Olsalazine is an oral diazo-bonded 5-aminosalicylate (5-ASA) and is a prodrug; bacterial azoreduction in the intestines releases the anti-inflammatory agent mesalamine (5-ASA) to produce the active effect. Olsalazine is used for the maintenance of remission in patients with ulcerative colitis (UC) who are intolerant to sulfasalazine. The guidelines support the use of standard-dose diazo-bonded 5-ASAs (e.g., olsalazine) for induction and maintenance of remission in patients with extensive mild to moderate UC. Those with moderate UC symptoms may benefit from early use of combination oral and rectal 5-ASA products. Use of combined oral and rectal 5-ASA in patients with extensive disease may improve rates of induction of remission, as may escalation to high-dose (more than 3 grams/day) oral with rectal 5-ASA in patients with suboptimal response to standard-dose therapy. In patients with inadequate response to optimized 5-ASA therapy, consider oral prednisone or budesonide MMX 9 mg/day to induce remission instead of changing to an alternate 5-ASA formulation. Systemic corticosteroids should not be used for maintenance of remission in patients with UC. In patients with mildly active ulcerative proctitis, rectal 5-ASA at a dose of 1 gram/day should be used to maintain remission rather than oral 5-ASA products, such as olsalazine. Those patients with suboptimal response or intolerance to rectal 5-ASA may opt to use rectal corticosteroids. Olsalazine use is commonly associated with dose-related diarrhea, which may occur anytime during therapy and may result in discontinuation and may be difficult to distinguish from the underlying symptoms of the disease.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-Administer with food.
-Patients should drink an adequate amount of fluids during treatment.
Clinical evaluation of olsalazine has included patients with acute ulcerative colitis, those in remission, and in patients who are either tolerant and intolerant to sulfasalazine therapy. In the trials, diarrhea was the most commonly reported adverse reaction, occurring in 11.1% to 17% of patients at some point during therapy, with 6% requiring discontinuation of the drug. Diarrhea appears to be dose-related, but it can be difficult to distinguish from symptoms of the disease. Abdominal pain/cramps (10.1%), dyspepsia (4%), and nausea (5%) were also reported during clinical trials. Less commonly reported gastrointestinal effects include bloating (1.5%), vomiting (1%), stomatitis (1%), increased blood in stool, flatulence, xerostomia, pancreatitis, rectal bleeding, rectal discomfort, epigastric discomfort, flares, pyrosis (heartburn), and anorexia (1.3%). Exacerbation of the symptoms of ulcerative colitis thought to have been caused by mesalamine or sulfasalazine has been noted. The manufacturer reports that in a double-blind, placebo-controlled study, increased frequency and severity of diarrhea were reported in patients randomized to olsalazine 500 mg twice daily with concomitant radiation. In rare cases, 5-ASA (mesalamine), the active moiety in olsalazine, can cause an acute intolerance syndrome, which may be difficult to distinguish from an ulcerative colitis exacerbation, with symptoms including abdominal pain or stomach cramps, melena, bloody diarrhea, fever, severe headache, malaise, or skin eruptions. Observe patients closely for worsening of these symptoms while on treatment. Acute intolerance syndrome occurs in approximately 3% of patients and is reversible upon discontinuation of the drug. Prompt withdrawal of olsalazine is recommended. Some patients have gone on to develop pancolitis. However, in clinical evaluations, the extension of upper disease boundary and flare-ups occurred less often in the mesalamine-treated group compared to the placebo-treated group.
Leukopenia, neutropenia, lymphopenia, eosinophilia, thrombocytopenia, anemia, hemolytic anemia, and reticulocytosis have rarely been reported during olsalazine therapy but with no evidence of causality. Aplastic anemia and pancytopenia have been noted in postmarketing reports. Reports from uncontrolled clinical studies and postmarketing reporting systems suggest a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, pancytopenia) in geriatric subjects (65 years and older) receiving 5-ASA related products vs. younger adult patients, which may also be associated with ulcerative colitis, use of interacting drugs, or reduced renal function.
