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(Simeikai) is a compound preparation. Each tablet contains dolutegravir sodium (calculated as dolutegravir) 50 mg, abacavir sulfate (calculated as abacavir) 600 mg and lamivudine 300 mg. It is suitable for the treatment of adults infected with human immunodeficiency virus (HIV) and adolescents over 12 years old (with a weight of at least 40 kg). Among them, dolutegravir can inhibit HIV integrase by binding to the active site of integrase and blocking the strand transfer step of reverse transcription deoxyribonucleic acid (DNA) integration (a key step in the HIV replication cycle).

What is the recommended dose of Dolutegra Abalami Tablets?

For adults and adolescents, the recommended dose of Trimax is one tablet once daily. Adults or adolescents whose body weight is less than 40 kg should not be given this product because this product is a fixed-dose tablet and the dose cannot be reduced. Dolutegravir is a fixed-dose tablet and should not be used in patients requiring dose adjustments. If discontinuation or dose adjustment of one of the active ingredients is required, separate formulations of dolutegravir, abacavir, or lamivudine may be used. In these circumstances, physicians should refer to the respective product information for these medicines.

Dotiabalamid tablets should be used by pregnant and lactating women:

pregnancy

In general, animal data as well as clinical experience in pregnant women should be considered when deciding to use antiretroviral drugs to treat HIV infection in pregnant women to reduce the risk of vertical transmission of HIV to the newborn.

There are no data on the use of dolutea in pregnant women.

Data on the use of dolutegravir in pregnant women are limited or non-existent. The effects of dolutegravir on human pregnancy are unknown. Regarding the coadministration of abacavir and lamivudine in pregnant women, there is a limited amount of data indicating no teratogenic toxicity (more than 400 results from first-trimester exposure). Regarding lamivudine, extensive data (more than 3000 results from first-trimester exposure) indicate no teratogenic toxicity. Regarding abacavir, a certain amount of data (more than 600 results from first-trimester exposure) suggests no teratogenic toxicity.

In animal reproductive toxicity studies, dolutegravir was found to cross the placenta. Animal studies have not shown any direct or indirect harmful effects in terms of reproductive toxicity. Abacavir and lamivudine may inhibit cellular DNA replication, and abacavir has been shown to be carcinogenic in animal models. The clinical significance of these results is unclear.

Dolutegra should be used during pregnancy only if the expected benefits outweigh the risks to the fetus.

If a patient coinfected with hepatitis B virus is receiving lamivudine-containing medicines, such as Trimax, and subsequently becomes pregnant, the possibility of hepatitis recurrence should be considered when discontinuing lamivudine.

mitochondrial dysfunction

Nucleosides and nucleoside analogs have been shown to cause varying degrees of mitochondrial damage in vitro and in vivo. Mitochondrial dysfunction has been reported in HIV-negative infants exposed to nucleoside analogues in utero and/or postnatally.

breastfeeding

It is unclear whether dolutegravir is secreted into human milk. Existing animal toxicology data shows that dolutegravir can be secreted into milk. Lactating rats received 50 mg/kg dolutegravir orally on day 10 postpartum. The concentration of dolutegravir detected in milk is usually higher than that in blood.

Abacavir and its metabolites are excreted into the milk of lactating rats. Abacavir is also excreted in human milk.

Based on data from more than 200 mother/child pairs receiving HIV treatment, serum concentrations of lamivudine in infants breastfed by mothers receiving HIV treatment are extremely low (less than 4% of maternal serum concentrations) and tend to decrease gradually, reaching undetectable levels by the time the infant reaches 24 weeks of age. No safety data are available for infants younger than 3 months of age receiving abacavir and lamivudine.

It is recommended that HIV-infected women should not breastfeed their infants under any circumstances to avoid transmitting HIV.

fertility

There are no data on the effects of dolutegravir, abacavir, or lamivudine on male or female fertility. Animal studies have shown that dolutegravir, abacavir, or lamivudine has no effect on male or female fertility.

elderly patients

There are limited data on the use of dolutegravir, abacavir, and lamivudine in patients aged ≥65 years, and there is no evidence that older patients require different doses than younger adults. Taking into account age-related changes, such as decreased renal function and changes in hematological parameters, special caution is recommended when administering the drug in this age group.

Miss a dose

If the patient misses a dose and there are more than 4 hours before the next dose, Suimeikan should be taken as soon as possible. If the next dose is less than 4 hours away, patients should not take the missed dose and simply resume their usual dosing schedule.