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Mebeverine Hydrochloride


Drug Approvals

(BANM, US Adopted Name, rINNM)

International Nonproprietary Names (INNs) in main languages (French, Latin, Spanish):

Synonyms: CSAG-144; Mebeverina, hidrocloruro de
BAN: Mebeverine Hydrochloride [BANM]
USAN: Mebeverine Hydrochloride
INN: Mebeverine Hydrochloride [rINNM (en)]
INN: Hidrocloruro de mebeverina [rINNM (es)]
INN: Mébévérine, Chlorhydrate de [rINNM (fr)]
INN: Mebeverini Hydrochloridum [rINNM (la)]
INN: Мебеверина Гидрохлорид [rINNM (ru)]
Chemical name: 4-[Ethyl(4-methoxy-αmethylphenethyl)amino]butyl veratrate hydrochloride
Molecular formula: C25H35NO5,HCl =466.0
CAS: 3625-06-7 (mebeverine); 2753-45-9 (mebeverine hydrochloride)
ATC code: A03AA04
Read code: y01Ov

Pharmacopoeias. In British.

British Pharmacopoeia 2008 (Mebevenne Hydrochlonde). A white or almost white crystalline powder. Very soluble in water freely soluble in alcohol practically insoluble in ether. A 2% solution in water has a pH of 4.5 to 6.5. Store in airtight containers at a temperature not exceeding 30°. Protect from light.

Adverse Effects and Precautions

Although adverse effects appear rare, gastrointestinal disturbances, dizziness, headache, insomnia, anorexia, and decreased heart rate have been reported in patients receiving mebeverine. Cases of hypersensitivity, including erythematous rash, urticaria, and angioedema, have also been reported. Mebeverine should be avoided in patients with paralytic ileus. Based on theoretical concerns, it should be used with care in patients with marked hepatic or renal impairment, and those with cardiac disorders such as heart block.

Cystic fibrosis. A 24-year-old man with cystic fibrosis, given mebeverine hydrochloride for lower abdominal pain and constipation, was found to have a perforated stercoral ulcer with generalised peritonitis. It was suggested that mebeverine produced colonic stasis, which predisposed the patient to ulceration, but

the manufacturers considered that the development of constipation and distal intestinal syndrome (meconium ileus equivalent) in this patient precipitated the development of stercoral ulceration. It was recommended that antispasmodics such as mebeverine should not be used for the symptomatic treatment of distal intestinal syndrome in cystic fibrosis.

Porphyria. Mebeverine hydrochloride is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in in-vitro systems.

Pharmacokinetics

Mebeverine is rapidly absorbed after oral doses with peak plasma concentrations occurring in 1 to 3 hours. It is 75% bound to albumin in plasma. Mebeverine is completely metabolised by hydrolysis to veratric acid and mebeverine alcohol, the latter of which may then be conjugated. The metabolites are excreted in the urine.

Uses and Administration

Mebeverine hydrochloride is an antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract. It is used in conditions such as irritable bowel syndrome in a usual oral dose of 135 mg three times daily before meals 100 mg three times daily has also been used. A modified-release preparation is also available, taken as 200 mg twice daily. The embonate is also used for oral liquid preparations in a dose equivalent to 150 mg of the hydrochloride three times daily. The BNFC suggests that the following hydrochloride-equivalent doses may be given three times daily, based on age:

• 25 mg for those aged 3 to 4 years

• 50 mg for those 4 to 8 years

• 100 mg for those 8 to 10 years

• 135 to 150 mg for those over 10 years

Preparations

British Pharmacopoeia 2008: Mebeverine Tablets.

Proprietary Preparations

Argentina: Duspatalin

Australia: Colese Colofac

Austria: Colofac

Belgium: Duspatalin Spasmonal

Brazil: Duspatalin

Chile: Doloverina Duspatal Evadol Meditoina

Czech Republic: Duspatalin

Denmark: Duspatalin

France: Colopriv Duspatalin Spasmopriv

Germany: Duspatal Mebemerck

Greece: Duspatalin Gastromins

Hong Kong: Duspatalin

Hungary: Duspatalin

India: Colospa

Indonesia: Duspatalin Irbosyd

Ireland: Colofac

Israel: Colotal

Italy: Duspatal

Malaysia: Duspatalin Lezpain Mebetin

Mexico: Arluy

The Netherlands: Duspatal

New Zealand: Colofac

Philippines: Duspatalin

Poland: Duspatalin

Portugal: Duspatal

Russia: Duspatalin

South Africa: Bevispas Colofac

Singapore: Duspatalin Mebetin

Spain: Duspatalin

Switzerland: Duspatalin

Thailand: Colofac Duspatin Menosor

Turkey: Duspatalin Duspaverin

UK: Colofac Equilon IBS Relief

Multi-ingredient

Hong Kong: Fybogel Mebeverine

Ireland: Fybogel Mebeverine

UK: Fybogel Mebeverine

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