Olopatadine hydrochloride.
Olopatadine hydrochloride equivalent to Olopatadine 1.0mg.
Excipients/Inactive Ingredients: Benzalkonium Chloride (as Preservative) 0.1mg.
Sterile Aqueous Vehicle q.s.
Pharmacology: Pharmacodynamics: Olopatadine is a potent selective antiallergic/antihistaminic agent that exerts its effects through multiple distinct mechanism of action. It antagonises histamine (the primary mediator of allergic response in humans) and prevents histamine induced inflammatory cytokine production by human conjunctival epithelial cells. Data from in vitro studies suggest that it may act on human conjunctival mast cells to inhibit the release of pro-inflammatory mediators. In patients with patent nasolacrimal ducts, topical ocular administration of olopatadine was suggested to reduce the nasal sign and symptoms that frequently accompany seasonal allergic conjunctivitis. It does not produce a clinically significant change in pupil diameter.
Pharmacokinetics: Absorption: Olopatadine ophthalmic solution is absorbed systemically, as are other topically administered medicinal products. However, systemic absorption of topically applied olopatadine is minimal with plasma concentration ranging from below the assay quantitation limit up to 1.3 ng/ml. These concentrations are 50-to 200-fold lower than those following well tolerated oral doses.
Elimination: The half-life of olopatadine in plasma was approximately eight to 12 hours, and elimination was predominantly through renal excretion. Approximately the dose was recovered in the urine as active substance. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentration in the urine.
Since olopatadine is excreted in urine primarily as unchanged active substance, impairment of renal function alters the pharmacokinetics of olopatadine with peak plasma concentrations 2.3-fold greater in patients with severe renal impairment compared to healthy adults.
Following a 10mg oral dose in patients undergoing haemodialysis (with no urinary output), plasma olopatadine concentration were significantly lower on the haemodialysis day than on non-haemodialysis day suggesting olopatadine can be removed by haemodialysis.
A renal impairment after oral dosing of olopatadine has been performed in patients with severe renal impairment. The results indicate that a somewhat higher plasma concentration can be expected with olopatadine in this population. Since plasma concentration following topical ocular dosing of olopatadine are 50-to 200-fold lower than after well-tolerated oral doses, dose adjustment is not expected to be necessary in the elderly or in the renally impaired population. Liver metabolism is a minor route of elimination. Dose adjustment is not expected to be necessary with hepatic impairment.
OLODIN (Olopatadine Hydrochloride Ophthalmic Solution 0.1% w/v) is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.
Route of Administration: Ocular.
No data are available in humans regarding overdose by accidental or deliberate ingestion. Accidental ingestion of the entire contents of a bottle of olopatadine ophthalmic solution would deliver a maximum systematic exposure of 5mg olopatadine. This exposure would result in a final dose of 0.5mg/kg in a 10kg infant, assuming 100% absorption.
In the case of overdose, appropriate monitoring and management of the patients should be implemented.
OLODIN (Olopatadine Hydrochloride Ophthalmic Solution 0.1% w/v) is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of Olodin.
OLODIN (Olopatadine Hydrochloride Ophthalmic Solution 0.1% w/v) is for topical use only and not for injection or oral use.
Information for patients: 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. Olodin (Olopatadine Hydrochloride Ophthalmic Solution 0.1% w/v) should not be used to treat contact lens related irritation. The preservative in Olodin, 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 Olodin (Olopatadine Hydrochloride Ophthalmic Solution 0.1% w/v) before they insert their contact lenses.
Carcinogenesis, mutagenesis, impairment of Fertility: Paediatric Use: Safety and effectiveness in paediatric patients below the age of 3 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patient.
No adequate and well controlled studies in pregnant woman. This drug should be used in pregnant woman only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. 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 hydrochloride ophthalmic solution) 0.1% is administered to a nursing mother.
Headaches have been reported at an incidence. The following adverse experiences have been reported in patients of; asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperaemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis and taste perversion.
No interaction studies with other medicinal products have been performed.
Store at temperature not exceeding 30°C. Protect from light.
After opening the bottle store at below 30°C. Discard contents 28 days after opening the bottle.
Shelf-Life: 24 months.
After opening: 28 days.
S01GX09 - olopatadine ; Belongs to the class of other ophthalmologic antiallergics.
Olodin ophth soln 0.1% w/v
5 mL x 1's
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