Warning & Precaution:

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.

Contact Lens Use:

Patients should be advised not to wear a contact lens if their eye is red. Bepokul should not be used to treat contact lens-related irritation.

Bepokul should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bepokul. The preservative in Bepokul, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bepokul.

Use In Specific Populations:

Pregnancy:

Pregnancy Category C:

Teratogenicity studies have been performed in animals. Bepotastine besilate was not found to be teratogenic in rats during organogenesis and fetal development at oral doses up to 200 mg/kg/day (representing a systemic concentration approximately 3300 times that anticipated for topical ocular use in humans), but did show some potential for causing skeletal abnormalities at 1000 mg/kg/day. There were no teratogenic effects seen in rabbits at oral does up to 500 mg/kg/day given during organogenesis and fetal development ( > 13,000 times the dose in humans on a mg/kg basis). Evidence of infertility was seen in rats given oral bepotastine besilate 1000 mg/kg/day, however, no evidence of infertility was observed in rats given 200 mg/kg/day (approximately 3300 times the topical ocular use in humans). The concentration of radio-labeled bepotastine besilate was similar in fetal liver and maternal blood plasma following a single 3 mg/kg oral dose. The concentration in other fetal tissues was one-third to one-tenth the concentration in maternal blood plasma.

An increase in stillborns and decreased growth and development were observed in pups born from rats given oral doses of 1000 mg/kg/day during perinatal and lactation periods. There were no observed effects in rats treated with 100 mg/kg/day.

There are no adequate and well-controlled studies of bepotastine besilate in pregnant women. Because animal reproduction studies are not always predictive of human response, Bepokul (bepotastine besilate ophthalmic solution 1.5% w/v) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Following a single 3 mg/kg oral dose of radio-labeled bepotastine besilate to nursing rats 11 days after delivery, the maximum concentration of radioactivity in milk was 0.40 mcg eq/mL 1 hour after administration; at 48 hours after administration the concentration was below detection limits. The milk concentration was higher than the maternal blood plasma concentration at each time of measurement. It is not known if bepotastine besilate is excreted in human milk. Caution should be exercised when Bepokul (bepotastine besilate ophthalmic solution 1.5% w/v) is administered to a nursing woman.

Pediatric Use:

Safety and efficacy of Bepokul (Bepotastine Besilate Ophthalmic Solution 1.5% w/v) have not been established in pediatric patients under 2 years of age. Efficacy in pediatric patients under 10 years of age was extrapolated from clinical trials conducted in pediatric patients greater than 10 years of age and from adults.

Geriatric Use:

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

Dosage:

Instill one drop of Bepokul into the affected eye(s) twice a day or as directed by the Ophthalmologist.

Storage:

Store below 30°C. Protect from light & moisture. Do not freeze. Keep out of reach of children.

NOT FOR INJECTION. FOR EXTERNAL USE ONLY.

Use the solution within one month after opening the container.

Packing:

Bepokul eye drops is available in a 5 ml container.