Pyridostigmine Bromide
Vistapharm, Inc.
Human Prescription Drug
NDC 66689-406Pyridostigmine Bromide is a human prescription drug labeled by 'Vistapharm, Inc.'. National Drug Code (NDC) number for Pyridostigmine Bromide is 66689-406. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Pyridostigmine Bromide drug includes Pyridostigmine Bromide - 60 mg/5mL . The currest status of Pyridostigmine Bromide drug is Active.
Drug Information:
| Drug NDC: | 66689-406 |
| 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: | Vistapharm, 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: | 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: | 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: | 06 Jan, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 Jan, 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: | ANDA211694 |
| 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: | VistaPharm, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 903843
|
| 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. |
| 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 |
|---|
| 66689-406-10 | 1 TRAY in 1 CASE (66689-406-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-406-01) | 06 Jan, 2020 | 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 sucrose glycerin sodium benzoate lactic acid raspberry sorbitol alcohol fd&c red no. 40 fd&c blue no. 1 water
Indications and Usage:
Indication: pyridostigmine bromide oral solution, usp 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 pyridostigmine bromide oral solution 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 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 genkins1 indicate that the differential diagnosis of the two types of crisis may require the use of tensilon⢠(edrophonium chloride) as well as clinical j
Read more...udgment. the treatment 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 genkins1, 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 oral solution during pregnancy or lactation in humans has not been established. therefore, use of pyridostigmine bromide oral solution 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: pyridostigmine bromide oral solution is available in the following form: solution: raspberry-flavored, containing 60 mg pyridostigmine bromide per 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. dosage: the size and frequency of the dosage must be adjusted to the needs of the individual patient. solution: the average dose is ten 5 ml doses daily, spaced to provide maximum relief when maximum strength is needed. in severe cases as many as twenty-five 5 ml doses a day may be required, while in mild cases one to six 5 ml doses 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 oral solution 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 oral solution 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 vistapharm, inc., at 1-888-655-1505 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients have not been established.
Description:
Description: pyridostigmine bromide oral solution, usp is an orally active cholinesterase inhibitor. chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. its structural formula is: pyridostigmine bromide oral solution, usp contains 60 mg pyridostigmine bromide per 5 ml in a vehicle containing 5% alcohol, glycerin, lactic acid, sodium benzoate, sorbitol solution, sucrose, fd&c red no. 40, fd&c blue no. 1, raspberry flavor and water. structure
How Supplied:
How supplied: pyridostigmine bromide oral solution, usp is a raspberry-flavored liquid containing 60 mg of pyridostigmine bromide per 5 ml and 5% alcohol, and is available as ndc 66689-406-01: 5 ml unit-dose cups ndc 66689-406-10: case containing 10 unit-dose cups each of 5 ml (66689-406-01), packaged in 1 tray of 10 unit-dose cups each. store at 20°c to 25°c (68°f to 77°f); excursions permitted to 15°c to 30°c (59°f to 86°f). [see usp controlled room temperature].
Package Label Principal Display Panel:
Principal display panel - lidding label pyridostigmine bromide oral solution, usp 60 mg/5 ml delivers 5 ml store at 20°c to 25°c (68°f to 77°f) (see usp controlled room temperature) alcohol 5% v/v for institutional use only rx only dist. by: vistapharm, inc. largo, fl 33771, usa vp2507 11/19 ndc 66689-406-01 lidding-label