NAZIN

Eye Drops

Composition:

Each ml contains: Naphazoline nitrate 0.05 mg and Zinc sulphate 0.2 mg.

Actions:

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.

Pharmacokinetics:

The pharmacokinetics of topically applied Nazin have not been investigated. Therefore, no concise information about absorption, distribution in ocular fluids and tissues, or elimination is available. Like all a-sympathomimetics, naphazoline is systemically absorbed through blood vessels, however, no data are present on the extent of absorption.

Indications:

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

Dosage & Administration:

Adults: One drop in the conjunctival sac, three to four times per day.

Children: Nazin has not been studied in children. Generally, in children the dosage of vasoconstrictors should be low and selected with caution.

Adverse reactions:

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).

Contraindications:

Hypersensitivity to zinc sulphate, naphazoline and other ingredients. Nazin is contraindicated in patients suffering from narrow-angle glaucoma, dry eye and especially keratoconjunctivits sicca (Sjögren’s syndrome). Nazin must not be used in infants.

Systemic effects:

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

Drug Interactions:

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.

Precautions: 

Uncontrolled use of Nazin 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 Nazin 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.

Pregnancy and lactation:

There are neither controlled animal studies nor studies in pregnant women available. Therefore, during pregnancy the product should only be used if the benefit out-weighs the risk to the fetus. The effects of Nazin treatment during lactation have not been investigated. (Pregnancy category C).

Overdose:

Unintentional oral ingestion may cause the following symptoms: cardiac arrhythmia, pallor, perspiration, mydriasis, increase of blood pressure, somnolence, and decreased body temperature. In infants bradycardia, and even-coma, may occur.

Note for patients wearing contact lenses:

Nazin can be used by patients wearing contact lenses if the lenses are remove before instillation and are not worn for at least 15 minutes after application of the eye drops.

Additional Information:

Close the bottle immediately after use. Do not use for more than one month after first opening. Store at room temperature. Keep all medicine out of the reach of children.

To be dispensed only by or on the prescription of a registered physician.

Packing:

Plastic dropper bottle of 10 ml.