Drug Catalog - Product Detail
BETHANECHOL CHLORIDE TAB 5MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50111-0323-01 | TEVA PHARMACEUTICALS USA | 100 | 5MG | TABLET |
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Description
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 7 H 17 CIN 2 0 2 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. structural formula
How Supplied
HOW SUPPLIED Bethanechol Chloride Tablets USP are available as follows: 5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/323 on the scored side and plain on the other side. Available in bottles of 100 (NDC 50111-323-01). 10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/324 on the scored side and plain on the other side. Available in bottles of 100 (NDC 50111-324-01). 25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/325 on the scored side and plain on the other side. Available in bottles of 100 (NDC 50111-325-01). 50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/326 on the scored side and plain on the other side. Available in bottles of 100 (NDC 50111-326-01). 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
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Dosage must be individualized, depending on the type and severity of the condition to be treated. Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur. The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially, and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes, and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour. If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE ).