Pyridostigmine Bromide
Zydus Pharmaceuticals (usa) Inc.
Human Prescription Drug
NDC 68382-659Pyridostigmine Bromide is a human prescription drug labeled by 'Zydus Pharmaceuticals (usa) Inc.'. National Drug Code (NDC) number for Pyridostigmine Bromide is 68382-659. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Pyridostigmine Bromide drug includes Pyridostigmine Bromide - 60 mg/1 . The currest status of Pyridostigmine Bromide drug is Active.
Drug Information:
| Drug NDC: | 68382-659 |
| 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: | Pyridostigmine Bromide |
| 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: | Zydus Pharmaceuticals (usa) Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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/1
|
| 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: | ANDA |
| 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: | 07 Aug, 2015 |
| 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: | ANDA205650 |
| 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, 2023 |
| 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: | Zydus Pharmaceuticals (USA) Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 903857
|
| 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: | 0368382659064
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 68382-659-01 | 100 TABLET in 1 BOTTLE (68382-659-01) | 07 Aug, 2015 | N/A | No |
| 68382-659-05 | 500 TABLET in 1 BOTTLE (68382-659-05) | 07 Aug, 2015 | N/A | No |
| 68382-659-06 | 30 TABLET in 1 BOTTLE (68382-659-06) | 07 Aug, 2015 | N/A | No |
| 68382-659-16 | 90 TABLET in 1 BOTTLE (68382-659-16) | 07 Aug, 2015 | 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:
Pyridostigmine bromide pyridostigmine bromide pyridostigmine bromide pyridostigmine anhydrous lactose hydroxypropyl cellulose, low substituted silicon dioxide stearic acid white to off-white 659
Indications and Usage:
Indications and usage pyridostigmine bromide tablets, usp are 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 pyridostigmine bromide 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 pyridostigmine bromide or other drugs of this class in the presence of cholinergic crisis or of a refractory or "insensitive" 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 tre
Read more...atment of the two conditions 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 pyridostigmine bromide during pregnancy or lactation in humans has not been established. therefore, use of pyridostigmine bromide in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.
Dosage and Administration:
Dosage and administration pyridostigmine bromide tablets, usp is available as conventional tablets - each containing 60 mg pyridostigmine bromide. dosage: the size and frequency of the dosage must be adjusted to the needs of the individual patient. conventional tablets - the average dose is ten 60 mg tablets, spaced to provide maximum relief when maximum strength is needed. in severe cases as many as 25 tablets a day may be required, while in mild cases one to six tablets a day may suffice. 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 pyridostigmine bromide tablets, usp are 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 pyridostigmine bromide 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.
Description:
Description pyridostigmine bromide tablets, usp are an orally active cholinesterase inhibitor. chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. its structural formula is: pyridostigmine bromide, usp is a white or almost white crystalline, deliquescent powder. it is very soluble in water and in alcohol, slightly soluble in hexane, practically insoluble in ether. each pyridostigmine bromide tablet, usp intended for oral administration contains 60 mg of pyridostigmine bromide, usp. in addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, low substituted hydroxypropyl cellulose, silicon dioxide and stearic acid. figure
Clinical Pharmacology:
Clinical pharmacology pyridostigmine bromide 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 pyridostigmine bromide tablets usp, 60 mg having functional scoring. pyridostigmine bromide tablets usp, 60 mg are white to off-white, round, flat, uncoated tablets with quadrisect breakline on one side and debossed with '659' on the other side and are supplied as follows: ndc 68382-659-06 in bottles of 30 tablets ndc 68382-659-16 in bottles of 90 tablets ndc 68382-659-01 in bottles of 100 tablets ndc 68382-659-05 in bottles of 500 tablets storage store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature] . dispense in original container. important: these tablets are hygroscopic. keep in a dry place with the silica gel enclosed.
Package Label Principal Display Panel:
Package label.principal display panel ndc 68382-659-06 in bottles of 30 tablets pyridostigmine bromide tablets usp, 60 mg 30 tablets rx only zydus figure