For the reduction of IOP in patients with POAG or OHTN When it's important to consider ocular and systemic side effects try Rescula (Unoprostone isopropyl opthalmic solution) 0.15%

Important Safety Information

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

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In clinical studies, the most common ocular adverse reactions with use of RESCULA were burning/stinging, burning/stinging upon drug instillation, dry eyes, itching, increased length of eyelashes, and injection. These were reported in approximately 10–25% of patients. 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.

Ocular adverse reactions occurring in approximately 5–10% of patients were abnormal vision, eyelid disorder, foreign body sensation, and lacrimation disorder.

Ocular adverse reactions occurring in approximately 1–5% of patients were blepharitis, cataract, conjunctivitis, corneal lesion, discharge from the eye, eye hemorrhage, eye pain, keratitis, irritation, photophobia, and vitreous disorder.

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. Nonocular adverse reactions reported in the 1–5% of patients were accidental injury, allergic reaction, back pain, bronchitis, increased cough, diabetes mellitus, dizziness, headache, hypertension, insomnia, pharyngitis, pain, rhinitis, and sinusitis.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of RESCULA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.

Voluntary reports of adverse reactions occurring with the use of RESCULA include corneal erosion.

There have been rare spontaneous reports with a different formulation of unoprostone isopropyl (0.12%) of chemosis, dry mouth, nausea, vomiting and palpitations.

USE IN SPECIFIC POPULATIONS

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.

Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have not been established.

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

No overall differences in safety or effectiveness of RESCULA have been observed between elderly and other adult populations

CLINICAL PHARMACOLOGY

Mechanism of Action

RESCULA is believed to reduce elevated intraocular pressure (IOP) by increasing the outflow of aqueous humor through the trabecular meshwork. Unoprostone isopropyl (UI) may have a local effect on BK (Big Potassium) channels and ClC-2 chloride channels, but the exact mechanism is unknown at this time.

STORAGE AND HANDLING

Store between 2°–25°C (36°–77°F).

For more detailed information please read the Prescribing Information.

Marketed by:

Sucampo Pharma Americas, LLC
Bethesda, MD 20814