URECHOLINE- bethanechol chloride tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Teva Women's Health, Inc.

Designación común internacional (DCI):

BETHANECHOL CHLORIDE

Composición:

BETHANECHOL CHLORIDE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Bethanechol Chloride Tablets USP 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

Resumen del producto:

Urecholine® (Bethanechol Chloride Tablets USP) is available as follows: 5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the scored side and plain on the other side. Available in bottles of 100 (NDC 51285-697-02). 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the scored side and plain on the other side. Available in bottles of 100 (NDC 51285-690-02). 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the scored side and plain on the other side. Available in bottles of 100 (NDC 51285-691-02). 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the scored side and plain on the other side. Available in bottles of 100 (NDC 51285-692-02). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 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 TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. A 9/2015

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

URECHOLINE- BETHANECHOL CHLORIDE TABLET
TEVA WOMEN'S HEALTH, INC.
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URECHOLINE
(BETHANECHOL CHLORIDE TABLETS USP)
DESCRIPTION
Bethanechol chloride, USP, 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
structural formula is:
C H CIN 0 M.W. 196.68
It is a white, hygroscopic crystalline powder having a slight
amine-like odor, freely soluble in water.
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
bethanechol chloride is one hour,
although large doses (300 to 400 mg) h