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Rowasa Generic Name & Formulations
Legal Class
Rx
General Description
Mesalamine 4g/60mL; enema; contains sulfites.
Pharmacological Class
Salicylate.
How Supplied
Enema—7, 14, 28
Manufacturer
Generic Availability
YES
Rowasa Indications
Indications
Mild to moderate distal ulcerative colitis, proctosigmoiditis, proctitis.
Rowasa Dosage and Administration
Adult
4g (60mL) daily at bedtime for 3–6 weeks. Retain enema for 8 hours.
Children
Not established.
Rowasa Contraindications
Not Applicable
Rowasa Boxed Warnings
Not Applicable
Rowasa Warnings/Precautions
Warnings/Precautions
Sulfite sensitivity. Sulfasalazine allergy. Discontinue if acute intolerance syndrome is suspected. Discontinue at the 1st signs/symptoms of severe cutaneous adverse reactions. Conditions predisposing to myocarditis or pericarditis. Atopic dermatitis or eczema: may have more severe photosensitivity reactions. Nephrolithiasis. Ensure adequate hydration. Renal or hepatic impairment. Assess renal function prior to and periodically during therapy. Discontinue if renal function deteriorates while on therapy. Elderly (monitor CBCs, platelets). Pregnancy. Nursing mothers.
Rowasa Pharmacokinetics
Elimination
Fecal, renal.
Rowasa Interactions
Interactions
Increased toxicity with nephrotoxic drugs (eg, NSAIDs). Increased risk for blood disorders, bone marrow failure, and associated complications with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity. May cause elevated test results when measuring urinary normetanephrine; consider other alternative assay.
Rowasa Adverse Reactions
Adverse Reactions
Abdominal pain/cramps/discomfort, headache, flatulence, nausea, diarrhea, flu, malaise, fever, sore throat, dizziness, bloating, joint, back, or rectal pain, hemorrhoids, itching, constipation, hair loss, pancolitis, pericarditis, rash; renal impairment, acute intolerance syndrome, hypersensitivity reactions, severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).
Rowasa Clinical Trials
See Literature
Rowasa Note
Not Applicable
Rowasa Patient Counseling
See Literature
