Emtor 1mg

Emtor 1mg tablets are used for the prophylaxis of organ rejection in patients aged 13 years or older getting renal transplants.

Sirolimus

Emtor

1mg

Emcure




Emtor 1mg

Emtor 1mg is an immunosuppressive agent. Emtor 1mg is a macrocyclic lactone obtained from Streptomyces hygroscopicus which acts by selectively stopping the transcriptional activation of cytokines thereby preventing cytokine production.

It is bioactive only when linked to immunophilins.

Emtor 1mg possesses both antifungal and antineoplastic properties.

Emtor 1mg is a prescription drug which is used under guidance of medical practioners.

Mechanism of action

Emtor tablets prohibits T lymphocyte activation and multiplication which occurs in response to antigenic and cytokine (Interleukin IL-2, IL-4, and IL-15) provocation by a mechanism that is obvious from that of other immunosuppressants. Emtoralso prohibits antibody production. In cells, Emtorjoints to the immunophilin, FK Binding Protein-12 (FKBP-12), to produce an immunosuppressive complex. The FKBP-12 complex (Emtor) on calcineurin activity has no effect. This complex link to and prevents the activation of the mammalian Target of Rapamycin (mTOR), a key regulatory kinase. This prohibition restrains cytokine-driven T-cell proliferation, prohibiting the progression from the G1 to the S phase of the cell cycle.



Pharmacokinetic

In healthy patients and renal transplant patients the peak plasma concentration is 1-2 hours and bioavailability are 27%.

human plasma protein binding is 92%

Emtor is extensively metabolized in the intestinal wall and liver. It is substrate for both CYP3A4 and P-gp

most of radioactivity was recovered from the faces is 91% and only little amount was excreted in urine is 2.2%.
Half-life of Emtor is 57-63 hours.



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drug
Brand Emtor
Ingredients Sirolimus
Strength 1mg
Manufactured Emcure
Rating

Emtor Is Used For The Prophylaxis Of Renal Transplant Rejection
Starting treatment combination with cyclosporine and corticosteroids

High immunologic risk
The loading dose is <40 kg: 3 mg/m² ≥40 kg: 15 mg PO loading dose Maintenance dose of Emtor is 5 mg/day PO if >40 kg and 1 mg/m²/day if <40 kg on day 2 and after that; produce trough levels between days 5 and 7.
Dose should be adjusted to regulate trough concentrations within desired range based on clinical state and combination therapy; further dose adjustment should not be done sooner than 7-14 days following a dose adjustment
Concomitant therapy: For the first year, following transplantation, Emtor should be used in concomitant with cyclosporine and corticosteroids; cyclosporine may be started at 7 mg/kg/day in divided doses with the dose modify to achieve trough concentrations; prednisone should be given at a dose of 5 mg/day The disease is very serious and requires a daily dose of 200 mg of Omnacortil for seven days. The further dosage is prescribed by the doctor based on the stage and seriousness of the disease.

Low-to-moderate immunologic risk
The loading dose <40 kg: 3 mg/m² ≥40 kg: 6 mg PO loading dose Maintenance: 2 mg/day PO if ≥ 40 k g and 1 mg/m²/day if <40 kg on day 2 and thereafter; obtain trough levels between days 5 and 7
Dose should be adjusted to regulate trough concentrations within desired range based on clinical state and combination therapy; further dose adjustment should not be done sooner than 7-14 days following a dose adjustment
Concomitant therapy: Following transplantation, Emtor should be used in concomitant with cyclosporine and corticosteroids; may stops cyclosporine gradually over 4-8 weeks two to four months after transplant in patients with low immunologic risk, &Emtor dose higher (serum concentrations of sirolimus may reduce following cyclosporine withdrawal).
LYMPHANGIOLEIOMYOMATOSIS
Emtor used for treatment of lymphangioleiomyomatosis (LAM) Starting dose: 2 mg/day PO given in 10-20 days and then check whole blood trough level

Over dosage

If overdose occurs all should provide general supportive measures.

Side effects of Emtor 1mg

Common side effects :
Fever, cold and cough, Mouth sores; Nausea, stomach pain, diarrhoea; Headache, muscle aches; Chest pain; Dizziness; or Acne.

Other side effects, if it occurs then immediately call doctor

Slow healing of a skin wound; A new skin lesion, Unusual bleeding Sudden discomfort in chest, cough, feeling short of breath; Pain around the transplanted kidney; Infection like--fever, chills, painful mouth sores, skin sores, cold or flu symptoms, pain or burning when you urinate; or Anemia- skin in pale, unusual weakness, feeling light-headed or dyspnea cold hands and feet.

Precautions

Emtor 1mg should be recommended only by physicians who have experience with immunosuppression in organ transplant recipients and can supply necessary follow-up and appropriate checking
Avoid use in liver or lung transplantation as safety and efficacy is not established
In liver transplant recipients have been observed Increased mortality, loss in graft, and hepatic artery thrombosis
In lung transplant recipients has been observed Bronchial anastomotic dehiscence
Emtor 1mg will increased risk of infection, lymphoma, and other malignancies due to raise immunosuppression
Greatest extend sun exposure because of increased skin cancer risk
Patients commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia will have reported Progressive multifocal leukoencephalopathy (PML), sometimes fatal

DRUG – DRUG INTERACTION

  • Emtor combination with cyclosporine will increases sirolimus concentration. Hence sirolimus should give 4 hours after administration of cyclosporine
  • Avoid combination use of Emtor with strong inducers and strong inhibitors will reduces interaction potential with sirolimus
  • Using with grapefruit juice will prohibits the CY3A4 – mediated metabolism of Emtor. Avoid during using with sirolimus

Contraindications

Emtor 1mg is contraindicated with patients having hypersensitivity to sirolimus




Pregnancy category is C .
Emtor 1mg: There are no sufficient and well-tolerated studies in pregnant women. Efficient contraception must be started before sirolimus therapy, during sirolimus therapy, and for 12 weeks after Emtor therapy has been stopped.

Many drugs are excreted in human milk, and because of the possible undesirable effects in nursing infants from Emtor 1mg, a decision should be considered whether to stops for nursing or to discontinue the drug, considering the necessary of the drug to the mother.

Emtor 1mg Stored at 20 - 25°C Avoid using if blister is torn or broken.

If dose is missed, have it soon before next dose reaches or skip the dose and follow normal timing Please Consult with the doctor.


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