Colazal or Balsalazide is a prodrug that is converted to its active compound, mesalamine, in the gastrointestinal tract. It inhibits the production of arachidonic acid resulting in an anti-inflammatory effect.

It is used as an off-label medicine for the treatment and remission of ulcerative colitis in adults.

Balsalazide Dose in Adults

Dose in the treatment of Ulcerative colitis:

• Capsules:
  • 2.25 gms orally three times a day for 8 -12 weeks
• Tablets:
  • 3.3 gms orally two times a day for up to 8 weeks

Off label use in the treatment of remission maintenance of Ulcerative colitis:

• 3 - 5 gms two times a day for 6 - 12 months

Balsalazide Dose in Childrens

Dose in the treatment of Ulcerative colitis:

• Children older than 5 years and Adolescents less than 17 years:
  • 2.25 gms orally (three capsules of 750 mg) 3 times a day to a total daily dose of 6.75 g/day for up to 8 weeks or
  • One 750 mg capsule orally 3 times a day to a total daily dose of 2.25 g/day for up to eight weeks

• Adolescents older than 18 years:
  • 2.25 gms orally (three capsules of 750 mg) 3 times a day to a total daily dose of 6.75 g/day for up to 8 - 12 weeks
  • 3.3 gms orally (three tablets of 1.1 gms each) two times a day to a total daily dose of 6.6 gms/day for up to eight weeks

Pregnancy Risk Factor B

• In animal reproduction studies, mesalamine, the active compound of balsalazide has not been shown to cause adverse reactions.

Balsalazide use during breastfeeding:

• It is unknown whether balsalazide can be found in breastmilk. It is recommended that you use it with caution if you are lactating.

Balsalazide Dose in Renal Disease:

• The manufacturer has not recommended any dose adjustment in patients with renal disease.
• Use with caution in patients with kidney disease as renal toxicity with other aminosalicylic acids have been observed.

Balsalazide Dose Liver Disease:

• The manufacturer has not recommended any dose adjustment in patients with liver disease.

Common Side Effects Of Balsalazide (Colazal) Include:

• Central Nervous System:
  • Headache
• Gastrointestinal:
  • Abdominal Pain

Less Common Side Effects Of Balsalazide (Colazal) Include:

• Central Nervous System:
  • Fatigue
  • Insomnia
• Gastrointestinal:
  • Vomiting
  • Diarrhea
  • Exacerbation Of Ulcerative Colitis
  • Nausea
  • Hematochezia
  • Stomatitis
  • Anorexia
  • Dyspepsia
  • Flatulence
  • Abdominal Cramps
  • Constipation
  • Xerostomia
• Genitourinary:
  • Urinary Tract Infection
  • Dysmenorrhea
• Hematologic & Oncologic:
  • Anemia
• Neuromuscular & Skeletal:
  • Arthralgia
  • Musculoskeletal Pain
  • Myalgia
• Respiratory:
  • Pharyngitis
  • Flu-Like Symptoms
  • Respiratory Infection
  • Cough
  • Pharyngolaryngeal Pain
  • Rhinitis
• Miscellaneous:
  • Fever

Contraindication to Balsalazide (Colazal) Include:

• Allergy reactions to salicylates, balsalazide, its metabolites or any component of formulation

Warnings and Precautions​​​​​​​

• Colitis
  • Sometimes, symptoms may get worse after starting therapy.
• Syndrome of intolerance:
  • If the patient experiences severe symptoms such as cramping, abdominal pain, fever, bloody diarrhea or headaches, it should be stopped immediately.
• Staining
  • Sprinkled on food can stain the teeth or tongue.
• Hepatic impairment
  • Other mesalamine (5,aminosalicylic acids) formulations have been linked to hepatic toxicities.
  • Patients with hepatic impairment should use it with caution.
• Pyloric stenosis
  • Patients suffering from pyloric Stenosis could experience delayed gastric release of the drug into their colon.
  • These patients should be cautious when using it.
• Renal impairment
  • Other mesalamine (5,aminosalicylic acids) formulations have been linked to renal toxicities.
  • Patients with impaired renal function should not use it.

Balsalazide: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitor:

• Renal functions (prior to treatment initiation, after 6 months, and yearly thereafter).
• Liver functions in patients with liver disease.
• Monitor the patient for improvement and/ or clinical worsening.

How to take Balsalazide (Colazal)? 

• It may be taken with or without food.
• The capsule should be swallowed whole or may be opened and sprinkled on applesauce and swallowed immediately.
• It should not be stored. Sprinkling on the food may result in staining of the teeth and tongue.

Mechanism of action of Balsalazide (Colazal):

• Balsalazide is a prodrug that is converted by bacterial azo-reduction to its active form 5-aminosalicylic acid (mesalamine), the inert form (4-aminobenzoyl-b-alanine), and their metabolites.
• 5-aminosalicylic Acid (mesalamine), blocks the production arachidonic acid metabolism in the colonic mucosa, resulting in an antiinflammatory effect.

The drug can only be taken in a very small amountabsorbed. 

The systemicHalf-lifeThe half-life of balsalazide takes 1.9 hours.

However, the drug is not affected by systemic absorption.

TheTime to achieve peak effectThe time it takes to open the capsule is approximately 1 - 2 hours, while the time it takes to open the tablet is about 0.5 hours. 

It isexcretedPrimarily in the feces.   

International Brands of Balsalazide:

• Ao Rui Xin
• Balsacolin
• Balsinova
• Balzide
• Basazyde
• Benoquin
• Colazal
• Colazid
• Colazide
• Colorex
• Enzectan
• Garian
• Intazide
• Kanvadear
• Premid
• Sai Lai De

Balsalazide Brands in Pakistan:

No brands available in Pakistan 

Budesonide for the treatment of Ulcerative Colitis