HOME >> API >> API List 2 >> Mesalazine >> Precautions

PRECAUTIONS
Mesalazine CAS Registry Number 89-57-6

General

Caution should be exercised if Mesalazine  is administered to patients with impaired hepatic function. Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Although the exact frequency of occurrence cannot be ascertained, it has occurred in 3% of patients in controlled clinical trials of mesalamine or sulfasalazine. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required. If a rechallenge is performed later in order to validate the hypersensitivity, it should be carried out under close medical supervision at reduced dose and only if clearly needed.

Renal

Caution should be exercised if Mesalazine  is administered to patients with impaired renal function. Single reports of nephrotic syndrome and interstitial nephritis associated with mesalamine therapy have been described in the foreign literature. There have been rare reports of interstitial nephritis in patients receiving Mesalazine . In animal studies, a 13-week oral toxicity study in mice and 13-week and 52-week oral toxicity studies in rats and cynomolgus monkeys have shown the kidney to be the major target organ of mesalamine toxicity. Oral daily doses of 2400 mg/kg in mice and 1150 mg/kg in rats produced renal lesions including granular and hyaline casts, tubular degeneration, tubular dilation, renal infarct, papillary necrosis, tubular necrosis, and interstitial nephritis. In cynomolgus monkeys, oral daily doses of 250 mg/kg or higher produced nephrosis, papillary edema, and interstitial fibrosis. Patients with preexisting renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

Pediatric Use

Safety and efficacy of Mesalazine  in pediatric patients have not been established.

Information Associated with Product:
DRUG DESCRIPTION DOSAGE SIDE EFFECTS PRECAUTIONS >> INTERACTION CONSUMER INFORMATION
PDF DOWNLOAD	WORD DOCUMENT

Api Manufacturer,Export,Supplies,Manufacturing

Gabapentin

Gemcitabine Hcl

Glimepiride

Granisetron Hcl

Ibandronate Sodium

Imatinib Mesylate

Irbesartan

Irinotecan Hcl

Isradipine

Lamotrigine

Lercanidipine

Letrozole

Losartan Potassium

Loteprednol Etabonate

Magnesium Valproate

Meloxicam

Memantine Hcl

Mesalazine

Metamizol Magnesium

Metaxalone

Metformin Hcl

Metoprolol Tartrate

Mifepristone

Mirtazapine

Modafinil

Mometasone Furoate

Naltrexone Hcl

Netaglinide

Investor Relations    Feedback     Contact Worldwide    Sitemap