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Drug overview for DIPENTUM (olsalazine sodium):
Generic name: OLSALAZINE SODIUM (ohl-SAL-uh-zeen)
Drug class: Inflammatory Bowel Agents
Therapeutic class: Gastrointestinal Therapy Agents
Olsalazine, a 5-aminosalicylic acid derivative, is a GI anti-inflammatory agent.
No enhanced Uses information available for this drug.
Generic name: OLSALAZINE SODIUM (ohl-SAL-uh-zeen)
Drug class: Inflammatory Bowel Agents
Therapeutic class: Gastrointestinal Therapy Agents
Olsalazine, a 5-aminosalicylic acid derivative, is a GI anti-inflammatory agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
DIPENTUM 250 MG CAPSULE
The following indications for DIPENTUM (olsalazine sodium) have been approved by the FDA:
Indications:
Ulcerative colitis remission
Professional Synonyms:
Colitis ulcerativa in remission
Ulcerative colitis in remission
Indications:
Ulcerative colitis remission
Professional Synonyms:
Colitis ulcerativa in remission
Ulcerative colitis in remission
The following dosing information is available for DIPENTUM (olsalazine sodium):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| DIPENTUM 250 MG CAPSULE | Maintenance | Adults take 2 capsules (500 mg) by oral route 2 times per day |
No generic dosing information available.
The following drug interaction information is available for DIPENTUM (olsalazine sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Azathioprine; Mercaptopurine/Aminosalicylate Derivatives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The exact mechanism is not known. Aminosalicylic acid and its derivatives (balsalazide, mesalamine, olsalazine, sulfasalazine) may inhibit azathioprine or mercaptopurine inactivation via the thiopurine methyltransferase (TPMT) pathway. Aminosalicylates, azathioprine and mercaptopurine are all associated risk for neutropenia, thrombocytopenia, and anemia and so these risks could be additive. CLINICAL EFFECTS: Concurrent use of azathioprine or mercaptopurine with aminosalicylates may increase the risk for anemia, neutropenia, or thrombocytopenia. PREDISPOSING FACTORS: Patients with reduced or absent thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) activity are at higher risk of accumulating thiopurine metabolites and severe myelosuppression. Approximately 0.3 % of patients of European, Latino, or African descent have mutations of the TPMT gene resulting in little to no TPMT activity (homozygous deficiency), and approximately 10 % have intermediate TPMT activity (heterozygous deficiency). NUDT15 deficiency is not seen in patients of African descent and is seen in less than 1 % of patients of European descent. Approximately 1 % of patients of East Asian descent, 0.5 % of patients of central/south Asian descent, and 2 % of patients of Latino descent have homozygous NUDT15 deficiency. About 17 % of patients of East Asian descent, 13 % of patients of central/south Asian descent, and 8 % of patients of Latino descent have heterozygous NUDT15 deficiency. Added risk for myelosuppression would be expected in patients who also receive allopurinol or other agents which block xanthine oxidase (XO), the other major inactivation pathway for azathioprine and mercaptopurine. PATIENT MANAGEMENT: Use the lowest possible dose of each drug and monitor closely for myelosuppression. DISCUSSION: Manufacturer prescribing information states that concurrent use of aminosalicylates with azathioprine or mercaptopurine has been reported to cause bone marrow suppression. In a prospective study, 22 inflammatory bowel disease (IBD) patients on concurrent 5-aminosalicylate with (2 g daily and later increased to 4 g daily) with azathioprine had increased levels of 6-thioguanine (6-TGN) metabolites. One patient had signs of myelosuppression.(3) A prospective study in 183 IBD patients on concurrent 5-aminosalicylic acid and thiopurines found no significant interaction between thiopurines and 5-aminosalicylic acid.(4) A retrospective study in 199 IBD patients reported an increased rate of adverse events in the dual 5-aminosalicylates and azathioprine dual therapy group compared (48%) to the monotherapy azathioprine group (30%)(chi = 6.4, p = 0.05). Discontinuation of azathioprine because of adverse events was higher in the dual therapy group (52% vs. 24%).(5) In a prospective study, 16 Crohn's disease patients on a stable dose of azathioprine with sulfasalazine or mesalamine discontinued the aminosalicylate after 3 months, which resulted in an average decrease 0f 10% in 6-TGN levels. Myelosuppression may be related to increased levels of 6-TGN.(6) In a 8 week non-randomized parallel group drug interaction study, 34 patients with Crohn's disease receiving azathioprine or 6-mercaptopurine with mesalamine (4 g/day), or sulfasalazine (4 g/day), or balsalazide (6.75 g/day) had a high frequency of leukopenia (20-55%) and significant increases in whole blood 6-TGN levels.(7) A 16 year-old Crohn's disease patient on concurrent 6-mercaptopurine (75 mg) and olsalazine (1000 mg) developed leukopenia (WBC count 1.7 x 10*9/L, ANC 1.309 x 10*9/L, hemoglobulin 113 gm/L, platelet count 550 x 10*9/L) and required a dose reduction for 6-mercaptopurine. Another episode occurred later on after increasing her dose of olsalazine and 6-mercaptopurine which resulted in discontinuation of olsalazine.(8) An in vitro study showed that sulfasalazine and other aminosalicylate derivatives were able to inhibit recombinant human TPMT.(9) In a prospective study, 17 IBD patients on stable mercaptopurine and mesalamine therapy had a 23% reduction in 6-TGN levels after discontinuing mercaptopurine.(10) |
AZASAN, AZATHIOPRINE, AZATHIOPRINE SODIUM, IMURAN, MERCAPTOPURINE, PURIXAN |
The following contraindication information is available for DIPENTUM (olsalazine sodium):
Drug contraindication overview.
