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Manufacturer Astellas Pharma
Distributor DKSH
Contents Tacrolimus
Indications Prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplants. Lupus nephritis when steroids is insufficient.
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Dosage Cap Adult kidney transplant patient In combination w/ azathioprine: 0.2 mg/kg/day. In combination w/ mycophenolate mofetil/IL-2 receptor antagonist: 0.1 mg/kg/day. Adult liver transplant patient 0.1-0.15 mg/kg/day. Ped liver transplant patient 0.15-0.2 mg/kg/day. To be given in 2 divided doses 12 hrly. Lupus nephritis Adult 3 mg once daily after supper. Inj Initially 0.03-0.05 mg/kg/day as continuous IV infusion no sooner than 6 hr after transplantation. Reserved for patients unable to take cap.
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Overdosage View Prograf 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 meals. Avoid grapefruit juice.).
Contraindications Hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil).
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Warnings For additional cautionary notes to warn of the potential risk of using the medicine... click to view Prograf detailed prescribing infomation
Special Precautions Insulin-dependent post-transplant DM. Nephrotoxicity, neurotoxicity, malignancy & lymphoproliferative disorders, immunosuppressed patients. HTN, renal or hepatic dysfunction, myocardial hypertrophy. Aggravated renal disorders in patients w/ lupus nephritis. Monitor serum K levels & creatinine fasting glucose, metabolic & hematologic system. Avoid exposure to sunlight & UV light. Pregnancy, lactation.
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Adverse Drug Reactions Tremor, headache, diarrhea, HTN, nausea, renal dysfunction, vomiting, hyperkalemia, hypomagnesemia, hyperglycemia, infection, constipation, abdominal pain, insomnia.
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Drug Interactions Aminoglycosides, amphotericin B, cisplatin, CYP3A enzyme inducers/inhibitors, Mg- & Al(OH)3, nephrotoxic drugs, nelfinavir, ritonavir, live vaccines, K-sparing diuretics, mycophenolate mofetil. May increase tacrolimus levels: Ca channel blockers, antifungal agents, macrolides, cisapride, metoclopramide, bromocriptine, chloramphenicol, cimetidine, cyclosporine, danazol, ethinyl estradiol, methyl prednisolone. May decrease tacrolimus levels: Carbamazepine, phenobarb, St. John's wort, phenytoin, sirolimus, rifabutin, caspofungin, rifampin.
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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 Prograf storage conditions for details to ensure optimal shelf-life.
Description View Prograf description for details of the chemical structure and excipients (inactive components).
Mechanism of Action View Prograf mechanism of action for pharmacodynamics and pharmacokinetics details.
Presentation/Packing
Form Packing Photo
Prograf capsule Prograf 0.5 mg x 5 x 10's
Prograf 1 mg x 5 x 10's
Prograf injection Prograf (amp) 5 mg/1 mL x 10's

Manufacturer: Astellas Pharma
Distributor: DKSH
