BETHANECHOL CHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4)

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

BETHANECHOL CHLORIDE

Composition:

BETHANECHOL CHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Bethanechol Chloride Tablets, USP, 5 mg are supplied as white, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘571’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100:              NDC 65162-571-10 Bottle of 500:              NDC 65162-571-50 Bottle of 1000:            NDC 65162-571-11 Bethanechol Chloride Tablets, USP, 10 mg are supplied as white, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘572’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100:              NDC 65162-572-10 Bottle of 500:              NDC 65162-572-50 Bottle of 1000:            NDC 65162-572-11 Bethanechol Chloride Tablets, USP, 25 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘573’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100:              NDC 65162-573-10 Bottle of 500:              NDC 65162-573-50 Bottle of 1000:            NDC 65162-573-11 Bethanechol Chloride Tablets, USP, 50 mg are supplied as yellow, round, flat-faced, bevelled tablets debossed with ‘AN’ above bisect and ‘574’ below bisect on one side and plain on the other side. They are available as follows: Bottle of 100:              NDC 65162-574-10 Bottle of 500:              NDC 65162-574-50 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]. 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 Rev. 05-2018-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETHANECHOL CHLORIDE- BETHANECHOL CHLORIDE TABLET
AMNEAL PHARMACEUTICALS LLC
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BETHANECHOL CHLORIDE TABLETS, USP
RX ONLY
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 H
CIN 0 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.
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
7
17
2 2
of bethanec