There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
Oral suspension
▶Mebeverine hydrochloride (Non-proprietary)
Mebeverine hydrochloride (as Mebeverine pamoate) 10 mg per
1 ml Mebeverine 50mg/5ml oral suspension sugar free sugar-free |
300 ml P £187.00 DT = £187.00
Modified-release capsule
CAUTIONARY AND ADVISORY LABELS 25
▶Mebeverine hydrochloride (Non-proprietary)
Mebeverine hydrochloride 200 mg Mebeverine 200mg modified-
release capsules | 60 capsule P £10.14 DT = £9.22
▶Aurobeverine MR (Milpharm Ltd)
Mebeverine hydrochloride 200 mg Aurobeverine MR 200mg
capsules | 60 capsule P £6.92 DT = £9.22
▶Colofac MR (Mylan)
Mebeverine hydrochloride 200 mg Colofac MR 200mg capsules |
60 capsule P £6.92 DT = £9.22
Tablet
▶Mebeverine hydrochloride (Non-proprietary)
Mebeverine hydrochloride 135 mg Mebeverine 135mg tablets |
100 tablet P £20.00 DT = £5.11
▶Colofac (Mylan)
Mebeverine hydrochloride 135 mg Colofac 135mg tablets |
100 tablet P £9.02 DT = £5.11
Colofac IBS 135mg tablets | 15 tablet p £2.83
Liver disorders and related
conditions
Biliary disorders
7.1
Cholestasis
Description of condition
Cholestasis is an impairment of bile formation and/or bile
flow, which may clinically present with fatigue, pruritus,
dark urine, pale stools and, in its most overt form, jaundice
and signs of fat soluble vitamin deficiencies.
Treatment of cholestatic pruritus
Several drugs are used to relieve cholestatic pruritus, even if
evidence to support their use is limited.
g Colestyramine p. 210 is the drug of choice for
treating cholestatic pruritus. It is an anion-exchange resin
that is not absorbed from the gastro-intestinal tract. It
relieves pruritus by forming an insoluble complex in the
intestine with bile acids and other compounds—the
reduction of serum bile acid levels reduces excess deposition
in the dermal tissue with a resultant decrease in pruritus. h
g Ursodeoxycholic acid p. 96 has a small and variable
impact on cholestatic pruritus. l
g Rifampicin p. 615 [unlicensed indication] can be used
as an alternative treatment for pruritus, but should be used
with caution in patients with pre-existing liver disease
because of possible hepatotoxicity. h
g Where previous therapy has proved ineffective or was
not tolerated, other drugs including sertraline p. 385
[unlicensed indication] and naltrexone hydrochloride p. 519
[unlicensed indication], may be used to treat cholestatic
pruritus. However, their use is limited due to significant
side-effects. l
Intrahepatic cholestasis in pregnancy
g Ursodeoxycholic acid is effective for the treatment of
pruritus associated with intrahepatic cholestasis in
pregnancy. l
Intrahepatic cholestasis usually occurs in late pregnancy
and is associated with adverse fetal outcomes. g There is
no evidence that ursodeoxycholic acid used in late
pregnancy affects birth weight in the infant or the risk of
preterm delivery. There is limited data about the effect of
fetal exposure during the first trimester. k
Gallstones
Description of condition
Gallstones (cholelithiases) occur when hard mineral or fatty
deposits form in the gallbladder. Gallstone disease is a
general term that describes the presence of one or more
stones in the gallbladder or in the bile duct, and the
symptoms and complications that they may cause.
The majority of patients with gallstones remain
asymptomatic. When the stones irritate the gallbladder or
block part of the biliary system, the patient can experience
symptoms such as pain, or infection and inflammation that if
left untreated, can lead to severe complications such as
biliary colic, acute cholecystitis, cholangitis, pancreatitis,
and obstructive jaundice.
Non-drug treatment
g Asymptomatic gallbladder stones do not need to be
treated unless symptoms develop.
The definitive treatment of symptomatic gallstones (and
all bile duct stones) is surgical removal by laparoscopic
cholecystectomy. h
Drug treatment
g Analgesia should be offered to control pain symptoms.
Paracetamol p. 465 or a nonsteroidal anti-inflammatory drug
(see Non-steroidal anti-inflammatory drugs p. 1193) is
recommended for intermittent mild-to-moderate pain.
Intramuscular diclofenac sodium p. 1198 can be given for
severe pain or, if not suitable, an intramuscular opioid (such
as morphine p. 484 or pethidine hydrochloride p. 490). h
Although ursodeoxycholic acid p. 96 has been used for the
management of gallstone disease, there is no evidence to
support its use.
Useful Resources
Gallstone disease: diagnosis and management. National
Institute for Health and Care Excellence. Clinical guideline
188. October 2014.
www.nice.org.uk/guidance/cg188
Inborn errors of primary bile acid
synthesis
Description of condition
Inborn errors of primary bile acid synthesis are a group of
diseases in which the liver does not produce enough primary
bile acids due to enzyme deficiencies. These acids are the
main components of the bile, and include cholic acid and
chenodeoxycholic acid.
Treatment
Cholic acid below is licensed for the treatment of inborn
errors in primary bile acid synthesis due to an inborn
deficiency of two specific liver enzymes. It acts by replacing
some of the missing bile acids, therefore relieving the
symptoms of the disease.
Chenodeoxycholic acid below is licensed for the treatment
of inborn errors of primary bile acid synthesis due to a
deficiency of one specific enzyme in the bile acid synthesis
pathway when presenting as cerebrotendinous
xanthomatosis.
Ursodeoxycholic acid p. 96 [unlicensed indication] has
been used to treat inborn errors of primary bile acid
synthesis, but there is an absence of evidence to recommend
its use.
Primary biliary cholangitis
Description of condition
Primary biliary cholangitis (or primary biliary cirrhosis) is a
chronic cholestatic disease which develops due to
progressive destruction of small and intermediate bile ducts
within the liver, subsequently evolving to fibrosis and
cirrhosis.
Treatment
g Ursodeoxycholic acid p. 96 is recommended for the
management of primary biliary cholangitis, including those
with asymptomatic disease. It slows disease progression, but
the effect on overall survival is uncertain. Liver
transplantation can be considered in patients with advanced
primary biliary cholangitis. h
BILE ACIDS
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