Olopatadine Hydrochloride Eye Drops

Pharmacological action: Olopatadine is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate hypersensitivity reactions in both in vivo and in vitro experiments. Olopatadine has no effect on α-adrenergic receptors, dopamine receptors, muscarinic type I and II receptors, and 5-hydroxytryptamine receptors. Toxicological studies: Carcinogenicity, mutagenesis, and impairment of reproductive function: Olopatadine was orally administered to mice and rats at doses of 500 mg/kg/day and 200 mg/kg/day, respectively, without causing carcinogenesis. Based on 40 μl per drop, these doses are 78, 125, and 31,250 times greater than the maximum recommended dose for the human eye. No possibility of inducing mutations was observed in in vitro bacterial reverse mutation tests, in vitro mammalian chromosome aberration tests, or mouse micronucleus tests. After oral administration of olopatadine to male and female rats at a dose of 62,500 times the maximum recommended human dose, the fertility index decreased slightly and the conception rate decreased; no effect on fertility was found when 7,800 times the maximum recommended human dose was taken orally.

Olopatadine hydrochloride.

Colorless to light yellow clear liquid.

No data yet

Take 1-2 drops twice a day, with an interval of 6-8 hours.

It has been reported that the incidence of headache after medication is 7%. The following adverse reactions have been reported with an incidence of less than 5%: fatigue, blurred vision, burning or tingling, cold syndrome, dry eyes, foreign body sensation, congestion, allergy, keratitis, eyelid edema, nausea, pharyngitis, itching, rhinitis, sinusitis and taste perversion. A considerable number of adverse reactions are similar to the symptoms of the disease itself.

It is contraindicated for those who are allergic to any ingredient of this product.

Precautions for children: The safety and effectiveness of this drug for children under 3 years of age have not been established. Precautions for pregnancy and lactation: Pregnancy: Pregnancy category C: Olopatadine was not found to be teratogenic in rats and rabbits. However, fetal survival was reduced when rats were given 600 mg/kg/day, or 93,750 times the maximum recommended human dose, and rabbits were given 400 mg/kg/day, or 62,500 times the maximum recommended human dose during the organogenesis period. There are no adequate controlled studies in pregnant women. Because animal studies do not always mirror human responses, pregnant women may use this drug when the benefits to the mother outweigh the possible risks to the embryo or fetus. Lactating women: Olopatadine was found in the milk of lactating rats that took this drug orally. It is not known whether topical eye drops will be absorbed systemically in sufficient amounts to allow the drug to be detected in breast milk. In any case, nursing mothers should be cautious when using this drug. Precautions for the elderly: This experiment has not been conducted and there are no reliable references.

This experiment has not been conducted and there are no reliable references.

Keep away from light and store in sealed container.

0.1% (5ml:5mg, calculated as C21H23NO3)

24 months