Rare cases of granulomatous hepatitis and nonspecific, reactive hepatitis have been reported in patients receiving olsalazine. Withdrawal of therapy may lead to complete recovery. Olsalazine and related products that are metabolized to (or contain) mesalamine have been reported in post-market use to cause rare cases of elevated hepatic enzymes, hepatitis, hyperbilirubinemia, jaundice, cholestasis with jaundice, cirrhosis, and possible hepatocellular damage including hepatic necrosis and hepatic failure. The incidence of hepatic adverse events is not known. In some cases, the reactions were fatal. One case of Kawasaki-syndrome, which included hepatic changes, was also reported.
CNS disturbances, such as vertigo/dizziness (1%), depression (1.5%), fatigue/drowsiness/lethargy (1.8%), and headache (5%) occur during therapy with olsalazine. Other neurologic disturbances including insomnia, irritability, paresthesias, mood swings, and tremor have been rarely reported. Peripheral neuropathy has been noted in postmarketing reports.
Dermatologic adverse reactions associated with olsalazine include rash (2.3%) and itching/pruritus (1.3%). Adverse reactions that were reported without any causal relationship include alopecia, erythema, photosensitivity, erythema nodosum, and angioedema. Postmarketing reports of severe cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of mesalamine, the active moiety in olsalazine. At the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity, discontinue olsalazine and consider further evaluation.
Rare reports list cardiac events after olsalazine therapy including chest pain (unspecified), second-degree heart block, palpitations, peripheral edema, shortness of breath, hypertension, orthostatic hypotension, and sinus tachycardia. Some olsalazine-related events might represent hypersensitivity-related events, as myocarditis and pericarditis have also been reported with other 5-ASA treatments. In one reported case, a treated patient had developed thyroid disease. After receiving propranolol and radioactive iodine, the patient developed shortness of breath and nausea. Five days later, the patient died with signs and symptoms of acute diffuse myocarditis.
Arthralgia/joint pain has been reported with a frequency of 4%. Myalgia and muscle cramps have been reported with the use of olsalazine without a causal relationship.
Upper respiratory infection was reported in 1.5% of patients administered olsalazine. Other, rare adverse events reported include bronchospasm, dyspnea, and interstitial lung disease.
5-ASA (mesalamine) is known to be substantially excreted by the kidney, and the risk of adverse reactions to olsalazine, which is converted to mesalamine, may be greater in patients with impaired renal function. Albuminuria (proteinuria), dysuria, increased urinary frequency, and hematuria were reported during ulcerative colitis and Crohn's disease trials with 5-ASA (mesalamine) products. In clinical practice, reports of renal failure (unspecified), nephropathy such as minimal change syndrome and nephrotic syndrome, and acute or chronic interstitial nephritis have been associated with products that contain (or are metabolized to) mesalamine. In addition, cases of nephrogenic diabetes insipidus have been reported during postmarketing experience. There are no particular signals for nephropathy; evaluate renal function in all patients prior to initiation and periodically while on mesalamine therapy. Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions. The risk of nephrotoxicity may be greater in patients with pre-existing renal impairment or other risk factors for decreased renal function. Patients should be made aware that urine may become discolored reddish-brown while taking 5-ASA (mesalamine) when it comes in contact with surfaces or water treated with hypochlorite-containing bleach. If urine discoloration is observed, advise patients to observe their urine flow and report to the healthcare provider only if urine is discolored on leaving the body, before contact with any surface or water (e.g., in the toilet).
Cases of nephrolithiasis have been reported with the use of 5-ASA (mesalamine), the active moiety in olsalazine, including stones of 100% mesalamine content. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with olsalazine.
Fever, chills, rigors, and hot flashes, have been reported rarely with the use of olsalazine.
Adverse reactions rarely reported with olsalazine involving the special senses include xerophthalmia, blurred vision, watery eyes, and tinnitus.
