Universal reference book for medicines
Product name: LAMIVUDINE (LAMIVUDINE)

Active substance: lamivudine

Type: Antiviral drug active against HIV

Manufacturer: ФП ОБОЛЕНСКОЕ (Russia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
An antiviral agent, a nucleoside reverse transcriptase inhibitor.
Penetrating into cells, it is metabolized to 5-triphosphate, which inhibits reverse transcriptase of HIV, which leads to inhibition of viral replication. It is active against strains resistant to zidovudine, and when used in combination with it, it slows down the development of virus resistance to zidovudine (in patients previously untreated). Has an in vitro therapeutic index higher than zidovudine (weaker than zidovudine, it depresses bone marrow precursor cells, and also has less pronounced cytotoxic effect on peripheral blood lymphocytes, lymphocytic and monocyte-macrophage cell lines).Slightly affects the metabolism of cellular deoxynucleotides and DNA content in mitochondria of intact cells.
Lamivudine is highly active against hepatitis B virus (HBV) in all cell lines studied and in all experimentally infected animals.

PHARMACOKINETICS
Quickly absorbed from the digestive tract.
Bioavailability is 80-88%. C max in blood plasma is achieved 1 h after administration. Lamivudine penetrates the GEB, the placental barrier. Binding to plasma proteins - 36%. Metabolized by phosphorylation to form 5-triphosphate. T 1/2 - 5-7 hours 68-71% is excreted in the urine unchanged.
INDICATIONS
Treatment of HIV infection in adults and children (as part of combination therapy with other antiretroviral drugs).

Chronic viral hepatitis B in the background of replication of HBV in patients aged 16 years and older.

DOSING MODE
The dose and treatment regimen is set depending on the indications.

SIDE EFFECT
On the part of the digestive system: pain and discomfort in the epigastric region, nausea, vomiting, diarrhea, decreased appetite, increased activity of hepatic transaminases.

From the side of the central nervous system: increased fatigue, headache.

On the part of the respiratory system: respiratory tract infections.

Other: general malaise.

CONTRAINDICATIONS
Hypersensitivity to lamivudine.

PREGNANCY AND LACTATION
Although there is no direct indication of teratogenic effects and changes in the reproductive function, lamivudine should be used during pregnancy only after a thorough assessment of the expected benefit and the potential risk of side effects.

If you need to use lamivudine during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution for violations of kidney function.
At CC less than 50 ml / min dose adjustment is necessary.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Correction of the dosing regimen in patients with impaired liver function is not required.
However, it should be used with caution in patients with severe hepatic cirrhosis due to the hepatitis B virus, given the risk of exacerbation after lamivudine withdrawal.
APPLICATION FOR CHILDREN
Experience with lamivudine in children younger than 3 months is not available.
In children with impaired renal function, correction of the dosing regimen in the same proportions as in adults is recommended.
SPECIAL INSTRUCTIONS
Use with caution for violations of kidney function.
At CC less than 50 ml / min dose adjustment is necessary.
Given that lamivudine is excreted almost exclusively by the kidneys, correction of the dosing regimen in patients with impaired liver function is not required.However, it should be used with caution in patients with severe hepatic cirrhosis due to the hepatitis B virus, given the risk of exacerbation after lamivudine withdrawal.

Lamivudine is not used in combination with zidovudine for neutropenia (neutrophil counts less than 750 / μl) or anemia (hemoglobin less than 7.5 g / dl or 4.65 mmol / l).

If abdominal pain, nausea, vomiting or an increase in the level of pancreatic enzymes in the blood plasma, lamivudine should be withdrawn and not reopened until the diagnosis of pancreatitis is eliminated.

The use of lamivudine does not prevent the possibility of infection during sexual intercourse or through blood.

During the treatment period, one should keep in mind the possibility of developing a secondary infection.

Use in Pediatrics

The experience of lamivudine in children under the age of 3 months is absent.
In children with impaired renal function, correction of the dosing regimen in the same proportions as in adults is recommended.
DRUG INTERACTION
With simultaneous use of lamivudine increases the duration of action of zidovudine by 13%, and its C max in blood plasma - by 28%.
Zidovudine does not affect the pharmacokinetics of lamivudine.
Synergy with zidovudine and other antiviral agents used in the treatment of infections caused by HIV with regard to HIV replication in cell culture has been noted.

When used simultaneously with didanosine, sulfonamides, zalcitabine, the risk of developing pancreatitis increases.

When used simultaneously with dapsone, didanosine, isoniazid, stavudine, zalcitabine, the risk of peripheral neuropathy increases.

Trimethoprim increases the concentration of lamivudine in blood plasma.

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