DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.

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

Capsules: 250 mg olsalazine sodium in beige capsules imprinted with DIPENTUM® 250 mg on the capsule shell

DIPENTUM is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the excipients in DIPENTUM

The following clinically significant adverse reactions are described elsewhere in the labeling:

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. The most common adverse reactions leading to discontinuation in DIPENTUM-treated patients were diarrhea/loose stools (6%), abdominal pain (1%), and rash/itching (1%).

In these controlled trials, adverse reactions reported in 1% or more of patients treated with DIPENTUM and greater than placebo are provided in Table 1.

Other adverse reactions reported in clinical trials or post-marketing experience:

A patient who developed thyroid disease 9 days after starting DIPENTUM was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. The patient died 5 days later with signs and symptoms of acute diffuse myocarditis.

DIPENTUM is an aminosalicylate, and symptoms of salicylate toxicity include: nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage.

There is no specific antidote for olsalazine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent of further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

The active ingredient in DIPENTUM (olsalazine sodium) is the sodium salt of a salicylate, disodium 3,3'-azobis (6-hydroxybenzoate) a compound that is effectively bioconverted to mesalamine (5-aminosalicylic acid,5-ASA), an aminosalicylate. Its empirical formula is C14H8N2Na2O6 with a molecular weight of 346.21.

The structural formula is:

Olsalazine sodium is a yellow crystalline powder, which melts with decomposition at 240°C. It is the sodium salt of a weak acid, soluble in water and DMSO, and practically insoluble in ethanol, chloroform, and ether. Olsalazine sodium has acceptable stability under acidic or basic conditions.

DIPENTUM is supplied in capsules for oral administration. Each DIPENTUM hard gelatin capsule contains 250 mg olsalazine sodium (equivalent to 233.4 mg of olsalazine). The inert ingredient in each capsule is magnesium stearate. The capsule shell contains the following inactive ingredients: black iron oxide, caramel, gelatin, and titanium dioxide.

Two double-blind controlled trials have demonstrated the efficacy of DIPENTUM as maintenance therapy in patients with ulcerative colitis. In the first trial, patients with ulcerative colitis in remission were randomized to DIPTENUM 500 mg twice daily or placebo, and relapse rates for a six month period of time were compared. For the 52 patients randomized to DIPENTUM, 12 relapses occurred, while for the 49 patients randomized to placebo, 22 relapses occurred. This difference in relapse rates was significant (p<0.02).

In the second trial, 164 patients with ulcerative colitis in remission were randomized to DIPENTUM 500 mg twice daily or sulfasalazine 1 gram twice daily, and relapse rates were compared after six months. The relapse rate for DIPENTUM-treated patients was 19.5% and 12.2% for sulfasalazine-treated patients, a non-significant difference.

DIPENTUM is supplied as beige colored capsules, containing 250 mg olsalazine sodium imprinted with “DIPENTUM

Bottles of 100’s NDC 0037-6860-10

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) [see USP Controlled Room Temperature].

Inform patients that DIPENTUM may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their healthcare provider

Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions

Instruct patients to stop taking DIPENTUM and report to their healthcare provider if they experience new or worsening symptoms of acute intolerance syndrome (cramping, abdominal pain, bloody diarrhea, fever, headache, and rash) or other symptoms suggestive of mesalamine-induced hypersensitivity

Advise patients with known liver disease to contact their healthcare provider if they experience signs or symptoms of worsening liver function

Severe Cutaneous Adverse Reactions

Inform patients of the signs and symptoms of severe cutaneous adverse reactions. Instruct patients to stop taking DIPENTUM and report to their healthcare provider at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity

Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors

Instruct patients to drink an adequate amount of fluids during treatment in order to minimize the risk of kidney stone formation and to contact their healthcare provider if they experience signs or symptoms of a kidney stone (e.g., severe side or back pain, blood in the urine)

Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their healthcare provider

Manufactured for:

Manufactured by:

© 2024 Viatris Inc.

DIPENTUM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company.

Rev. 7/2024

Store at 25°C (77°F); excursions

Manufactured for:

Manufactured by:

©2023 Viatris Inc.

DIPENTUM is a registered trademark

LB-686010-05