Indications
To obtain miosis of the iris in seconds after delivery of the lens in cataract surgery, in penetrating keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis may be required.
Contraindications
Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.
Warnings and precautions
DO NOT GAS STERILIZE. If blister or peelable backing is damaged or broken, sterility of the enclosed vial and ampule cannot be assured. Open under aseptic conditions only.
Adverse reactions
Infrequent cases of corneal edema, corneal clouding, and corneal decompensation have been reported with the use of intraocular acetylcholine. Adverse reactions have been reported rarely, which are indicative of systemic absorption. These include bradycardia, hypotension, flushing, breathing difficulties, and sweating. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Composition
- Active ingredients
- ACETYLCHOLINE CHLORIDE 20MG/VIAL
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA020213.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Miochol-E
- Active substance
- acetylcholine chloride
- Drug class
- Parasympathomimetics
- Route
- Eye
- Dosage form
- For solution
- Applicant
- Bausch and Lomb
- Status
- Prescription
- FDA approval
- 22 Sept 1993
- Application
- NDA020213-001
- RxCUI
- 20814