Reproductive system adverse reactions rarely reported with olsalazine include impotence (erectile dysfunction) and menorrhagia.
Olsalazine is contraindicated in patients with hypersensitivity to olsalazine or other salicylate hypersensitivity, including other 5-aminosalicylates hypersensitivity. Patients with severe allergies or asthma should be monitored for signs of worsening symptoms. Of note, clinical evaluation of olsalazine has included patients tolerant and intolerant to sulfasalazine therapy. Olsalazine is converted to mesalamine. 5-ASA (mesalamine)-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue olsalazine if an alternative etiology for the signs or symptoms cannot be established. Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by worsening colitis and symptoms such as abdominal cramping, acute abdominal pain, bloody diarrhea (melena and hematochezia), fever, headache, malaise, pruritus, rash (unspecified), and conjunctivitis. In rare cases, pancolitis has occurred. In cases of acute exacerbation of disease, prompt withdrawal of olsalazine therapy is required; symptoms typically resolve after discontinuation. The patient's history of sulfasalazine intolerance, if any, should be re-evaluated.
Overall, approximately 17% of subjects receiving olsalazine in clinical studies reported diarrhea sometime during therapy. This diarrhea resulted in withdrawal of treatment in 6% of patients. This diarrhea appears to be dose-related, although it may be difficult to distinguish from the underlying symptoms of the disease. Exacerbation of the symptoms of colitis thought to have been caused by mesalamine or sulfasalazine has also been noted. If diarrhea occurs, patients should contact their physician.
Evaluate renal function in all patients prior to initiation and periodically while on olsalazine therapy. 5-ASA (mesalamine) products, such as olsalazine, are known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with renal impairment or renal failure. Monitor patients with a known history of renal disease or taking nephrotoxic drugs for decreased renal function and olsalazine-related adverse reactions. Discontinue olsalazine if renal function deteriorates while on therapy. AGA guidelines recommend the periodic monitoring of renal function in all patients.
Hepatic failure has been reported in patients with pre-existing hepatic disease who received 5-ASA (mesalamine) products. Caution is advised if olsalazine therapy is administered to a patient with hepatic disease; consider the risks and benefits of treatment. Less than 0.1% of an olsalazine dose is metabolized by the liver, but there have been postmarket reports of hepatic events in patients receiving the drug.
Experts recommend that patients maintained on olsalazine pre-pregnancy continue their treatment regimens during pregnancy. The use of olsalazine during pregnancy appears to pose no significant harm to the developing fetus, and the maternal benefits of therapy appear to outweigh any potential for risk to the fetus. Mesalamine, the active metabolite of olsalazine, is known to cross the placental barrier. However, following administration of olsalazine only a small portion of a dose is absorbed systemically and then is rapidly excreted in the urine. Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active metabolite of olsalazine, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. The human data include case series, controlled prospective trials, and population-based cohort studies. In animal reproduction studies, olsalazine produced fetal developmental toxicity as indicated by reduced fetal weights, retarded ossifications, and immaturity of the fetal visceral organs when given during organogenesis to pregnant rats in doses 5 to 20 times the human dose (100 to 400 mg/kg). Guidelines state that medical therapy for IBD does not decrease fertility.
The manufacturer recommends against olsalazine use during breast-feeding unless the benefits outweigh the risks. Experts, however, consider the use of olsalazine compatible with breast-feeding. Mesalamine (5-ASA), the active metabolite of olsalazine, is excreted into breast milk in small amounts. Monitor a nursing infant for alterations in bowel function, such as persistent changes in stool frequency. Infant diarrhea has been infrequently reported with the maternal use of 5-ASA. Oral administration of olsalazine to lactating rats in doses 5 to 20 times the human dose produced growth retardation in their pups ; however, due to differences in animal physiology during lactation, the implications to human lactation are unknown. Among the 5-ASA agents, the drugs mesalamine, balsalazide, and olsalazine are preferred to sulfasalazine during lactation due to the unknown side effects of sulfasalazine's sulfapyridine metabolite, which is excreted into milk at higher concentrations than the parent drug and has hemolytic and antimicrobial properties.
