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Manufacturer Astellas Pharma 
Distributor DKSH 
Contents Tacrolimus
Indications Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment w/ other immunosuppressants in adult.
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Dosage Prophylaxis of kidney transplant rejection 0.2-0.3 mg/kg/day w/in 24 hr post-op. Prophylaxis of liver transplant rejection 0.1-0.2 mg/kg/day approx 12-18 hr post-op. Conversion from other immunosuppressant: Heart transplantation 0.15 mg/kg/day. Lung transplantation Initially 0.1-0.15 mg/kg/day. Pancreas transplantation Initially 0.2 mg/kg/day. Intestine transplantation Initially 0.3 mg/kg/day. All doses to be administered once daily in the morning.
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Overdosage View Advagraf overdosage for action to be taken in the event of an overdose.
Administration Should be taken on an empty stomach (Take on an empty stomach at least 1 hr before or 2-3 hr after meal. Avoid grapefruit juice.).
Contraindications [Click for Advagraf detailed prescribing infomation]
Special Precautions Monitor BP, ECG, neurological & visual status, fasting blood glucose levels, elecrolytes (particularly K), liver & renal function tests, haematology parameters, coagulation values, plasma protein determinations. Epstein-Barr virus (EBV)-polymerase chain reaction. Avoid concomitant St. John's wort or other herbal prep, ciclosporin. Preexisting heart disease, corticosteroid usage, HTN, renal or hepatic dysfunction, infections, fluid overload, oedema, congenital long QT syndrome, EBV-associated lymphoproliferative disorders. Avoid sun or UV light exposure. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Pregnancy, lactation.
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Adverse Drug Reactions Tremor, headache, diarrhoea, nausea, renal impairment, hyperglycaemic conditions, DM, hyperkalaemia, HTN, insomnia.
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Drug Interactions CYP3A4 inhibitors or inducers, high dose prednisolone or methylprednisolone. Increased conc by antifungal agents, erythromycin, HIV PIs (eg ritonavir), clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole & nefazodone. Lansoprazol, ciclosporin. Decreased conc by rifampicin, phenytoin, St. John's wort, phenobarb, corticosteroids, carbamazepine, metamizole, INH. Pentobarbital & antipyrine, metoclopramide, cisapride, cimetidine, Mg(OH)2, Al(OH)3. Aminoglycosides, gyrase inhibitors, vancomycin, co-trimoxazole, NSAIDs, ganciclovir or aciclovir; amphotericin B, ibuprofen, K-sparing diuretics, live attenuated vaccines, oral anticoagulants, oral antidiabetics, alcohol.
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Pregnancy Category (US FDA)      
     
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. 
Storage View Advagraf storage conditions for details to ensure optimal shelf-life.
Description View Advagraf description for details of the chemical structure and excipients (inactive components).
Mechanism of Action View Advagraf mechanism of action for pharmacodynamics and pharmacokinetics details.

Presentation/Packing
Form Packing Photo
Advagraf prolonged-release capsule  Advagraf 0.5 mg x 5 x 10's 

Advagraf 1 mg x 5 x 10's 
 

Manufacturer: Astellas Pharma
 
Distributor: DKSH