Sustiva
Sustiva (Efavirenz)Pharmacological action
Sustiva (Efavirenz) an inhibitor against human immunodeficiency virus type 1 (HIV-1).
Indications
The combined antiviral therapy of adults, teenagers and children infected with a HIV-1.
Dosage regimen
Sustiva is necessary to prescribe in a combination with others preparations (inhibitors of proteases).
The adult recommended Sustiva dose makes 600 mg/sut inside.
To children and teenagers (from 3 till 17 years) preparation doses establish depending on age and body mass.
The recommended dose for children with mass of a body more than 40 kg makes 600 mg/days
Sustiva is necessary to prescribe only to children who are capable to swallow of capsules easily. At children about 3 years are elderly and less than 13 kg Sustiva application was not studied by mass of a body.
Frequency rate of reception of 1 times/days can be accepted the Preparation irrespective of food intake.
For improvement of shipping of side-effects from nervous system within the first 2-4 weeks of treatment, and also patient who continue to test these symptoms, it is recommended to accept a preparation before a dream.
Side effect
In controllable clinical tests in a subgroup from 413 patients receiving Sustiva daily on 600 mg in a combination to inhibitors of proteases, most often becoming perceptible undesirable phenomena bound to treatment, at least moderately severe were: an eruption (13.1 %), a nausea (10.4 %), giddiness (9.2 %), a diarrhoeia (6.8 %), a headache (6.3 %), a sleeplessness (6.1 %), fatigability (5.6 %), depression of concentration of attention (5.3 %). In control group the nausea was observed more often, and a diarrhoeia - approximately with peer frequency.
In clinical tests for 57 type sick children and frequency of collateral reactions were as a whole similar to those at adult patients except that at children occurrence of a new eruption (35 %) was more often observed.
Sustiva was studied more than on 2000 patients and usually during clinical tests it was well transferred. Following by-effects became perceptible:
Dermatological reactions: easy or moderate makulo-papular dermal rashes (appeared within first two weeks and at the majority of patients passed within a month without the treatment termination). In clinical tests the eruption is noted at 28 % of the patients receiving a preparation on 600 mg/sut, in comparison with 18 % among the patients receiving preparations in control group. The dermal eruption was is considered caused by treatment at 18 % of the patients receiving Sustiva. The serious eruption accompanied by blisters, a soaked ecdysis and ulcers, has developed at 0.7 % of the patients Sustiva receiving. At 1.7 % in this connection treatment should be cancelled. Among more than 2000 patients receiving Sustiva.
From party TSNS and peripheric nervous system: at the patients receiving Sustiva on 600 mg/24h, during clinical tests became perceptible: giddiness (9.2 %), a headache (6.3 %), a sleeplessness (6.1 %), fatigability (5.6 %), depression of concentration of attention (5.3 %), dream disturbances. In controllable clinical tests in which Sustiva in a dose of 600 mg was prescribed together with others preparations, neurologic symptoms of average and strong intensity became perceptible at 22 % of patients (in comparison with 10.1 % among the patients receiving the control scheme of treatment). These symptoms were serious at 2.9 % of the patients receiving Sustiva on 600 mg/24h, and at 1.3 % of the patients receiving control treatment. In clinical tests at 2.7 % of the patients receiving Sustiva on 600 mg, in connection with neurologic symptoms treatment has been cancelled. These symptoms arose within 1-2nd day of treatment and, as a rule, passed in 2-4 weeks. In research on not infected volunteers the representative symptom from nervous system arose on the average through 1 h after reception of a dose and lasted on the average 3 h.
From the alimentary system: a nausea (10.4 %), a diarrhoeia (6.8 %).
From laboratory indicators: in the table clinically important deviations of results of laboratory analyses which were observed during three controllable clinical tests are generalised.
Contraindications
Clinically significant hypersensibility to a preparation;
Pregnancy and lactemia
Adequate and strictly controllable researches at pregnant women it was not spent. Sustiva is necessary to apply at pregnancy only in the event that its prospective advantage for mother justifies potential risk for a foetus.
Women of genital age should use reliable methods of contraception in preparation application.
Special indicatings
Sustiva is impossible to apply as a unique preparation to treatment of a HIV or to add as a unique preparation to unsuccessful treatment; a preparation always prescribe in a combination with one or several new preparations which the given patient did not receive earlier. At a choice new preparations for their application in a combination with Sustiva is necessary to consider possibility of two-dimensional fastness of a virus.
At cancellation of Sustiva treatment is necessary to survey also possibility of cancellation of treatment by others preparations to avoid occurrence of refractory viruses.
Overdosage
It was informed on intensifying of neurologic symptoms at the patients who have casually accepted on 600 mg of 2 times/days At one patient there were consensual muscular reductions.
Treatment: the general actions, including monitoring of indicators of the vital functions and observation over a clinical condition of the patient. It is possible to apply the activated coal to acceleration of excision of not absorbed preparation. The specific antidote is not present.
Conditions and periods of storage
The preparation should be stored at temperature from 15 to 30 C.
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