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Rescula

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Rescula

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Iris Pigmentation

Unoprostone isopropyl ophthalmic solution may gradually increase the pigmentation of the iris. The pigmentation change is believed to be due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with administration of unoprostone isopropyl ophthalmic solution may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. Treatment with Rescula solution can be continued in patients who develop noticeably increased iris pigmentation.

Patients who receive treatment with Rescula should be informed of the possibility of increased pigmentation [see PATIENT INFORMATION].

Lid Pigmentation

Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as unoprostone isopropyl is administered, but has been reported to be reversible upon discontinuation of unoprostone isopropyl ophthalmic solution in most patients.

Intraocular Inflammation

Rescula should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.

Macular Edema

Macular edema, including cystoid macular edema, has been reported. Rescula should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Contamination of Tip And Solution

To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products [see PATIENT INFORMATION].

Use with Contact Lenses

Rescula contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration [see PATIENT INFORMATION].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Unoprostone isopropyl was not carcinogenic in rats administered oral doses up to 12 mg/kg/day for up to 2 years (approximately 580 and 240 fold the recommended human dose of 0.005 mg/kg/day based on AUC0–24 in male and female rats, respectively). Under the conditions tested, unoprostone isopropyl and unoprostone free acid were neither mutagenic in an Ames assay nor clastogenic in a chromosome aberration assay in Chinese hamster lung–derived fibroblast cells. Under the conditions tested, unoprostone isopropyl was not genotoxic in a mouse lymphoma mutation assay or clastogenic in an in vivo chromosomal aberration test in mouse bone marrow. Unoprostone isopropyl did not impair male or female fertility in rats at subcutaneous doses up to 50 mg/kg (approximately 10,000 fold the recommended human dose of 0.005 mg/kg/day).

Use In Specific Populations

Pregnancy

Pregnancy Category C - Teratogenic effects

There were no teratogenic effects observed in rats and rabbits up to 5 and 0.3 mg/kg/day (approximately 1,000 and 60 fold the recommended human dose of 0.005 mg/kg/day in the rat and rabbit, respectively). There was an increase in the incidence of miscarriages and a decrease in live birth index in rats administered unoprostone isopropyl during organogenesis at subcutaneous doses of 5 mg/kg. There was an increase in incidence of miscarriages and resorptions and a decrease in the number of live fetuses in rabbits administered unoprostone isopropyl during organogenesis at subcutaneous doses of 0.3 mg/kg. The no observable adverse effect level (NOAEL) for embryofetal toxicity in rats and rabbits was 2 and 0.1 mg/kg (approximately 400 and 20 fold the recommended human dose of 0.005 mg/kg/day in the rat and rabbit, respectively).

There was an increase in incidence of premature delivery, a decrease in live birth index, and a decrease in weight at birth and through postpartum Day 7 in rats administered unoprostone isopropyl during late gestation through postpartum Day 21 at subcutaneous doses of 1.25 mg/kg. In addition, pups from rats administered 1.25 mg/kg subcutaneously exhibited delayed growth and development characterized by delayed incisor eruption and eye opening. There was an increase in the number of stillborn pups and a decrease in perinatal survival in rats administered unoprostone isopropyl during late gestation through weaning at subcutaneous doses of ≥ 0.5 mg/kg. The NOAEL for pre- and postnatal toxicity in rats was 0.2 mg/kg (approximately 40 fold the recommended human dose of 0.005 mg/kg/day).

There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, Rescula should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether Rescula is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Rescula 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 other adult patients.

Last reviewed on RxList: 1/3/2013
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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