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Takfa 0.25mg is used in organ transplantation condition, in some patients who are attain organ transplant, their body white blood cells are trying to reject the transplanted organ. In this condition, Takfa 0.25mg is helps to accept the transplanted organ by the patient’s body, through weakening the body’s immune system. This leads the body to acquire the new organ which is transplanted

Prophylaxis of organ rejection in kidney transplant:
Takfa 0.25mg is used in the treatment of organ rejection in patients who are receiving kidney transplant In this condition, Takfa 0.25mg concomitant with azathioprine or Mycophenolate

Prophylaxis of organ rejection in liver transplant:
Takfa 0.25mg is used in the treatment of organ rejection in patients who are receiving liver transplant Takfa 0.25mg with adrenal corticosteroids is taken in this condition

Prophylaxis of organ rejection in heart transplant:
Takfa 0.25mg is used in the treatment of organ rejection in patients who are receiving heart transplant Takfa 0.25mg with azathioprine or Mycophenolate and adrenal corticosteroid is used

Tacrolimus exact mechanism of action has not been established; but it prohibits T-lymphocyte activation Tacrolimus, known as FK506, it is a macrolide antibiotic with immunosuppressant properties Binding of Tacrolimuswith intracellular protein like FKBP-12

This bonding complex inhibits calcineurin phosphatase. Tacrolimusprohibits calcium dependent events like:
• Interleukin 2 gene transcription
• Nitric acid synthase activation
• Cell degranulation
• Apoptosis

GenerallyTacrolimusis used to suppress the immune response after the organ transplantation process. Immune system suppressed by prohibition of interleukin 2 productions Human body has acquired immune system which builds a memory for the body after an infection produced by some pathogens. If body is suspected with same infection, that immune cells will fight against the pathogens vigorously

T-cells it is a type of lymphocytes or white blood cells which is essential for immunity. Interleukin 2 builds up and proliferate the T-cells. Whereas Tacrolimusis exhibits its action by inhibiting the interleukin 2. Interleukin 2 is a protein and a cytokine signaling molecule of the immune system. If interleukin 2 get inhibited, then body’s immune response also diminished. Thus, the body accept the newly transplanted organs



ADME properties

Absorption

The absorption of Takfa 0.25mg 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: Takfa 0.25mg should be taken with or without food, because with food will decrease the bioavailability of Takfa 0.25mg

Distribution

The human plasma protein binding of Takfa 0.25mg is approximately 99% Takfa 0.25mg highly bound to plasma protein like albumin and alpha-1-acid glycoprotein

Metabolism

Takfa 0.25mg is largely metabolized by mixed function oxidase system, by cytochrome P-450 enzyme The main metabolites of Takfa 0.25mg in human liver microsomes is 13-demethyl Takfa 0.25mg

Elimination

The route of elimination of Takfa 0.25mg 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 : Takfa
Ingredients : Tacrolimus
Strength : 0.25mg
Manufactured : Intas
Package : 60 Tablets

Dosage and administration of Takfa 0.25mg

The usual dose of Tacrolimusfor organ transplant-rejection therapy

KIDNEY TRANSPLANT
Immediate release

While combining with azathioprine, the initial dose of Tacrolimusis 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 Tacrolimuswith MMF, basiliximab and corticosteroid, starting dose is 0.15mg/kg/day orally as once daily Co administration of Tacrolimuswith 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 Tacrolimusis 0.05 to 0.075mg/kg should be taken as orally for twice daily

HEART TRANSPLANT

The initial dose of Tacrolimusis 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, Tacrolimusshould be taken as twice daily, whereas in case of extended release the dose should be taken as once a time Tacrolimusshould be taken on an empty stomach. Grape juice must be avoided during Takfa 0.25mg administration

Takfa 0.25mg causes Side effects
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

Precautions and warning

Elevate the risk of infection and lymphoma, latent virus activation Risk of post-transplant diabetes mellitus Discontinue cyclosporine 24 hours before taking Takfa 0.25mg

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 Takfa 0.25mg QT prolongation



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Drug interactions

Takfa 0.25mg is metabolized by CYP3A enzymes, by inhibiting these cytochrome enzymes leads to increasing plasma concentration of Takfa 0.25mg CYP3A inducers: may decrease the concentration of Takfa 0.25mg Mycophenolic acid products: increase exposure to Mycophenolic acid Grape fruit/grape fruit juice: this will prohibit CYP3A enzymes, leads to increase the Takfa 0.25mg whole blood trough concentrations Protease inhibitors: increase the concentration of Takfa 0.25mg

Anti-fungal agents: depending on whole blood concentration of Takfa 0.25mg , anti-fungal drugs are used. While concomitant voriconazole or posaconazole with Takfa 0.25mg, the dose of Takfa 0.25mg decreased to one-third of initial dose Calcium channel blockers: inhibit CYP3A enzymes, increase the concentration of Takfa 0.25mg Anti-bacterial: erythromycin, clarithromycin, troleandomycin, chloramphenicol are inhibit CYP3A enzyme, leads to elevate concentration of Takfa 0.25mg

Anti-mycobacterial: are rifampin and rifabutin; induce CYP3A enzymes causes decrease the Takfa 0.25mg concentration Anti-convulsant: decrease the concentration of Takfa 0.25mg St. Johns wort: decrease the concentration of Takfa 0.25mg Gastric acid regulator and suppressor: increase the concentration of Takfa 0.25mg

contraindicated to

Hypersensitivity reaction or anaphylactic reactions occurs


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