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BETHANECHOL CHLORIDE tablet
[Rising Pharmaceuticals Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 C7H17CIN2O2 and its structural formula is:
Molecular Formula

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: lactose monohydrate, silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and povidone.

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. Following oral administration, the usual duration of action of bethanechol 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, 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.

INDICATIONS & USAGE


Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.

CONTRAINDICATIONS


Hypersensitivity to bethanechol chloride tablets, 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.

PRECAUTIONS

General


In urinary retention, if the sphincter fails to relax as bethanechol contracts the bladder, urine may be forced up the ureter into the kidney pelvis. If there is bacteriuria, this may cause reflux infection.

Information for Patients


Bethanechol chloride tablets should preferably be taken one hour before or two hours after meals to avoid nausea or vomiting. Dizziness, lightheadedness or fainting may occur, especially when getting up from a lying or sitting position.

Drug Interactions


Special care is required if this drug is given to patients receiving ganglion blocking compounds because a critical fall in blood pressure may occur. Usually, severe abdominal symptoms appear before there is such a fall in the blood pressure.

Carcinogenesis & Mutagenesis & Impairment Of Fertility


Long-term studies in animals have not been performed to evaluate the effects upon fertility, mutagenic or carcinogenic potential of bethanechol chloride.

Pregnancy


Teratogenic effects: Pregnancy Category C
Animal reproduction studies have not been conducted with bethanechol chloride. It is also not known whether bethanechol chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bethanechol chloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers


It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk and because of the potential for serious adverse reactions from bethanechol chloride in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use


Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS


Adverse reactions are rare following oral administration of bethanechol, 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 has not been established: Body as a Whole: malaise; Nervous System: seizures.

OVERDOSAGE


Early signs of overdosage are abdominal discomfort, salivation, flushing of the skin (“hot feeling”), 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 LD50 of bethanechol chloride is 1510 mg/kg in the mouse.

DOSAGE & 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).

HOW SUPPLIED


Bethanechol ChlorideTablets USP
5 mg – White, round, scored tablets in bottles of 100.
Debossed EP 118 on one side and plain on reverse side.

10 mg – White, round, scored tablets in bottles of 100.
Debossed EP 119 on one side and plain on reverse side.

25 mg – White, round, scored tablets in bottles of 100.
Debossed EP 120 on one side and plain on reverse side.

50 mg -White, round, scored tablets in bottles of 100.
Debossed EP 121 on one side and plain on reverse side.
 Dispense in a tight container as defined in the USP.
Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
 
Emcure Pharmaceutials USA Inc.
21/B, Cotters Lane,
East Brunswick, New Jersey 08816,
USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Bethanechol Chloride Tablets, 5 mg
100 Tablets
Rx only
NDC 64980-160-01
Each Tablet Contains:
Bethanechol Chloride, USP 5 mg
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
WARNING: KEEP THIS AND ALL THE DRUGS OUT OF THE REACH OF CHILDREN.
Dispense in a tight container as defined in the USP.
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Manufactured by:
Emcure Pharmaceuticals USA Inc.
21/B, Cotters Lane, East Brunswick,
New Jersey 08816, USA
label-5mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL




Bethanechol Chloride Tablets, 50 mg
100 Tablets
Rx only
NDC 64980-163-01
Each Tablet Contains:
Bethanechol Chloride, USP 50 mg
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
WARNING: KEEP THIS AND ALL THE DRUGS OUT OF THE REACH OF CHILDREN.
Dispense in a tight container as defined in the USP.
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Manufactured by:
Emcure Pharmaceuticals USA Inc.
21/B, Cotters Lane, East Brunswick,
New Jersey 08816, USA
label-50mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL




Bethanechol Chloride Tablets, 25 mg
100 Tablets
Rx only
NDC 64980-162-01
Each Tablet Contains:
Bethanechol Chloride, USP 25 mg
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
WARNING: KEEP THIS AND ALL THE DRUGS OUT OF THE REACH OF CHILDREN.
Dispense in a tight container as defined in the USP.
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Manufactured by:
Emcure Pharmaceuticals USA Inc.
21/B, Cotters Lane, East Brunswick,
New Jersey 08816, USA
label-25mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL




Bethanechol Chloride Tablets, 10 mg
100 Tablets
Rx only
NDC 64980-161-01
Each Tablet Contains:
Bethanechol Chloride, USP 10 mg
Usual Dosage: See package insert.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
WARNING: KEEP THIS AND ALL THE DRUGS OUT OF THE REACH OF CHILDREN.
Dispense in a tight container as defined in the USP.
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
Manufactured by:
Emcure Pharmaceuticals USA Inc.
21/B, Cotters Lane, East Brunswick,
New Jersey 08816, USA
 
label-10mg
BETHANECHOL CHLORIDE 
bethanechol chloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64980-160
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code EP118
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64980-160-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09125608/24/2010
BETHANECHOL CHLORIDE 
bethanechol chloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64980-161
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code EP119
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64980-161-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09125604/06/2010
BETHANECHOL CHLORIDE 
bethanechol chloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64980-162
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code EP120
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64980-162-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09125604/06/2010
BETHANECHOL CHLORIDE 
bethanechol chloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64980-163
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
SILICON DIOXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code EP121
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64980-163-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09125604/06/2010
Labeler - Rising Pharmaceuticals Inc. (041241766)
Registrant - Emcure Pharmaceuticals Ltd. (916921919)
Establishment
NameAddressID/FEIBusiness Operations
Emcure Pharmaceuticals USA Inc.189630168ANALYSIS, MANUFACTURE

Revised: 8/2010
 
Rising Pharmaceuticals Inc.

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