Miochol E
acetylcholine chloride · Kit
Uses
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.
Dosage and administration
Miochol ™ -E (acetylcholine chloride intraocular solution) is instilled into the anterior chamber before or after securing one or more sutures. Instillation should be gentle and parallel to the iris face and tangential to pupil border. If there are no mechanical hindrances, the pupil starts to constrict in seconds and the peripheral iris is drawn away from the angle of the anterior chamber. Any anatomical hindrance to miosis must be released to permit the desired effect of the drug. In most cases, 0.5 to 2 mL produces satisfactory miosis. Note that the syringe filter supplied with Miochol-E has a priming volume of 0.6 mL (approximately). In cataract surgery, use Miochol-E only after delivery of the lens. Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution that is not clear and colorless. Discard any solution that has not been used.
Contraindications
Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.
Warnings
WARNINGS 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.
Precautions
General If miosis is to be obtained quickly with Miochol-E, anatomical hindrances to miosis, such as anterior or posterior synechiae, must be released, prior to administration of Miochol-E. During cataract surgery, use Miochol-E only after delivery of the lens. Aqueous solutions of acetylcholine chloride are unstable. Prepare solution immediately before use. Do not use solution which is not clear and colorless. Discard any solution that has not been used. Drug Interactions Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with topical nonsteroidal anti-inflammatory agents. Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Side effects
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.
Pediatric use
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Overdosage
Atropine sulfate (0.5 to 1 mg) should be given intramuscularly or intravenously and should be readily available to counteract possible overdosage. Epinephrine (0.1 to 1 mg subcutaneously) is also of value in overcoming severe cardiovascular or bronchoconstrictor responses.
Description
Miochol ™ -E (acetylcholine chloride intraocular solution) is a parasympathomimetic preparation for intraocular use. It is packaged in a blister pack containing one vial and one diluent ampule. The vial contains 20 mg acetylcholine chloride and 56 mg mannitol. The accompanying ampule contains 2 mL of a modified diluent of calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, and sterile water for injection. The reconstituted liquid will be a sterile isotonic solution (275–330 milliosmoles/kg) containing 20 mg acetylcholine chloride (1:100 solution) and 2.8% mannitol. The pH range is 5.0–8.2. Mannitol is used in the process of lyophilizing acetylcholine chloride, and is not considered an active ingredient. The chemical name for acetylcholine chloride, C 7 H 16 ClNO 2 , is Ethanaminium, 2-(acetyloxy) -N,N,N -trimethyl-, chloride and is represented by the following chemical structure: ChemStructure
How supplied
Miochol ™ -E (acetylcholine chloride intraocular solution)............................NDC 24208-539-20 One blister pack containing the following components:
• Vial of 20 mg acetylcholine chloride powder for intraocular solution
• Ampule of 2 mL diluent One 0.2 micron sterile filter
• Priming volume 0.6 mL (approximately) Storage Store at 4°C to 25°C (39°F to 77°F). KEEP FROM FREEZING. Keep out of reach of children. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Avara Liscate Pharmaceutical Services S.p.A 20050 Liscate (Milan), Italy Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2023 Bausch & Lomb Incorporated or its affiliates Rev. 03/2023 9735301
Label text from the FDA structured product label by Bausch & Lomb Incorporated (revised Mar 17, 2023). Long sections are shortened; the complete label is on DailyMed.
Miochol E NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 24208-539 | Kit | Bausch & Lomb Incorporated | NDA |
Miochol E recalls
- D-0994-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse
Frequently asked questions
What is Miochol E used for?
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.
What are the side effects of Miochol E?
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… See the full label for the complete list.
Who makes Miochol E?
Miochol E is listed by 1 labeler in the FDA NDC directory, including Bausch & Lomb Incorporated.
Has Miochol E been recalled?
The FDA enforcement database lists 1 recall for Miochol E, most recently D-0994-2022 (class ii): cGMP deviations: Temperature abuse