PATANOL

PATANOL Eye Drops (Prescription Medicine)

Patanol Eye Drops contain 1.0 mg/mL (0.1%) olopatadine. They are indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

The recommended therapy is one to two drops in the affected eye(s) twice daily.

Use in Pregnancy
Olopatadine was not teratogenic in rats and rabbits at oral doses of 600 mg/kg and 400 mg/kg, respectively (> 90,000 and > 60,000 times the maximum recommended ocular human use level, respectively). Given that animal studies are not always predictive of human responses, and that no adequate and well controlled studies in pregnant women have been performed, it should be carefully considered whether the potential benefit to the mother justifies the potential risk to the embryo or foetus.

Use in Lactation
Olopatadine has been identified in the milk of nursing rats following oral administration. Rat pups of mothers administered olopatadine orally at greater than 4 mg/kg/day showed (625 times - but not at 312 times - the maximum recommended ocular human use level demonstrated) reduced body weight gain during the nursing period. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. PATANOL Eye Drops should be used with caution in breastfeeding woman.

Use in Children
Safety and effectiveness have not been established in children below 3 years of age.

Carcinogenicity / Mutagenicity / Fertility
Long term studies in mice and rats did not provide any evidence of carcinogenicity at oral olopatadine doses up to 500 mg/kg/day and 200 mg/kg/day, respectively (78,000 and 31,000 times the maximum recommended ocular human use level, respectively). No mutagenic potential was observed when olopatadine was tested in an in vitro bacterial reverse mutation (Ames) test, an in vitro mammalian chromosome aberration assay or an in vivo mouse micronucleus test.

There are no human data addressing the effects of olopatadine on fertility. In animal reproductive/fertility studies, olopatadine had no effect on the fertility of male and female rats at oral doses up to 50 mg/kg/day (7,800 times the maximum recommended ocular human use level). However, decreases in the fertility index, number of corpora lutea and implantation rate were seen at an oral dose of 400 mg/kg/day.

Before using Patanol, tell your doctor if you have any type of infection in your eye.

Do not use Patanol while you are wearing contact lenses. Patanol may contain a preservative that can be absorbed by soft contact lenses. Wait at least 10 minutes after using Patanol before putting your contact lenses in. Avoid wearing contact lenses while your eyes are red or irritated.

Avoid using other eye medications not prescribed by your doctor.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Stop using Patanol and call your doctor at once if you have severe redness, swelling, burning, stinging, drainage, crusting, or other irritation when using the eye drops.

Headaches have been reported at an incidence of 7%. Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. The following adverse experiences have been reported in less than 5% of patients: asthenia, blurred vision, burning or stinging, conjunctivitis, dry eye, cold syndrome, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus, nausea, rhinitis, sinusitis, asthenia, back pain, flu syndrome, increased cough, infection and taste perversion. Some of these events were similar to the underlying disease being studied.

Overdosage
No specific ocular side effects are known for a topical overdosage of PATANOL Eye Drops. Results from studies indicated that topical ocular administration resulted in very low systemic concentrations. Multiple oral doses that resulted in plasma concentrations at least 2 to 3 orders of magnitude greater than those from topical ocular dosing were well tolerated.

A topical overdosage of PATANOL Eye Drops may be flushed from the eye(s) with warm tap water.

If PATANOL Eye Drops are accidentally ingested the following information may be useful. One bottle contains 5 mg of olopatadine. In single dose oral studies, olopatadine was well tolerated up to a dose of 360 mg, with rapid absorption and rapid excretion of the parent drug in the urine. Approximately 84 % of the dose was recovered in the urine as parent drug within the first 24 hours. The most often observed side effect was tiredness usually of a mild to moderate nature, although severe tiredness has been reported.