Miostat
Carbachol
Alcon Laboratories, Inc.
Human Prescription Drug
NDC 0065-0023Miostat also known as Carbachol is a human prescription drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Miostat is 0065-0023. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Miostat drug includes Carbachol - .1 mg/mL . The currest status of Miostat drug is Active.
Drug Information:
| Drug NDC: | 0065-0023 |
| 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: | Miostat |
| 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: | Carbachol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Alcon Laboratories, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | CARBACHOL - .1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | OPHTHALMIC
|
| 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: | 15 Apr, 1974 |
| 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: | NDA016968 |
| 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: | Alcon Laboratories, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 308966
991606
|
| 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. |
| UNII: | 8Y164V895Y
|
| 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. |
| Pharmacologic Class: | Cholinergic Agonists [MoA]
Cholinergic Receptor Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0065-0023-15 | 12 VIAL, GLASS in 1 CARTON (0065-0023-15) / 1.5 mL in 1 VIAL, GLASS | 15 Apr, 1974 | 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:
Miostat carbachol carbachol carbamoylcholine sodium chloride potassium chloride calcium chloride magnesium chloride sodium acetate trisodium citrate dihydrate sodium hydroxide hydrochloric acid water backing paper label carton label carton label bottle label
Indications and Usage:
Indications and usage: intraocular use for obtaining miosis during surgery. in addition, miostat* (carbachol intraocular solution, usp) 0.01% reduces the intensity of iop elevation in the first 24 hours after cataract surgery.
Warnings:
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. the vial stopper contains natural rubber (latex) which may cause severe allergic reactions.
Dosage and Administration:
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 instillation. 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.
Contraindications:
Contraindications: should not be used in those persons showing hypersensitivity to any of the components of this preparation.
Adverse Reactions:
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. the following additional reactions have been identified during post-approval use of miostat (carbachol intraocular solution, usp) 0.01% in clinical practice. because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. the reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to miostat, or a combination of these factors, include: corneal edema, drug effect prolonged (miosis), eye inflammation, eye pain, intraocular pressure increased, ocular hyperemia, vision blurred, visual impairment, and
Read more...vomiting.
Use in Pregnancy:
Pregnancy: there are no adequate and well-controlled studies in pregnant women. miostat* (carbachol intraocular solution, usp) 0.01% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use:
Pediatric use: safety and efficacy in pediatric patients have not been established.
Geriatric Use:
Geriatric use: no overall differences in safety or effectiveness have been observed between elderly and younger patients.
Description:
Description: miostat⢠(carbachol intraocular solution, usp) 0.01% is a sterile balanced salt solution of carbachol for intraocular injection. the active ingredient is represented by the chemical structure: established name: carbachol chemical name: ethanaminium, 2-[(aminocarbonyl)oxy]-n,n,ntrimethyl-, chloride. molecular formula: c 6 h 15 cin 2 o 2 molecular weight: 182.65 each ml of miostat⢠(carbachol intraocular solution, usp) 0.01% contains: active: carbachol 0.01%. inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dehydrate 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) and water for injection. ph range is 6.5-7.5. chemical
Clinical Pharmacology:
Clinical pharmacology: carbachol is a potent cholinergic (parasympathomimetic) agent which produces constriction of the iris and ciliary body resulting in reduction in intraocular pressure (iop). the exact mechanism by which carbachol lowers iop is not precisely known.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis: studies in animals to evaluate the carcinogenic potential have not been conducted.
How Supplied:
How supplied: in a 2.0 ml glass vial with a 1.5 ml fill, grey butyl stopper and aluminum seal packaged twelve to a carton â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦â¦..ndc 0065-0023-15 storage: store at 15° - 30°c (59° - 86°f). © 2021 alcon inc. distributed by: alcon laboratories, inc. fort worth, texas 76134 300048977-0621
Package Label Principal Display Panel:
Principal display panel ndc 0065-0023-15 miostat⢠(carbachol intraocular solution, usp) 0.01% twelve 1.5 ml sterile glass vials alcon laboratories, inc., fort worth, texas 76134 usa alcon usual dosage: 0.5 ml storage: store at 15 - 30c (59 - 86f). warning: for single-dose intraocular use only. discard unused portion. rx only ingredients: a sterile balanced salt solution containing (per ml) active: carbachol 0.01%. inactives: 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) and water for injection. gtin: 10300650023150 s/n: lot: exp.: 300048975-0621 ndc 0065-0023-15 miostat * (carbachol intraocular solution, usp) 0.01% twelve 1.5 ml sterile glass vials alcon laboratories, inc., fort worth, texas 76134 usa * a trademark of novartis ©2004, 2013, 2015 novartis alcon ® a novartis company usual dosage: 0.5 ml storage: store at 15 - 30c (59 - 86f). rx only ingredients: a sterile balanced salt solution containing (per ml) active: carbachol 0.01%. inactives: 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) and water for injection. gtin: 10300650023150 s/n lot: exp.: 9011781-0415 miostat ⢠(carbachol intraocular solution, usp) 0.01% alcon 300056865 lot: exp.: miostat ® (carbachol intraocular solution, usp) 0.01% alcon ® © 2001, 2018 alcon, inc. h15348-0718 lot: exp.: lot: exp: 305190-1104 ndc 0065-0023-15 miostat® (carbachol intraocular solution, usp) 0.01% 1.5ml rx only. sterile unless package open or damaged read enclosed insert. ingredients: active: carbachol 0.01%. inactives: 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) and water for injection. usual dosage: 0.5ml storage: store at 15° - 30°c (59° - 86°f). ©2004 alcon, inc. alcon labs., inc. fort worth, tx. 76134