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acetylcholine chloride
Overview
What is Miochol E?
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, CHClNO, is Ethanaminium, 2-(acetyloxy)-trimethyl-, chloride and is represented by the following chemical structure:
What does Miochol E look like?
What are the available doses of Miochol E?
Sorry No records found.
What should I talk to my health care provider before I take Miochol E?
Sorry No records found
How should I use Miochol E?
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.
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.
What interacts with Miochol E?
Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.
What are the warnings of Miochol E?
If CDAD is suspected or confirmed, ongoing antiobiotic use not directed against
may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of
, and surgical evaluation should be instituted as clinically indicated.
What are the precautions of Miochol E?
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.
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, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Miochol E?
Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.
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.
What might happen if I take too much Miochol E?
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.
How should I store and handle Miochol E?
Store olanzapine orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Protect olanzapine orally disintegrating tablets from light and moisture.Store olanzapine orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Protect olanzapine orally disintegrating tablets from light and moisture.Store olanzapine orally disintegrating tablets at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses.Protect olanzapine orally disintegrating tablets from light and moisture.Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920 Miochol-E(acetylcholine chloride intraocular solution)............................NDC 24208-539-20One blister pack containing the following components:One 0.2 micron sterile filterStorageStore at 4°-25°C (39°-77°F)KEEP FROM FREEZINGKEEP OUT OF REACH OF CHILDRENManufactured for:Manufactured by:Miochol is a trademark of Bausch & Lomb Incorporated or its affiliates.©Bausch & Lomb IncorporatedRev. 05/20179214904AB53920
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Acetylcholine is a naturally occurring neurohormone which mediates nerve impulse transmission at all cholinergic sites involving somatic and autonomic nerves. After release from the nerve ending, acetylcholine is rapidly inactivated by the enzyme acetylcholinesterase by hydrolysis to acetic acid and choline.
Direct application of acetylcholine to the iris will cause rapid miosis of short duration. Topical ocular instillation of acetylcholine to the intact eye causes no discernible response as cholinesterase destroys the molecule more rapidly than it can penetrate the cornea.
Non-Clinical Toxicology
Miochol-E is contraindicated in persons with a known hypersensitivity to any component of this product.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.
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.
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.
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, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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