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Included as part of the PRECAUTIONS section.

Poor Illumination

Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm.

Patients should be advised not to drive or use machinery if vision is not clear.

Pre-existing Retinal Disease

As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with pre-existing retinal disease; therefore, a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy.

Iritis

Isopto® Carpine (pilocarpine) is not recommended to be used when iritis is present.

Primary Congenital Glaucoma

Caution is advised when using Isopto® Carpine (pilocarpine) in pediatric patients with primary congenital glaucoma for control of intraocular pressure (IOP) as cases of a paradoxical increase in IOP have been reported. In addition, the use of Isopto® Carpine (pilocarpine) is not recommended in pediatric patients diagnosed with glaucoma secondary to anterior segment dysgenesis or uveitis (especially if uveitis is active).

Contact Lens Wear

Contact lens wearers should be advised to remove their lenses prior to the instillation of Isopto® Carpine (pilocarpine) ophthalmic solution and to wait 10 minutes after dosing before reinserting their contact lenses.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies done using pilocarpine hydrochloride in animals to evaluate carcinogenic potential.

Use In Specific Populations

Pregnancy

Pregnancy. Category C. Animal reproduction studies have not been conducted with pilocarpine hydrochloride. It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isopto® Carpine (pilocarpine) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isopto® Carpine (pilocarpine) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 7/21/2010
This monograph has been modified to include the generic and brand name in many instances.