Prescribing Information
Important Safety Information
RESCULA is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product. Indicated for lowering of IOP in patients with POAG and OHTN
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Important Safety Information



INDICATIONS AND USAGE
Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.


DOSAGE AND ADMINISTRATION
The recommended dosage is one drop in the affected eye(s) twice daily.

Rescula may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If two drugs are used, they should be administered at least five (5) minutes apart.


CONTRAINDICATIONS
Rescula is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product.


WARNINGS AND 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.


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.


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.


ADVERSE REACTIONS
Clinical Studies Experience
In clinical studies, ocular adverse events above 5% with use of Rescula were burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%), itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation (9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%), and eyelid disorder (5.8%). Approximately 10%-14% of patients were observed to have an increase in the length of eyelashes (≥1 mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes. Also note that corneal lesions were reported in 2.3% of patients.


The most frequently reported nonocular adverse reaction associated with the use of Rescula in the clinical trials was flu-like syndrome that was observed in approximately 6% of patients.


USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
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.



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Important Safety Information



INDICATIONS AND USAGE
Rescula (unoprostone isopropyl ophthalmic solution) 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.


DOSAGE AND ADMINISTRATION
The recommended dosage is one drop in the affected eye(s) twice daily.

Rescula may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If two drugs are used, they should be administered at least five (5) minutes apart.


CONTRAINDICATIONS
Rescula is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product.


WARNINGS AND 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.


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.


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.


ADVERSE REACTIONS
Clinical Studies Experience
In clinical studies, ocular adverse events above 5% with use of Rescula were burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%), itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation (9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%), and eyelid disorder (5.8%). Approximately 10%-14% of patients were observed to have an increase in the length of eyelashes (≥1 mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes. Also note that corneal lesions were reported in 2.3% of patients.


The most frequently reported nonocular adverse reaction associated with the use of Rescula in the clinical trials was flu-like syndrome that was observed in approximately 6% of patients.


USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
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.



DOWNLOAD 'IMPORTANT SAFETY INFORMATION' AS A PDF DOCUMENT