Olsalazine

Dosage Forms & Strengths

capsule

• 250mg

Ulcerative Colitis

Maintenance: 1g PO qDay in 2 divided doses

Administration

Take with food

Other Indications & Uses

Maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine

Safety & efficacy not established

Contraindications

Hypersensitivity to salicylates

Cautions

Kidney disease, hepatic impairment

Mesalamine, which is the active form of olsalazine, may be secreted into breast milk and cause diarrhea in the infant.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take olsalazine with a full glass of water.

Store olsalazine at room temperature away from moisture and heat.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, and diarrhea.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using olsalazine and call your doctor at once if you have any of these serious side effects:

• worsening colitis (fever, stomach pain, cramping, or bloody diarrhea);

• chest pain, shortness of breath, fast or pounding heartbeats; or

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild stomach discomfort;

• nausea, heartburn;

• skin rash, itching;

• headache;

• muscle or joint pain; or

• urinating more often than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with olsalazine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Dipentum

Ulcerative colitis, treatment:

According to the Ulcerative Colitis Practice Guidelines in the American College of Gastroenterology (ACG), olsalazine use has been shown to be beneficial in achieving remission of ulcerative colitis [ACG 2010].

Cardiac Glycosides: 5-ASA Derivatives may decrease the serum concentration of Cardiac Glycosides. Monitor therapy

Heparin: 5-ASA Derivatives may enhance the adverse/toxic effect of Heparin. Specifically, the risk for bleeding/bruising may be increased. Monitor therapy

Heparin (Low Molecular Weight): 5-ASA Derivatives may enhance the adverse/toxic effect of Heparin (Low Molecular Weight). Specifically, the risk for bleeding/bruising may be increased. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of 5-ASA Derivatives. Monitor therapy

Thiopurine Analogs: 5-ASA Derivatives may decrease the metabolism of Thiopurine Analogs. Monitor therapy

Varicella Virus-Containing Vaccines: 5-ASA Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Consider therapy modification

Concerns related to adverse effects:

• Colitis: May exacerbate symptoms of colitis.

• Diarrhea: A common adverse effect is diarrhea.

Disease-related concerns:

• Asthma: Use with caution in patients with severe allergies or asthma.

• Hepatic impairment: Use with caution in patients with hepatic impairment; monitor closely.

• Renal impairment: Use with caution in patients with renal impairment; monitor closely.

Special populations:

• Elderly: Use with caution.

Study (n=56)
Greater than or equal to 2 years: 30 mg/kg/day (maximum, 2 g/day), starting at 25% of calculated daily dose, and increasing by one dose every third day, to four doses per day.