Temivir Meyer - BPC supports the treatment of HIV -I infection or chronic hepatitis B treatment (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Tenofovir disoproxil fumarat, lamivudin

Ingredient

Composition informationContent
Tenofovir disoproxil fumarat300mg
Lamivudin100mg

Uses

indications

Temivir drugs are indicated in the following cases:

  • Treatment for patients with HBV infection has failed treatment with tenofovir disoproxil fumarat or single lamivudin. kg).

    Therapy pharmacological group: antiviral drugs.

    ATC code: J05AF07.

    Tenofovir is a nucleotid inhibiting the backward enzyme, which is used in combination with other Retrovirus anti -Retrovirus drugs in the treatment of HIV infection 1 in adults. Drugs used by oral in the form of disoproxil fumarat ester. Tenofovir Disoproxil Fumarat is a salt of the pre -Pharmaceutical Tenofovir Disoproxil quickly absorbed and transformed into Tenofovir and then Tenofovir Diphosphate in cells. This substance inhibits the reverse code enzyme of the HIV-1 virus, due to disputes with natural substrates, Deoxyadenosin 5'-triphosphate and after attaching it to DNA, it will extend to the DNA chain.

    For HIV In vitro, the Tenofovir concentration is needed to inhibit 50% (CE50) wild strains in HIV -1 laboratory is from 1 - 6 micromol/liter in lymphocytes. Tenofovir also works for HIV-2 In vitro, with a 50% inhibitor of 4.9 micromol/liters in MT4 cells. Sensitive HIV-1 strains for Tenofovir Disoproxil Fumarat can produce in vitro, and also found in clinical treatment when treated with this drug.

    These strains all have a mutant K65R. Tenofovir can be resistant to other reverse transcription enzyme inhibitors

    * Related to lamivudin:

    Pharmacological Group: anti -Retrovirus and virus drugs.

    ATC code: J05AF05.

    lamivudin (2 ', 3'-dideoxythiactidin) belongs to the nucleosid group inhibits the backing enzyme. Lamivudin has the same structure as Zalcitabin. Lamivudine is transformed by enzymes in cells into active derivatives as lamivudin-5'-triphosphate (3TC-TP). Due to the similar structure of Deoxyctidin Triphosphate is a natural substrate for reverse transcription enzymes, 3TC-TP competes with the natural Deoxyctidin Triphosphate and the Summary of the virus's DNA is ended early. Lamivudin has very low toxicity for cells.

    Lamivudin has an activity on HIV and 2 (HIV-1, HIV-2) virus and also has the effect of inhibiting the hepatitis B virus in chronic patients. Although lamivudin is well tolerated, but not used lamivudin is alone because it is easy to produce resistance. This drug resistance due to an enzyme mutation is reverse transcription, reducing sensitivity more than 100 times and losing antiviral effects on patients. Lamivudine -resistant HIV strains are M184i strains (isoleucin replacing methionine in codon 184) and M184V (valin replacement methionine in codon 184) of the enzyme. Treatment of chronic hepatitis B with lamivudin for a while, the anti -drug mutant strains will appear on the polymerase enzyme. The lamivudin anti -anti -Lamivudin strains are M552V (valin replacement methionine in codon 552) and M552i (isoleucin instead of methionine). Despite the appearance of anti-HBE antibodies, DNA-HBV increased after stopping lamivudin and ALT increased, recurrent disease. The lamivudine resistance rate after 1 year of treatment is 24%, after 2 years is 38%, after 3 years is 50%. Lamivudin and Zidovudin combination therapy in patients who have not been treated before, reduces about 10 times the virus density in plasma, lasts more than 1 year, despite the mutations of the backward enzyme.

    pharmacokinetics

    * Related to tenofovir:

  • After giving HIV people taking Tenofovir Disoproxil Fumarat, the drug is quickly absorbed and converted into Tenofovir. Tenofovir peak concentration in plasma is 296 ± 90 nanogam/ml after taking 300 mg is 1-2 hours. The percentage of drugs attached to plasma proteins is less than 1%, attached to serum protein is about 7%. The sale time is 12 - 18 hours. Hematopopare removes the drug from the blood.

    • * Related to lamivudin:

  • After drinking, Lamivudin absorbed quickly and the serum peak concentration reached about 1 hour (drinking at hunger), 3.2 hours (drinking at full). Food slows down but does not reduce the absorption of the drug. Birth in adults infected with HIV is about 80 - 87%; In children from 5 months to 12 years of HIV infection is 66%. The distribution volume is 1.3 liters/kg, regardless of the dose and not correlated with weight. The concentration ratio in the brain -marrow solution/serum concentration is 0.12. The drug is metabolized in the liver and is excreted mainly through the kidneys in the form of unchanged. The sale time in lymphocytes in peripheral blood is 10 - 19 hours. The sale time after taking one -time dose is 5-7 hours in adults; is 2 hours in children from 4 months to 14 years old.

