Dipentum

OLSALAZINE SODIUM

Manufacturer: Meda Pharmaceuticals Inc.

Score: 141.0

Quick Summary

Dipentum (Olsalazine Sodium) is used for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. The drug works by being converted into 5-aminosalicylic acid (5-ASA) in the colon, which has a topical anti-inflammatory effect on colonic epithelial cells. Key clinical findings include its effectiveness in maintaining remission in ulcerative colitis patients. Important safety information includes the risk of renal impairment, hypersensitivity reactions, and adverse effects such as diarrhea, abdominal pain, and rash. The recommended dosage is 500 mg orally twice daily, and special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Maintenance of remission of ulcerative colitis in adult patients intolerant of sulfasalazine
Effective in maintaining remission in ulcerative colitis patients

Important Safety Information

Warning

Risk of renal impairment, hypersensitivity reactions, and adverse effects

Contraindications

Known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the excipients in DIPENTUM

Adverse Reactions

Diarrhea
Abdominal pain/cramps
Nausea
Arthralgia/Joint Pain
Rash
Upper Respiratory Infection
Depression

Dosing Recommendations

General Guidance

None specified

Ulcerative Colitis

Adult Dose

500 mg orally twice daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Published data from meta-analyses, cohort studies and case series on the use of mesalamine during pregnancy have not reliably informed an association with major birth defects, miscarriage, or adverse maternal or fetal outcomes

Nursing Mothers

No information available

Pediatric Use

Safety and effectiveness in pediatric patients have not been established

Geriatric Use

Clinical studies of DIPENTUM did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
Consider monitoring of complete blood cell counts and platelet counts in patients 65 years and over during treatment with DIPENTUM

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