"The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare dis"...
Postmarketing cases of overdose with tacrolimus have been reported. Some of these cases were symptomatic with adverse reactions including nervous system disorders (tremor, headache, confusional state, balance disorders, encephalopathy, lethargy and somnolence), gastrointestinal disturbances (nausea, vomiting, and diarrhea), abnormal renal function (increased blood urea nitrogen and elevated serum creatinine), urticaria, hypertension, peripheral edema, and infections. One fatal postmarketing case of bilateral pneumopathy and CMV infection was attributed to tacrolimus (extended-release) overdose.
Based on the poor aqueous solubility and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus is not dialyzable to any significant extent; there is no experience with charcoal hemoperfusion. The oral use of activated charcoal has been reported in treating acute overdoses, but experience has not been sufficient to warrant recommending its use. General supportive measures and treatment of specific symptoms should be followed in all cases of overdosage.
In acute oral toxicity studies, mortality was observed at or above the following doses: in orally administered adult rats, 80-fold the recommended human dose for adults; in orally administered immature rats, 18-fold the maximum adult human dose. All doses are based on body surface area conversions (mg/m²).
ASTAGRAF XL is contraindicated in patients with hypersensitivity to tacrolimus.
Last reviewed on RxList: 3/18/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Astagraf XL Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.