Known hypersensitivity to salicylates. Known hypersensitivity to olsalazine or any ingredient in the formulation.
Known hypersensitivity to salicylates. Known hypersensitivity to olsalazine or any ingredient in the formulation.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diarrhea |
| Disease of liver |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for DIPENTUM (olsalazine sodium):
Adverse reaction overview.
Adverse effects occurring in 1% or more of patients receiving olsalazine include diarrhea, abdominal pain or cramps, nausea, dyspepsia, heartburn, bloating, anorexia, vomiting, stomatitis, rectal bleeding, headache, fatigue, drowsiness, lethargy, depression, insomnia, vertigo, dizziness or lightheadedness, rash, pruritus, arthralgia or joint pain, and upper respiratory infection.
Adverse effects occurring in 1% or more of patients receiving olsalazine include diarrhea, abdominal pain or cramps, nausea, dyspepsia, heartburn, bloating, anorexia, vomiting, stomatitis, rectal bleeding, headache, fatigue, drowsiness, lethargy, depression, insomnia, vertigo, dizziness or lightheadedness, rash, pruritus, arthralgia or joint pain, and upper respiratory infection.
There are 37 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute generalized exanthematous pustulosis Acute pancreatitis Anemia Angioedema Aplastic anemia Blurred vision Bronchospastic pulmonary disease Chest pain Chills DRESS syndrome Drug-induced hepatitis Dry eye Dyspnea Erythema nodosum Exacerbation of ulcerative colitis Hematuria Hemolytic anemia Hyperbilirubinemia Hypersensitivity drug reaction Hypertension Increased alanine transaminase Increased aspartate transaminase Interstitial lung disease Interstitial nephritis Kidney stone Leukopenia Myocarditis Pancytopenia Paresthesia Pericarditis Peripheral edema Renal failure Stevens-johnson syndrome Thrombocytopenic disorder Tinnitus Toxic epidermal necrolysis |
There are 39 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Gastrointestinal irritation |
Abdominal distension Arthralgia Depression Dizziness Drowsy Dyspepsia Headache disorder Heartburn Insomnia Nausea Pruritus of skin Skin rash Stomatitis Upper abdominal pain Upper respiratory infection Vertigo Vomiting |
| Rare/Very Rare |
|---|
|
Alopecia Anorexia Cramps Dysuria Erectile dysfunction Erythema Fever Flatulence Increased urinary frequency Irritability Menorrhagia Mood changes Myalgia Orthostatic hypotension Palpitations Peripheral neuropathy Skin photosensitivity Tachycardia Tremor Xerostomia |
The following precautions are available for DIPENTUM (olsalazine sodium):
Safety and efficacy not established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
In rats, administration of olsalazine sodium in dosages of 5-20 times the usual human dosage during lactation resulted in growth retardation in pups; however, it is not known whether the drug is distributed in human milk. Olsalazine should be administered with caution to nursing women.
Experience in those 65 years of age and older insufficient to determine whether they respond differently from younger adults.
The following prioritized warning is available for DIPENTUM (olsalazine sodium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DIPENTUM (olsalazine sodium)'s list of indications:
| Ulcerative colitis remission | |
| K51.00 | Ulcerative (chronic) pancolitis without complications |
| K51.20 | Ulcerative (chronic) proctitis without complications |
| K51.30 | Ulcerative (chronic) rectosigmoiditis without complications |
| K51.40 | Inflammatory polyps of colon without complications |
| K51.50 | Left sided colitis without complications |
| K51.80 | Other ulcerative colitis without complications |
| K51.90 | Ulcerative colitis, unspecified, without complications |
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