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Use during pregnancy and lactation
There is currently insufficient data on the safety of lamivudine during pregnancy. Lamivudine should be used during pregnancy only if the expected benefit to the mother exceeds the potential risk to the fetus. Although the results of animal experiments cannot always be extrapolated to humans, data from studies on rabbits indicate a possible risk of spontaneous abortion in the early stages of pregnancy.
In newborns and children under the age of 1 year, whose mothers took drugs from the group of nucleoside reverse transcriptase inhibitors during pregnancy and childbirth, cases of a slight transient increase in serum lactic acid concentration, obviously caused by mitochondrial dysfunction, have been described. The clinical significance of a temporary increase in the concentration of lactic acid in serum has not been established. In addition, very rare cases of developmental delay, convulsive syndrome and other neurological disorders have been reported. However, the relationship of these complications with the use of nucleoside reverse transcriptase inhibitors during pregnancy and their effect on postnatal development has not been proven. Therefore, HIV-infected women during pregnancy are recommended to take antiretroviral drugs to prevent vertical transmission of HIV.
According to experts, all HIV-infected women should, if possible, refuse to breastfeed in order to avoid transmission of the virus to the child through breast milk. After oral administration, lamivudine is excreted in breast milk; at the same time, its concentration in breast milk practically does not differ from its concentration in serum (1-8 mcg / ml). Women taking lamivudine are not recommended to breastfeed.
Hypersensitivity to lamivudine or any other component of the drug Epivir. The age is younger than 3 months due to the fact that data on the use of the drug in this age group are limited.
It should be used with caution in patients with renal insufficiency; pancreatitis (including a history); peripheral neuropathy; during pregnancy and lactation.