Item nanme:Lamif film Item character:The drug is a grey diamond film coated tablet with "gxej7" engraved on one side
Indication: It is mainly suitable for chronic hepatitis B with hepatitis B virus replication[ 1] Combined with other antiretroviral drugs, it is used to treat adults and children infected with human immunodeficiency virus (HIV).
Item specifications:0.1g*14tab/box
Usage and dosage:The initial treatment of patients should be carried out by doctors with experience in the treatment of HIV infection.
Adults and adolescents over 12 years old: the recommended dose is lamivudine 300 mg daily. You can choose to take 150 mg twice daily or 300 mg once daily (see Precautions). 300 mg tablet is only suitable for once a day.
If the patient takes the medicine once a day instead of twice a day, he should take 300 mg tablets once a day in the morning of the next day after taking 150 mg tablets twice a day. If the patient changes from taking medicine twice a day to taking medicine once a night, he can take 150 mg tablets once in the morning and 300 mg tablets in the evening. If the patient wants to take the medicine twice a day instead of once a day, he needs to take enough treatment dose on the same day and take 150 mg tablets twice a day in the morning of the next day.
Children: children aged 3 months to 12 years: the recommended dose is 4 mg / kg twice a day, and the maximum dose is 300 mg / day.
Children under 3 months of age: few data are available at present, which is not enough to propose a special recommended dose for this patient group (see pharmacokinetics).
For patients and children who are not suitable for taking tablets, it is beneficial to Pingwei oral liquid.
Yipingwei can be taken with food or alone.
Renal damage: in patients with moderate to severe renal damage, the clearance of lamivudine is reduced and the plasma concentration (AUC) of lamivudine is increased. Therefore, for patients with creatinine clearance rate < 30 ml / min, the dose of lamivudine should be reduced as follows.
Adults and children over 12 years old:
For patients with creatinine clearance rate ≥ (greater than or equal to) 50 ml / min, the first dose was 150 mg, and the maintenance dose was 150 mg, twice a day;
For patients with creatinine clearance rate ≥ (greater than or equal to) 30 - < 50 ml / min, the first dose was 150 mg, and the maintenance dose was 150 mg, once a day;
If the creatinine clearance rate is less than 30 ml / min, oral liquid is recommended if the required dose is less than 150 mg.
The data of lamivudine use in children with renal damage are not enough. Since the clearance of lamivudine in children and adults is similar, the dosage of lamivudine should be reduced by the same percentage in children with kidney injury.
Children aged 3 months to 12 years:
For patients with creatinine clearance rate ≥ 50 ml / min, the first dose was 4 mg / kg, and the maintenance dose was 4 mg / kg, twice a day;
For patients with creatinine clearance rate ≥ (greater than or equal to) 30 - < 50 ml / min, the first dose was 4 mg / kg, and the maintenance dose was 4 mg / kg, once a day;
When creatinine clearance rate was 15 - < 30 ml / min, the first dose was 4 mg / kg, and the maintenance dose was 2.6 mg / kg, once a day;
When creatinine clearance rate was 5 - < 15 ml / min, the first dose was 4 mg / kg and the maintenance dose was 1.3 mg / kg, once a day;
For patients with creatinine clearance rate < 5 ml / min, the first dose was 1.3 mg / kg, and the maintenance dose was 0.7 mg / kg, once a day.
Liver damage: data from patients with moderate to severe liver damage show that liver dysfunction has no significant effect on the pharmacokinetics of lamivudine. According to these data, it is not necessary to adjust the dosage for patients with moderate to severe liver damage, unless accompanied by renal dysfunction.
Adverse reactions In the treatment of HIV with this product, the following adverse events have been reported. In many cases, it is not clear whether these adverse events are drug-related or potential disease related.
The list of adverse events that may be associated with treatment is as follows, according to the body system, organ category and incidence, respectively:
The general expression of adverse reactions classification is: very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), extremely rare (< 0.01%).
The symptoms of blood and lymph system are not common: neutrophils, anemia (both of which are sometimes serious), thrombocytopenia; Extremely rare: true red blood cell dysplasia.
Nervous system is common: headache, insomnia; Extremely rare: peripheral neuropathy or sensory abnormality.
Respiratory tract, chest and mediastinum are common: cough, nose symptoms.
Gastrointestinal tract is common: nausea, vomiting, upper abdominal pain or abdominal pain, diarrhea; Rare: serum amylase increased, pancreatitis has been reported.
Liver is not common: liver enzyme once increased (AST, ALT); Rare: hepatitis.
Skin and subcutaneous tissue are common: rash, hair loss.
Musculoskeletal and joint tissue are common: joint pain, muscle dysfunction; Rare: striatum dissolution.
Other common: fatigue, discomfort, fever.
In patients with nucleoside analogues, there are cases of lactate acidosis, which usually accompanied by severe hepatomegaly and fatty liver, sometimes endangering life (see note).
HIV patients who received combined antiretroviral therapy had a redistribution of fat (dysmetabolism of fat) in the body, including decreased subcutaneous fat around the face, increased abdominal and visceral fat, breast enlargement and accumulation of fat in the back of neck (Buffalo like scapular fat deposition).
