NDC 50268-638 Pyridostigmine Bromide

Pyridostigmine Bromide

NDC Product Code 50268-638

NDC Code: 50268-638

Proprietary Name: Pyridostigmine Bromide What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Pyridostigmine Bromide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
OCEANSIDE;302
Score: 4

NDC Code Structure

  • 50268 - Avpak

NDC 50268-638-15

Package Description: 50 TABLET in 1 BOX

NDC Product Information

Pyridostigmine Bromide with NDC 50268-638 is a a human prescription drug product labeled by Avpak. The generic name of Pyridostigmine Bromide is pyridostigmine bromide. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Avpak

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pyridostigmine Bromide Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PYRIDOSTIGMINE BROMIDE 60 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cholinesterase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Cholinesterase Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avpak
Labeler Code: 50268
FDA Application Number: NDA009829 What is the FDA Application Number?
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.

Marketing Category: NDA AUTHORIZED GENERIC - A product marketed as a “generic” drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Pyridostigmine Bromide Product Label Images

Pyridostigmine Bromide Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Pyridostigmine Bromide Tablets, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is:Pyridostigmine bromide is available as tablets containing 60 mg pyridostigmine bromide; each tablet also contains lactose, silicon dioxide and stearic acid.

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.

Indications And Usage

Pyridostigmine Bromide Tablets are useful in the treatment of myasthenia gravis.

Contraindications

Pyridostigmine Bromide Tablets 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.

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 Tablets 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 Tablets 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 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 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 Tablets during pregnancy or lactation in humans has not been established. Therefore, use of Pyridostigmine Bromide Tablets in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.

Precautions

Pyridostigmine is mainly excreted unchanged by the kidney.


6,7,8 Therefore, lower doses may be required in patients with renal disease, and treatment should be based on titration of drug dosage to effect.


6,7

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

The side effects of Pyridostigmine Bromide Tablets 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 AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dosage And Administration

Pyridostigmine Bromide Tablets contain 60 mg pyridostigmine bromide each.

Dosage

The size and frequency of the dosage must be adjusted to the needs of the individual patient.The average dose is ten 60 mg tablets daily 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).

How Supplied

Pyridostigmine Bromide Tablets, USP are available containing 60 mg of pyridostigmine bromide supplied in unit dose packaging. NDC 50268-638-15 (10 tablets per card, 5 cards per carton). Each tablet is cross-scored on one side and engraved "OCEANSIDE 302" on the other side.Store Pyridostigmine Bromide Tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59°-86°F). Keep Pyridostigmine Bromide Tablets in a dry place.Dispensed in Unit Dose Package. For Institutional Use Only.

References

  • Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis.
  • JAMA. Jan 1963; 183:97-101.
  • Osserman KE, Genkins G. Studies in myasthenia gravis.
  • NY State J Med. June 1961; 61:2076-2085.
  • Grob D. Myasthenia gravis. A review of pathogenesis and treatment.
  • Arch Intern Med. Oct 1961; 108:615-638.
  • Schwab RS. Management of myasthenia gravis.
  • New Eng J Med. Mar 1963; 268:596-597.
  • Schwab RS. Management of myasthenia gravis.
  • New Eng J Med. Mar 1963; 268:717-719.
  • Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function.
  • Clin Pharmacol Ther. 1980; 28: No. 1, 78-81.
  • Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Rueg-heimer E, Zindler M, ed.
  • Anaesthesiology. (Hamburg, Germany: Congress; Sep 14-21,1980; 222-223.) (Int Congr. No. 538), Amsterdam, Netherlands: Excerpta Medica; 1981.
  • Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F. Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis.
  • Clin Pharmacol Ther. 1985; 5:495-501.
  • Manufactured for:AvKARE, Inc.Pulaski, TN 38478Mfg. Rev. 08/16AV 08/19 (P)AvPAK

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