Napolin

For the symptomatic treatment of allergic conjunctivitis

Ophthalmic Non-Steroid Combined preparations

This is a combined preparation of Naphazoline Hydrochloride and Pheniramine Maleate ophthalmic solution. This ophthalmic solution combines the effects of the antihistamine, Pheniramine Maleate, and the decongestant, Naphazoline Hydrochloride. Naphazoline Hydrochloride is a direct acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the arterioles of the conjunctiva to produce vasoconstriction, resulting in decreased conjunctival congestion. Pheniramine Maleate is an alkylamine derivative with antimuscarinic and central sedative properties which is used for the symptomatic relief of hypersensitivity reactions including conjunctivitis.

One to two drops of this Eye Drops should be instilled into the affected eye(s) three to four times daily

Arrhythmia may occur if this preparation is administered concomitantly with cardiac glycosides, tricyclic antidepressants or quinidine. Patients being treated with monoamine oxidase inhibitors may experience a severe hypertensive reaction if given a sympathomimetic drug. Although this reaction has not specifically been reported with Naphazoline, the possibility of such an interaction should be considered.

The use of this Eye Drops is contraindicated in patients who are known to experience narrow-angle glaucoma or who have known hypersensitivities to one or more of the components of this preparation .

Blurring of vision,mild stinging and/or irritation,mydriasis and increased or decreased intraocular pressure. When used in high doses in elderly,naphazoline may liberate pigment granules from the iris.

There are no or a limited amount of data from the use of topical ophthalmic naphazoline or pheniramine in pregnant women; naphazoline hydrochloride may be absorbed systemically following ophthalmic administration. this Eye Drops should only be used by a pregnant woman if clearly needed. Animal studies are insufficient with respect to reproductive toxicity. Breast-feeding There are no well-controlled studies in breast-feeding women; naphazoline hydrochloride may be absorbed systemically following ophthalmic administration. It is unknown whether topical naphazoline / metabolites are excreted in human milk. However,a risk to the breastfed child cannot be excluded. this Eye Drops should only be used by a breast-feeding woman if clearly needed.

In case of overdosage or accidental ingestion, Naphazoline can cause the following, particularly in children: depression of the central nervous system with a clear fall in body temperature and symptoms of bradycardia, excessive sweating, drowsiness and coma; hypertension followed by hypotension. A topical overdose of this eye drops may be flushed from the eye(s) with warm tap water.

Store below 30° C temperature. Keep away from light and wet place. Keep out of reach of children. Patients must be instructed to remove contact lenses prior to application of this eye drop and wait at least 15 minutes before reinsertion. To prevent contamination of the dropper tip and solution, care should be taken, not to touch the eyelids, surrounding areas, finger or other surfaces with the dropper tip of the bottle. The bottle should be tightly closed when not in use. Do not use after 4 weeks of first opening.

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