    • Before taking Temivir Meyer - BPC supports the treatment of HIV -I infection or chronic hepatitis B treatment (3 blisters x 10 tablets)

    How to use

    oral tablets. Take the tablet with a glass of water with or not with food.

    In exceptional cases in patients with extremely difficult swallowing, it can be used after disintegrating Tenofovir/Lamivudin tablets in at least 100 ml of water, orange juice or grape juice.

    Dosage

    Dosage in case of treatment:

    Adults

  • The recommended dose of the tablet combined with the fixed dose of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg (1 tablet) is once a day, orally orally with food. To best absorb Tenofovir, the tablet combined with a fixed dose of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg is recommended to be used with food. Tenofovir disoproxil fumarat and single lamivudin. The custom of taking drugs over time for their normal schedule. If the patient forgets a fixed dose of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg after more than 12 hours and is almost time for the next dose, should be abandoned and continue to take the medication over time for their normal schedule. Mg, should take a combination. If the patient vomits after 1 hour after taking a tablet combined with a fixed dose of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg, there is no need to re -tablet.
  • tablets containing tenofovir disoproxil fumarat are not recommended for children.

    There is no data available to give recommendations for patients over 65 years old.

    kidney failure

  • Teams of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg is not recommended for patients with medium or severe renal impairment (creatinine clearance

    The adjustment of the dose of the tablet combined with the fixed dose of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg is not necessary for patients with medium or severe liver failure unless it is accompanied by renal failure.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

    What to do when overdose?

  • There is no adequate data on overdose. If the overdose is suspected, it is necessary to go to the anti -toxic center. Considering the pharmacokinetic properties of the drug, the peritoneal diagnosis or hemolysis may increase the speed of Tenofovir elimination. It is unclear whether this method changes the clinical disease of the overdose of the drug. Pay attention to psychological assistance for patients with suicide.
  • There are very little information about overdose. There is no specific antidote. Hematomopiagia or peritoneal appraisal after 4 hours only takes away a negligible amount. Severe poisoning (pancreatitis, peripheral neuropathy, fatty liver, acute renal failure, acidosis) occur after treatment without occurring immediately after overdose. Long -term use can be toxic to the mitochondria leading to lactic acidosis or without microidal fat in the liver. mg/kg/day is divided into 3 times, each 2 -hour transmission for patients does not appraise or transmit continuously 100 mg/kg/day for patients who are in the feces); use stimulating drugs to create granulocytes (if infected with granulocytosis); use medications causing vasoconstriction if there is many viscera; closely monitor clinical signs, electrolytes, liver enzymes, find infections in patients, especially if there is neutropenia.

    • What to do when forgetting 1 dose? Disoproxil Fumarat 300 mg/lamivudin 100 mg with food as soon as possible and continue to take the drug over time for their normal schedule. If the patient forgets a fixed dose of Tenofovir Disoproxil Fumarat 300 mg/lamivudin 100 mg after more than 12 hours and is almost time for the next dose, the forgotten dose should be abandoned and continued to take the drug over time.

    Side Effects

    When using the drug often has unwanted effects (ADR) such as:

    involves tenofovir

  • Common, 1/100 ≤ ADR Body: Muscle fatigue, headache The urine. Fast, uncomfortable body, muscle pain or cramps, nausea, drowsiness). Acute renal failure, proteinuria, fanconi syndrome, kidney necrosis.
  • Pancreatitis.

    The rate of side effects below is on adults, treated with HIV or HBV with lamivudin in combination with other anti -Retrovirus drugs.

  • Very common, ADR ≥ 1/10:
  • Central nervous system: headache, insomnia, discomfort, fatigue. Muscle, peripheral neuropathy, muscle - bone pain. > Skin: Rashes. 1/1,000 ≤ ADR Neurological - muscle: Perception, myasthenia, melting muscle, peripheral neuropathy, convulsions, abnormal behavior. Bilirubin hepatitis B's hepatitis B added, spleen enlargement. > Instructions on how to handle ADR:

    Notice immediately to the doctor or pharmacist with harmful reactions encountered when using the drug

    • Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    contraindicated

    Temivir drugs are contraindicated in case of sensitivity to tenofovir disoproxil fumarat, lamivudin or any ingredient of the drug.

    Be cautious when using

    need to be very careful when taking the drug for patients in the following cases:

    * Related to tenofovir:

  • Tenofovir disoproxil fumarat must be discontinued when the aminotransferase level increases rapidly, liver gradually or fatty liver, or metabolic acidosis or lactic acid for unknown cause. It must be very cautious when using tenofovir for people with large liver disease, or other risks of liver. Especially, it is very careful for patients with an additional hepatitis C using interferon alpha and ribavirin. If the patient has more hepatitis B, when the tenofovir stops, there may be a risk of severe hepatitis. Liver function must be closely monitored for at least a few months in this patient. Kidney function and serum phosphate must be monitored before starting treatment, every 4 weeks of testing in the first year of treatment, and then every 3 months for people with stones with kidney damage. If the serum phosphate concentration is greatly reduced or clearly cleared below 50 ml/min, the kidney function must be assessed within 1 week, and must adjust the distance for the doses, or to stop the drug.

