Methscopolamine Bromide

Bayshore Pharmaceuticals Llc
Human Prescription Drug
NDC 76385-100

Methscopolamine Bromide is a human prescription drug labeled by 'Bayshore Pharmaceuticals Llc'. National Drug Code (NDC) number for Methscopolamine Bromide is 76385-100. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Methscopolamine Bromide drug includes Methscopolamine Bromide - 2.5 mg/1 . The currest status of Methscopolamine Bromide drug is Active.

Drug Information:

Drug NDC:	76385-100
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:	Methscopolamine 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:	Methscopolamine Bromide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bayshore Pharmaceuticals Llc
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:	METHSCOPOLAMINE BROMIDE - 2.5 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:	01 Oct, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	01 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:	ANDA200602
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:	BAYSHORE PHARMACEUTICALS LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	314088 403914
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:	0376385100018 0376385101602
UPC stands for Universal Product Code.
UNII:	RTN51LK7WL
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:	Anticholinergic [EPC] Cholinergic Antagonists [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
76385-100-01	100 TABLET in 1 BOTTLE (76385-100-01)	01 Oct, 2013	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.

Other medicines with the same generic name

Product Elements:

Methscopolamine bromide methscopolamine bromide methscopolamine bromide methscopolamine cellulose, microcrystalline starch, corn silicon dioxide magnesium stearate by1 methscopolamine bromide methscopolamine bromide methscopolamine bromide methscopolamine cellulose, microcrystalline starch, corn silicon dioxide magnesium stearate by2

Drug Interactions:

4. drug interactions additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. concomitant administration with antacids may interfere with the absorption of methscopolamine bromide.

Indications and Usage:

Indications and usage adjunctive therapy for the treatment of peptic ulcer. methscopolamine bromide has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence or preventing complications.

Warnings:

Warnings in the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with drug use. diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. in this instance treatment with this drug would be inappropriate and possibly harmful. methscopolamine bromide may produce drowsiness or blurred vision. the patient should be cautioned regarding activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug. with overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.

General Precautions:

1. general precautions use methscopolamine bromide tablets, usp 2.5 mg and 5 mg with caution in the elderly and in all patients with: autonomic neuropathy; hepatic or renal disease; or ulcerative colitis âlarge doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason precipitate or aggravate "toxic megacolon," a serious complication of the disease. the drug also should be used with caution in patients having hyperthyroidism, coronary heart disease, congestive heart failure, tachyarrhythmia, tachycardia, hypertension, or prostatic hypertrophy.

Dosage and Administration:

Dosage and administration the average dosage of methscopolamine bromide tablets, usp is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. a starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects. if the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one-half hour before meals and at bedtime. if very unpleasant side effects develop promptly, the daily dosage should be reduced. if neither symptomatic relief nor side effects appear, the daily dosage may be increased. some patients have tolerated 30 mg daily with no unpleasant reactions. patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects. the ultimate aim of therapy Read more...

is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. many patients report no side effects on a dosage which gives complete relief of symptoms. on the other hand, some patients have reported severe side effects without appreciable symptomatic relief. such patients must be considered unsuited for this therapy. usually they have been or will prove to be similarly intolerant to other anticholinergic drugs. if methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.

Contraindications:

Contraindications glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. methscopolamine bromide tablets, usp 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.

Adverse Reactions:

Adverse reactions the following adverse reactions have been observed, but there is not enough data to support an estimate of frequency. cardiovascular: tachycardia, palpitation. allergic: severe allergic reaction or drug idiosyncrasies including anaphylaxis. cns: headaches, nervousness, mental confusion, drowsiness, dizziness. special senses: blurred vision, dilation of the pupil, cycloplegia, increased ocular tension, loss of taste. renal: urinary hesitancy and retention. gastrointestinal: nausea, vomiting, constipation, bloated feeling. dermatologic: decreased sweating, urticaria and other dermal manifestations. miscellaneous: xerostomia, weakness, insomnia, impotence, suppression of lactation.

Drug Interactions:

Use in Pregnancy:

6. pregnancy teratogenic effects pregnancy category c. animal reproduction studies have not been conducted with methscopolamine bromide. it is also not known whether methscopolamine bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. methscopolamine bromide should be given to a pregnant woman only if clearly needed.

Pediatric Use:

8. pediatric use safety and efficacy in children have not been established.

