No Title 1572552234 ⮝
Carbastat
(CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%
No Title 1572451705 ⮝
Carbastat
(CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01%
Description ⮝
CARBASTAT (Carbachol Intraocular Solution, USP) 0.01% is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the structural formula:
Established name: Carbachol
Chemical name: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,N -trimethyl-, chloride.
Each mL contains: Active: Carbachol 0.01%.
Inactive: 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 (5.0-7.5) and water for injection USP.
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, Carbastat (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 ⮝
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. Carbastat 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.
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 irrigation. 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 ⮝
CARBASTAT (Carbachol Intraocular Solution, USP) 0.01%
1.5 mL sterile glass vials in cartons of 12 (12 x 1.5 mL)
NDC 58768-735-12
Store at controlled room temperature 15 -30 C (59 -86 F).
Rx only
Manufactured by OMJ Pharmaceuticals, Inc.,
San Germ n, P.R. 00683
for Novartis Ophthalmics
Duluth, GA 30097
5007-D
March, 2001
CARBASTAT
carbachol injection, solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58768-735 Route of Administration INTRAOCULAR
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbachol (UNII: 8Y164V895Y) (Carbachol - UNII:8Y164V895Y) 0.1 mg in 1 mL
Inactive Ingredients Ingredient Name Strength calcium chloride dihydrate (UNII: M4I0D6VV5M) 0.481 mg in 1 mL hydrochloric acid (UNII: QTT17582CB) magnesium chloride hexahydrate (UNII: 02F3473H9O) 0.3 mg in 1 mL potassium chloride (UNII: 660YQ98I10) 0.75 mg in 1 mL sodium acetate trihydrate (UNII: 4550K0SC9B) 3.9 mg in 1 mL Sodium chloride (UNII: 451W47IQ8X) 6.4 mg in 1 mL sodium citrate dihydrate (UNII: B22547B95K) 1.7 mg in 1 mL sodium hydroxide (UNII: 55X04QC32I) water (UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58768-735-12 12 in 1 CARTON 1 1.5 mL in 1 VIAL, GLASS
Labeler - Novartis Ophthalmics Revised: 9/2006 Document Id: 048AF9C6-4866-4500-9914-CD7071A19B63 Set id: 048AF9C6-4866-4500-9914-CD7071A19B63 Version: 1 Effective Time: 20060919 Novartis Ophthalmics
