Pyridostigmine Bromide
Rising Pharmaceuticals, Inc.
Human Prescription Drug
NDC 64980-220Pyridostigmine Bromide is a human prescription drug labeled by 'Rising Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Pyridostigmine Bromide is 64980-220. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Pyridostigmine Bromide drug includes Pyridostigmine Bromide - 180 mg/1 . The currest status of Pyridostigmine Bromide drug is Active.
Drug Information:
| Drug NDC: | 64980-220 |
| 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: | Rising Pharmaceuticals, 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 - 180 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: | 15 Aug, 2017 |
| 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: | ANDA205464 |
| 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: | Rising Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 903847
|
| 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: | 0364980220033
|
| 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 |
|---|
| 64980-220-03 | 30 TABLET in 1 BOTTLE (64980-220-03) | 15 Aug, 2017 | 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 silicon dioxide carnauba wax tribasic calcium phosphate zein magnesium stearate light straw color nm180
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 treat
Read more...ment 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 is available in one dosage form. extended-release 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 extended-release tablet is about equal to that of a 60 mg conventional tablet, however, its duration of effectiveness, although varying in individual patients, averages 2 ½ times that of a 60 mg dose. dosage the size and frequency of the dosage must be adjusted to the needs of the individual patient. extended-release 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 ta
Read more...blets or syrup in conjunction with extended-release 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 pyridostigmine bromide 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 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. to report suspected adverse reactions, contact rising pharmaceuticals, inc. at 1-866-562-4597 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Description:
Description pyridostigmine bromide is an orally active cholinesterase inhibitor. chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. its structural formula is: pyridostigmine bromide is available in the following form: extended-release tablets containing 180 mg pyridostigmine bromide, each tablet also contains colloidal silicon dioxide, carnauba wax, tribasic calcium phosphate, zein (corn protein) and magnesium stearate. actions 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. indication pyridostigmine bromide is useful in the treatment of myasthenia gravis. structure
How Supplied:
How supplied extended-release tablets are available as light straw colored capsule-shaped tablets containing 180 mg pyridostigmine bromide in bottles of 30 (ndc 64980-220-03). each tablet is engraved "nm 180" on one side and is single-scored on the other. note : because of the hygroscopic nature of the extended-release tablets, mottling may occur. this does not affect their efficacy. store pyridostigmine bromide extended-release tablets, 180 mg at 25°c (77°f), excursions permitted to 15°c-30°c (59°f-86°f). keep pyridostigmine bromide extended-release tablets, 180 mg in a dry place with the silica gel enclosed.
Package Label Principal Display Panel:
Package label.principal display panel rising® ndc 64980-220·03 pyridostigmine bromide extended-release tablets 180 mg caution: extremely moisture sensitive. do not remove desslcant. close tightly 30 tablets rx only label