BETHANECHOL CHLORIDE- 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:

AvPAK

INN (International Name):

BETHANECHOL CHLORIDE

Composition:

BETHANECHOL CHLORIDE 10 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 5 mg - White, round, scored tablets, debossed AN 571 10 mg-White, round, scored tablets, debossed AN 572. NDC 50268-113-15, 10 tablets per card, 5 cards per carton 25 mg-Yellow, round, scored tablets, debossed AN 573. NDC 50268-114-15, 10 tablets per card, 5 cards per carton 50 mg -Yellow, round, scored tablets, debossed AN 574. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature]. Dispensed in Blister Punch Material. For Institutional Use Only. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. Manufactured for: AvKARE, Inc. Pulaski, TN  38478 Mfg. Rev. 12/07                   AV Rev. 02/15 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BETHANECHOL CHLORIDE- BETHANECHOL CHLORIDE TABLET
AVPAK
----------
BETHANECHOL CHLORIDE TABLETS, USP
FULL PRESCRIBING INFORMATION
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 Gl 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
bethanecho