DESCRIPTION SECTION

ISOPTO® Carbachol (carbachol ophthalmic solution) is a cholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:

Established name: Carbachol
Chemical name: 2-[(Aminocarbonyl)oxy]-N,N,Ntrimethylethanaminium chloride.
Each mL contains: Active: carbachol, 1.5% or 3.0%. Preservative: benzalkonium chloride 0.005%. Vehicle: hypromellose 1.0%. Inactives: boric acid, sodium chloride, sodium borate, purified water.

CLINICAL PHARMACOLOGY SECTION

A cholinergic (parasympathomimetic) agent. Carbachol acts directly to stimulate muscarinic (smooth muscle) and nicotinic (autonomic ganglia) receptors and indirectly to inhibit cholinesterase enzyme activity. Carbachol is resistant to hydrolysis by cholinesterases.

INDICATIONS & USAGE SECTION

For lowering intraocular pressure in the treatment of glaucoma.

CONTRAINDICATIONS SECTION

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

WARNINGS SECTION

FOR TOPICAL OPHTHALMIC 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’s disease, recent myocardial infarct, systemic hypertension or hypotension. As with all miotics, retinal detachment has been reported when used in certain susceptible individuals. Remove contact lenses before using.

PRECAUTIONS SECTION

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

No long-term animal studies have been conducted to evaluate the carcinogenic potential of carbachol.

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.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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

ADVERSE REACTIONS SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

15 mL in plastic DROP-TAINER® Dispensers.
1.5%: 15 mL NDC 0998-0223-15
3%: 15 mL NDC 0998-0225-15

STORAGE SECTION

Store at 8° - 27°C (46° - 80°F).

Rx Only

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Revised: June 2007
Printed in USA
©2002, 2003, 2007 Alcon, Inc.

9002666-0607

PRINCIPAL DISPLAY PANEL

NDC 0998-0223-15

Alcon®

Isopto® Carbachol 1.5%
(carbachol ophthalmic solution)

15 mL Sterile

ISOPTO CARBACHOL
carbachol solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0998-0223
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Carbachol (Carbamoylcholine)	Carbachol	15 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzalkonium Chloride
Hypromelloses
Boric Acid
Sodium Chloride
Sodium Borate
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0998-0223-15	1 BOTTLE, DROPPER in 1 CARTON	contains a BOTTLE, DROPPER
1		15 mL in 1 BOTTLE, DROPPER	This package is contained within the CARTON (0998-0223-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/19/1981

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE

Revised: 06/2007 Alcon Laboratories, Inc.