INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE

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

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CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Hypersensitivity to olsalazine, other salicylates, or any of the excipients.

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ADVERSE REACTIONS SECTION

ADVERSE REACTIONS

Olsalazine has been evaluated in ulcerative colitis patients in remission, as well as those with acute disease. Both sulfasalazine-tolerant and intolerant patients have been studied in controlled clinical trials. Overall, 10.4% of patients discontinued olsalazine because of an adverse experience compared with 6.7% of placebo patients. The most commonly reported adverse reactions leading to treatment withdrawal were diarrhea or loose stools (olsalazine 5.9%; placebo 4.8%), abdominal pain, and rash or itching (slightly more than 1% of patients receiving olsalazine). Other adverse reactions to olsalazine leading to withdrawal occurred in fewer than 1% of patients ( ). Table 1

Table 1 Adverse Reactions Resulting In Withdrawal From Controlled Studies Total

For those controlled studies, the comparative incidences of adverse reactions reported in 1% or more patients treated with olsalazine or placebo are provided in Table 2.

Table 2 Comparative Incidence (%) of Adverse Effects Reported By One Percent Or More of Ulcerative Colitis Patients Treated With Olsalazine Or Placebo in Double Blind Controlled Studies

Over 2,500 patients have been treated with olsalazine in various controlled and uncontrolled clinical studies. In these as well as in post-marketing experience, olsalazine was administered mainly to patients intolerant to sulfasalazine. There have been rare reports of the following adverse effects in patients receiving olsalazine. These were often difficult to distinguish from possible symptoms of the underlying disease or from the effects of prior and/or concomitant therapy. A causal relationship to the drug has not been demonstrated for some of these reactions.

Anemia, Eosinophilia, Hemolytic anemia, Interstitial pulmonary disease, Leukopenia, Lymphopenia, Neutropenia, Reticulocytosis, Thrombocytopenia Blood and Lymphatic System Disorders:

Chest pains, Heart block second degree, Myocarditis, Palpitations, Pericarditis, Peripheral edema, Shortness of breath, TachycardiaCardiac Disorders:

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.

TinnitusEar and Labyrinth Disorders:

Dry eyes, Vision blurred, Watery eyesEye Disorders:

Abdominal pain (upper), Diarrhea with dehydration, Dry mouth, Epigastric discomfort, Flare in symptoms, Flatulence, Increased blood in stool, Pancreatitis, Rectal bleeding, Rectal discomfortGastrointestinal Disorders:

In a double-blind, placebo-controlled study, increased frequency and severity of diarrhea were reported in patients randomized to olsalazine 500 mg B.I.D. with concomitant pelvic radiation.

Rare cases of granulomatous hepatitis and nonspecific, reactive hepatitis have been reported in patients receiving olsalazine. Additionally, a patient developed mild cholestatic hepatitis during treatment with sulfasalazine and experienced the same symptoms two weeks later after the treatment was changed to olsalazine. Withdrawal of olsalazine led to complete recovery in these cases.

Fever chills, Hot flashes, Irritability, RigorsGeneral Disorders and Administration Site Conditions:

Bronchospasm, Erythema nodosumImmune System Disorders:

ALT (SGPT) or AST (SGOT) elevated beyond the normal range.Laboratory:

Muscle crampsMusculoskeletal and Connective Tissue Disorders:

Insomnia, Paraesthesia, TremorsNervous System Disorders:

Mood swingsPsychiatric Disorders:

Dysuria, Hematuria, Interstitial nephritis, Nephrotic syndrome, Proteinuria, Urinary frequencyRenal and Urinary Disorders:

Impotence, MenorrhagiaReproductive System and Breast Disorders:

Alopecia, Erythema, Photosensitivity reactionSkin and Subcutaneous Tissue Disorders:

Hypertension, Orthostatic hypotensionVascular Disorders:

Postmarketing

The following events have been identified during post-approval use of products that contain (or are metabolized to) mesalamine in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:

Aplastic anemia, PancytopeniaBlood and Lymphatic System Disorders:

PyrexiaGeneral Disorders and Administration Site Conditions:

Hepatic enzyme increased, Hepatitis, Increased bilirubinHepatobiliary Disorders:

Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. One case of Kawasaki-like syndrome, which included hepatic function changes, was also reported.

MyalgiaMusculoskeletal and Connective Tissue Disorders:

Dyspnoea, Interstitial lung diseaseRespiratory, Thoracic and Mediastinal Disorders:

Angioneurotic oedemaSkin and Subcutaneous Tissue Disorders:

Paraesthesia, Peripheral neuropathyNervous System Disorders:

Interstitial nephritisRenal and Urinary Disorders:

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