Naphalon Ophthalmic Solution

Acute and chronic non-infectious conjunctivitis, nonspecific conjunctival irritation; also after successful treatment of bacterial and viral conjunctivitis. Irrigation of the tear ducts.

Zinc ions, the active compound of zinc sulphate, have an astringent, i.e. tissue-sealing and slightly anti-septic effect. Naphazoline constricts the blood vessels and reduces the inflammation and swelling of the conjunctiva. This effect of naphazoline, a substance of the benzylimidazoline group, is due to direct binding to a-adrenergic receptor sites on unstriated muscle cells in the blood vessels.

Adults: 1 drop in the conjunctival sac, three to 4 times per day.

Children: Naphazoline nitrate and Zinc sulphate drops has not been studied in children. Generally, in children the dosage of vasoconstrictors should be low and selected with caution.

Naphazoline containing products should not be administered during treatment with MAO-blockers nor during 10 days after discontinuation of such treatment. The effects of Naphazoline may be increased by concomitant use of tricyclic antidepressants.

Hypersensitivity to zinc sulphate, Naphazoline and other ingredients. Naphazoline & Zinc is contraindicated in patients suffering from narrow-angle glaucoma, dry eye and especially keratoconjunctivits sicca Sjogren's syndrome. Naphazoline & Zinc must not be used in infants.

Mydriasis and a slight increase of intraocular pressure in isolated cases. A slight and transient burning sensation may occur after instillation, which does not affect the success of the treatment. Long term use may result in reactive redness of the eye (rebound effect).

In very rare cases systemic cardiovascular effects, such as hypertension and arrhythmia, may occur. Nonspecific fatigue has been observed in some patients.

Use in pregnancy: There are neither controlled animal studies nor studies in pregnant women available.

Use in lactation: The effects of Naphazoline & Zinc treatment during lactation have not been investigated.

Uncontrolled use of Naphazoline & Zinc over extended periods of time should be avoided. If no improvement is seen after 2 days, treatment should be discontinued and other therapeutic measures should be considered. If ocular discomfort or visual disturbance occurs during Naphazoline & Zinc treatment, the therapy must be discontinued. Caution is indicated in patients with predisposition to glaucoma and in patients suffering from hypertension, cardiovascular diseases, pheochromocytoma, aneurysm, hyperglycemia, and hyperthyroidism.

Ophthalmic Non-Steroid drugs