SONEXA

Sterile Eye Drops & Ointment

Composition:

Sonexa Eye Drops: Each ml contains Dexamethasone Sodium Phosphate USP equivalent to Dexamethasone Phosphate 1mg.

Sonexa Eye Ointment: Each gram contains Dexamethasone Sodium Phosphate USP equivalent to Dexamethasone Phosphate 0.5 mg.

Indications:

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, keratitis, iritis, scleritis, corneal injury from chemical or thermal burns, or penetration of foreign bodies.

Dosage & administration:

Sonexa Eye Drops: Instill one or two drops into the conjunctival sac every hour during the day and every two hours during the night as initial therapy. When a favourable response is observed, reduce dosage to one drop every four hours. Later, further reduction in dosage to one drop three or four times daily may suffice to control symptoms.

Sonexa Eye Ointment: Apply a thin coating of ointment 3 or 4 times a day. When a favorable response is observed, reduce the number of daily applications to twice and later to once a day as maintenance dose if this is sufficient to control symptoms. Dexamethasone Phosphate eye ointment is particularly convenient when an eye pad is used.

Contraindications:

Patients wearing contact lenses, Herpes simplex & other virus conditions, mycosis, glaucoma, new born babies, fungal diseases of ocular or auricular structures, hypersensitivity to any component of this product including sulfites.

Side-effects:

A slight burning sensation may occur for a short time after instilling the drops into the eye. After several weeks of administration to predisposed patients there may be a reversible increase in intraocular pressure. Regular pressure checks are advisable. Systemic adverse reactions may also occur after long-term topical application of corticosteriods in children. Others include cataract and corneal softening.

Precautions & Warnings:

• If no improvement is observed after 7-8 days, other therapeutic measures should be considered.

• Corticosteroids may mask, activate or exacerbate eye infections.

• Due to the risk of systemic response the administration to the children under 2, and to hyper or-hypotonics is not advisable.

• During treatment the intraocular pressure should be measured regularly.

• Prolonged use may result intraocular hypertension and /or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior sub capsular cataract formation.

• Patients wearing contact lenses must not use the drops during the time the lenses are worn.

Use in Pregnancy and lactation:

It should only be administered during pregnancy if the potential benefit exceeds the foreseeable risk to the fetus (Pregnancy Category C). It should be given in lactating mother if clearly indicated by the physician.

Storage:

• Store at room temperature (15-25ºC).

• Close the bottle/tube immediately after use.

• Do not use for longer than one month after first opening.

• Keep all medicines out of the reach of the children.

• It is advisable to destroy any remaining medicament after completing treatment.

Packing:

Sonexa Eye Drops: Plastic dropper bottle containing 5 ml eye drops.

Sonexa Eye Ointment: Tube contains 3 g eye ointment.