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Balsalazide Sodium

Drug Approvals

(BANM, rINNM)

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

Balsalazida sodica; Balsalazide Disodium (USAN); Balsalazide Sodique; Balsalazine Disodium; BX-66IA; Natrii Balsalazidum.

Balsalazide SodiumAdverse Effects and Precautions

As for Mesalazine, p. 1745. If a blood dyscrasia is suspected treatment should be stopped immediately and a blood count performed. Patients or their carers should be told how to recognise signs of haematotoxicity and should be advised to seek immediate medical attention if symptoms such as fever, sore throat, mouth ulcers, bruising, or bleeding develop. Balsalazide should not be used in patients with severe hepatic impairment or moderate or severe renal impairment, care is required in those with lesser degrees of hepatic or renal impairment, and in asthma, bleeding disorders, or active peptic ulcer disease.

Hypersensitivity

A case of acute pericarditis, cholestasis, and vasculitis resulting from hypersensitivity to balsalazide has been reported.l The authors noted similarities to mesalazine-associat-ed pericarditis and lupus-like syndrome (see Effects on the Cardiovascular System).

Pharmacokinetics

Very little of an oral dose of balsalazide is absorbed via the upper gastrointestinal tract, and almost the entire dose reaches its site of action in the colon intact. It is broken down by the colonic bacterial flora into 5-aminosalicylic acid (mesalazine), which is active, and 4-aminobenzoylalanine, which is considered to be an inert carrier. About 25% of the released mesalazine is absorbed and acetylated, as described under mesalazine. A small proportion of 4-aminobenzoylalanine is absorbed and acetylated by first-pass metabolism through the liver. The acetylated metabolites are excreted in the urine.

Balsalazide SodiumUses and Administration

Balsalazide consists of mesalazine linked to 4-aminobenzoylalanine via an azo bond. This bond is broken by colonic bacteria, releasing the active mesalazine. Balsalazide sodium is given in the treatment of mild to moderate active ulcerative colitis, in an oral dose of 2.25 g three times daily until remission or for up to 12 weeks. For maintenance of remission of ulcerative colitis a dose of 1.5 g twice daily is recommended, adjusted as necessary up to 6 g daily. For doses in children, see below.

Administration in children

Balsalazide sodium is not licensed in the UK for use in children under 18 years of age. However, the BNFC suggests that, in those aged 12 years and over, 2.25 g may be given orally three times daily for an acute attack of mild to moderate ulcerative colitis, until remission occurs, or for up to 12 weeks. For maintenance, 1.5 g twice daily is recommended, adjusted according to response up to a maximum of 6 g daily.

In the USA, licensed doses in children aged 5 to 17 years are 750 mg three times daily by mouth, or 2.25 g three times daily treatment may be continued for up to 8 weeks.

Preparations

Proprietary Preparations

Argentina: Benoquin
Australia: Colazide
Czech Republic: Colazide
Denmark: Premid
Italy: Balzide
Norway: Colazid
United Kingdom: Colazide
USA: Colazal.

Multi-ingredient: Sweden: Colazid

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