Carbachol

Description

DESCRIPTION: MIOSTAT™ (carbachol intraocular solution, USP) 0.01% 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: C 6 H 15 CIN 2 O 2 Molecular Weight: 182.65 Each mL of MIOSTAT™ (carbachol intraocular solution, USP) 0.01% 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. chemical

What Is Carbachol Used For?

INDICATIONS AND USAGE: Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT* (carbachol intraocular solution, USP) 0.01% reduces the intensity of IOP elevation in the first 24 hours after cataract surgery.

Dosage and Administration

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.

Side Effects (Adverse Reactions)

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. The following additional reactions have been identified during post-approval use of MIOSTAT (carbachol intraocular solution, USP) 0.01% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to MIOSTAT, or a combination of these factors, include: corneal edema, drug effect prolonged (miosis), eye inflammation, eye pain, intraocular pressure increased, ocular hyperemia, vision blurred, visual impairment, and vomiting.

Contraindications

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

Pregnancy and Breastfeeding

Pregnancy: There are no adequate and well-controlled studies in pregnant women. MIOSTAT* (carbachol intraocular solution, USP) 0.01% 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.

How Supplied

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). © 2021 Alcon Inc. Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 300048977-0621