Side effects of the lamivudine

[Adverse reactions]
in alarm and notes also describe the use of lamivudine to report a variety of serious adverse events (associated with lactic acidosis and severe enlargement of the liver steatosis, hepatitis B treatment increased, pancreatitis, and decreased drug sensitivity and decreased response to treatment related to the emergence of virus mutation).
in chronic hepatitis B patients to conduct clinical studies have shown that most patients have good tolerance of lamivudine. Most of the incidence of adverse events in the lamivudine group and the placebo group patients, similar to the table below.
The most common adverse events for the discomfort and fatigue, respiratory infections, headache, abdominal discomfort and abdominal pain, nausea, vomiting and diarrhea. The 2200 cases in China, Ⅳ clinical studies the following adverse reactions were observed: one case of dry mouth: one case of scarlet fever rash body, creatine phosphate activity of enzymes and thrombocytopenia in 1 case, 1 case of severe hepatitis patient. Conducted in three adult placebo-controlled clinical trials during the treatment of some adverse events (incidence> 5%) (Research 1.3)

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observed in clinical activities: In the lamivudine allowed during the clinical use of the following events found. As these events from a sample size of people's voluntary reporting unknown, therefore, to estimate the incidence can not. These events included the reason why is because of the seriousness of these events reporting frequency, possible causal relationship or with lamivudine in the consolidated results of all these factors,
Digestive: Stomatitis;
Endocrinology and Metabolism: High blood sugar; general: weakness;
blood and lymphatic system: anemia, pure red cell aplasia, lymphadenopathy, splenomegaly.
liver palms and pancreas: lactic acidosis and steatosis, pancreatitis, hepatitis, increased after treatment (see Warnings and Precautions)
allergy: allergic reactions, rubella;
Musculoskeletal: rhabdomyolysis;
nerve tissue: paresthesia, peripheral neuropathy;
Respiratory: Abnormal breath sounds / wheezing.
Skin: alopecia, pruritus, rash.
[taboo] drugs,drugs question and answers
to lamivudine or any other preparation components forbids
[Note]
1 should remind the patient attention, lamivudine is not a curable B hepatitis drugs. The patient must be treated in a hepatitis B drug under the guidance of experienced specialists, can not stop taking this medicine, and be regularly monitored during treatment. At least once every 3 months, ALT levels measured every 6 months, another test HBVDNA and HBeAg.
2. However, HBsAg-positive patients with normal ALT levels, even if the HBeAg and / or HBVDNA positive, should not be starting lamivudine therapy should be followed up regularly, consider the condition of patients change.
3. Time of treatment with lamivudine, in some patients can be detected YMDD mutant hepatitis B virus, this mutant decreased sensitivity to lamivudine (see [Clinical Research] section).
stable if the patient's clinical condition, HBVDNA and ALT levels remain lower than before treatment, may - continued treatment and close observation. A small number of patients in the event of YMDD mutation, due to the reduced role of lamivudine may be manifested as recurrent hepatitis, ALT levels may occur HBVDNA and recovered to baseline levels or above. Some patients with YMDD mutation, in particular, has been associated with liver function in decompensated cirrhosis or patients with a rare disease progress reported cases result in serious consequences or even death, as in this case may also disable lamivudine lead to disease progression, therefore the use of lamivudine for treatment of decompensated liver function occurs or cirrhosis patients, lamivudine should not be arbitrarily suspended. Therefore, if the suspect and the emergence of YMDD mutation should be strengthened clinical and laboratory monitoring may help children to make treatment decisions. drugs,drugs question and answers
4 So far, there is no merger of lamivudine treatment of hepatitis B or hepatitis C, hepatitis D long-term efficacy data. HBeAg-negative patients with lamivudine therapy, or concomitant immunosuppressive treatment, including chemotherapy patients is limited.
5 if the HBeAg-positive patients before seroconversion stop using this product, or to stop drug treatment were poor - some patients may be declared hepatitis increases, mainly for the re-emergence of HBVDNA and elevated serum ALT .
6 If you stop lamivudine therapy (see Dosage), respond to patient's clinical condition and serum liver function (ALT and bilirubin levels) regularly monitored at least 4 months, were followed up according to clinical needs. After cessation of treatment for relapse of hepatitis patients treated with lamivudine re-start the information is not yet fully
7. For organ transplant or advanced liver disease such as decompensated cirrhosis patients at greater risk of viral replication and poor prognosis. The group of patients in the safety and efficacy has not yet been established. There is no sufficient data for approval of lamivudine in clinical research for organ transplant or advanced liver disease such as decompensated cirrhosis patient treatment. According to foreign research data on clinical, rational use of lamivudine can improve liver function in patients with recent decompensation survival in these patients, lamivudine should not be disabled. But as antiviral drugs, lamivudine can reverse the changes in end-stage liver structure and its complications on the patients in this group should also consider other (including liver transplantation) more effective treatment. For patients with HIV infection complicated. If you are accepted or intends to accept the lamivudine or lamivudine? Combination therapy of zidovudine, lamivudine for HIV infection should be to maintain the recommended dose (usually 150 mg each, twice daily administration, At the same time with other antiretroviral drugs combined). For concurrent HIV infection, but do not require antiretroviral therapy for patients, such as lamivudine treatment of chronic hepatitis B, HIV mutation may have occurred.

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