Miochol E
Acetylcholine Chloride
Bausch & Lomb Incorporated
Human Prescription Drug
NDC 24208-539Miochol E also known as Acetylcholine Chloride is a human prescription drug labeled by 'Bausch & Lomb Incorporated'. National Drug Code (NDC) number for Miochol E is 24208-539. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Miochol E drug includes . The currest status of Miochol E drug is Active.
Drug Information:
| Drug NDC: | 24208-539 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Miochol E |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Acetylcholine Chloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bausch & Lomb Incorporated |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 22 Sep, 1993 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 26 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA020213 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Bausch & Lomb Incorporated
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 876551
876553
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0324208539200
|
| UPC stands for Universal Product Code. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 24208-539-20 | 1 KIT in 1 BLISTER PACK (24208-539-20) * 2 mL in 1 VIAL * 2 mL in 1 AMPULE | 22 Sep, 1993 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Miochol e acetylcholine chloride miochol e acetylcholine chloride acetylcholine chloride acetylcholine mannitol diluent diluent calcium chloride magnesium chloride potassium chloride sodium acetate water
Drug Interactions:
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.
Indications and Usage:
Indications and usage 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.
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.
General 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.
Dosage and Administration:
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:
Contraindications miochol-e is contraindicated in persons with a known hypersensitivity to any component of this product.
Adverse Reactions:
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 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Drug Interactions:
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:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Overdosage:
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:
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 (275â330 milliosmoles/kg) containing 20 mg acetylcholine chloride (1:100 solution) and 2.8% mannitol. the ph range is 5.0â8.2. 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: chemical formula
Clinical Pharmacology:
Clinical 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.
How Supplied:
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° to 25°c (39° to 77°f). keep from freezing. keep out of reach of children. distributed by: bausch + lomb, a division of bausch health us, llc bridgewater, nj 08807 usa manufactured by: sanofi s.r.l. via valcanello, 4 03012 anagni (fr) italy miochol is a trademark of bausch & lomb incorporated or its affiliates. © 2021 bausch & lomb incorporated or its affiliates rev. 01/2021 9214905
Package Label Principal Display Panel:
Package/label principal display panel ndc 24208-539-20 miochol ⢠-e (acetylcholine chloride intraocular solution) 20 mg/2 ml (10 mg/ml) sterile 1:100 with electrolyte diluent for intraocular use only rx only contents: one blister pack containing: -20mg vial -2 ml diluent ampule one 0.2 micron sterile filter bausch + lomb carton