Naphazoline Hydrochloride + Pheniramine Maleate

This eye drop is indicated for the symptomatic treatment of allergic conjunctivitis.

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 should be instilled into the affected eye(s) three to four times daily. Safety and effectiveness in children under 6 years of age have not been established.

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.

• Hypersensitivity to any of its components
• Narrow-angle glaucoma

• Ocular discomfort
• Keratitis
• Eye pain
• Eye edema
• Ocular hyperemia

Pregnancy category C. There are no or a limited amount of data from the use of topical ophthalmic Naphazoiine or Pheniramine in pregnant women. It should only be used by a pregnant woman if clearly needed. There are no well-controlled studies in breast-feeding women. It should only be used by a breast-feeding woman if clearly needed.

Patients being treated with monoamine oxidase inhibitors (MAOIs) may experience a severe hypertensive crisis if given a sympathomimetic drug. Patients already using an eye product obtained on prescription should use this ophthalmic solution only after consultation with a doctor or pharmacist. This preparation should be used with caution in children, the elderly, patients with cardiovascular disease including cardiac arrhythmia, patients with poorly controlled hypertension, patients with diabetes (especially when the diabetes is not adequately controlled) and patients who have urinary retention or prostate hypertrophy. Use with caution in patients with sympathetic denervation (e.g. patients with insulin dependent diabetes, orthostatic hypotension, hypertension, hyperthyroidism) due to the risk for possible systemic effects. Caution should also be taken if patients are known to suffer from pyloroduodenal obstruction or epilepsy. Prolonged and/or excessive use may lead to rebound ocular vasodilatation or congestion.

Eye Drops may cause transient mydriasis, temporary blurred vision or other visual disturbances that may affect the ability to drive or use machines. If there is mydriasis or if blurred vision occurs after instillation, the patient must wait until the vision clears before driving or using machinery.

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.

Ophthalmic Non-Steroid Combined preparations

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.