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  • Patanol
    / Lapidot


    Active Ingredient
    Olopatadine (HCl) 0.111%

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Eye Drops

    5 ml

    not in the basket chart 65020 16703, 16917

    Dosage

    The dose is one drop of PATANOL in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary.
    Use in elderly: No dosage adjustment in elderly patients is necessary.
    Paediatric patients: PATANOL may be used in paediatric patients three years of age and older at the same dose as in adults. The safety and efficacy of PATANOL in children aged under 3 years has not been established. No data are available.
    Use in hepatic and renal impairment: Olopatadine in the form of eye drops (PATANOL) has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment.
    Method of administration: For ocular use only.
    After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use.
    In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications. Eye ointments should be administered last.


    Indications

    For the temporary prevention of itching of the eye due to allergic conjunctivitis.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Breastfeeding.


    Special Precautions

    PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1% is for topical use only and not for injection or oral use.
    PATANOL is an antiallergic/antihistaminic agent and, although administered topically, is absorbed systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment.
    PATANOL contains benzalkonium chloride which may cause eye irritation.
    Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
    Contact lenses: Benzalkonium is known to discolour soft contact lenses. Avoid contact with soft contact lenses.
    Patients should be instructed to remove contact lenses prior to administration of the eye drop and wait at least 15 minutes after instillation before re-inserting contact lenses.


    Side Effects

    The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0.7%.
    Common: headache, dysgeusia, eye pain, eye irritation, dry eye, abnormal sensation in eyes, nasal dryness, fatigue.
    See prescribing information for full details.


    Drug interactions

    No interaction studies with other medicinal products have been performed.
    In vitro studies have shown that olopatadine did not inhibit metabolic reactions which involve cytochrome P-450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that olopatadine is unlikely to result in metabolic interactions with other concomitantly administered active substances.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration.
    Olopatadine is not recommended during pregnancy and in women of childbearing potential not using contraception.
    Breast-feeding: Available data in animals have shown excretion of olopatadine in milk following oral administration. A risk to the newborn/infants cannot be excluded.
    PATANOL should not be used during breast-feeding.


    Overdose

    No data are available in humans regarding overdose by accidental or deliberate ingestion.
    Olopatadine has a low order of acute toxicity in animals. Accidental ingestion of the entire contents of a bottle of PATANOL would deliver a maximum systemic exposure of 5 mg olopatadine. This exposure would result in a final dose of 0.5 mg/kg in a 10 kg infant, assuming 100% absorption.
    See prescribing information for full details.


    Manufacturer
    Alcon
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