Classes
DEA Class; Rx
Common Brand Names; Paser
- 5-Aminosalicylic Acid Derivatives;
- Antitubercular Agents
Description
Oral antituberculosis agent that may inhibit folic acid synthesis and/or inhibit synthesis of a cell wall component
Use second-line to treat tuberculosis infection; often used for multi-drug resistant tuberculosis
Must be used as part of a multi-drug treatment regimen
Indications
Indicated for treatment of TB in combination with other active agents; most commonly used in regimens for multi-drug resistant TB or when intolerance to other antitubercular agents occurs
Treatment of mild-to-moderate ulcerative colitis in patients intolerant to sulfasalazine
Contraindications
Hypersensitivity
End-stage renal disease
Adverse Effects
GI intolerance manifested by nausea, vomiting, diarrhea, and abdominal pain
Hypersensitivity reactions: Fever, skin eruptions of various types, including exfoliative dermatitis, infectious mononucleosis-like, or lymphoma-like syndrome, leucopenia, agranulocytosis, thrombocytopenia, Coombs’ positive hemolytic anemia, jaundice, hepatitis, pericarditis, hypoglycemia, optic neuritis, encephalopathy, Leoffler’s syndrome, vasculitis and a reduction in prothrombin
Crystalluria (prevent by maintaining urine at neutral or alkaline pH)
Warnings
Monitor liver function; reports of drug-induced hepatitis with rapidly absorbed aminosalicylic acid preparations
Pregnancy and Lactation
Pregnancy Category: C
Lactation: Distributed in human breast milk; caution advised
Maximum Dosage
12 g/day PO.
12 g/day PO.
300 mg/kg/day (Max: 12 g/day) PO.
300 mg/kg/day (Max: 10 g/day) PO.
300 mg/kg/day PO.
Safety and efficacy have not been established.
How supplied
Aminosalicylic acid
oral granules, delayed-release
- 4g/packet
