(ole SAL a zeen)
- Olsalazine Sodium
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral, as sodium:
Dipentum: 250 mg
Brand Names: U.S.
- 5-Aminosalicylic Acid Derivative
Mesalamine (5-aminosalicylic acid) is the active component of olsalazine; the specific mechanism of action of mesalamine is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF); action appears topical rather than systemic.
<3%; very little intact olsalazine is systemically absorbed
Primarily via colonic bacteria to active drug, 5-aminosalicylic acid (5-ASA)
Primarily feces; urine (<1%)
Time to Peak
Use: Labeled Indications
Maintenance of remission of ulcerative colitis in patients intolerant to sulfasalazine
Hypersensitivity to olsalazine, salicylates, or any component of the formulation
Ulcerative colitis: Oral: 1 g/day in 2 divided doses
Refer to adult dosing.
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling. Monitor patients with impaired renal function.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling. Monitor patients with impaired hepatic function.
Administer with food in evenly divided doses.
Take with food.
Store at 20°C to 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
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
>10%: Gastrointestinal: Diarrhea (11% to 17%; dose related)
1% to 10%:
Central nervous system: Depression (2%), dizziness/vertigo (1%)
Dermatologic: Rash (2%), pruritus (1%)
Gastrointestinal: Abdominal pain/cramps (10%), nausea (5%), bloating (2%), stomatitis (1%), vomiting (1%)
Neuromuscular & skeletal: Arthralgia (4%)
Respiratory: Upper respiratory infection (2%)
<1% (Limited to important or life-threatening): Alkaline phosphatase increased, Alopecia, ALT increased, anemia, angioedema, aplastic anemia, AST increased, bilirubin increased, blood in stool, blurred vision, bronchospasm, cholestatic hepatitis, cholestatic jaundice, chest pain, chills, cirrhosis, dehydration, dry eyes, dyspnea, dysuria, eosinophilia, epigastric discomfort, erythema, erythema nodosum, fever, flare of symptoms, flatulence, GGT increased, heart block (second degree), hematuria, hemolytic anemia, hepatitis, hepatic failure, hepatic necrosis, hot flashes, hypertension, impotence, insomnia, interstitial nephritis, interstitial pneumonia, irritability, jaundice, Kawasaki-like syndrome, LDH increased, leukopenia, lymphopenia, menorrhagia, mood swings, muscle cramps, myalgia, myocarditis, nephrotic syndrome, neutropenia, orthostatic hypotension, palpitation, pancreatitis, pancytopenia, paresthesia, pericarditis, peripheral edema, peripheral neuropathy, photosensitivity, proteinuria, rectal bleeding, rectal discomfort, reticulocytosis, rigors, tachycardia, thrombocytopenia, tinnitus, tremor, urinary frequency, watery eyes, xerostomia
Concerns related to adverse effects:
• Colitis: May exacerbate symptoms of colitis.
• Diarrhea: A common adverse effect is diarrhea.
• 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.
• Elderly: Use with caution.
CBC, hepatic function, renal function; stool frequency
Pregnancy Risk Factor
Animal studies have demonstrated fetal developmental toxicities. There are no well-controlled studies in pregnant women. Use during pregnancy only if clearly necessary.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience cramps, nausea, diarrhea, or joint pain. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), severe abdominal pain, bloody diarrhea, urinary retention, change in amount of urine passed, angina, tachycardia, arrhythmia, shortness of breath, bruising, or bleeding (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about olsalazine
- Other brands: Dipentum