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Prograf 0.5 Mg

ASTELLAS PHARMA INDIA PVT.LTD
GENERIC NAME : TACROLIMUS

What is Prograf ?

Prograf (tacrolimus) lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
Prograf is used together with other medicines to prevent your body from rejecting a heart, liver, or kidney transplant.

Indication and Usage of Prograf

Prograf is a calcineurin-inhibitor immunosuppressant indicated for:

Prophylaxis of organ rejection in patients receiving allogeneicliver, kidney or heart transplants
Use concomitantly with adrenal corticosteroids; in kidney and heart transplant, use in conjunction with azathioprine or mycophenolate mofetil.
Limitations of Use :
Do not use simultaneously with cyclosporine
Intravenous use reserved for patients who cannot tolerate capsules orally
Use with sirolimus is not recommended in liver and heart transplant; use    with sirolimus in kidney transplant has not been established.
Dosage and Administration of Prograf

Patient Population	Recommended Initial Oral Dosage (two divided doses every 12 hours)
Adult Kidney transplant In combination with azathioprine In combination with MMF/IL-2 receptor antagonist	0.2 mg/kg/day 0.1 mg/kg/day
Adult Liver transplant   Pediatric Liver transplant	0.10-0.15 mg/kg/day 0.15-0.20 mg/kg/day
Adult Heart transplant	0.075 mg/kg/day

 
Careful and frequent monitoring of tacrolimus trough concentrations is recommended;
Black patients may require higher doses in order to achieve comparable trough concentrations
Hepatic/Renal impaired patients should receive doses at the lowest value of the recommended initial oral dosing range
Administer capsules consistently with or without food; do not drink grapefruit juice
Adverse Reactions of Prograf

Kidney Transplant: The most common adverse reactions ( ≥ 30%) were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia, anemia
Liver Transplant: The most common adverse reactions (≥ 40%) were tremor, headache, diarrhea, hypertension, nausea, abnormal renal function, abdominal pain, insomnia, paresthesia, anemia, pain, fever, asthenia, hyperkalemia, hypomagnesemia, and hyperglycemia
Heart Transplant: The most common adverse reactions ( ≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection and hyperlipemia
 
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