Sunways India Pvt Ltd. More Than 60 Years of Dedicated & Commited Effort in the Field of OPTHAMOLOGY
OLOTOP DS - OLOPATADINE 0.2 % Eye Drops
CAP-SR    
DESCRIPTION
Olopatadine hydrochloride ophthalmic solution 0.2% is a sterile ophthalmic solution containing olopatadine for topical administration to the eyes
CLINICAL PHARMACOLOGY
Olopatadine is a relatively selective histamine H1 antagonist and an inhibitor of the release of histamine from the mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated. Olopatadine is devoid of effects on alpha-adrenergic, dopaminergic, and muscarinic type 1 and 2 receptors.
INDICATIONS

Olopatadine hydrochloride ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
SIDE EFFECTS
  • Mild burning, stinging, irritation, itching, redness, or dryness of the eyes;
  • Blurred vision;
  • Feeling that something is in your eye;
CONTRAINDICATIONS

Hypersensitivity to any components of this product.
WARNINGS
For topical ocular use only. Not for injection or oral use.
OLOTOP DS 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.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since OLOTOP DS contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.

Contact lenses:
Patients should be instructed to wait 10-15 minutes after instillation of OLOTOP DS before inserting contact lenses. OLOTOP DS should not be administered while wearing contact lenses.
PRECAUTIONS

General
As with any eye drop, to prevent contamination of 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.
Olopatadine hydrochloride ophthalmic solution should not be used to treat contact
Lens related irritation. The preservative in OLOTOP DS, 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 OLOTOP DS before they insert their contact lenses.

If using other eye drops, patients should wait at least five to ten minutes between putting in OLOTOP DS and the other drops.
ADVERSE REACTIONS

Ocular: blurred vision, burning or stinging, conjunctivitis, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, pain and ocular pruritus.

Non-ocular: asthenia, back pain, flu syndrome, headache, increased cough, infection, nausea, rhinitis, sinusitis and taste perversion
DOSAGE AND ADMINISTRATION

Adults: The recommended dose is one drop in each affected eye once a day.

No dosage adjustment is required in hepatic or renal impairment.
STORAGE AND STABILITY
Store at 4° - 25°C. Discard the container at the end of treatment.