Bethanechol Chloride

Major Pharmaceuticals
Human Prescription Drug
NDC 0904-6178

Bethanechol Chloride is a human prescription drug labeled by 'Major Pharmaceuticals'. National Drug Code (NDC) number for Bethanechol Chloride is 0904-6178. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Bethanechol Chloride drug includes Bethanechol Chloride - 25 mg/1 . The currest status of Bethanechol Chloride drug is Active.

Drug Information:

Drug NDC:	0904-6178
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:	Bethanechol Chloride
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:	Bethanechol Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Major Pharmaceuticals
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:	BETHANECHOL CHLORIDE - 25 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 Apr, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 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:	ANDA040855
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:	Major Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	857328
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:	H4QBZ2LO84
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:	Cholinergic Muscarinic Agonist [EPC] Cholinergic Muscarinic Agonists [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
0904-6178-61	100 BLISTER PACK in 1 CARTON (0904-6178-61) / 1 TABLET in 1 BLISTER PACK	01 Apr, 2010	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:

Bethanechol chloride bethanechol chloride bethanechol chloride bethanechol anhydrous lactose silicon dioxide magnesium stearate microcrystalline cellulose sodium starch glycolate type a potato d&c yellow no. 10 fd&c yellow no. 6 an;573

Indications and Usage:

Indications and usage bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

Dosage and Administration:

Dosage and administration dosage must be individualized, depending on the type and severity of the condition to be treated. preferably give the drug when the stomach is empty. if taken soon after eating, nausea and vomiting may occur. the usual adult oral dose ranges from 10 to 50 mg three or four times a day. the minimum effective dose is determined by giving 5 to 10 mg initially, and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. the effects of the drug sometimes appear within 30 minutes, and are usually maximal within 60 to 90 minutes. the drug effects persist for about one hour. if necessary, the effects of the drug can be abolished promptly by atropine (see overdosage ).

Contraindications:

Contraindications hypersensitivity to bethanechol chloride, hyperthyroidism, peptic ulcer, latent or active bronchial asthma, pronounced bradycardia or hypotension, vasomotor instability, coronary artery disease, epilepsy and parkinsonism. bethanechol chloride should not be employed when the strength or integrity of the gastrointestinal or bladder wall is in question, or in the presence of mechanical obstruction; when increased muscular activity of the gastrointestinal tract or urinary bladder might prove harmful, as following recent urinary bladder surgery, gastrointestinal resection and anastomosis, or when there is possible gastrointestinal obstruction; in bladder neck obstruction, spastic gastrointestinal disturbances, acute inflammatory lesions of the gastrointestinal tract, or peritonitis; or in marked vagotonia.

Adverse Reactions:

Adverse reactions adverse reactions are rare following oral administration of bethanechol chloride, but are more common following subcutaneous injection. adverse reactions are more likely to occur when dosage is increased. the following adverse reactions have been observed: body as a whole: malaise digestive: abdominal cramps or discomfort, colicky pain, nausea and belching, diarrhea, borborygmi, salivation renal: urinary urgency nervous system: headache cardiovascular: a fall in blood pressure with reflex tachycardia, vasomotor response skin: flushing producing a feeling of warmth, sensation of heat about the face, sweating respiratory: bronchial constriction, asthmatic attacks special senses : lacrimation, miosis causal relationship unknown: the following adverse reactions have been reported, and a causal relationship to therapy with bethanechol chloride has not been established: body as a whole: malaise nervous system: seizures to report suspected adverse reactions, contact amneal p Read more...

harmaceuticals at 1-877-835-5472 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Overdosage:

Overdosage early signs of overdosage are abdominal discomfort, salivation, flushing of the skin (âhot feelingâ), sweating, nausea, and vomiting. atropine sulfate is a specific antidote. the recommended dose for adults is 0.6 mg. repeat doses can be given every two hours, according to clinical response. the recommended dosage in infants and children up to 12 years of age is 0.01 mg/kg (to a maximum single dose of 0.4 mg) repeated every two hours as needed until the desired effect is obtained or adverse effects of atropine preclude further usage. subcutaneous injection of atropine is preferred except in emergencies when the intravenous route may be employed. the oral ld 50 of bethanechol chloride is 1510 mg/kg in the mouse.

