Adult Dosing

Maintenance of remission of ulcerative colitis

• 500 mg PO bid

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Maintenance of remission of ulcerative colitis in patients who are intolerant of sulfasalazine

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to salicylates
• Influenza, varicella, or febrile viral infections (patients <20 yrs)

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; monitor closely

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; monitor closely

See Supplemental Patient Information

• Therapy may cause diarrhea, which could be dose related, leading to discontinuation of treatment
• Instances of exacerbation of colitis symptoms have been caused by mesalamine or sulfasalazine
• Monitor for signs of worsening symptoms in patients with severe allergies or asthma
• Closely monitor patients with renal or hepatic impairment. Chances of renal tubular damage due to absorbed mesalamine or its n-acetylated metabolite should be kept in mind, especially for patients with preexisting renal disease. Monitoring with urinalysis, BUN, and creatinine in these patients is advised
• Concomitant use of salicylates and low molecular weight heparins or heparinoids may cause an increased risk of bleeding following neuraxial anesthesia
• Combined use of olsalazine with 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression

Supplemental Patient Information

• Instruct patients to take olsalazine in evenly divided doses with food
• Advise patients to contact their physicians if diarrhea occurs during therapy

Pregnancy Category:C

Breastfeeding: Olsalazine is poorly excreted into breast milk; however, it is a mesalamine prodrug. N-acetyl-5-ASA is a mesalamine metabolite, which appears in high levels in breastmilk and its effects on breastfed infants are unknown. A few cases of diarrhea have been reported in infants exposed to mesalamine. European experts consider mesalamine derivatives to be safe during breastfeeding. If olsalazine is required by a nursing mother, it is not a reason to discontinue breastfeeding, but carefully monitor for diarrhea in breastfed infants during maternal use of olsalazine. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 1 June 2011). As per manufacturer's data, small amounts of 5-ASA may pass into breastmilk, which may cause harmful effects such as diarrhea in infants. Unless the benefit of the treatment outweighs the risks, olsalazine should not be taken by nursing mothers or patients should be advised to discontinue breastfeeding during therapy.

• CNS: Headache, depression, fatigue, drowsiness, dizziness
• GI: Diarrhea, nausea, vomiting, abdominal pain, dyspepsia, bloating, anorexia, pancreatitis, stomatitis
• HEPA: Hepatotoxicity
• RESP: URTI
• DERM: Rash, itching
• HEMA: Myelosuppression
• MUSC: Arthralgia
• GU: Interstitial nephritis
• MISC: Reye syndrome, heartburn

• GI anti-inflammatory agent; exact mechanism of action is unknown. Olsalazine is converted to 5-aminosalicylic acid (mesalamine) in the colon which reduces inflammation of colon topically by preventing production of substances involved in inflammatory process such as arachidonic acid
• Metabolized in liver (0.1%) and colon; in the colon, olsalazine is converted into 5-aminosalicylic acid (5-ASA) by colonic bacteria; active metabolite: 5-ASA
• Excreted in feces, urine (<1%)
• Half-life:
• Olsalazine: 0.9 hr
• Olsalazine-S: 7 days

US Trade Name(s)

• Dipentum

US Availability

Dipentum

• CAPS: 250 mg

Canadian Trade Name(s)

• Dipentum

Canadian Availability

Dipentum

• CAPS: 250 mg

UK Trade Name(s)

• Dipentum

UK Availability

Dipentum

• CAPS: 250 mg
• TABS: 500 mg

Australian Trade Name(s)

• Dipentum

Australian Availability

Dipentum

• CAPS: 250 mg
• TABS: 500 mg

[Outline]

Gastrointestinal

5-aminosalicylates (GI)

Pricing data from www.DrugStore.com in U.S.A.

• Dipentum 250 MG CAPS [Bottle] (MEDA PHARMACEUTICALS)
  100 mg = $625.01
  300 mg = $1839.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Dipentum 250 MG Oral Capsule

Ingredient(s): Olsalazine

Imprint: DIPENTUM;250;mg

Color(s): White

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): magnesium stearate / ferrosoferric oxide / caramel / gelatin / titanium dioxide

Drug Label Author:
Alaven Pharmaceutical LLC

DEA Schedule:
Non-Scheduled

Drug Name: Dipentum 250 MG Oral Capsule

Ingredient(s): Olsalazine

Imprint: DIPENTUM;250;mg

Color(s): White

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): magnesium stearate / black iron oxide / caramel / gelatin / titanium dioxide

Drug Label Author:
UCB, Inc.

DEA Schedule:
Non-Scheduled