Safety and effectiveness of olsalazine have not been established in neonates, infants, and children. Off-label use has been reported for olsalazine in children and adolescents. In one clinical trial, olsalazine was inferior to sulfasalazine therapy in treating pediatric patients with ulcerative colitis (UC). Mesalamine (5-ASA) or sulfasalazine products are preferred by guidelines given the strong evidence of efficacy of 5-ASA for induction and maintenance of remission in mild-moderate UC, and the availability of sulfasalazine in oral dosage forms amenable for use in younger children.
Mesalamine, the active metabolite of olsalazine, has been reported to cause photosensitivity. Patients should be advised to limit sunlight (UV) exposure. Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Use with caution in patients with a previous history of a skin photosensitivity disorder. Instruct patients to avoid sunlight (UV) exposure and tanning booths, and to wear sunscreen (and if possible protective clothing) on exposed skin.
Cases of nephrolithiasis have been reported with the use of 5-ASA (mesalamine) products, including kidney stones of 100% mesalamine content. Mesalamine is the active moiety in olsalazine. Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with olsalazine.
Clinical studies of olsalazine did not include sufficient numbers of older adults aged 65 and over to determine whether they respond differently from younger subjects. Reports from uncontrolled clinical studies and postmarketing reporting systems suggest a higher incidence of blood dyscrasias (i.e., agranulocytosis, neutropenia, pancytopenia) in geriatric subjects receiving 5-ASA (mesalamine) products such as olsalazine vs. younger adult patients, which may also be associated with ulcerative colitis, use of interacting drugs, or reduced renal function. Caution should be taken to closely monitor complete blood cell (CBC) and platelet counts during drug therapy, especially if the patient is also taking anticoagulants. Because older adult patients are more likely to have decreased renal function, care should be taken when prescribing olsalazine, and monitoring of renal function may be advisable.
The use of olsalazine, which is converted to 5-ASA (mesalamine), may lead to laboratory test interference. Spuriously elevated test results may occur when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, Nacetylaminosalicylic acid (N-Ac-5-ASA). Consider an alternative, selective assay for normetanephrine.
For the maintenance of remission of ulcerative colitis in patients intolerant of sulfasalazine:
Oral dosage:
Adults: 500 mg PO twice daily (Max: 1 gram/day PO) for maintenance of remission of UC. Olasalazine is effective for induction and remission of UC with similar efficacy to mesalamine, however, the drug may cause a high (20%) incidence of secretory diarrhea and is thus often less well-tolerated than either mesalamine or basalazide, and guidelines prefer mesalamine or basalazide for use in these patients. Up to 3 grams/day PO has been used off-label for induction therapy.
Children* and Adolescents*: Efficacy of olsalazine is not established. In one clinical trial, olsalazine 30 mg/kg/day PO, given in 2 divided doses, was inferior to sulfasalazine therapy. Clinical improvement was seen in nearly twice as many pediatric patients randomized to sulfasalazine (79%) vs. olsalazine (39%). Mesalamine (5-ASA) or sulfasalazine products are preferred by guidelines given the strong evidence of efficacy of 5-ASA for induction and maintenance of remission in mild-moderate UC, and the availability of sulfasalazine in oral dosage forms amenable for use in younger children.
Maximum Dosage Limits:
-Adults
1 gram/day PO.
-Geriatric
1 gram/day PO.
-Adolescents
Safety and efficacy have not been established; however, off-label use has been reported.
-Children
2 years and older: Safety and efficacy have not been established; however, off-label use has been reported.
Less than 2 years: Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are recommended for patients with hepatic impairment; however, monitor these patients during treatment.
Patients with Renal Impairment Dosing
Olsalazine is converted to mesalamine, which is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Dosage adjustments may be needed; however, specific guidelines for olsalazine dosage adjustments in renal impairment are not available. Discontinue olsalazine if renal function deteriorates while on therapy.
