ZEFFIX Tablet

ក្រុមហ៊ុនផលិតឱសថ:

 

GlaxoSmithKline Pte Ltd, Singapore

  • សារធាតុសកម្ម
  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់
  • ហាមប្រើ
  • ផលរំខាន
  • អន្តរប្រតិកម្ម
  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន
  • ការប្រុងប្រយ័ត្នជាពិសេស
  • សកម្មភាពឱសថ
  • បរិយាយប័ណ្ណឱសថ 
  • សារធាតុសកម្ម

  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់

    For the treatment of patients≥16 years of age with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication with one or more of the following conditions:

    - elevated serum alanine aminotransferase (ALT)≥2 times normal

    - liver cirrhosis

    - decompensated liver disease

    - biopsy-proven necro-inflammatory liver disease

    - immunocompromised state

    - liver transplant

    Dosage and Administration

    100mg once daily.

    Zeffix can be taken with or without food.

    Optimum duration of therapy has not been established.

    Discontinuation of Zeffix may be considered in the following situation:

    - in immuocompetent patients with HbeAg and/or HBsAg seroconversion confirmed

    - when a female patient becomes pregnant during therapy

    - when a patient shows signs of intolerance to Zeffix while on treatment

    - where in the treating doctor’s opinion, there is a loss of efficacy of Zeffix e.g. when persistent return of serum ALT to pre-treatment values or when the patient experiences deterioration in liver histology

    Patient compliance should be monitored while on Zeffix therapy. If Zeffix is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis.

    Discontinuation of treatment is not recommended in patients with decompensated liver disease. There are limited data regarding the maintenance of seroconversion long term after stopping treatment with Zeffix.

    Zeffix should be used in accordance with available official recommendations.

    See the package insert about the details below:

    - Renal impairment

    - Hepatic impairment

  • ហាមប្រើ

    In patients with known hypersensitivity to lamivudine or to any ingredient of the preparation.

  • ផលរំខាន

    See the package insert about the details below:

    The most common adverse events reported were malaise and fatigue, respiratory tract infections, headache, abdominal discomfort and pain, nausea, vomiting and diarrhoea.

    Hepato-biliary disorders

    Very common: Elevations of ALT

    Musculoskeletal, connective tissue and bone disorders

    Common: Elevations of CPK

    Blood and the lymphatic system disorders

    Very rare: Thrombocytopenia

    Musculoskeletal, connective tissue and bone disorders

    Common: Muscle disorders, including myalgia and cramps.

    Very rare: Rhabdomyolysis

    In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) have been reported, although no relationship to treatment with lamivudine has been clearly established. In patients with chronic hepatitis B there was no observed difference in incidence of these events between placebo and Zeffix treated patients.

    Cases of lactic acidosis, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of combination nucleoside analogue therapy in patients with HIV. There have been occasional reports of these adverse events in hepatitis B patients with decompensated liver disease.

  • អន្តរប្រតិកម្ម

    The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding and almost complete renal elimination of unchanged drug.

    Lamivudine is predominantly eliminated by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system e.g. trimethoprim. Other drugs (e.g. ranitidine, cimetidine) are eliminated only in part by this mechanism and were shown not to interact with lamivudine.

    Drugs shown to be predominately excreted either via the active organic anionic pathway or by glomerular filtration are unlikely to yield clinically significant interactions with lamivudine.

    See the package insert about the details below:

    - Trimethoprim/sulphamethoxazole

    - Zidovudine

    - Alpha-interferon

    - Zalcitabine

    - Emtricitabine

  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន

    See the package insert about the details below:

    Pregnancy

    Use in pregnancy should be considered only if the benefit outweighs the risk.

    Zeffix administration is not recommended during the first 3 months of pregnancy.

    Lactation

    Mothers taking Lamivudine do not breast feed their infants.

  • ការប្រុងប្រយ័ត្នជាពិសេស

    During initiation and maintenance of treatment with Zeffix patients should be monitored regularly by a physician experienced in the management of chronic hepatitis B. Serum ALT levels should be monitored at 3 months intervals and HBV DNA and HbeAg should be assessed every 6 months.

