Important Safety Information
Contraindications: ROWASA® (mesalamine) Rectal Suspension Enema is contraindicated for patients known to have hypersensitivity to the drug or any component of this medication.
Warning: ROWASA® (mesalamine) Rectal Suspension Enema contains potassium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but probably low.
Precautions: Mesalamine has been implicated in the production of an acute intolerance syndrome characterized by cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache and a rash; in such cases prompt withdrawal is required. Caution should be exercised when mesalamine is initially used in patients known to be allergic to sulfasalazine.
Adverse Reactions: ROWASA® (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient. The most frequently reported adverse events include abdominal cramps, headache, gas, nausea, flu, fatigue, fever and rash.
|