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Pharmacokinetics

Absorption

The absorption of Vingraf 0.5mg is incomplete and irregular. The bioavailability of the drug in;
Kidney transplant:
17±10%; liver transplant: 22±6; heart transplant: 23±9%
Effect of food:
Vingraf 0.5mg should be taken with or without food, because with food will decrease the bioavailability of Vingraf 0.5mg

Distribution

The human plasma protein binding of Vingraf 0.5mg is approximately 99%
Vingraf 0.5mg highly bound to plasma protein like albumin and alpha-1-acid glycoprotein

Metabolism

Vingraf 0.5mg is largely metabolized by mixed function oxidase system, by cytochrome P-450 enzyme
The main metabolites of Vingraf 0.5mg in human liver microsomes is 13-demethyl Vingraf 0.5mg

Elimination

The route of elimination of Vingraf 0.5mg metabolites
Feces 92.6% urine 2.3%
The terminal half-life of the drug in;
Kidney transplant: 19 hours
Liver transplant: 12 hours
Heart transplant: 24 hours
In pediatric liver transplant: 11.5±3.8 hours
In pediatric kidney transplant: 10.2±5.0 hours.


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Brand : Vingraf
Ingredients : Tacrolimus
Strength : 0.5mg
Manufactured : Emcure pharma
Package : 60 tablets

The usual dose of Tacrolimus for organ transplant-rejection therapy
KIDNEY TRANSPLANT:
Immediate release:
While combining with azathioprine, the initial dose of Tacrolimus is 0.1mg/kg taken orally for every 12 hours, initiate within 24 hours of surgery While combining with Mycophenolate mofetil or interleukin 2 receptor antagonist, initial dose is 0.05mg/kg for every 12 weeks
Extended dose:
Co administration of Tacrolimus with MMF, basiliximab and corticosteroid, starting dose is 0.15mg/kg/day orally as once daily
Co administration of Tacrolimus with MMF, corticosteroids without basiliximab:
Pre-operative dose:
0.1mg/kg/day within 12 hours before reperfusion
Post-operative dose:
0.2mg/kg/day
LIVER TRANSPLANT:
The initial dose of Tacrolimus is 0.05 to 0.075mg/kg should be taken as orally for twice daily
HEART TRANSPLANT:
The initial dose of Tacrolimus is 0.0375mg/kg orally as twice daily
In pediatric:
LIVER TRANSPLANT:
The initial dose is 0.075 to 0.1mg/kg as twice daily
In immediate release, Tacrolimus should be taken as twice daily, whereas in case of extended release the dose should be taken as once a time.
Tacrolimus should be taken on an empty stomach. Grape juice must be avoided during Vingraf 0.5mg administration

Elevate the risk of infection and lymphoma, latent virus activation
Risk of post-transplant diabetes mellitus
Discontinue cyclosporine 24 hours before taking Vingraf 0.5mg
Hypertension occurs
Caution with use, in concomitant with nephrotoxicity or calcium channel blockers
Myocardial hypertrophy
Care should be taken while using CYP3A inhibitors and inducers
Monitor blood glucose level
Nephrotoxicity and neurotoxicity
Risk of viral, fungal, bacterial infection due to immunosuppressant activity of Vingraf 0.5mg
QT prolongation

In kidney transplant:
Nervous system: tremor, headache, insomnia, paresthesia, dizziness Gastrointestinal: diarrhea, nausea, constipation, vomiting, dyspepsia
Cardio vascular: hypertension, chest pain
Urogenital: creatinine increased, urinary tract infection
Metabolic and nutritional: hypophosphatemia, hypomagnesemia, hyperlipemia, hypo/hyperkalemia, diabetes mellitus, hyperglycemia, edema
Blood: anemia, leucopenia
Miscellaneous: infection, peripheral edema, asthenia, abdominal pain, fever, back pain
Pulmonary: dyspnea, cough
Muscle: arthralgia
Skin: rash, Pruritus
Injury: post-procedural pain, incision site complication, graft dysfunction
In liver transplant:
Nervous system: tremor, headache, insomnia, paresthesia, dizziness
Metabolic and nutritional: hypophosphatemia, hypomagnesemia, hyperlipemia, hypo/hyperkalemia, diabetes mellitus, hyperglycemia, edema
Blood: anemia, leucopenia, thrombocytopenia
Miscellaneous: infection, peripheral edema, asthenia, abdominal pain, fever, back pain, ascites
Pulmonary: dyspnea, cough, pleural effusion, atelectasis
Gastrointestinal: diarrhea, nausea, constipation, vomiting, dyspepsia, LFT abnormal
Cardio vascular: hypertension, chest pain
Urogenital: creatinine increased, urinary tract infection, kidney abnormal, BUN increased, oliguria Incision site complication, graft dysfunction, post-procedural pain
Musculoskeletal: arthralgia
Skin: rash, Pruritus
In heart transplant:
CVS: hypertension, pericardial effusion
Whole body: CMV infection
Metabolic disorders: diabetic mellitus, hyperglycemia, hyperlipemia
Hemic and lymphatic system: anemia and leucopenia
Urogenital: kidney function abnormal and urinary tract infection
Respiratory: bronchitis
Nerve system: tremor
Some adverse reactions:
Lymphoma, serious infections, polyoma virus infections, CMV infections, new onset of diabetes, nephrotoxicity, neurotoxicity, hyperkalemia, hypertension, anaphylactic reactions, myocardial hypertrophy, pure red cell aplasia, gastrointestinal perforation



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Drug interaction

Vingraf 0.5mg is metabolized by CYP3A enzymes, by inhibiting these cytochrome enzymes leads to increasing plasma concentration of Vingraf 0.5mg
CYP3A inducers: may decrease the concentration of Vingraf 0.5mg
Mycophenolic acid products: increase exposure to Mycophenolic acid
Grape fruit/grape fruit juice: this will prohibit CYP3A enzymes, leads to increase the Vingraf 0.5mg whole blood trough concentrations
Protease inhibitors: increase the concentration of Vingraf 0.5mg
Anti-fungal agents: depending on whole blood concentration of Vingraf 0.5mg, anti-fungal drugs are used. While concomitant voriconazole or posaconazole with Vingraf 0.5mg, the dose of Vingraf 0.5mg decreased to one-third of initial dose
Calcium channel blockers: inhibit CYP3A enzymes, increase the concentration of Vingraf 0.5mg
Anti-bacterial: erythromycin, clarithromycin, troleandomycin, chloramphenicol are inhibit CYP3A enzyme, leads to elevate concentration of Vingraf 0.5mg Anti-mycobacterial: are rifampin and rifabutin; induce CYP3A enzymes causes decrease the Vingraf 0.5mg concentration
Anti-convulsant: decrease the concentration of Vingraf 0.5mg
St. Johns wort: decrease the concentration of Vingraf 0.5mg
Gastric acid regulator and suppressor: increase the concentration of Vingraf 0.5mg.

CONTRAINDICATIONS

Hypersensitivity reaction or anaphylactic reactions occurs






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