SUNEPHRINE Phenylephrine 10% Eye Drops

Composition   

Phenylephrin IP 10%

Chlorbutol IP    0.5%

(as preservative)          

Sterile Isotonic Base     q.s.

Dosage Form

Ophthalmic Solution (Eye Drops)

Category

Mydriatic

Description

Phenylephrine hydrochloride ophthalmic solution, is a sterile solution used as a mydriatic for use in ophthalmology.

Indications

Sunephrine (phenylephrine ophthalmic solution) is indicated for mydriasis.

Dosage

One to two in the eye to be dilated.

Contraindications

Phenylephrine ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.

Precautions

Pregnanacy

Phenylephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemic absorption of phenylephrine may occur when applied topically. Because of the potential for serious, adverse reactions in nursing infants from phenylephrine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The safety and efficacy in pediatric patients below 1 year of age have not been established.

Pediatric Use

The safety and efficacy in pediatric patients below 1 year of age have not been established

Geriatric Use

No overall difference in safety or effectiveness have been observed between elderly and younger, adult patients

Adverse Effects

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of phenylephrine ophthalmic solution

Storage

Store in a cool dry place. Protect from light.

Presentation

Sunephrine is available in 5 ml plastic bottle.