Prosp Pharma


Prosp Pharma
Full Prescribing Info
Olopatadine hydrochloride.
Each mL contains Olopatadine Hydrochloride 1.11 mg Equivalent to Olopatadine 1 mg.
Preservative: Benzalkonium Chloride 0.01%.
Pharmacology: Pharmacodynamics: Olopatadine is an inhibitor of histamine release from the mast cell and a relatively selective histamine H1-antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction. Olopatadine is devoid of effects on alpha-adrenergic, dopamine, muscarinic type 1 and 2, and serotonin receptors.
Pharmacokinetics: Olopatadine has low systemic exposure. Plasma concentrations are generally below the quantitation limit of the assay (less than 0.5 ng/mL). Sample in which olopatadine is quantifiable are typically found within 2 hours of dosing and range from 0.5 to 1.3 ng/mL. The half-life in plasma is approximately 3 hours, and elimination is predominantly through renal excretion. Approximately 60% to 70% of the dose is recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentration in urine.
Treatment of the signs and symptoms of allergic conjunctivitis.
Dosage/Direction for Use
Recommended Dose: Adults and children 3 years of age and older: Usual dosage: 1 to 2 drops in each affected eye 2 times per day at an interval of 6 to 8 hours.
Mode of Administration: Not for injection. Do not install while wearing contact lenses.
The overdosage following oral ingestion of the commercially available ophthalmic solution is unlikely given the limited amount (1 mg/mL) of olopatadine. Single oral olopatadine doses up to 360 mg have been well tolerated in humans. However, symptoms of antihistamine overdosage may include drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness, in children. If overdosage occurs, symptomatic or supportive treatment is recommended, taking into account any concomitantly ingested medications.
Hypersensitivity to the drug or any component of this product.
Special Precautions
Patients should be informed that improper handling of ocular solutions can result in contamination of the solution by common bacteria known to cause ocular infections and that they should avoid allowing the tip of the dispensing container to contact the eye, eyelids, or surrounding structures. The dropper bottle should be tightly closed when not in use.
Olopatadine ophthalmic solutions should not be used to treat contact lens-related irritation. Patients who wear contact lenses should be advised not to wear contact lenses if their eyes are red. Because this product contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses, patients who wear soft contact lenses (and whose eyes are not red) should be instructed to remove their lenses prior to administration of a dose of olopatadine and to wait at least 10 minutes after administration of the ophthalmic solution before reinserting the lenses.
Use in Children: Safety and efficacy in children younger than 3 years of age have not been established. Olopatadine ophthalmic solution appears to be well tolerated in children 3-16 years of age. Treatment-related adverse effects were not observed in children 3-16 years of age receiving 1 or 2 drops of olopatadine 0.1% ophthalmic solution in each eye 3 times daily for 6 weeks.
Use in the Elderly: Geriatric patients (65-80 years of age) were included in clinical studies that evaluated safety and efficacy of olopatadine ophthalmic solution. No overall differences in safety and effectiveness have been observed between geriatric and younger patients.
Use In Pregnancy & Lactation
Pregnancy: Category C. Olopatadine was not found to be teratogenic in rats and rabbits. There are no adequate and well controlled studies in pregnant women. Use this drug in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Lactation: Olopatadine has been identified in 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 breast milk. Exercise caution when olopatadine is administered to a nursing women.
Adverse Reactions
Ophthalmic: Burning or stinging, dry eye, foreign body sensation, hyperemia, keratitis, lid edema, pruritus.
Miscellaneous: Headache, asthenia, cold syndrome, pharyngitis, rhinitis, sinusitis, taste perversion.
Drug Interactions
Specific drug interaction studies involving olopatadine ophthalmic solution and other drugs have not been conducted to date. Olopatadine does not inhibit the in vitro metabolism of substrates of cytochrome P-450 (CYP) isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4. Interactions with drugs that inhibit hepatic enzymes (e.g., CYP microsomal enzymes) are unlikely because olopatadine is eliminated predominantly by renal excretion.
Store below 30°C and protect from light.
Discard 30 days after first opening.
ATC Classification
S01GX09 - olopatadine ; Belongs to the class of other ophthalmologic antiallergics.
Ophth soln 0.1% w/v (clear, colorless, sterile) x 5 mL x 1's.
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