PATANERGIC EYE DROPS

Description

PHARMACEUTICAL DOSAGE FORM:
Sterile ophthalmic solution.
PROPERTIES:
PATANERGIC 0.1% sterile ophthalmic solution contains the active ingredient olopatadine which is a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes.
PHARMACOKINETICS:
Olopatadine was shown to have low systemic exposure.
Olopatadine was quantifiable typically within 2 hours of dosing and ranged from 0.5 to 1.3 ng/ml.
The half-life in plasma was approximately 3 hours and elimination was predominantly through renal excretion.
Approximately 60 – 70% of the dose was recovered in the urine as parent drug. Two metabolites the monodesmethyl and the N-oxide, were detected at low concentrations in the urine.
INDICATIONS:
Treatment of signs and symptoms of allergic conjunctivitis.
USAGE & ADMINISTRATION:
The recommended dosage is one drop to be instilled in each affected eye two times daily at an interval of 6 to 8 hours.
CONTRAINDICATIONS:
Persons with a known hypersensitivity to olopatadine hydrochloride or any other component in PATANERGIC 0.1% sterile ophthalmic solution.
SIDE EFFECTS:
Headaches, 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, pruritis, rhinitis, sinusitis and taste perversion. Some of these events were similar to the underlying disease being studied.
DRUG INTERACTIONS:
Not known.

PREGNANCY & LACTATION:
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. Also caution should be exercised when the drug is administered to a nursing mother
PRECAUTIONS & WARNING:
 This product is for topical use only and not for injection or oral use.
 Patients should be advised not to wear contact lens if their eye is red.
 This product should not be used for the treatment of contact lens related irritation.
 Patients whose eyes are not red should be instructed to wait at least 10 minutes after instilling PATANERGIC 0.1% sterile ophthalmic solution before inserting their soft contact lens.
 Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
PACKING:
Carton box containing a 5 ml ophthalmic sterile solution into a labeled low density plastic (LDP) dropper of high density plastic (HDP) cap and nozzle and a pamphlet.
STORAGE:
Keep at temperature not exceeding 30C.
Keep one month after opening.
Keep out of reach of children.
INSTRUCTION TO PATIENTS:
 Do not touch dropper tip to the eye lids or any surface, as this may contaminate the contents.
 Contact lenses should not be worn during the use of this product.
 Keep tightly closed when not in use.