Olsalazine

Pronunciation

(ole SAL a zeen)

U.S. Brand Names

Dipentum®

Synonyms

Olsalazine Sodium

Generic Available

Canadian Brand Names

Dipentum®

Use

Maintenance of remission of ulcerative colitis in patients intolerant to sulfasalazine

Pregnancy Risk Factor

Lactation

Enters breast milk/use caution (monitor for diarrhea)

Contraindications

Hypersensitivity to olsalazine, salicylates, or any component of the formulation

Warnings/Precautions

Diarrhea is a common adverse effect of olsalazine; use with caution in patients with hypersensitivity to salicylates, sulfasalazine, or mesalamine

Adverse Reactions

>10%: Gastrointestinal: Diarrhea, cramps, abdominal pain

1% to 10%:

Central nervous system: Headache, fatigue, depression

Dermatologic: Rash, itching

Gastrointestinal: Nausea, heartburn, bloating, anorexia

Neuromuscular & skeletal: Arthralgia

<1% (Limited to important or life-threatening): Blood dyscrasias, hepatitis, jaundice, cholestatic jaundice, cirrhosis, hepatic necrosis, and Kawasaki-like syndrome

Overdosage/Toxicology

Symptoms of overdose include decreased motor activity and diarrhea. Treatment is supportive.

Drug Interactions

Azathioprine, mercaptopurine, thioguanine: Aminosalicylates may increase the risk of myelosuppression (due to TPMT inhibition).

Warfarin: Olsalazine has been reported to increase the prothrombin time in patients taking warfarin.

Mechanism of Action

The mechanism of action appears to be topical rather than systemic

Pharmacodynamics/Kinetics

Absorption: <3%; very little intact olsalazine is systemically absorbed

Protein binding, plasma: >99%

Metabolism: Primarily via colonic bacteria to active drug, 5-aminosalicylic acid

Half-life elimination: 56 minutes

Time to peak: ~1 hour

Excretion: Primarily feces

Dosage

Adults: Oral: 1 g/day in 2 divided doses

Administration

Take with food in evenly divided doses.

Monitoring Parameters

Stool frequency

Test Interactions

Increased ALT, AST (S)

Dietary Considerations

Administer with food, increases residence of drug in body.

Patient Education

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed, with meals, in evenly divided doses. May cause flu-like symptoms or muscle pain (consult prescriber for approved analgesic); diarrhea (buttermilk, boiled milk, or yogurt may help); or nausea or loss of appetite (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help). Report persistent diarrhea or abdominal cramping, skin rash or itching, or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause drowsiness or depression

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Capsule, as sodium: 250 mg

International Brand Names

Dipentum® (AR, AT, AU, CA, CH, CL, DE, DK, FI, FR, GB, HK, HU, IE, IL, IT, NL, NO, NZ, SE, TR, ZA); Rasal® (ES)

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