(BANM, US Adopted Name, rINNM)
International Nonproprietary Names (INNs) in main languages (French, Latin, Spanish):
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.
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.
Mebeverine hydrochloride is considered to be unsafe in patients with porphyria because it has been shown to be porphyrinogenic in in-vitro systems.
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
British Pharmacopoeia 2008: Mebeverine Tablets.
Australia: Colese Colofac
Belgium: Duspatalin Spasmonal
Chile: Doloverina Duspatal Evadol Meditoina
Czech Republic: Duspatalin
France: Colopriv Duspatalin Spasmopriv
Germany: Duspatal Mebemerck
Greece: Duspatalin Gastromins
Hong Kong: Duspatalin
Indonesia: Duspatalin Irbosyd
Malaysia: Duspatalin Lezpain Mebetin
The Netherlands: Duspatal
New Zealand: Colofac
South Africa: Bevispas Colofac
Singapore: Duspatalin Mebetin
Thailand: Colofac Duspatin Menosor
Turkey: Duspatalin Duspaverin
UK: Colofac Equilon IBS Relief
Hong Kong: Fybogel Mebeverine
Ireland: Fybogel Mebeverine
UK: Fybogel Mebeverine