Tacrolimus


Generic Medicine Info
Administration
Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before or 2-3 hr after meals. Avoid grapefruit & grapefruit juice.
Special Precautions
Patient w/ risk factors for QT prolongation; skin disease which may increase systemic absorption (e.g. Netherton's syndrome). Topical application on the face or neck, large areas of the body (i.e. >50% of the total BSA), or areas of broken skin. Avoid unsupervised switching of immediate- or extended-release formulation. Renal and hepatic impairment. Pregnancy and lactation. Patient Counselling This drug may cause visual and neurological disturbances, if affected do not drive or operate machinery. Avoid excessive exposure to UV light and sunlight during treatment. Use of IUD may increase risk of infection. Monitoring Parameters Monitor ECG, BP, fasting blood-glucose concentration, haematological, neurological (including visual) and coagulation parameters, electrolytes, hepatic and renal function, whole blood-tacrolimus trough concentration (esp during diarrhoea episodes).
Adverse Reactions
Systemic: Headache, tremor, paraesthesia, HTN, insomnia, nausea, diarrhoea, renal impairment; serum electrolyte disturbances (e.g. hyperkalaemia); hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia; leucopenia, anaemia, thrombocytopenia, agranulocytosis, haemolytic anaemia; anxiety, mood changes, dizziness, confusion, tinnitus, hearing loss, visual disturbances, peripheral neuropathies, convulsions; dyspepsia, constipation, GI haemorrhage and ulceration; dyspnoea, parenchymal lung disorders, pleural effusions, cough, nasal congestion and inflammation, pharyngitis; acne, alopecia, skin rashes, pruritus; muscle cramps, asthenia, arthralgia, febrile disorders, oedema, ascites, liver dysfunction; thromboembolic and ischaemic events, tachycardia; cardiac arrest, heart failure, ventricular arrhythmias, palpitations, ECG changes; cardiomyopathies (including ventricular hypertrophy); coagulation disorders, neutropenia, pancytopenia; acute resp distress syndrome, asthma, dysmenorrhoea, hypoproteinaemia, uterine bleeding, deep limb venous thrombosis, paralytic ileus, acute and chronic pancreatitis, peritonitis, haemolytic uraemic syndrome; CNS effects (e.g. CNS haemorrhage, coma, paralysis, amnesia, speech and language abnormalities); posterior reversible encephalopathy syndrome, post-transplant DM, pure red cell aplasia. Topical: Local irritation (e.g. pruritus, burning sensations), skin disorders (e.g. rosacea, acne); lymphadenopathy, flu-like symptoms. Rarely, hirsutism, thrombotic thrombocytopenic purpura, hypoprothrombinaemia; Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic artery thrombosis, veno-occlusive liver disease.
Potentially Fatal: Polyoma virus infections (e.g. polyoma virus associated nephropathy mostly due to BK virus and JC virus-associated progressive multifocal leucoencephalopathy); GI perforation.
Drug Interactions
Increased blood levels w/ HCV protease inhibitors (e.g. boceprevir, telaprevir), HIV protease inhibitors (e.g. saquinavir, ritonavir, nelfinavir), macrolide antibiotics (e.g. erythromycin), antifungal agents (e.g. fluconazole, ketoconazole, itraconazole, voriconazole), ciclosporin, lansoprazole, amiodarone, cimetidine, Mg-Al-hydroxide, metoclopramide. Decreased blood levels w/ rifampicin, phenytoin, metamizole, carbamazepine, isoniazid. May increase nephrotoxic or neurotoxic effects of NSAIDs, aminoglycosides, vancomycin, gyrase inhibitors, sulfamethoxazole+trimethoprim, ganciclovir, aciclovir. May reduce effect of live attenuated vaccines. Increased hyperkalaemic effect w/ K-sparing diuretics (e.g. spironolactone, amiloride, triamterene).
CIMS Class
Immunosuppressants / Other Dermatologicals
ATC Classification
D11AH01 - tacrolimus ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
L04AD02 - tacrolimus ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Disclaimer: This information is independently developed by CIMS based on tacrolimus from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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