Mestinon
Pyridostigmine Bromide
Bausch Health Us, Llc
Human Prescription Drug
NDC 0187-3012Mestinon also known as Pyridostigmine Bromide is a human prescription drug labeled by 'Bausch Health Us, Llc'. National Drug Code (NDC) number for Mestinon is 0187-3012. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Mestinon drug includes Pyridostigmine Bromide - 60 mg/5mL . The currest status of Mestinon drug is Active.
Drug Information:
| Drug NDC: | 0187-3012 |
| 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: | Mestinon |
| 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: | Pyridostigmine Bromide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bausch Health Us, Llc |
| 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: | PYRIDOSTIGMINE BROMIDE - 60 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 25 Jan, 1965 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | NDA015193 |
| 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 Health US, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 903843
903845
903847
903849
903857
903859
|
| 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: | KVI301NA53
|
| 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: | Cholinesterase Inhibitor [EPC]
Cholinesterase Inhibitors [MoA]
|
| 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 |
|---|
| 0187-3012-20 | 473 mL in 1 BOTTLE (0187-3012-20) | 25 Jan, 1965 | 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:
Mestinon pyridostigmine bromide pyridostigmine bromide pyridostigmine alcohol glycerin lactic acid, unspecified form sodium benzoate sorbitol sucrose fd&c red no. 40 fd&c blue no. 1 water mestinon pyridostigmine bromide pyridostigmine bromide pyridostigmine lactose, unspecified form silicon dioxide stearic acid mestinon;v;60 mestinon pyridostigmine bromide pyridostigmine bromide pyridostigmine carnauba wax magnesium stearate silicon dioxide tribasic calcium phosphate water isopropyl alcohol light straw capsule-shaped mes;v;180
Indications and Usage:
Indication: mestinon is useful in the treatment of myasthenia gravis.
Warnings:
Warnings: although failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. as is true of all cholinergic drugs, overdosage of mestinon may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a symptomatic basis. such differentiation is extremely important, since increases in doses of mestinon or other drugs of this class in the presence of cholinergic crisis or of a refractory or âinsensitiveâ state could have grave consequences. osserman and genkins 1 indicate that the differential diagnosis of the two types of crisis may require the use of tensilon (edrophonium chloride) as well as clinical judgment. the treatment of the two condi
Read more...tions obviously differs radically. whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, according to osserman and genkins 1 , calls for the prompt withdrawal of all drugs of this type. the immediate use of atropine in cholinergic crisis is also recommended. atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis. for detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by osserman and genkins 2 , grob 3 or schwab. 4,5 usage in pregnancy : the safety of mestinon during pregnancy or lactation in humans has not been established. therefore, use of mestinon in women who may become pregnant requires weighing the drugâs potential benefits against its possible hazards to mother and child.
Dosage and Administration:
Dosage and administration: mestinon is available in three dosage forms: oral solution - raspberry-flavored, containing 60 mg pyridostigmine bromide per teaspoonful (5 ml). this form permits accurate dosage adjustment for children and âbrittleâ myasthenic patients who require fractions of 60 mg doses. it is more easily swallowed, especially in the morning, by patients with bulbar involvement. conventional tablets - each containing 60 mg pyridostigmine bromide. timespan tablets - each containing 180 mg pyridostigmine bromide. this form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily. the immediate effect of a 180 mg timespan tablet is about equal to that of a 60 mg conventional tablet; however, its duration of effectiveness, although varying in individual patients, averages 2½ times that of a 60 mg dose. dosage: the size and frequency of the dosage must be adjusted to th
Read more...e needs of the individual patient. oral solution and conventional tablets - the average dose is ten 60 mg tablets or ten 5 ml teaspoonfuls daily, spaced to provide maximum relief when maximum strength is needed. in severe cases as many as 25 tablets or teaspoonfuls a day may be required, while in mild cases one to six tablets or teaspoonfuls a day may suffice. timespan tablets - one to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average. the interval between doses should be at least 6 hours. for optimum control, it may be necessary to use the more rapidly acting regular tablets or oral solution in conjunction with timespan therapy. note: for information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on tensilon (edrophonium chloride).
Contraindications:
Contraindications: mestinon is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. care should be observed in the use of atropine for counteracting side effects, as discussed below.
Adverse Reactions:
Adverse reactions: the side effects of mestinon are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness. muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. as with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. such reactions usually subside promptly upon discontinuance of the medication. to report suspected adverse reactions, contact bausch health us, llc at 1-800-321-4576 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Use in Pregnancy:
Usage in pregnancy : the safety of mestinon during pregnancy or lactation in humans has not been established. therefore, use of mestinon in women who may become pregnant requires weighing the drugâs potential benefits against its possible hazards to mother and child.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients have not been established.
Description:
Description: mestinon (pyridostigmine bromide) is an orally active cholinesterase inhibitor. chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. its structural formula is: mestinon is available in the following forms: oral solution containing 60 mg pyridostigmine bromide per teaspoonful in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol, sucrose, fd&c red no. 40, fd&c blue no. 1, flavors and water. tablets containing 60 mg pyridostigmine bromide; each tablet also contains lactose, silicon dioxide and stearic acid. timespan tablets containing 180 mg pyridostigmine bromide; each tablet also contains carnauba wax, corn-derived proteins, isopropyl alcohol, magnesium stearate, silica gel, tribasic calcium phosphate and water. mestinon-01.jpg
Mechanism of Action:
Actions: mestinon inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. pyridostigmine is an analog of neostigmine (prostigmin), but differs from it in certain clinically significant respects; for example, pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects.
How Supplied:
How supplied: oral solution, 60 mg pyridostigmine bromide per teaspoonful (5 ml) and 5% alcohol - bottles of 1 pint (473 ml) (ndc 0187-3012-20). tablets, are available as white, flat-faced tablets containing 60 mg pyridostigmine bromide in bottles of 100 (ndc 0187-3010-30). each tablet is engraved âmestinon 60 vâ on one side and is quadrisect scored on the other. timespan tablets, are available as light straw-colored, capsule-shaped tablets containing 180 mg pyridostigmine bromide in bottles of 30 (ndc 0187-3013-30). each tablet is engraved âmes v 180â on one side and is single-scored on the other. note: because of the hygroscopic nature of the timespan tablets, mottling may occur. this does not affect their efficacy. store mestinon (pyridostigmine bromide) oral solution, usp, mestinon tablets, and timespan tablets at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f). keep mestinon tablets and timespan tablets in a dry place with the s
Read more...ilica gel enclosed.
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc 0187-3012-20 rx only mestinon ® (pyridostigmine bromide). oral solution, usp 1 pint (473 ml) 5 ml = 60 mg 5 ml (1 teaspoonful) contains 60 mg pyridostigmine bromide. alcohol 5% bausch health label
Principal display panel - 60 mg tablets bottle label ndc 0187-3010-30 rx only mestinon ® (pyridostigmine bromide) tablets, usp 60 mg 100 tablets each tablet contains 60 mg pyridostigmine bromide bausch health dispense in tight containers as defined in usp/nf. important: these tablets are hygrosciopic. keep in dry place with the silica gel enclosed. usual dosage: see accompanying package insert. store at 25°c (77°f); excursions permitted to 15° to 30°c (59° to 86°f). 60mg-label.jpg
Principal display panel - 180 mg bottle label ndc 0187-3013-30 rx only mestinon ® (pyridostigmine bromide) timespan ® tablets 180 mg 30 tablets each tablet contains180 mg pyridostigmine bromide in a specially constructed tablet for sustained release bausch health 9549902 50104061c label