Overdosage:

Overdosage the symptoms of overdosage with methscopolamine bromide tablets, usp 2.5 mg and 5 mg progress from intensification of the usual side effects to cns disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma. measures to be taken are (1) induction of emesis and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. fever may be treated symptomatically (alcohol sponging, ice packs). excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 to 200 ml of a 2% solution) by rectal infusion. in the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. the oral ld 50 in rats is 1,352 to 2,617 mg/kg. no data is available on the dialyzability of methscopolamine bromide.

Description:

Description methscopolamine bromide tablets, usp 2.5 mg and 5 mg contain methscopolamine bromide usp, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. methscopolamine bromide melts at about 225Â°c with decomposition. the drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform. the chemical name for methscopolamine bromide is 3-oxa-9-azoniatricyclo [3.3.1.0 2, 4 ]nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, bromide, [7(s)-(1Î±, 2Î², 4Î², 5Î±, 7Î²)]- and the molecular weight is 398.30. the structural formula is represented below: methscopolamine bromide tablets, usp 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide usp. methscopolamine bromide tablets, usp 5 mg for oral administration contain 5 mg of methscopolamine bromide usp. inactive ingredients: microcrystalline cellulose nf, pregelatinized starch nf, colloidal silicon dioxide nf, magnesium stearate nf. contains no lactose. chemical-structure

Clinical Pharmacology:

Clinical pharmacology methscopolamine bromide is an anticholinergic agent which possesses most of the pharmacologic actions of that drug class. these include reduction in volume and total acid content of gastric secretion, inhibition of gastrointestinal motility, inhibition of salivary excretion, dilation of the pupil and inhibition of accommodation with resulting blurring of vision. large doses may result in tachycardia. pharmacokinetics methscopolamine bromide is a quaternary ammonium derivative of scopolamine. as a class, these agents are poorly and unreliably absorbed. 1, 2 total absorption of quaternary ammonium derivatives of the alkaloids is 10 to 25%. rate of absorption is not available. quaternary ammonium salts have limited absorption from intact skin, and conjunctival penetration is poor. 1 little is known of the fate and excretion of most of these agents. 1 following oral administration, drug effects appear in about one hour and persist for 4 to 6 hours. 2 methscopolamine b Read more...

romide has limited ability to cross the blood-brain barrier. 3,4,5 the drug is excreted primarily in the urine and bile, or as unabsorbed drug in feces. 2 there is no data on the presence of methscopolamine in breast milk; traces of atropine have been found after administration of atropine. 1

Pharmacokinetics:

Pharmacokinetics methscopolamine bromide is a quaternary ammonium derivative of scopolamine. as a class, these agents are poorly and unreliably absorbed. 1, 2 total absorption of quaternary ammonium derivatives of the alkaloids is 10 to 25%. rate of absorption is not available. quaternary ammonium salts have limited absorption from intact skin, and conjunctival penetration is poor. 1 little is known of the fate and excretion of most of these agents. 1 following oral administration, drug effects appear in about one hour and persist for 4 to 6 hours. 2 methscopolamine bromide has limited ability to cross the blood-brain barrier. 3,4,5 the drug is excreted primarily in the urine and bile, or as unabsorbed drug in feces. 2 there is no data on the presence of methscopolamine in breast milk; traces of atropine have been found after administration of atropine. 1

Carcinogenesis and Mutagenesis and Impairment of Fertility:

5. carcinogenesis, mutagenesis, impairment of fertility no long-term studies in animals have been performed to evaluate carcinogenic potential.

How Supplied:

How supplied methscopolamine bromide tablets, usp 2.5 mg are available as white, round tablets, debossed with "by1" on one side and plain on the other side, in the following package size: bottles of 100 (ndc 76385-100-01) methscopolamine bromide tablets, usp 5 mg are available as white, oval tablets, debossed with "by2" on one side and plain on the other side, in the following package size: bottles of 60 (ndc 76385-101-60) store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container as defined in the usp, with a child-resistant closure (as required). keep this and all medications out of the reach of children.

Information for Patients:

2. information for patient see statement under warnings .

Package Label Principal Display Panel:

Package label.principal display panel ndc 76385-100-01 methscopolamine bromide tablets, usp 2.5 mg rx only 100 tablets bayshore ndc 76385-101-60 methscopolamine bromide tablets, usp 5 mg rx only 60 tablets bayshore 25-mg-container-label-100-count 5-mg-container-label-60-count

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