Lamzidivir Stella supports HIV infection treatment (5 blisters x 6 tablets)

Caution when using

Chemical infections:

Patients with Lamzidivir or any other Retrovirus resistance can continue to progress to the opportunity and other complications of HIV infection. Therefore, patients need to be closely monitored by doctors who have experience in the treatment of HIV infection.

Unwanted reaction of hematology:

Anemia, neutropenia and leukopenia (usually after neutropenia) can occur in patients using zidovudine. These symptoms occur more frequently in the higher zidovudine (1200 - 1500 mg/day) and in patients with marrow failure before treatment, especially for progressive HIV disease.

Therefore, hematological parameters should be carefully monitored in patients using Lamzidivir.

Pancreatitis:

Cases of pancreatitis rarely occur in patients treated with lamivudine and zidovudine. It is unclear these cases due to Retrovirus resistance or HIV. Stop treatment with Lamzidivir immediately if clinical signs, clinical symptoms, or tests are related to pancreatitis.

Lactic acid infection:

There has been reports of lactic acid infections that are often associated with large liver and fatty liver when using zidovudine. Initial symptoms (hyperlactic lactate symptoms) include benign gastrointestinal symptoms (nausea, vomiting and abdominal pain), unknown discomfort, anorexia, weight loss, respiratory symptoms (rapid breathing and/or deep breathing) or neurological symptoms (including movement impairment).

Lactic acid infection has a high mortality rate and may be associated with pancreatitis, liver failure or renal failure. Lactic acid infections usually occur after a few or more months of treatment. Zidovudine should be discontinued if symptomic lactate and metabolic acidosis or lactic acidosis, progressive liver, or aminotransferase levels increase rapidly.

Be careful when using zidovudine for any patient (especially obese women) with large liver disease, hepatitis or other known risk factors for liver and fatty liver disease (including certain drugs and alcohol). Patients with hepatitis C and treatment with interferon alpha and ribavirin are at risk. Patients with high risk should be closely monitored.

Mercenary dysfunction:

Similar substances nucleosid and nucleotid have been shown to in vitro and in vivo, causing the degree of transformation of the company's lesions. There have been reports on dysfunction of mitochondria in children infected with HIV in the uterus and/or postpartum for nucleosid similar substances.

The unwanted effects are reported as hematological disorders (anemia, neutropenia), metabolic disorders (hyperlipidemia). These reactions are often transient. Some late triggered neurological disorders have been reported (superiority, convulsions, abnormal behaviors).

neurological disorders are transient or permanently unknown. Any child in contact with the uterus with nucleosid and nucleotid -similar substances, even children negative with HIV, need clinical monitoring and testing and fully research on mitochondrial dysfunction in the event of signs or symptoms related.

Fatty tissue atrophy:

Zidovudine treatment is associated with loss of subcutaneous fat, related to the toxicity of the mitochondria. The ratio and severity of fat tissue atrophy are associated with the accumulated concentration. The amount of fat lost is most evident in the face, limbs and buttocks, may not recover when switching to an non -zidovudine mode.

Patients should be regularly evaluated with signs of fat tissue atrophy after treatment with zidovudine and products that contain zidovudine. Should switch to alternative treatment regimen if suspected of the development of fat tissue atrophy.

Weight and metabolic parameters:

Gain weight and increase blood lipid and blood glucose levels may occur during antiviral treatment. These changes may be partly related to controlling disease and lifestyle. For lipids, there are some evidence due to treatment effects, while weight gain has no evidence related to any treatment.

Monitor blood lipids and blood glucose to set instructions in HIV treatment. Lipid disorders should be appropriate clinical control.

Immunity syndrome:

In patients with HIV infection with severe immunodeficiency at the time of combined treatment with antiviral (Cart), inflammatory reactions to diseases have no symptoms or remaining may arise and cause severe clinical manifestations, or increase symptoms.

