Isopto Carbachol Ophthalmic Solution

Generic Name: carbachol
Dosage Form: ophthalmic solution

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Isopto® Carbachol
(carbachol ophthalmic solution)
Sterile

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.

Slideshow: HealthQuiz: Basics About Stroke Signs and Symptoms

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 LABEL 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  
Packaging
# Item Code Package Description
1 NDC:0998-0223-15 1 BOTTLE, DROPPER in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/1981
ISOPTO CARBACHOL  
carbachol solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0998-0225
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbachol (Carbamoylcholine) Carbachol 30 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride  
Hypromelloses  
Boric Acid  
Sodium Chloride  
Sodium Borate  
Water  
Packaging
# Item Code Package Description
1 NDC:0998-0225-15 1 BOTTLE, DROPPER in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
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(0998-0225)
Revised: 06/2007
 
Alcon Laboratories, Inc.



Hide
(web1)