*non-FDA-approved indication
Amlodipine; Celecoxib: (Moderate) Monitor patients for signs of worsening renal function during coadministration of olsalazine and celecoxib. Coadministration may increase the risk for drug-induced nephrotoxicity. Olsalazine is converted to mesalamine in the gastrointestinal tract; nephrotoxicity has been observed during mesalamine treatment.
Azathioprine: (Moderate) 5-aminosalicylates (e.g., sulfasalazine, mesalamine, olsalazine) may interact with azathioprine and increase the risk of azathioprine-related toxicity. The inhibition of thiopurine methyltransferase activity, one of the enzymes responsible for azathioprine metabolism, by 5-aminosalicylates has been described via in vitro and in vivo study. Theoretically, this interaction could result in a higher risk of bone marrow suppression or other azathioprine dose-related side effects. If concurrent therapy cannot be avoided, closely monitor platelet and complete blood cell counts.
Celecoxib: (Moderate) Monitor patients for signs of worsening renal function during coadministration of olsalazine and celecoxib. Coadministration may increase the risk for drug-induced nephrotoxicity. Olsalazine is converted to mesalamine in the gastrointestinal tract; nephrotoxicity has been observed during mesalamine treatment.
Celecoxib; Tramadol: (Moderate) Monitor patients for signs of worsening renal function during coadministration of olsalazine and celecoxib. Coadministration may increase the risk for drug-induced nephrotoxicity. Olsalazine is converted to mesalamine in the gastrointestinal tract; nephrotoxicity has been observed during mesalamine treatment.
Dalteparin: (Moderate) Coadministration of 5-aminosalicylates and low molecular weight heparins may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Discontinue 5-aminosalicylates prior to the initiation of a low molecular weight heparins. If this is not possible, it is recommended to monitor patients closely for bleeding.
Enoxaparin: (Moderate) Coadministration of 5-aminosalicylates and low molecular weight heparins may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Discontinue 5-aminosalicylates prior to the initiation of a low molecular weight heparins. If this is not possible, it is recommended to monitor patients closely for bleeding.
Heparin: (Moderate) Coadministration of 5-aminosalicylates and heparin may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Discontinue 5-aminosalicylates prior to the initiation of heparin. If this is not possible, it is recommended to monitor patients closely for bleeding.
Low Molecular Weight Heparins: (Moderate) Coadministration of 5-aminosalicylates and low molecular weight heparins may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Discontinue 5-aminosalicylates prior to the initiation of a low molecular weight heparins. If this is not possible, it is recommended to monitor patients closely for bleeding.
Mercaptopurine, 6-MP: (Moderate) Increased bone marrow suppression may occur if mercaptopurine is coadministered with olsalazine. If concomitant use is necessary, use the lowest possible doses of each drug and closely monitor the patient for myelosuppression. 5-Aminosalicylates, such as olsalazine, have been shown to inhibit the thiopurine methyltransferase (TPMT) enzyme in vitro. Mercaptopurine is inactivated via the TPMT enzyme.
Thioguanine, 6-TG: (Moderate) Use these drugs together with caution; concomitant use may result in reduced metabolism of thioguanine via TPMT and an increased risk for thioguanine-induced toxicity. Monitor patients for signs and symptoms of hematologic and hepatic toxicity. There is in vitro evidence that 5-aminosalicylate derivatives inhibit thiopurine methyltransferase (TPMT), the enzyme that metabolizes thioguanine. Increased thioguanine concentrations can lead to an increased risk for severe thioguanine-induced myelosuppression. In cases of bone marrow suppression, a dose reduction of thioguanine may be necessary.
Warfarin: (Moderate) Olsalazine does not interfere with the protein binding of warfarin, however increased prothrombin time (PT) in patients taking concomitant warfarin has been reported. Closely monitor a patient's PT and INR during and following concomitant olsalazine therapy; dosage adjustments of anticoagulants may be necessary. In elderly patients taking olsalazine with anticoagulants, consider regularly monitoring complete blood cell counts and platelet counts, as an increased risk for blood dyscrasia has been reported in geriatric adults.
