Lamivudine

Brand GlaxoSmithKline

In stock 1779 Items

Available since: 2019-09-19

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Clinical Pharmacology

Antiviral drug - nucleoside analog. Zeffix is highly active against the hepatitis B virus. In both infected and uninfected cells, lamivudine is metabolized to lamivudine triphosphate, which is the active form of the drug and serves as a substrate for the hepatitis B virus polymerase. further formation of viral DNA. Lamivudina triphosphate does not interfere with normal cellular DNA metabolism. It is also a weak inhibitor of mammalian α- and β-DNA polymerases. Lamivudina triphosphate does not have a significant effect on the DNA content of cells.

Indications

Chronic hepatitis B against the backdrop of hepatitis B virus replication

Composition

1 tab. contains lamivudine 100 mg.

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Dosage and Administration

Zeffiks take orally, regardless of the meal. Adults and children aged 12 years and older: 100 mg 1 time per day.

Adverse reactions

The most common side effects are general malaise and fatigue, respiratory infections, headache, discomfort and pain in the abdomen, nausea, vomiting and diarrhea.

The frequency of changes in laboratory parameters in patients with chronic hepatitis B is similar when using Zeffix and placebo; the exception is more frequent increases in the level of ALT after completion of therapy with Zeffix. However, there is no significant difference in the incidence of elevated ALT levels, combined with an increase in bilirubin levels and / or signs of liver failure. It is not known whether these cases of exacerbation of hepatitis are associated with treatment with Zeffix or with the course of chronic hepatitis itself.

In patients with HIV infection, cases of pancreatitis and peripheral neuropathy (or paresthesia) were observed, but the association of these complications with lamivudine therapy has not been proven. There was no significant difference in the incidence of these complications in the groups of patients with chronic hepatitis B who took Zeffix and placebo.

In patients with HIV infection who received combination therapy with nucleoside analogs, there were cases of lactic acidosis, which was usually accompanied by severe hepatomegaly and fatty liver dystrophy. There are separate reports of the same side effects in patients with viral hepatitis B and liver failure; however, there is no data confirming the connection of these complications with Zeffix.

Contraindications

Hypersensitivity to lamivudine or to any other component of Zeffix, pregnancy (I term).

Caution should be used for renal failure, pancreatitis (including history), peripheral neuropathy, pregnancy (II-III trimester), during lactation, in childhood (up to 2 years).

Drug interactions

Consideration should be given to the possibility of lamivudine interacting with drugs, the main mechanism of elimination of which is active renal secretion through the system of transport of organic cations, for example, with trimethoprim. The simultaneous use of trimethoprim / sulfamethoxazole (160 mg / 800 mg) increases the concentration of lamivudine in plasma by approximately 40% (in the absence of renal failure there is no need to reduce its dose). Dr. Drugs (for example, ranitidine, cimetidine) are only partially excreted from the body using this mechanism and do not interact with lamivudine. Drugs that are derived primarily through active transport of organic anions or by glomerular filtration, apparently, do not enter into clinically significant interactions with lamivudine. With simultaneous use of lamivudine and zidovudine, there is a moderate (28%) increase in Cmax of zidovudine, while the overall exposure (AUC) does not change significantly. Pharmacokinetic interaction with the combination of lamivudine with interferon alpha or with immunosuppressants (for example, cyclosporin A) is not observed (no special studies have been conducted). With the simultaneous appointment of lamivudine and zalcitabine, lamivudine can inhibit the intracellular phosphorylation of the latter (a combination of these drugs is not recommended). Simultaneous administration of didanosine, pentamidine, sulfonamides and ethanol increases the risk of developing pancreatitis. Dapsone, didanosine, isoniazid and stavudine increase the risk of developing peripheral neuropathy. Increases the duration of zidovudine by 13%, Cmax - by 28%; zidovudine does not affect lamivudine pharmacokinetics. Administration in combination with retrovir slows down the appearance of zidovudine-resistant strains in patients who have not previously received antiretroviral therapy. There is synergism with other drugs used against HIV (especially zidovudine) regarding HIV replication in cell culture.

Special instructions

During treatment with Zeffix, the patient’s condition should be regularly monitored by a physician experienced in the treatment of chronic hepatitis B.

Overdosage

Symptoms: no specific symptoms of lamivudine overdose have been identified. It is recommended gastric lavage, the appointment of Activated charcoal, monitor the patient's condition and carry out standard maintenance therapy. Continuous hemodialysis may be used to remove lamivudine, but no special studies have been conducted.