Dicycloverine Hydrochloride

Dicycloverine Hydrochloride

Drug Nomenclature

Date of monograph revision: 27-Mar-1997; 02-Sep-1998; 28-Jun-1999; 14-Nov-2001; 01-Jun-2004; 08-Mar-2006; 20-Jul-2006
Synonyms: Cloridrato de Dicicloverina; Dicicloverina, hidrocloruro de; Dicikloverin-hidroklorid; Dicikloverino hidrochloridas; Dicyclomine Hydrochloride; Dicycloverini Hydrochloridum; Dicykloverin-hydrochlorid; Dicykloverinhydroklorid; Disykloveriinihydrokloridi
BAN: Dicycloverine Hydrochloride [BANM]
INN: Dicycloverine Hydrochloride [rINNM (en)]
INN: Hidrocloruro de dicicloverina [rINNM (es)]
INN: Dicyclovérine, Chlorhydrate de [rINNM (fr)]
INN: Dicycloverini Hydrochloridum [rINNM (la)]
INN: Дицикловерина Гидрохлорид [rINNM (ru)]
Chemical name: 2-Diethylaminoethyl bicyclohexyl-1-carboxylate hydrochloride
Molecular formula: C19H35NO2,HCl =345.9
CAS: 77-19-0 (dicycloverine); 67-92-5 (dicycloverine hydrochloride)
ATC code: A03AA07
Read code: y01ON
Chemical Structure of Dicycloverine

Chemical Structure of Dicycloverine

Pharmacopoeias:

In Eur. (see Go to European Pharmacopoeia Convention Signatories) and US.

Ph. Eur. 5.5 (Dicycloverine Hydrochloride). A white or almost white, crystalline powder. It shows polymorphism. Soluble in water; freely soluble in alcohol and in dichloromethane. A 1% solution in water has a pH of 5.0 to 5.5.

USP 29 (Dicyclomine Hydrochloride). A fine white, practically odourless, crystalline powder. Soluble 1 in 13 of water, 1 in 5 of alcohol, 1 in 2 of chloroform and of glacial acetic acid, and 1 in 770 of ether. pH of a 1% solution in water is between 5.0 and 5.5.

Adverse Effects, Treatment, and Precautions

As for Atropine Sulfate, Go to Adverse Effects, Go to Treatment of Adverse Effects, and Go to Precautions. Dicycloverine hydrochloride should not be given to infants younger than 6 months of age.

Apnoea.

Reports1-3 of severe apnoea in infants aged 5 to 10 weeks associated with the use of dicycloverine.

  1. 1. Williams J, Watkin-Jones R. Dicyclomine: worrying symptoms associated with its use in some small babies. BMJ 1984; 288: 901. PubMed
  2. 2. Edwards PDL. Dicyclomine in babies. BMJ 1984; 288: 1230.
  3. 3. Spoudeas H, Shribman S. Dicyclomine in babies. BMJ 1984; 288: 1230.

Pregnancy.

For a review of the risks to the fetus of antiemetic therapy during pregnancy, with particular reference to Debendox (Bendectin: dicycloverine with doxylamine and pyridoxine), see under Antihistamines on Go to Pregnancy..

Interactions

As for antimuscarinics in general (see Atropine Sulfate, Go to Interactions).

Uses and Administration

Dicycloverine hydrochloride is a tertiary amine antimuscarinic with effects similar to but weaker than those of atropine (Go to Adverse Effects); it also has a direct antispasmodic action.

Dicycloverine is used in gastrointestinal spasm, particularly that associated with the irritable bowel syndrome. For adults, 10 to 20 mg of dicycloverine hydrochloride is given 3 times daily; in the USA, up to 40 mg four times daily has been recommended where adverse effects permit. Children aged 6 months to 2 years may be given 5 to 10 mg up to 3 or 4 times daily; doses are usually given 15 minutes before meals. Children aged 2 to 12 years may be given 10 mg three times daily.

Dicycloverine hydrochloride may be given intramuscularly in doses of 20 mg given 4 times daily to patients in whom oral therapy is temporarily impractical, but should not be used for longer than 1 to 2 days.

Preparations

Single-ingredient Preparations

The symbol ¤ denotes a preparation which is discontinued or no longer actively marketed.

Argentina: Babypasmil; Australia: Merbentyl; Brazil: Bentyl; Canada: Bentylol; Formulex¤; Lomine; Protylol¤; Spasmoban¤; Hong Kong: Dicymine; India: Cyclominol; Cyclopam; Dysmen; Spasmo-Proxyvon; Spasmonil; Ireland: Merbentyl; Israel: Notensyl; Italy: Bentyl¤; Mexico: Bentyl; Clominal; Dicigon; Diclomin; Sediclon; New Zealand: Merbentyl; Portugal: Optimal; South Africa: Clomin¤; Medicyclomine; Merbentyl; Spain: Bentylol¤; Tarestin¤; Thailand: Clomin¤; Dicomin; Dicymine; United Kingdom: Merbentyl; United States: Antispas; Bemote¤; Bentyl; Byclomine; Di-Spaz¤; Dibent; Dilomine¤; Or-Tyl; Spasmoject¤; Venezuela: Ciclan; Diciclor; Mabex;



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