Although the mechanism of action of olsalazine has not been fully elucidated, it appears to be local rather than systemic. Olsalazine is converted to mesalamine (5-ASA) in the GI tract by colonic bacteria. The antiinflammatory mechanism of mesalamine is believed to occur, at least in part, through the inhibition of prostaglandin production in the bowel mucosa by inhibition of cyclooxygenase. This effectively diminishes the production of arachidonic acid metabolites, thereby reducing colonic inflammation. Production of arachidonic metabolites appears to be increased in patients with inflammatory bowel disease. Mesalamine also inhibits leukotriene synthesis, possibly through the inhibition of lipoxygenase, which catalyzes the production of arachidonic acid. This activity has been suggested as a major component of the drug's antiinflammatory effects. Inhibition of colonic mucosal sulfidopeptide leukotriene synthesis and chemotactic stimuli for polymorphonuclear leukocytes also may occur. Other possible mechanisms include alterations in colonic fluid balance, immunosuppression, and alteration of the GI bacterial flora.
Olsalazine is administered orally. The pharmacokinetics of olsalazine are similar in both healthy volunteers and in patients with ulcerative colitis. Very little of a dose is systemically absorbed. Olsalazine is 99% bound to plasma proteins. Olsalazine has a very short serum half-life, approximately 0.9 hour. Approximately 0.1 % of an oral dose of olsalazine is metabolized in the liver to olsalazine-O-sulfate (olsalazine-S). Olsalazine-S, in contrast to olsalazine, has a long half-life of 7 days. Olsalazine-S accumulates to steady state within 2 to 3 weeks. Olsalazine-S is more than 99% bound to plasma proteins and its long half-life is mainly due to slow dissociation from the protein binding site. Less than 1% of both olsalazine and olsalazine-S appears undissociated in plasma. N-acetyl-5-ASA (Ac-5-ASA), the major metabolite of 5-ASA found in plasma and urine, and is acetylated (deactivated) in at least 2 sites, the colonic epithelium and the liver. Ac-5-ASA is found in the serum, with peak values of 1.7 to 8.7 micromol/L after a single 1 gram dose. and approximately 20% of the total 5-ASA is recovered in the urine, where it is found almost exclusively as Ac-5-ASA. The remaining 5-ASA is partially acetylated and is excreted in the feces. No accumulation of 5-ASA or Ac-5-ASA in plasma has been detected.
Affected cytochrome P450 (CYP450) isoenzymes and drug transporters: None
-Route-Specific Pharmacokinetics
Oral Route
Based on oral and intravenous dosing studies, approximately 2.4% of a single 1 gram oral dose is absorbed. Approximately 99% of olsalazine reaches the colon after oral administration. Once in the colon, each molecule of olsalazine is rapidly converted into 2 molecules of 5-ASA by colonic bacteria. The liberated 5-ASA is absorbed slowly resulting in very high local concentrations in the colon. More than 0.9 gram of 5-ASA would usually be made available in the colon from 1 gram of olsalazine. Serum concentrations of 5-ASA are detected 4 to 8 hours after oral administration. Patients on daily doses of 1 gram of oral olsalazine for 2 to 4 years show a stable plasma concentration of olsalazine-S (3.3 to 12.4 micromole/L).
-Special Populations
Hepatic Impairment
Given the low systemic absorption and that approximately 0.1 % of an oral dose of olsalazine is metabolized in the liver to olsalazine-O-sulfate (olsalazine-S), hepatic impairment is not expected to change the pharmacokinetic parameters to a clinically relevant extent. However, patients with impaired liver function should be monitored.
Renal Impairment
The urinary recovery of olsalazine is below 1%; renal impairment is not expected to change the pharmacokinetic parameters to a clinically relevant extent. However, patients with impaired renal function should be monitored.