OLODROP 0.1%

  • Therapeutic Category
    • OTHER OPHTHALMOLOGICAL DRUGS
    • OPHTHALMOLOGICAL DRUGS
  • Pharmaceutical Form : Eye Drops
  • Composition : Olopatadine ( HCl ) 1mg / 1 ml
  • Active Substance : (Olopatadine ( HCl

DESCRIPTION:

Olo drop 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H 1 -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes.

 

CLINICAL PHARMACOLOGY:

Olo drop is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H 1 -antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in man, olopatadine was shown to have low systemic exposure.

The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion.

INDICATIONS AND USAGE:

Olo drop 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

CONTRAINDICATIONS:

Olo drop 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of Olo drop.

WARNINGS:

Olo drop 0.1% 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.
  • Olo drop should not be used to treat contact lens related irritation.
  • The preservative in Olo drop, 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 Olo drop before they insert their contact lenses.

Pregnancy: Pregnancy Category C.

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.

Nursing Mothers:

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 Olo drop is administered to a nursing mother

Pediatric Use:

Safety and effectiveness in pediatric patients below the age of 3 years have not been established

ADVERSE REACTIONS:

Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, and sinusitis.

DOSAGE AND ADMINISTRATION:

The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.

STORAGE:

  Store at (15°C to 25°C).

How Supplied:    5 ml in plastic bottle