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Side effects when ingested
Efavirenz has been studied in more than 2,000 patients and is usually well tolerated in clinical trials. In controlled clinical trials in a subgroup of 413 patients receiving 600 mg/day of efavirenz in combination with protease inhibitors and/or nucleoside reverse transcriptase inhibitors, the most frequently reported adverse events of at least moderate severity associated with treatment were:
From the nervous system and sensory organs: dizziness (9.2%), headache (6.3%), insomnia (6.1%), fatigue (5.6%), decreased concentration (5.3%).
In controlled clinical trials in which efavirenz (600 mg) was administered together with other antiretroviral drugs, neurological symptoms of moderate to severe intensity were observed in 22.8% of patients compared with 10.1% in the control group. Severe neurological symptoms were observed in 2.9% of patients receiving efavirenz (600 mg / day), and 1.3% of patients in the control group, in 2.7% of patients due to neurological symptoms, treatment was canceled. These symptoms usually occurred during the first 1-2 days of treatment and, as a rule, passed after 2-4 weeks.
Serious psychiatric side effects have been reported in patients taking efavirenz. In controlled trials, the frequency of serious psychiatric symptoms in patients treated with efavirenz and in the control group was, respectively: severe depression – 1.6 and 0.6%, suicidal thoughts – 0.6 and 0.3%, nonfatal suicide attempts – 0.4 and 0%, aggressive behavior – 0.4 and 0.3%, paranoid reactions – 0.4 and 0.3%, manic reactions – 0.1 and 0%. In addition, depression — 15.8 and 13.1%, anxiety — 11.1 and 7.6%, nervousness — 6.3 and 2% were found with a frequency of more than 2% in patients treated with efavirenz and in the control group.
From the gastrointestinal tract: nausea (10.4%), diarrhea (6.8%), rarely – dyspepsia, abdominal pain.
From the skin: rash (in the form of mild or moderate maculopapular skin rashes that appeared during the first 2 weeks after the start of treatment; in most patients, the rash passed with continued treatment for 1 month, in clinical trials on patients receiving 600 mg of efavirenz, a severe rash developed in 0.7% of patients, in 1.7% treatment was canceled due to the rash); erythema multiforme or Stevens—Johnson syndrome (0.14% among more than 2000 patients ).
PREGNANCY AND LACTATION
Pregnancy should be excluded in women receiving efavirenz (in experiments on primates, efavirenz passed through the placenta and had a teratogenic effect). Before starting treatment, women of childbearing age should undergo pregnancy testing and always use barrier contraception methods in combination with other methods (for example, oral or other hormonal contraceptives) during treatment.
In the case of pregnancy, the use of efavirenz is permissible only in cases where its possible benefit justifies the potential risk to the fetus (adequate and well-controlled studies have not been conducted in pregnant women).
The category of action on the fetus according to the FDA- D.
Breastfeeding is not recommended due to the potential risk of transmission of the virus and, although it is not known whether efavirenz is excreted in human milk, possible severe side effects of efavirenz in infants. Studies on rats have shown that efavirenz is excreted in milk.