Brand Name : Mylimus
Active ingredient : Tacrolimus
Strength availability : 1mg
Manufactured by : Mylan Pharmaceuticals
Dosage Form : capsule
Packing : pack of 60 tablets
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Mylimus 1mg belongs to macrolide antibiotic originally developed from Streptomyces tsukubaensis. Mylimus 1mg joints to immunophilins known as FK506-binding proteins (FKBPs). The resulting tacrolimus-immunophilin complex gives the same action and effects as described for cyclosporine. Mylimus 1mg is authorized for prophylaxis against rejection of allogeneic liver transplants. The drug is also possibly as useful as cyclosporine for other conditions. Mylimus 1mg has been shown to exert profound antipsoriatic effects, potentially by direct concomitant with keratinocytes.
Mylimus 1mg is indicated after allogenic organ transplant to decrease the activity of the patient's immune system and so the risk of organ rejection.
Mylimus 1mg was first approved by the FDA in 1994 for usage in liver transplantation, this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants.
Mylimus 1mg has also been indicated for a topical preparation in the treatment of severe atopic dermatitis.
MECHANISM OF ACTION
Mylimus 1mg prevents the T-lymphocyte activation. The drug binds to a protein (FKBP- 12) inside the cell and forms complex of Mylimus 1mg - FKBP-12, calcium, calmodulin, and calcineurin. The alteration of nuclear factor of activated T- cells(NF-AT), a nuclear component which initiate gene transcription for the formation of lymphokines (as interleukin-2, gamma interferon). Finally, results prevention of T-lymphocyte activation.
Kidney transplant - Organ Transplant – Rejection prophylaxis
Dose is depending on body weight and should be described by your doctor. The initial dose is generally 0.1 to 0.2 milligram per kilogram (mg/kg) of body weight per day, divided into 2 doses and have every 12 hours. Your doctor may adjust the dose as needed
High dose: 0.1mg/kg/day continuous IV infusion.
Mylimus combination with azathioprine: initial dose 0.1mg/kg orally every 12hours. Initiate within 24 hours surgery.
In combination with mycophenolate: Initial dose 0.05mg/kg orally every 12hours started with 24hrs of surgery
Children – The prescribed dose is 0.3 mg/kg per day, divided in 2 doses, given every 12 hours
Liver transplant - Organ Transplant – Rejection prophylaxis :
In Adults the Dose is depending on body weight and should be described by your doctor. The initial dose is commonly 0.1 to 0.15 milligram per kilogram (mg/kg) of body weight per day, divided into 2 doses and taken every 12 hours. Your doctor may adjust the dose as needed.
Children prescribed Dose is depending on body weight and should be described by your doctor. The initial dose is commonly 0.15 to 0.2 mg/kg of body weight per day, divided into 2 doses and taken every 12 hours.
Heart transplant- Organ Transplant– Rejection prophylaxis:
In Adults the Dose is depending on body weight and should be described by your doctor. The initial dose is commonly0.075 milligram per kilogram (mg/kg) of body weight per day, divided into 2 doses and taken every 12 hours. Your doctor may adjust the dose as needed.
Children prescribed dose is 0.3 mg/kg per day, divided in 2 doses, given every 12 hours. Your doctor may adjust your dose as needed.
Graft versus host disease in adult
Initial dose: 0.03mg/kg/day, initiate at least 24hrs before to stem cell infusion. Treatment :
IV: initial dose 0.03mg/kg/day (continuous infusion) To convert IV to oral then multiply total daily IV dose 4 times and administer in 2 divided oral dose /day, every 12hrs.
Pediatric dose for organ transplant – Rejection Reversal :
Liver transplant :
Initial dose: 0.075 to 0.1 mg/kg orally every 12 hrs.
IV, Initial dose: 0.03 to 0.05 mg/kg/day as continuous infusion
Graft versus host disease :
IV, initial dose 0.03 mg/kg/day (continuous IV), started at least 24 hrs. before to stem cell infusion, it used only if oral medication can be tolerated.
IF OVERDOSE OCCURS: Mylimus overdose may leads to passing out or breathing trouble. Call emergency medical or poison control for rapid action.
Absorption: Oral slowly absorbed in the GI tract, total bioavailability 20 to 25%, highest blood plasma concentration reached after 1-3hrs.
With food slows down resorption and reduces bioavailability,
Distribution: In the blood Mylimus 1mg is mainly bound to erythrocytes, plasma 5%, plasma protein binding 98.8%.
Metabolism: Mylimus 1mg is metabolized in liver, mainly via CYP3A and in the intestinal wall.
Elimination: Mylimus 1mg exerted through feces in form of its metabolites. Biological half-life 43 hrs. (healthy), liver transplation person 12hrs, for kidney transplation 16 hrs.
Avoid Mylimus 1mg , if you allergic to its own or hydrogenated castor oil, cyclosporine with the past 24 hrs.
Discuss with doctor, if Mylimus 1mg used for longer periods of time, it will develop skin cancer, that weaken immune system and the possible risk.
Inform early to doctor about : • Have kidney or liver disease;
• Have cardiac disease, hypertension, hyperlipidemia or triglycerides (a type of fat in the blood);
• a cardiac rate disorder or history of long QT syndrome;
• taking heart rhythm medication; or
• usage of other medications that can weaken your immune system
• pregnancy, not known whether harm unborn baby
• while Mylimus 1mg therapy, avoid breast feed.
Concomitant use of Mylimus 1mg with
Aluminum/magnesiumantacid, cyclosporine, sirolimus, temsirolimus, ziprasidone, causes increase the level of potassium in the blood and with other drugs ( natalizumab, rituximab) will weaken the immune system and increase the risk of infection.
Cimetidine, danazol, nefazodone, ethinyl estradiol, methylprednisolone, antifungal drugs, rifamycin, anti-seizure will remove tacrolimus from the body and affect its work.
Hypersensitivity reaction by Mylimus 1mg , the symptoms reported dyspnea, rash, pruritis and acute respiratory distress syndrome.
MISSED DOSEIf dose is failed to take then immediately have the dose you remember before next dose or skip the missed, if next dose time reached. Do not take double dose at a time. Take advice of the doctor about missed dose.
More common side effects:
Abnormal dreams, Agitation, Chills, Confusion, Cough, Diarrhoea, Dizziness, Fever, Frequent Urination, General Feeling of Discomfort or Illness, Headache, Itching, Skin Rash, Joint Pain, Loss of Appetite, Loss of energy or weakness, Mental depression.
Severe side effects:
Cardiac damage, Liver and kidney problem, Increase in potassium, glucose level, Diabetes mellitus, Hypomagnesemia, Lung damage.
Fungal infection: herpes zoster or polyoma
Carcinogenesis and mutagenesis: Non- Hodgkin’s lymphoma
Topical use common: burning or itching sensation; less common flu like symptoms, head pain.