:   ISOPTO® CARBACHOL is a cholinergic prepared as a sterile topical ophthalmic solution.

Chemical name: 2- [ (Aminocarbonyl)oxy]- N,N,N  -trimethylethanaminium chloride.

Each mL contains:   Active: Carbachol 0.75%, 1.5%, 2.25%, or 3.0%. Preservative Benzalkonium Chloride 0.005%. Vehicle Hydroxypropyl Methylcellulose 1.0%. Inactive: Boric Acid, Sodium Chloride, Sodium Borate, Purified Water.

Clinical Pharmacology: A cholinergic (parasympathomimetic) agent. Carbachol has a double action, it not only stimulates the motor endplate of the muscle cell, as do all cholinesters, but it also partially inhibits cholinesterase.

and Usage:   For lowering intraocular pressure in the treatment of glaucoma.

Contraindications:   Miotics are contraindicated where constriction is undesirable such as acute iritis. Contraindicated in those persons showing hypersensitivity to any component of this preparation.

:   For topical use only. Not for injection. Carbachol should be used with caution in the presence of corneal abrasion to avoid excessive penetration which can produce systemic toxicity; and in patients with acute cardiac failure, bronchial asthma, active peptic ulcer, hyperthyroidism, gastrointestinal spasm, urinary tract obstruction, Parkinson' disease, recent myocardial infarct, systemic hypertension or hypotension. As with all miotics, retinal detachment has been reported when used in certain susceptible individuals.

Precautions:    General:   Avoid overdosage.

Information for Patients: The miosis usually causes difficulty in dark adaptation. Patient should be advised to exercise caution in night driving and other hazardous occupations in poor light. Do not touch dropper tip to any surface, as this may contaminate the solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility. There have been no long-term studies done using carbachol in animals to evaluate carcinogenic potential.

Pregnancy.   Pregnancy Category C. Animal reproduction studies have not been conducted with carbachol. It is also not known whether carbachol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Carbachol 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 carbachol is administered to a nursing woman.

Adverse Reactions:   Transient symptoms of stinging and burning may occur. This preparation is capable of producing systemic symptoms of a cholinesterase inhibitor even when the epithelium is intact. Transient ciliary and conjunctival injection, headache, and ciliary spasm with resultant temporary decrease of visual acuity may occur. Salivation, syncope, cardiac arrhythmia, gastrointestinal cramping, vomiting, asthma, hypotension, diarrhea, frequent urge to urinate, increased sweating, and irritation of eyes may occur.

Overdosage: Atropine should be administered parenterally (for dosage refer to Goodman & Gilman or other pharmacology reference).

Dosage and Administration: Instill two drops topically in the eye(s) up to three times daily or as indicated by physician.

How Supplied: 15mL and 30mL in plastic DROP-TAINER® Dispensers.

0.75%:  15 mL NDC 0998-0221-15
1.5%:    15 mL NDC 0998-0223-15
30 mL NDC 0998-0223-30
2.25%: 15 mL NDC 0998-0224-15
3%:      15 mL NDC 0998-0225-15
30 mL NDC 0998-0225-30

Storage   Store at 46°-80°F (8°-27°C).

Rx Only.