Normally, these reactions were observed within the first few weeks or the first month after starting treatment combined with Retrovirus resistance. Any inflammatory symptoms should be evaluated and treated when necessary. Autoimmune disorders (such as Graves disease) are also reported in immunosuppressing.

However, the time from the report to the onset is very changing and these symptoms may occur months after the beginning of treatment.

Liver disease:

The safety and effectiveness of zidovudine has not been established in patients with significant hidden liver disorders. Patients with chronic hepatitis B or C and Cart are at risk of increasing unwanted effects on the liver and likely to cause death. In case of simultaneous treatment with hepatitis B or C drugs, refer to the relevant information in these drugs. If stopping lamzidivir in patients with hepatitis B virus infections, it is recommended to periodically monitor the liver function test and the signs of HBV copy for 4 months, because the stop use of Lamivudine can lead to acute hepatitis.

Patients with previous liver dysfunction, including chronic hepatitis, have an abnormal liver function frequency when treating cart, and should be monitored. If there is evidence of the deterioration of liver disease in these patients, it is necessary to consider interrupting or stopping treatment.

Patients who are co -infected with hepatitis C virus:

It is not recommended to simultaneously use ribavirin with zidovudine due to an increased risk of anemia.

Bone necrosis:

Although the cause is thought to be multi -factor (including the use of corticosteroids, drinking alcohol, severe immunodeficiency, higher body mass index), there has been reporting special cases of bone necrosis in HIV -infected patients progressing and/or long -term contact with cart. Patients should be medical advice if pain and joint pain, stiffness or difficulty moving.

Lamzidivir should not be used with other drugs that contain lamivudine or emtricitabin.

Do not recommend combining lamivudine with cladribin.

lamzidivir contains lactose. This drug should not be used for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or poorly absorbed glucose-galactose.

The ability to drive and operate machinery

There is no research on the effect of the drug on the ability to drive and operate machinery. However, Lamzidivir can cause unwanted effects on the nervous system such as headache, dizziness. Patients with these effects when using Lamzidivir should not drive and operate machinery.

Pregnancy

The use of zidovudine in pregnant women then treating babies has shown to reduce the rate of HIV transmission from mother to child. The data on pregnant women using lamivudine or zidovudine shows no monster toxicity.

The active ingredients of Lamzidivir can inhibit cell copy and zidovudine has been shown to be cancer -causing fetal cancer in an animal study.

For patients with hepatitis co -infected with lamivudine -containing preparations such as Lamzidivir and then pregnant, it is necessary to consider the possibility of recurrence of hepatitis when stopping lamivudine.

Mercenary dysfunction: Nucleosid and nucleotid -like substances that have been shown in vitro and in vivo causes the degree of transformation of the mitochondrial damage. There has been a report on the dysfunction of mitochondria in negative children with HIV contact with nucleosid in the uterus and/or after birth.

The period of breastfeeding

both lamivudine and zidovudine are excreted into breast milk at the same concentration as in the serum. It is recommended that HIV -infected mothers do not breastfeed in any case to avoid HIV infection.

Drug interaction

lamzidivir contains lamivudine and zidovudine, so any interactions are determined for each individual active ingredient is related to Lamzidivir. Clinical studies show that there is no clinical interaction between Lamivudine and Zidovudine.

Zidovudine is metabolized mainly by UGT enzymes; Simultaneous use of induction drugs or enzyme inhibitors can change zidovudine levels. Lamivudine is cleared in the kidneys.

Active lamivudine excretion in the kidneys through urine through intermediaries of organic cation (octs); Simultaneous use of lamivudine with oct inhibitors or single -to -singing drugs may increase lamivudine levels.

lamivudine and zidovudine are not significantly metabolized by cytochrom HP450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor inhibit or touch this enzyme system. Therefore, there is very little potential to interact with protease inhibitors I resistance of Retrovirus, non -nucleosid substances and other drugs are metabolized mainly by P450 enzymes.

Drug interactive studies are only done in adults. The list below is not considered complete, but the representative of the drug groups studied