Viramune
Viramune (Nevirapine)Pharmacological action
Antiviral preparation. Viramune immediately blocks activity RNK-DEPENDENT and DNA-polymerase DNA-dependent, causing destruction of a catalytic site of this enzyme
Indications
- HIV-infection treatment in a combination with others antivirus preparations applied to treatment of a HIV-1 of an infection
- For the prevention of transfer of a HIV-1 from mother to the child, at pregnant women who do not receive antivirus therapy in sorts is recommended.
Dosage regimen
The adult in an initial stage the preparation is prescribed in a dose of 1 times/sut by of 200 mg daily within the first 14 days (it is established, that at such regimen of dosage frequency of development of an eruption decreases), then the dose is enlarged to 200 mg by 2 times/sut daily (in a combination at least with 2 antivirus preparations). In case of application of the combined therapy it is necessary to follow the dosage and monitoring rules recommended by manufacturers.
To children at the age from 2 months till 8 years the preparation is prescribed in a dose of mass of a body of 1 times/sut by of 4 mg/kg within the first 14 days, then on 7 mg/kg/sut 2 times/days the Recommended dose for children at the age of 8 years and is more senior makes 4 mg/kg of 1 times/sut within the first 14 days, then on 4 mg/kg 2 times/days
The maximum daily dose for patients of any age makes 400 mg.
For preventive maintenance of transfer of a HIV from mother to the child recommend unitary Viramune appointment to the pregnant woman during sorts (as soon as possible after the beginning of sorts) in a dose of 200 mg with the subsequent unitary peroral introduction to the newborn during 72 h after a birth in a dose of mass of a body of 2 mg/kg. If mother has accepted Viramune less than for 2 h to sorts, the newborn should enter the first dose (2 mg/kg) immediately after a birth, and the second dose (2 mg/kg) - within 24-72 hours after the first.
Patients need to be informed on necessity to accept Viramune daily how it is offered to them. In case of the admission of reception of a preparation the patient should not double the following dose, it is necessary to accept the next dose as soon as possible. Prior to the beginning of Viramune reception and through corresponding intervals during therapy biochemical researches, including researches of function of a liver should be carried out.
Patients at whom during a 14-day initial stage of daily reception of a preparation in a dose of 200 mg/sut the eruption becomes perceptible, should not enlarge a dose until the eruption will not disappear.
The patients who have interrupted Viramune reception for the term of more than 7 days, at therapy renewal should use a recommended regimen of dosage again: to accept a preparation in a dose of 200 mg (at children of 4 mg/kg/sut) 1 time/sut (initial stage), and then 200 mg 2 times/sut (at children of 4 mg/kg or 7 mg/kg 2 times/sut, depending on age).
Side effect
At adults
Most often during all clinical researches by the undesirable phenomena bound to Viramune therapy, there was a nausea, fatigability, a fever, a headache, vomiting, a diarrhoeia, an abdominal pain; very seldom - an anaemia and a neutropenia.
In rare instances at the patients receiving Viramune as a part of regimens of therapy, it was informed on arthralgias, as the unique undesirable phenomenon.
Application experience has shown, that the most serious side-effects are Stevens-Johnson's syndrome, a toxic epidermal necrolysis, a serious hepatitis / hepatic insufficiency and the syndrome of hypersensitivity characterised by an eruption, the general symptoms (a fever, arthralgias, a lymphadenopathy) and symptoms of a lesion of internal organs (a hepatitis, an eosinophilia, a granulocytopenia and dysfunction of kidneys). The critical period during which the careful control is required, the first 18 weeks of treatment are.
Dermatological reactions
The most frequent clinical sign of Viramune toxicity is the eruption.
Dermal reactions serious or dangerous to a life meet approximately in 2 %. They include Stevens-Johnson's syndrome and, less often, a toxic epidermal necrolysis which arise more often within the first 6 weeks of therapy.
The eruption usually weakly or is moderately expressed, characterised by the erythematic elements which are accompanied or not accompanied by an itch, localised on a trunk, the person and extremities. It was informed on allergic reactions (including an anaphylaxis, a Quincke's disease and an urticaria). The eruption (any degree of expression) develops in the first 6 weeks of treatment more often.
Collateral reactions from a liver
The critical period which demands the careful control, the first 18 weeks of treatment are. The greatest risk of development of reactions from a liver becomes perceptible in the first 6 weeks of therapy. However this risk remains and in the subsequent, therefore the frequent control should proceed during all period of treatment.
The clinical expressed hepatitis can be isolated or to be accompanied by an eruption and-or the general symptoms.
At children
Contraindications
- Clinically significant raised by sensitivity to Nevirapine or to any other component of a preparation.
Special indicatings
It is necessary to consider, that the first 18 weeks of Viramune treatment are the important period demanding careful observation over patients for the purpose of timely revealing of dermal reactions possible serious and menacing to a life (including Stevens-Johnson's syndrome, a toxic epidermal necrolysis), the expressed hepatitis or hepatic insufficiency. The greatest risk of hepatotoxic and dermatological reactions exists in the first 6 weeks of therapy. The risk of the undesirable phenomena from a liver is raised at women and at patients with higher number CD4 of cells. During the initial 14-day period the special attention should be given careful observance of a regimen of dosage.
At the patients receiving Viramune, serious and menacing lives dermatological reactions, including with a lethal outcome became perceptible. Cases of a syndrome of Stevens-Johnson, a toxic epidermal necrolysis and the syndrome of hypersensitivity characterised by an eruption, the general reactions and a lesion of internal organs were observed. Careful observation of patients within the first 18 weeks of treatment is necessary. Observation is required and in case of development of the isolated eruption.
Overdosage
Symptoms: there are reports on overdosage cases at Viramune application in a daily dose of 800-6000 mg with duration of treatment till 15 days. At patients edemas, a nodulose erythema, fatigability, a fever, a headache, a sleeplessness, a nausea, infiltrates in lungs, an eruption, giddiness, vomiting, augmentation of level of transaminases and depression of mass of a body became perceptible. After preparation cancellation the involution of all symptoms is noted.
Treatment: preparation cancellation. The antidote is unknown.
Conditions and periods of storage
The preparation should be stored at temperature not above 30 C. The Period of validity - 3 years. The preparation should be used during 2 months from the moment of vial opening.
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