देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
BETHANECHOL CHLORIDE (UNII: H4QBZ2LO84) (BETHANECHOL - UNII:004F72P8F4)
Teva Women's Health, Inc.
BETHANECHOL CHLORIDE
BETHANECHOL CHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
URECHOLINE- BETHANECHOL CHLORIDE TABLET TEVA WOMEN'S HEALTH, INC. ---------- 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 पूरा दस्तावेज़ पढ़ें