Takfa Capsule
Tacrolimus
0.5mg
Intas Pharmaceuticals Ltd.
| Pack size | |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price |
Available as:
Indications
Takfa Capsule is used for:
Prophylaxis of rejection in kidney, liver & cardiac graft transplant
Adult Dose
Oral
Prophylaxis of rejection in kidney graft transplant
Adult: Initially, 0.2-0.3 mg/kg/day in 2 divided doses every 12 hr. Begin oral dose within 24 hr of transplant.
Prophylaxis of rejection in liver graft transplant
Adult: Initially, 0.1-0.2 mg/kg/day in 2 divided doses every 12 hr. Start treatment 12 hr after transplantation.
Fistulising Crohn's disease
Adult: 200 mcg/kg/day in 2 divided doses for 10 wk.
Prophylaxis of cardiac graft rejection
Adult: With or without antibody induction: Starting within 5 days of transplantation but no earlier than 6 hr after transplantation. 75 mcg/kg daily in 2 divided doses.
Hepatic impairment: Severe impairment (Child-Pugh score of ?10): Use lower dosages and close monitoring of blood concentrations needed.
Child Dose
Oral
Prophylaxis of rejection in liver graft transplant
Child: Initially, 0.15-0.20 mg/kg/day in 2 divided doses every 12 hr. Begin no sooner than 6 hr after transplant.
Renal Dose
Renal impairment: Dose reduction needed.
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 & grapefruit juice.
Contra Indications
Hypersensitivity, lactation.
Precautions
Monitoring of blood trough serum concentrations to prevent organ rejection and to reduce drug-related toxicity. Topical: Used with caution on the face or neck, large areas of the body (not >50% of the total BSA), or areas of broken skin. Infections at the treatment site should be cleared prior to therapy. Delay use in patients with unknown cause of lymphadenopathy or acute infectious mononucleosis till resolution. Use in patients with Netherton's syndrome is not recommended. Pregnancy.
Pregnancy-Lactation
Interactions
Increased nephrotoxicity with ciclosporin, aminoglycosides, amphotericin B, cisplatin, NSAIDs, vancomycin, co-trimoxazole, aciclovir, ganciclovir. Increased risk of hyperkalemia with potassium-sparing diuretics. Increased plasma concentrations and toxicity with azole antifungals, calcium-channel blockers, cimetidine, danazol, HIV-protease inhibitors, macrolide antibacterials and metoclopramide. Antacids, rifampin, rifabutin, casofungin, phenytoin, phenobarbital and carbamazepine decrease tacrolimus plasma concentrations. Concurrent admin of sirolimus and tacrolimus decrease levels of both.
Adverse Effects
Side effects of Tacrolimus :
Systemic: Tremor, headache, paraesthesias, nausea and diarrhoea, hypertension, blood dyscrasias, leucocytosis, impaired renal function, serum electrolyte disturbances, infectious complications. Mood changes, sleep disturbances, confusion, dizziness, tinnitus, visual disturbances convulsions, alterations in glucose metabolism, ECG changes, tachycardia, myocardial hypertrophy, constipation, dyspepsia and GI haemorrhage; dyspnoea, asthma, pleural effusions; alopoecia, hirsutism, skin rash and pruritus; myalgia, spasm, leg cramps, peripheral oedema, liver dysfunction and coagulation disorders. Topical: Burning, stinging, soreness, pruritus, skin disorders, headache and flu-like symptoms. Increased incidence of malignancy.
Potentially Fatal: Nephrotoxicity, neurotoxicity and anaphylactic reaction.
Mechanism of Action
Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action unclear. Tacrolimus bind to cytosolic receptors known as immunophilins (i.e., cyclophilin and FK binding protein-12 [FKBP-12], respectively), forming complexes that inhibit the production of cytokines via the calcineurin pathway. Inhibition of calcineurin activity inhibits early activation of T-cells (ie.immunosuppresion results).
Note
Takfa 0.5mg Capsule manufactured by Intas Pharmaceuticals Ltd.. Its generic name is Tacrolimus. Takfa is availble in Nepal.
Farmaco Nepal drug index information on Takfa Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.