    If Zeffix is discontinued or there is a loss of efficacy due to the development of YMDD variant HBV, some patients may experience clinical or laboratory evidence of recurrent hepatitis. If Zeffix is discontinued, patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least 4 months for evidence of recurrent hepatitis; patients should then be followed as clinically indicated. For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of Zeffix treatment. Exacerbation of hepatitis has primarily been detected by serum ALT elevations, in addition to the re-emergence of HBV DNA. Clinical Studies for more information regarding frequency of post treatment ALT elevations. Most events appear to have been self-limited. Fatalities are very rare and the casual relationship to discontinuation of lamivudine treatment is unknown.

    In patients with moderate to severe renal impairment, serum lamivudine concentrations (AUC) are increased due to decreased renal clearance, therefore the dose should be reduced for patients with a creatinine clearance of <50mL/min.

    Transplantation recipients and patients with advanced liver disease are at greater risk from active viral replication. Due to marginal liver function in these patients, hepatitis reactivation at discontinuation of lamivudine or loss of efficacy during treatment may induce severe and even fatal decompensation. It is recommended that these patients are monitored for parameters associated with hepatitis B, for liver and renal function, and for antiviral response during treatment at least every month. If treatment is discontinued for any reason, and for antiviral response during monitored for at least 6 months post cessation of treatment, Laboratory parameters to be monitored should include (as a minimum) serum ALT, bilirubin, albumin, blood urea nitrogen, creatinine, ad virological status: HBV antigen/antibody, and serum HBV DNA concentrations when possible. Patients experiencing signs of hepatic insufficiency during or post-treatment should be monitored frequently, as appropriate.

    There are limited data on the use of lamivudine in patients receiving concurrent immunosuppressive regimes, including cancer chemotherapy.

    HBV viral subpopulations (YMDD variant HBV) with reduced susceptibility to lamivudine have been identified during extended therapy. In a minority of cases this variant can lead to recurrent hepatitis.

    For the treatment of patient who are co-infected with HIV and are currently receiving or are planning to receive an antiretroviral treatment regimen including lamivudine, the dose of lamivudine usually prescribed for HIV infection should be maintained. For HIV co-infected patients not requiring anti-retroviral therapy, there is a risk of HIV mutation when using lamivudine aloe for treating chronic hepatitis B.

    There is no information available on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with Zeffix. The standard recommended procedures for hepatitis B virus immunization in infants should be followed.

    Patients should be advised that therapy with Zeffix has not been proven to reduce the risk of transmission of hepatitis B virus to others and therefore, appropriate precautions should still be taken.

  • សកម្មភាពឱសថ

    Lamivudine is an antiviral agent which is highly active against hepatitis B virus in all cell lines tested and in experimentally infected animals.

    Lamivudine is metabolised by both infected and uninfected cells to the triphosphate (TP) derivative which is the active form of the parent compound. The intracellular half life of the triphosphate in hepatocytes is 17-19 hours in vitro.

    Lamivudine-TP acts as a substrate for the HBV viral polymerase. The formation of further viral DNA is blocked by incorporation of lamivudine-TP into the chain and subsequent chain termination.

    Lamivudine-TP does not interfere with normal cellular deoxynucleotide metabolism. It is also only a weak inhibitor of mammalian DNA polymerasesαand β. Furthermore, lamivudine-TP has little effect on mammalian cell DNA content.

    In assays relating to potential drug effects on mitochondrial structure and DNA content and function, lamivudine lacked appreciable toxic effects.

    It has a very low potential to decrease mitochondrial DNA content, is not permanently incorporated into mitochondrial DNA, and does not act as an inhibitor of mitochondrial DNA polymeraseɤ.

*ព័ត៌មានឱសថត្រូវបានរៀបរៀងដោយ អ៊ីម៉ាតុគឹ មេឌីក (ខេមបូឌា) ដោយផ្អែកលើប្រភពព័ត៌មានខាងក្រោម។ សម្រាប់ព័ត៌មានលម្អិត សូមស្វែងរកនៅក្នុងក្រដាសព័ត៌មាននៃឱសថនីមួយៗ ឬ សាកសួរទៅកាន់ក្រុមហ៊ុនឱសថឬតំណាងចែកចាយនៃឱសថនីមួយៗ។

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