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Advagraf 0.5mg, 1mg, 3mg and 5mg Prolonged-release hard capsules(十二)
pseudocyst, subileus
Hepatobiliary disorders
very common:
liver function tests abnormal
common:
bile duct disorders, hepatocellular damage and hepatitis, cholestasis and jaundice
rare:
venoocclusive liver disease, hepatitic artery thrombosis
very rare:
hepatic failure
Skin and subcutaneous tissue disorders
common:
rash, pruritus, alopecias, acne, sweating increased
uncommon:
dermatitis, photosensitivity
rare:
toxic epidermal necrolysis (Lyell's syndrome)
very rare:
Stevens Johnson syndrome
Musculoskeletal and connective tissue disorders
common:
arthralgia, back pain, muscle cramps, pain in limb
uncommon:
joint disorders
Renal and urinary disorders
very common:
renal impairment
common:
renal failure, renal failure acute, nephropathy toxic, renal tubular necrosis, urinary abnormalities, oliguria, bladder and urethral symptoms
uncommon:
haemolytic uraemic syndrome, anuria
very rare:
nephropathy, cystitis haemorrhagic
Reproductive system and breast disorders
uncommon:
dysmenorrhoea and uterine bleeding
General disorders and administration site conditions
common:
febrile disorders, pain and discomfort, asthenic conditions, oedema, body temperature perception disturbed, blood alkaline phosphatase increased, weight increased
uncommon:
weight decreased, influenza like illness, blood lactate dehydrogenase increased, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance
rare:
fall, ulcer, chest tightness, mobility decreased, thirst
very rare:
fat tissue increased
Injury, poisoning and procedural complications
common:
primary graft dysfunction
Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed. A number of associated cases of transplant rejection have been reported (frequency cannot be estimated from available data)
Go to top of the page4.9 Overdose
Experience with overdose is limited. Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
No specific antidote to tacrolimus therapy is available. If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Based on its high molecular weight, poor aqueous solubility, and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus will not be dialysable. In isolated patients with very high plasma levels, haemofiltration or -diafiltration have been effective in reducing toxic concentrations. In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be h |
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