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Olopatadine ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine ophthalmic solution, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. (1)
The recommended dose is one drop in each affected eye once a day.
The recommended dose is one drop in each affected eye once a day. (2)
Ophthalmic solution 0.2%: each ml contains 2.22 mg of Olopatadine.
Ophthalmic solution 0.2%: each ml contains 2.22 mg of Olopatadine. (3)
For topical ocular use only. Not for injection or oral use.
For topical ocular use only. Not for injection or oral use.
As with any eye drop, to prevent 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.
Patients should be advised not to wear a contact lens if their eye is red.
Olopatadine ophthalmic solution, 0.2% should not be used to treat contact lens related irritation.
The preservative in Olopatadine ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling Olopatadine ophthalmic solution, 0.2% before they insert their contact lenses.
Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%.
The following adverse experiences have been reported in 5% or less of patients:
Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.
Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion.
Some of these events were similar to the underlying disease being studied.
Symptoms similar to cold syndrome and pharyngitis were reported at an incidence of approximately 10%. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Olopatadine was found not to be teratogenic in rats and rabbits. However, rats treated at 600 mg/kg/day, or 150,000 times the MROHD and rabbits treated at 400 mg/kg/day, or approximately 100,000 times the MROHD, during organogenesis showed a decrease in live fetuses. In addition, rats treated with 600 mg/kg/day of olopatadine during organogenesis showed a decrease in fetal weight. Further, rats treated with 600 mg/kg/day of olopatadine during late gestation through the lactation period showed a decrease in neonatal survival and body weight. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Olopatadine has been identified in the milk of nursing rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine ophthalmic solution, 0.2% is administered to a nursing mother.
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Olopatadine ophthalmic solution, 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes. Olopatadine is a white, crystalline, water-soluble powder with a molecular weight of 373.88 and a molecular formula of C21H23NO3-HCl.
The chemical structure is presented below:
Chemical Name: 11-[(Z)-3-(Dimethylamino)propylidene]-6-11-dihydrodibenz[b,e]oxepin-2-acetic acid, hydrochloride.
Each mL of Olopatadine ophthalmic solution, 0.2% contains: Active: 2.22 mg Olopatadine equivalent to 2 mg olopatadine. Inactives: povidone; dibasic sodium phosphate; sodium chloride; edetate disodium; benzalkonium chloride 0.01% (preservative); hydrochloric acid/sodium hydroxide (adjust pH); and purified water for injection.
It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.
Olopatadine is a mast cell stabilizer and a histamine H1 antagonist. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated.
Systemic bioavailability data upon topical ocular administration of Olopatadine ophthalmic solution are not available. Following topical ocular administration of olopatadine 0.15% ophthalmic solution in man, olopatadine was shown to have a low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (˂0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The elimination half-life in plasma following oral dosing was 8 to 12 hours, and elimination was predominantly through renal excretion. Approximately 60 to 70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.
Olopatadine administered orally was not carcinogenic in mice and rats in doses up to 500 mg/kg/day and 200 mg/kg/day, respectively. Based on a 40 µL drop size and a 50 kg person, these doses were approximately 150,000 and 50,000 times higher than the maximum recommended ocular human dose (MROHD). 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. Olopatadine administered to male and female rats at oral doses of approximately 100,000 times MROHD level resulted in a slight decrease in the fertility index and reduced implantation rate; no effects on reproductive function were observed at doses of approximately 15,000 times the MROHD level.
Results from clinical studies of up to 12 weeks duration demonstrate that Olopatadine ophthalmic solution, 0.2% when dosed once a day is effective in the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine ophthalmic solution, 0.2% is supplied in a white, round, low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and a white polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package:
2.5 mL fill in 4 mL bottle NDC 61314-272-25
Store at 2° to 25°C (36° to 77°F).
DROP-TAINER® is a registered trademark of Alcon Research, Ltd.
For topical ophthalmic administration only.
Patients should be advised to not touch dropper tip to any surface, as this may contaminate the contents.
Patients should be advised not to wear a contact lens if their eyes are red. Patients should be advised that Olopatadine ophthalmic solution, 0.2% should not be used to treat contact lens-related irritation. Patients should also be advised to remove contact lenses prior to instillation of Olopatadine ophthalmic solution, 0.2%. The preservative in Olopatadine ophthalmic solution, 0.2% benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted following administration of Olopatadine ophthalmic solution, 0.2%.
Alcon Laboratories, Inc.
Fort Worth, Texas,, 76134
For Sandoz Inc.
Princeton, NJ 08540
Olopatadine Ophthalmic Solution
FOR TOPICAL OPHTHALMIC USE ONLY
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Depending on the reaction of the Olopatadine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Olopatadine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Olopatadine addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology