Olsalazine is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. It is available as capsules for oral use. MedsAcross supplies Olsalazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. DIPENTUM is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.
Source: US FDA prescribing information
Upon reaching the colon, colonic bacteria convert olsalazine into 5‑aminosalicylic acid (5-ASA or mesalazine). The mechanism of action of 5-ASA (mesalamine) is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (i.e., prostanoids) and through the lipoxygenase pathways (i.e., leukotrienes and hydroxyeicosatetraenoic acids) is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.
Source: US FDA prescribing information
Evaluate renal function before initiating therapy with DIPENTUM. The recommended dosage is 500 mg orally twice daily. Drink an adequate amount of fluids during treatment. • Evaluate renal function prior to initiation of DIPENTUM and periodically while on therapy. • The recommended dosage is 500 mg orally twice daily. • Drink an adequate amount of fluids.
Source: US FDA prescribing information
DIPENTUM is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the excipients in DIPENTUM. Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DIPENTUM.
Source: US FDA prescribing information
• Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment. Discontinue DIPENTUM if renal function deteriorates while on therapy. • Mesalamine-Induced Acute Intolerance Syndrome: Discontinue treatment if acute intolerance syndrome (cramping, acute abdominal pain, bloody diarrhea, sometimes fever, headache and rash) is suspected. • Hypersensitivity Reactions, including myocarditis and pericarditis: Discontinue DIPENTUM if a hypersensitivity reaction is suspected. • Hepatic Failure: Evaluate the risks and benefits of using DIPENTUM in patients with known liver impairment. • Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. • Photosensitivity: Avoid sun exposure if pre-existing skin conditions.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: • Renal impairment • Mesalamine-induced acute intolerance syndrome • Hypersensitivity reactions • Hepatic failure • Severe cutaneous adverse reactions • Photosensitivity • Nephrolithiasis The following adverse reactions have been identified from clinical studies or postmarketing reports of olsalazine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In double-blind, placebo- and active-controlled clinical trials of ulcerative colitis, discontinuations due to adverse reactions were reported in 10% of DIPENTUM-treated patients (N=441) and 7% of placebo-treated patients (N=208). Both sulfasalazine-tolerant and intolerant patients were included.
Source: US FDA prescribing information
• Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs): Increased risk of nephrotoxicity, monitor for changes in renal function and mesalamine-related adverse reactions. • Azathioprine or 6-Mercaptopurine: Increased risk of blood dyscrasias, monitor complete blood cell counts and platelet counts. • Low Molecular Weight Heparins or Heparinoids: Increased risk of bleeding following neuraxial anesthesia, if possible, discontinue DIPENTUM or closely monitor for bleeding. • Varicella Vaccine: Avoid use for 6 weeks after vaccination.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Olsalazine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Dipentum 250 mg capsuleOral | Viatris Specialty | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 31 July 1990 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Olsalazine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Olsalazine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Olsalazine, including Dipentum.
Yes. The US FDA first approved Olsalazine on 31 July 1990, according to Drugs@FDA.
No listed presentation of Olsalazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Olsalazine is classified under ATC code A07EC03 (Olsalazine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.