Composition

Each 100 ml contains: Cyclopentolate HCl ………… 1gm (1%)

Pharmacological properties

Cyclopentolate hydrochloride is a mydriatic & cycloplegic drug which shares the pharmacologic effects of atropine on the eye.

Cyclopentolate hydrochloride blocks the action of acetycholine resulting in relaxation of the cholinergically innervated sphincter muscle of the iris. Cholinergic stimulation of the accommodative ciliary muscle of the lens is also blocked.

Anticholinergic effects of cyclopentolate in the eye produce dilatation of the pupil (mydriasis) & paralysis of accommodation (cycloplegia).

Pentolate® has a rapid onset of action. The maximum mydriatic & cycloplegic effect occurs within about 15-60 minutes following topical application to the eye.

Mydriasis & cycloplegia generally last about 24 hours.

Uses & administration

Pentolate® is used to produce mydriasis & cycloplegia for ophthalmic diagnostic procedures either alone or in conjunction with phenylephrine containing preparation.

Also Pentolate® is used in the treatment of uveititis & iritis usually in conjunction with anti-inflammatory agents to avoid posterior synechiae & to relieve the discomfort of ciliary muscle spasm.

Also Pentolate® could be used to minimize posterior synechiae that may accompany iritis occurring with acid burns of the eye.

Adverse reactions

Transient stinging may occur when drops are instilled.
Hypersensitivity rarely may occur following repeated use, in the form of persistent irritation occurring within minutes of instillation.
The intraocular pressure may increase & caution must be observed when drops are used in elderly patients & in conditions where increase in intraocular pressure may be encountered.

Precautions

Glaucoma: the intraocular pressure should be determined & the depth of the angle of the anterior chamber before & during use to avoid glaucoma attacks.
Elderly: use with caution in elderly & others where increased IOP may be encountered.
Pregnancy : category C safety during pregnancy has not been established. Use during pregnancy only when clearly indicated.
Nursing : caution is necessary when administering the drug to lactating females.
Use with caution in infants & young children due to increased susceptibility to side effects.

Dosage

Adults & children: instill 1-2 drops of Pentolate® 1% solution into eye(s). Repeat in 5-10 minutes, if necessary.

Although recovery from mydriasis & cycoplegia usually occurs within 24 hours , 1 or 2 % pilocarpine solution instilled into the eye(s) may reduce recovery time to 3-6 hours.

How supplied

Pentolate® 1% 10 ml plastic dropper bottles, containing sterile ophthalmic solution.

Keep all medicaments out of reach of children

Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: S01FA04