Combined with antiretroviral therapy, metabolic abnormalities such as hyperglycemia, hypercholesterolemia, insulin resistance, hyperglycemia and hyperlactatemia (see note).
Taboo: It is forbidden for patients who are known to be allergic to lamivudine or any component in lamivudine preparations.
Matters needing attention: It is not recommended to use this medicine alone.
For patients with moderate to severe renal damage, the end plasma half-life increases due to the decrease of lamivudine clearance. Therefore, the dosage should be adjusted (see usage and dosage).
Once daily dose (300 mg once daily): clinical studies have shown that there is no significant difference between taking lamivudine once or twice daily. The results were obtained in asymptomatic patients (CDC stage a) with HIV infection who had never used antiretroviral drugs.
Patients receiving this drug or any other antiretroviral therapy may continue to develop opportunistic infections and other HIV infection complications. Therefore, close clinical observation should be conducted by doctors with experience in the treatment of HIV related diseases.
Patients should be told that current antiretroviral therapy, including this drug, has not been shown to prevent the risk of HIV transmission through sexual contact or blood contamination. Appropriate prevention should continue.
Pancreatitis: there are few reports of pancreatitis in patients treated with this drug. But it is not clear whether these cases are due to antiretroviral therapy or potential HIV disease. In case of abnormal clinical signs, symptoms or laboratory examination, the patient should consider the occurrence of pancreatitis and stop using immediately.
Lactic acidosis: lactic acidosis has been reported after the use of nucleoside analogues, usually associated with severe hepatomegaly and fatty liver. Early symptoms include benign gastrointestinal symptoms (such as nausea, vomiting and abdominal pain), unclear physical discomfort, loss of appetite, weight loss, respiratory symptoms (shortness of breath and / or deep breathing) or neurological symptoms (including motor neurasthenia).
Lactic acidosis, with high mortality, may be associated with pancreatitis, liver injury, kidney injury.
Lactic acidosis usually occurs several months after treatment.
When the patient has unexplained metabolic / lactic acidosis, progressive hepatomegaly or rapid elevation of transaminase, the treatment of nucleoside analogues should be stopped immediately.
Any patient with hepatomegaly, hepatitis or risk factors for liver disease and fatty liver (including drugs or alcohol), especially obese women, should be careful when taking nucleoside analogues. Co infection with hepatitis C and the use of α Patients treated with interferon or triazole nucleoside drugs may pose special risks.
The above patients should be closely observed.
HIV patients receiving combined antiretroviral therapy are associated with fat redistribution (dyslipidemia). The long-term consequences of these events are unknown; The understanding of its mechanism is not comprehensive. It has been hypothesized that visceral lipomatosis is related to proteinase inhibitors (PIs) and lipodystrophy is related to nucleoside reverse transcriptase inhibitors (NRTIs). The high risk of fatty disorder is related to both individual factors (such as age) and drug-related factors, such as long-term antiretroviral therapy and metabolic disorders. Clinical examination should include evaluation of signs of fat redistribution. Fasting blood lipid and blood glucose levels should be considered. It should be controlled by clinical application.
Patients with hepatitis B virus infection: clinical trials and the use of lamivudine after marketing show that some patients with chronic hepatitis B virus (HBV) infection will have evidence of hepatitis recurrence in clinical and laboratory examination once they stop using lamivudine. This condition may have more serious adverse consequences in patients with decompensated liver disease. If patients with HBV infection discontinue the drug, regular monitoring of liver function test and HBV replication markers should be considered.
Immune reconstitution syndrome: HIV infected patients with severe immunodeficiency can cause asymptomatic or residual opportunistic inflammatory response when they begin to use antiretroviral drugs (Art), and lead to severe clinical conditions or symptoms deterioration. Generally, these reactions can be observed in the first few weeks or months of art treatment. Such as cytomegalovirus retinitis, systemic and / or focal mycobacterial infection and Pneumocystis carinii pneumonia. Any inflammatory symptoms must be evaluated immediately and treated if necessary.
Impact on driving and machine operation: the impact of lamivudine on driving behavior and machine operation has not been studied.
Medication for pregnant and lactating women: Pregnancy: the effect of lamivudine on human pregnancy safety has not been determined. The study on animal reproduction did not show that lamivudine had teratogenic effect, and the drug had no effect on the fertility of male and female animals. When lamivudine in pregnant female rabbits is at the same dose as human, lamivudine causes early embryo death in animals. The drug can be transported passively through placenta, and the serum lamivudine concentration at birth is the same as that of cord serum and mother at birth.
Although animal reproductive studies do not always predict human responses, lamivudine is not recommended for the first three months of pregnancy.
Lactation: Lamivudine can be excreted by milk, and the concentration of drug in milk is the same as that of serum. Since lamivudine and the virus can enter milk, it is recommended that mothers taking this drug do not breastfed the baby. In order to avoid the spread of HIV, it is recommended that mothers infected with HIV do not breastfed their babies in any case.
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