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:

Lannett Company, Inc.

INN (International Name):

BETHANECHOL CHLORIDE

Composition:

BETHANECHOL CHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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.

Product summary:

Bethanechol Chloride Tablets, USP are supplied as follows: 5 mg tablets:  off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1332 on one side and plain on the other side. They are supplied in bottles of 100 tablets; NDC 0527-1332-01. 10 mg tablets:  off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1340 on one side and plain on the other side. They are supplied in bottles of 100 tablets; NDC 0527-1340-01. 25 mg tablets:  off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1356 on one side and plain on the other side. They are supplied in bottles of 100 tablets; NDC 0527-1356-01. 50 mg tablets:  yellow, round, flat-faced beveled edge, bisected tablets debossed LCI over 1329 on one side and plain on the other side. They are supplied in bottles of 100 tablets; NDC 0527-1329-01. Dispense in a tight container as defined in the USP with a child resistant closure. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70471D Rev. 03/20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETHANECHOL CHLORIDE- BETHANECHOL CHLORIDE TABLET
LANNETT COMPANY, INC.
----------
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:
microcrystalline cellulose, sodium starch
glycolate, colloidal silicon dioxide, talc, and magnesium stearate;
the 50 mg tablet also contains D&C
Yellow No. 10 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 of
bethanechol is one hour, although large
doses (300 to 400 mg) have bee