Description:

Description bethanechol chloride, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. it is designated chemically as 2-[(aminocarbonyl) oxy]- n, n, n -trimethyl-1-propanaminium chloride. its molecular formula is c 7 h 17 cin 2 0 2 and its structural formula is: it is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, usp. tablets also contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. the 25 mg and 50 mg tablets also contain d&c yellow #10 aluminum lake and fd&c yellow #6 aluminum lake. 38055a93-figure-01

Clinical Pharmacology:

Clinical pharmacology bethanechol chloride acts principally by producing the effects of stimulation of the parasympathetic nervous system. it increases the tone of the detrusor urinae muscle, usually producing a contraction sufficiently strong to initiate micturition and empty the bladder. it stimulates gastric motility, increases gastric tone and often restores impaired rhythmic peristalsis. stimulation of the parasympathetic nervous system releases acetylcholine at the nerve endings. when spontaneous stimulation is reduced and therapeutic intervention is required, acetylcholine can be given, but it is rapidly hydrolyzed by cholinesterase and its effects are transient. bethanechol chloride is not destroyed by cholinesterase and its effects are more prolonged than those of acetylcholine. effects on the gi and urinary tracts sometimes appear within 30 minutes after oral administration of bethanechol chloride, but more often 60 to 90 minutes are required to reach maximum effectiveness. f Read more...

ollowing oral administration, the usual duration of action of bethanechol chloride is one hour, although large doses (300 to 400 mg) have been reported to produce effects for up to six hours. subcutaneous injection produces a more intense action on bladder muscle than does oral administration of the drug. because of the selective action of bethanechol chloride, nicotinic symptoms of cholinergic stimulation are usually absent or minimal when orally or subcutaneously administered in therapeutic doses, while muscarinic effects are prominent. muscarinic effects usually occur within 5 to 15 minutes after subcutaneous injection, reach a maximum in 15 to 30 minutes, and disappear within two hours. doses that stimulate micturition and defecation and increase peristalsis do not ordinarily stimulate ganglia or voluntary muscles. therapeutic test doses in normal human subjects have little effect on heart rate, blood pressure or peripheral circulation. bethanechol chloride does not cross the blood-brain barrier because of its charged quaternary amine moiety. the metabolic rate and mode of excretion of the drug have not been elucidated. a clinical study (diokno, a.c.; lapides, j.; urol 10: 23-24, july 1977) was conducted on the relative effectiveness of oral and subcutaneous doses of bethanechol chloride on the stretch response of bladder muscle in patients with urinary retention. results showed that 5 mg of the drug given subcutaneously stimulated a response that was more rapid in onset and of larger magnitude than an oral dose of 50 mg, 100 mg, or 200 mg. all the oral doses, however, had a longer duration of effect than the subcutaneous dose. although the 50 mg oral dose caused little change in intravesical pressure in this study, this dose has been found in other studies to be clinically effective in the rehabilitation of patients with decompensated bladders.

How Supplied:

How supplied bethanechol chloride tablets, usp, 25 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with âanâ above bisect and â573â below bisect on one side and plain on the other side. they are available as follows: cartons of 100 capsules (10 capsules each blister pack x 10), ndc 0904-6178-61 store at 20Â° to 25Â°c (68Â° to 77Â°f); excursions permitted between 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. this container is not intended for household use. 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. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 distributed by: majorÂ® pharmaceuticals livonia, mi 48152 usa refer to package label for distributor's ndc number rev. 05-2018-03

Package Label Principal Display Panel:

Package/label display panel bethanechol chloride tablets, usp 25 mg 100 tablets carton label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.