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Latanoprost 0.005%   COMPOSITION Each ml contains: Latanoprost......................................... 50 mcg Preservative Benzalkonium Chloride NF ............ ….0.01%w/v aqueous vehicle................................... q.s.

INDICATIONS
Latanoprost Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.

DOSAGE AND ADMINISTRATION
The recommended dosage is one drop in the affected eye(s) once daily in the evening. The dosage of Latanoprost Sterile Ophthalmic solution should not exceed once daily since it has been shown that more frequent administration may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. Latanoprost may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

CONTRAINDICATIONS
Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

PACKAGING INFORMATION
Latanoprost 0.005%  Eye Drops................................... Container of 2.5 ml

DESCRIPTION
Latanoprost is a prostaglandin F2 (alpha) analogue. Latanoprost is a prostanoid selective FP receptor agonist which is believed to reduce the intraocular pressure by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow.

UNDESIRABLE EFFECTS
Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema.

INFORMATION FOR PATIENTS
Patients should be informed about the possibility of iris color change due to anincrease of the brown pigment and resultant cosmetically different eye colorationthat may occur when only one eye is treated. Iris pigmentation changes may be more noticeable in patients with green-brown, blue/gray-brown or yellow-brown irises.

Patients should also be informed of the possibility of eyelash changes in the treated eye, which may result in a disparity between eyes in lash length, thickness, pigmentation, and/or number. Patients should also be informed about the possibility of eyelid skin darkening. The increased pigmentation to the iris and eyelid, as well as the changes to the eyelashes, may be permanent.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Patients also should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of the multidose container.

Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician’s advice.

Patients should also be advised that Latanoprost contains benzalkonium chloride which may be absorbed by contact lenses. Contact lenses should be removed.

Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.