Class: Anti-inflammatory Agents
VA Class: GA900
Chemical Name: 3,3′-azobis[6-hydroxybenzoic acid disodium salt
Molecular Formula: C14H8N2Na2O6
CAS Number: 6054-98-4
Uses for Olsalazine Sodium
Olsalazine Sodium Dosage and Administration
Dosage of olsalazine sodium, which is commercially available as the disodium salt, is expressed in terms of olsalazine sodium.1
Daily dosage of 1g usually provides >0.9 g of mesalamine in the colon.1
Cautions for Olsalazine Sodium
Occasionally bloody2 and difficult to distinguish from underlying disease symptoms1 or may be distinguishable by its high water content and absence of blood.4 Possibly more severe and frequent in patients with extensive ulcerative colitis.2 4 5
Exacerbation of preexisting symptoms of ulcerative colitis has been reported with other 5-aminosalicylic acid derivatives (e.g., mesalamine, sulfasalazine).1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
Use with caution in patients with renal impairment, since renal tubular damage has been reported in animals and rarely in postmarketing surveillance;1 perform urinalysis, monitor serum creatinine and BUN concentrations in such patients.1
Common Adverse Effects
Diarrhea/loose stools,1 2 3 4 6 abdominal pain or cramps,1 4 nausea,1 4 dyspepsia,1 heartburn,1 bloating,1 anorexia,1 vomiting,1 stomatitis,1 rectal bleeding,1 headache,1 2 4 fatigue,1 2 drowsiness,1 lethargy,1 depression,1 insomnia,1 vertigo,1 dizziness or lightheadedness,1 4 rash,1 2 4 pruritus,1 arthralgia or joint pain,1 4 upper respiratory infection.1
Interactions for Olsalazine Sodium
Potential interaction (increased prothrombin time).1
Olsalazine Sodium Pharmacokinetics
Plasma Protein Binding
Crosses placenta in animals.1
Distributed into milk in rats; not known whether distributed into human milk.1
Mesalamine is excreted principally in feces as N-acetyl-5-acetylsalicylic acid,1 4 6 and to a lesser extent in urine (about 20%) mostly as N-acetyl-5-acetylsalicylic acid;7 9 25 <1% of olsalazine excreted in urine unchanged.1
25°C (may be exposed to 15–30°C).1
May reduce inflammation in the colon by inhibiting cyclooxygenase and lipoxygenase, which catalyze the formation of prostaglandin precursors (endoperoxides) and of leukotrienes and hydroxyeicosatetraenoic acids, respectively, from arachidonic acid and/or its metabolites.1 4 7 8 9 11 12 13 14 15 16 18 19 20 21 23 32 35 38 39
Advice to Patients
Importance of taking with food.1
Importance of taking in equally divided doses.1
Importance of informing clinicians if diarrhea occurs.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
AHFS DI Essentials. © Copyright 2017, Selected Revisions September 1, 2005. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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Other brands: Dipentum