    * Related to lamivudin:

  • It is necessary to stop the medication in patients with abdominal pain, nausea or vomiting or abnormal biochemical results that suspect pancreatitis. Only use the drug when eliminating pancreatitis. ADR worn the liver. Must monitor liver function in these people. Before using lamivudin to treat hepatitis B, the patient must not have HIV at the same time because the use of low -dose lamivudine to treat hepatitis will lead to lamivudine -resistant HIV strains. The drug must be stopped as soon as there are clinical signs or test results suggesting pancreatitis. HIV -infected children or care for children or pancreatic symptoms. Patients still have to be monitored and taken continuously. Clearly tell the patient that Lamivudin does not reduce the risk of HIV transmission and they have to use condoms to protect their partners.

    • The effect of the drug on the ability to drive and operate machinery

    drivers and operating machinery should be cautious when using the drug because the drug can cause dizziness and drowsiness.

    Use drugs for women during pregnancy

    pregnancy

    Tenofovir is not for pregnant women.

    Be cautious when using lamivudin for pregnant women, to consider the benefits of the mother and the risk of the fetus. Do not use lamivudin for the first 3 months and the middle 3 months of pregnancy because there is a risk of birth defects for the fetus. Using lamivudine for babies in 1 week can be effective as using zidovudin in the prevention of HIV transmission from mother to child (long -term use Zidovudin for mothers and for children is the most effective measure to prevent mother -to -child transmission but also the most expensive measure).

    Breastfeeding period

    It is unclear whether Tenofovir will be in milk. However, the mother uses Tenofovir to treat HIV not to breastfeed to prevent infection.

    lamivudin is excreted in milk. HIV women do not breastfeed. HIV -infected mother is using lamivudin without breastfeeding.

    Drug interaction

    * Related to tenofovir:

  • Tenofovir is not used with Adefovir Dipivoxil. Tenofovir reduces the concentration of acanavir sulfate in plasma. If used simultaneously with Didanosin, Tenofovir must be taken before taking Didanosin for 2 hours or after 1 hour of Didanosin. > Tenofovir simultaneously used with Lopinavir and Ritonavir: Increasing the level of Tenofovir in plasma, reducing Lopinavir concentration and ritonavir peak concentration in plasma. Increasing the serum concentration of Tenofovir or the other drug due to the elimination of the sugar.

    * Related to lamivudin:

  • Anti-invasive drugs into the cell and anti-membrane of the HIV virus (Enfuvirtid, Maravioc): Having a synergistic effect with HIV-1 resistant Lamivudin. (Amprenavir/Fosamprenavir, Nelfinavir, Ritonavir, Saquinavir, Tipranavir): Has a copper effect (in vitro) with lamivudin. There is no evidence of antagonism between Lamivudin and Atazanavir or Darunavir. It is unclear that the pharmacokinetic interaction between Darunavir is enhanced by Ritonavir and Lamivudin. It is unclear that there is a pharmacokinetic interaction between a combined preparation with lopinavir and ritonavir and lamivudin when used simultaneously. LAMIVUDIN's plasma and AUC peak concentration increases when used simultaneously with nelfinavir; However, this has no clinical significance and does not need to adjust the dose. Tipanavir simultaneous use is enhanced with ritonavir that does not affect the pharmacokinetics of lamivudin. There is no need to adjust the dose when used simultaneously Efavirenz and Lamivudin. There is no pharmacokinetic interaction when simultaneously used lamivudin and rilpivirin. When used simultaneously. Abacavir, Satavudin reduces the AUC of Lamivudin but has no clinical significance. Tenofovir reduces 24% of lamivudine plasma concentrations. Do not simultaneously use lamivudin and emtricitabin (emtricitabin is the same substance as lamivudin, used simultaneously without benefits because the two drugs are equally resistant and does not have the effect of strengthening each other). Do not simultaneously use lamivudin and zalcitabin because lamivudin strongly inhibits the phosphorylation zalcitabin inside the cell. The liver failure is fatal. Closely monitor patients to simultaneously use lamivudin and interferon alpha (or peginterferon alpha) with or without ribavirin in toxicity, especially liver failure and to stop the drug if necessary. If the condition is worse (for example, liver failure at level 6 according to the Child-Pugh ladder), it may be necessary to stop or reduce the dose of interferon alpha (or peginterferon) and/or ribavirin. During Retrovirus and Interferon alpha (or Peginterferon alpha) with or without ribavirin. No need to adjust the dose when used simultaneously. No need dose if used simultaneously.

    • * Cavalry of the drug:

    Due to the absence of studies on the correlation of the drug, not mixing this drug with other drugs.

    Storage

    Leave a cool place, avoid light, temperatures below 30⁰C.

    To be out of reach of children, read the instructions carefully before use.

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