Olsalazine (Dipentum) is a pro-drug that is metabolized by the colonic bacteria into the active metabolite 5-ASA (5-amino-salicylic acid) or mesalamine.

Olsalazine (Dipentum) Uses:

• Maintenance Treatment of Ulcerative colitis:

  • In adult patients with ulcerative colitis who cannot take sulfasalazine, it is advised for the maintenance of remission.

• Off Label:

  • Therapy of Ulcerative colitis:

Olsalazine (Dipentum) Dose in Adults

Olsalazine (Dipentum) Dose in the Maintenance Treatment of Ulcerative Colitis:

• 1 g/day in two equally divided doses.

Olsalazine (Dipentum) Dose in the treatment of Ulcerative colitis (off-label):

• 500 mg to 3 g/day orally in 2 equally divided doses.

Use in Children:

The drug's effectiveness and safety in youngsters have not been shown.

Pregnancy Risk Factor C

• In animal reproduction studies, fetal developmental toxicities were demonstrated.
• The drug has not been tested in human pregnancies.
• It should not be used if the benefits outweigh any risks. This is clearly stated.

Olsalazine use during breastfeeding:

• It is best to avoid it in breastfeeding women, as 5-aminosalicylic acids, the active metabolite of the product, can pass into breast milk and cause diarrhea.

Olsalazine (Dipentum) Dose in Kidney Disease:

No dosage adjustments have been provided in the manufacturer's labeling in patients with kidney disease.

Olsalazine (Dipentum) Dose in Liver Disease:

No dosage adjustments have been provided in the manufacturer's labeling in patients with liver disease.

Side Effects of Olsalazine (Dipentum):

• Gastrointestinal:

  • Diarrhea

Less Common Side Effects of Olsalazine (Dipentum):

• Respiratory:

  • Upper Respiratory Tract Infection

• Central Nervous System:

  • Vertigo
  • Depression
  • Dizziness

• Gastrointestinal:

  • Queasiness
  • Bloating
  • Abdominal Cramps
  • Abdominal Pain
  • Stomatitis
  • Vomiting

• Dermatologic:

  • Skin Rash
  • Pruritus

• Neuromuscular & Skeletal:

  • Arthralgia

Contraindications to Olsalazine (Dipentum):

Allergies to salicylates, olsalazine or any other component of the formulation

Warnings and precautions

• Colitis

  • Patients might notice a worsening of symptoms due to colitis, especially if the drug is being used to reduce the dosage.

• Diarrhea:

  • The treatment may cause diarrhea in some patients. This should be distinguished from worsening diseases activity.

• Asthma

  • The drug should not be used by patients suffering from severe allergies or asthma.

• Hepatic impairment

  • Patients with hepatic impairment must be warned and should be closely monitored.

• Renal impairment

  • Patients with impaired renal function should be warned and closely monitored.

Olsalazine: 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

Monitoring Parameters:

• CBC
• Liver function tests and Renal function tests before treatment initiation, at 6 and 12 months during treatment, and yearly thereafter.
• Monitor stool frequency
• Observe for improvement in the clinical signs and symptoms of ulcerative colitis

How to administer Olsalazine (Dipentum)?

Administer the drug with food in equally divided doses

Mechanism of action of Olsalazine (Dipentum):

• The active component of olsalazine is 5-aminosalicylic acid (Mesalamine). 
• It acts locally as a free radical scavenger, inhibiting inflammation by inhibiting the release of local chemical mediators, particularly leukotrienes.
• It also inhibits TNF (tumour-necrosis factor) release at the site of inflammation.

Half-life elimination:

• 54 minutes

Plasma Protein binding of the absorbed drug:

• The majority of the medication that is absorbed is bonded to plasma proteins.

Excretion:

• Primarily feces
• urine (<1%)

Metabolism:

• Colonic bacteria in the digestive system metabolise it locally to produce 5-aminosalicylic acid (5-ASA), which is the substance's active metabolite.

Time to peak:

• About one hour

Absorption:

• Less than 3% of the drug is absorbed systemically.

International Brands of Olsalazine:

• Dipentum
• Chang Mei
• Motilsalin
• Olsanium
• Ulcecoloct

Olsalazine Brand Names in Pakistan:

No Brands Available in Pakistan.