MIOSTAT

Alcon Laboratories, Inc.
Alcon Laboratories, Inc.

®(CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%

FULL PRESCRIBING INFORMATION: CONTENTS*

• MIOSTAT DESCRIPTION
• CLINICAL PHARMACOLOGY
• MIOSTAT INDICATIONS AND USAGE
• MIOSTAT CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Carcinogenesis
  • Pregnancy
  • Nursing Mothers
• Pediatric Use
• Geriatric Use
• MIOSTAT ADVERSE REACTIONS
• MIOSTAT DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

DESCRIPTION

MIOSTAT® (carbachol intraocular solution, USP) is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure:

Established name:

Carbachol

Chemical name:

Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,Ntrimethyl-, chloride.

Molecular Formula: C₆H₁₅CIN₂O₂

Molecular Weight: 182.65

Each mL contains: Active: carbachol 0.01%.

Inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dehydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH) and Water for Injection. pH range is 6.5-7.5.

CLINICAL PHARMACOLOGY

Carbachol is a potent cholinergic (parasympathomimetic) agent which produces constriction of the iris and ciliary body resulting in reduction in intraocular pressure. The exact mechanism by which carbachol lowers intraocular pressure is not precisely known.

INDICATIONS AND USAGE

Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT (carbachol intraocular solution, USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery.

CONTRAINDICATIONS

Should not be used in those persons showing hypersensitivity to any of the components of this preparation.

WARNINGS

For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease.

PRECAUTIONS

Use only if the container is undamaged.

Carcinogenesis

Studies in animals to evaluate the carcinogenic potential have not been conducted.

Pregnancy

Category C. There are no adequate and well-controlled studies in pregnant women. MIOSTAT® (carbachol intraocular solution, USP) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.

Pediatric Use

Safety and efficacy 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

Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported.

Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol.

DOSAGE AND ADMINISTRATION

Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray. Withdraw the contents into a dry sterile syringe, and replace the needle with an atraumatic cannula prior to intraocular instillation. No more than one-half milliliter should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application.

HOW SUPPLIED

In a 2.0 mL glass vial with a 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to a carton.

NDC 0065-0023-15

STORAGE: Store at 15° - 30°C (59° - 86°F).

Rx Only

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

Printed in USA

© 2002, 2003 Alcon, Inc.

Revised: December 2003 340121-1203

PRINCIPAL DISPLAY PANEL

NDC 0065-0023-15

MIOSTAT^®

(CARBACHOL INTRAOCULAR

SOLUTION, USP) 0.01%

TWELVE

1.5 mL Sterile Glass Vials

Alcon^®

Alcon Laboratories, Inc., Fort Worth, Texas 76134 USA