 and 12 times, respectively, the maximum dose recommended for human topical ocular use.

Apraclonidine HCl was not mutagenic in a series of in vitro mutagenicity tests, including the Ames test, a mouse lymphoma forward mutation assay, a chromosome aberration assay in cultured Chinese hamster ovary (CHO) cells, a sister chromatid exchange assay in CHO cells, and a cell transformation assay. An in vivo mouse micronucleus assay conducted with apraclonidine HCl also provided no evidence of mutagenicity.

Reproduction and fertility studies in rats showed no adverse effect on male or female fertility at a dose of 0.5 mg/kg (5 to 10 times the maximum recommended human dose).

Pregnancy

Apraclonidine HCl has been shown to have an embryocidal effect in rabbits when given in an oral dose of 3.0 mg/kg (60 times the maximum recommended human dose). Dose related maternal toxicity was observed in pregnant rats at 0.3 mg/kg (6 times the maximum recommended human dose). There are no adequate and well controlled studies in pregnant women. IOPIDINE 0.5% Ophthalmic Solution 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, caution should be exercised when IOPIDINE 0.5% Ophthalmic Solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 4/25/2017
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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