HOW SUPPLIED SECTION.

HOW SUPPLIED:. In 2.0 mL glass vial with 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to carton......................................................................................NDC 0065-0023-15 STORAGE: Store at 15 30C (59 86F).(C) 2002, 2003, 2015,2018 Novartis Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 trademark of NovartisRevised: July 2018 W9016486-0718.

INDICATIONS & USAGE SECTION.

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.

DESCRIPTION SECTION.

DESCRIPTION:. MIOSTAT (carbachol intraocular solution, USP) 0.01% is 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 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto sterile tray. Withdraw the contents into 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.

ADVERSE REACTIONS SECTION.

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 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 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.

CLINICAL PHARMACOLOGY SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0065-0023-15 MIOSTAT (CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01% TWELVE 1.5 mL Sterile Glass Vials Alcon Laboratories, Inc., Fort Worth, Texas 76134 USA trademark of Novartis(C)2004, 2013, 2015 Novartis Alcon (R) Novartis company USUAL DOSAGE: 0.5 mL STORAGE: Store at 15 30C (59 86F). Rx Only INGREDIENTS: sterile balanced salt solution containing (per mL) Active: carbachol 0.01%. Inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 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. GTIN: 10300650023150 S/N LOT: EXP.: 9011781-0415 MIOSTAT(R) (carbachol intraocular solution, USP) 0.01%Alcon(R) (C) 2001, 2018 Alcon, Inc. H15348-0718 LOT: EXP.: LOT: EXP: 305190-1104 NDC 0065-0023-15 MIOSTAT(R) (CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01% 1.5mL Rx Only. Sterile Unless Package Open or Damaged Read enclosed insert. INGREDIENTS: Active: carbachol 0.01%. Inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 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. USUAL DOSAGE: 0.5mL STORAGE: Store at 15 30C (59 86F). (C)2004 Alcon, Inc. Alcon Labs., Inc. Fort Worth, TX. 76134.

PRECAUTIONS SECTION.

PRECAUTIONS:. Use only if the container is undamaged.. Carcinogenesis:. Studies in animals to evaluate the carcinogenic potential have not been conducted.. 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 nursing woman.

PREGNANCY SECTION.

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.

WARNINGS SECTION.

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 Parkinsons disease. The vial stopper contains natural rubber (latex) which may cause severe allergic reactions.