Label: BETHANECHOL CHLORIDE- bethanechol chloride tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 10, 2019

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  • 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 7H 17ClN 20 2 and its structural formula is:

    Bethanechol chloride structural 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: 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.

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  • 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 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.

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  • 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.

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  • 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.

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  • PRECAUTIONS

    General
    In urinary retention, if the sphincter fails to relax as bethanechol chloride 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.

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  • 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 Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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  • 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 LD 50 of bethanechol chloride is 1510 mg/kg in the mouse.

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  • 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).

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  • HOW SUPPLIED

    Bethanechol Chloride Tablets, USP, 10 mg are supplied as white, round, flat-faced, bevelled tablets debossed 'AN' above bisect and '572' below bisect on one side and plain on the other side.
    They are available as follows:
    Unit dose packages of 100 (10 x 10) NDC 68084-365-01

    Bethanechol Chloride Tablets, USP, 25 mg are supplied as yellow, round, flat-faced, bevelled tablet, debossed 'AN' above bisect and '573' below bisect on one side and plain on the other side.
    They are available as follows:
    Unit dose packages of 100 (10 x 10) NDC 68084-704-01

    Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

    FOR YOUR PROTECTION: Do not use if blister is torn or broken.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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  • PACKAGING INFORMATION

    American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Amneal Pharmaceuticals LLC as follows:
    (10 mg / 100 UD) NDC 68084-365-01 packaged from NDC 65162-572
    (25 mg / 100 UD) NDC 68084-704-01 packaged from NDC 65162-573

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8236501/0519F

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  • Package/Label Display Panel – Carton – 10 mg

    10 mg Bethanechol Chloride Tablets Carton

    NDC 68084- 365-01

    Bethanechol
    Chloride Tablets, USP

    10 mg

    100 Tablets (10 × 10) Rx Only

    Each Tablet Contains:
    Bethanechol Chloride, USP..............................................10 mg

    Usual Dosage: See package insert for full prescribing
    information.

    Store at 20º to 25ºC (68º to 77ºF); excursions permitted
    between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room
    Temperature].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or
    broken.

    The drug product contained in this package is from
    NDC # 65162-572, Amneal Pharmaceuticals LLC.

    Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    036501
    0236501/0519OS

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  • Package/Label Display Panel – Blister – 10 mg

    10 mg Bethanechol Chloride Tablet Blister

    Bethanechol
    Chloride
    Tablet, USP

    10 mg

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  • Package/Label Display Panel – Carton – 25 mg

    25 mg Bethanechol Chloride Tablets Carton

    NDC 68084- 704-01

    Bethanechol
    Chloride Tablets, USP

    25 mg

    100 Tablets (10 × 10) Rx Only

    Each Tablet Contains:
    Bethanechol Chloride, USP............................................. 25 mg

    Usual Dosage: See package insert for full prescribing
    information.

    Store at 20º to 25ºC (68º to 77ºF); excursions permitted
    between 15º to 30ºC (59º to 86ºF) [see USP Controlled Room
    Temperature].

    Keep this and all drugs out of reach of children.

    FOR YOUR PROTECTION: Do not use if blister is torn or
    broken.

    The drug product contained in this package is from
    NDC # 65162-573, Amneal Pharmaceuticals LLC.

    Distributed by:
    American Health Packaging
    Columbus, Ohio 43217

    070401
    0270401/0519OS

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  • Package/Label Display Panel – Blister – 25 mg

    25 mg Bethanechol Chloride Tablet Blister

    Bethanechol
    Chloride
    Tablet, USP

    25 mg

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  • INGREDIENTS AND APPEARANCE
    BETHANECHOL CHLORIDE 
    bethanechol chloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-365(NDC:65162-572)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color white Score 2 pieces
    Shape ROUND Size 11mm
    Flavor Imprint Code AN;572
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68084-365-01 100 in 1 BOX, UNIT-DOSE 02/04/2015
    1 NDC:68084-365-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040855 02/04/2015
    BETHANECHOL CHLORIDE 
    bethanechol chloride tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-704(NDC:65162-573)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4) BETHANECHOL CHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color yellow Score 2 pieces
    Shape ROUND Size 11mm
    Flavor Imprint Code AN;573
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68084-704-01 100 in 1 BOX, UNIT-DOSE 02/05/2015
    1 NDC:68084-704-11 1 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040855 02/05/2015
    Labeler - American Health Packaging (929561009)
    Establishment
    Name Address ID/FEI Business Operations
    American Health Packaging 929561009 repack(68084-365, 68084-704)
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