Universal reference book for medicines
Name of the drug: NEVIRAPINE-TL (NEVIRAPINE-TL)

Active substance: nevirapine

Type: Antiviral drug active against HIV

Manufacturer: DRUG TECHNOLOGY (Russia)
Composition, form of production and packaging
The tablets covered with a film shell of
white color, oval, biconcave.

1 tab.

nevirapine 200 mg

Excipients: microcrystalline cellulose - 330 mg, lactose monohydrate - 520.5 mg, sodium carboxymethyl starch - 33 mg, silicon colloidal dioxide - 11 mg, magnesium stearate - 5.5 mg.

The composition of the film shell: film coating opadray II white (polyvinyl alcohol - 46.9%, macrogol 4000 - 23.6%, talc - 17.4%, titanium dioxide - 12.1%) - 40 mg.

10 pieces.
- packings contour mesh (6) - packs cardboard.
10 pieces.
- Packings contour mesh (10) - packs cardboard.
60 pcs.
- bottles (1) - packs of cardboard.
100 pieces.
- bottles (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Antiviral drug, non-competitive non-nucleoside reverse transcriptase inhibitor HIV-1.
Combining with reverse transcriptase, blocks the activity of RNA and DNA-dependent DNA polymerase, causing destruction of the catalytic site of the enzyme. Does not inhibit the reverse transcriptase of HIV-2 and alpha, beta, gamma or delta-DNA polymerase of a human. In combination with other antiretroviral drugs, it reduces viral load and increases the number of CD4 + cells. With monotherapy, the stability of viruses quickly and practically always develops. In vitro, there is cross-resistance with other non-nucleoside reverse transcriptase inhibitors.
PHARMACOKINETICS

Nevirapine is well (> 90%) absorbed after ingestion.
Absolute bioavailability of nevirapine tablets after a single dose of 50 mg was 93 ± 9% (mean ± SD). C maxnevirapine in plasma after a single dose of 200 mg was achieved after 4 hours and was 2 ± 0.4 μg / ml (7.5 μmol). After repeated administration of the drug at doses of 200 to 400 mg / day, the maximal nevirapine increases linearly with the dose. The basal level of nevirapine concentrations during the steady state of pharmacokinetics at a dose of 400 mg / day was 4.5 ± 1.9 μg / ml (17 ± 7 μmol). The ingestion of food, antacids or drugs, the dosage form of which contains an alkaline buffer (eg, didanosine), does not affect the absorption of nevirapine.
Nevirapine has a high lipophilicity and is practically not ionized at a physiological pH.
Nevirapine penetrates well through the placental barrier and is determined in breast milk. The binding of nevirapine to plasma proteins is about 60%, its plasma concentration varies from 1 to 10 μg / ml. Concentrations of nevirapine in cerebrospinal fluid in humans are 45% (± 5%) of plasma concentrations; this ratio roughly corresponds to the fraction of the drug not associated with plasma proteins.
Nevirapine is extensively metabolized with the participation of cytochrome P450 to several hydroxylated metabolites.
Oxidative metabolism of nevirapine is mainly carried out using cytochrome P450 isoenzymes from the CYP3A subfamily, and other isozymes may play an additional role. According to the results of the pharmacokinetic study, approximately 91.4 ± 10.5% of the isotope-labeled dose of the drug was excreted, mainly (81.3 ± 11.1%) through the kidneys and, to a lesser extent (10.1 ± 1.5%), through the intestine. More than 80% of the radioactive label found in urine was associated with conjugates of hydroxylated metabolites with glucuronides.
Thus, the main pathway of biotransformation and removal of nevirapine in humans consists in the metabolism involving cytochrome P450, conjugation with glucuronides and excretion of metabolites associated with glucuronides through the kidneys.
Only a small fraction (<5%) of radioactivity in urine (corresponding <3% of the total dose) was associated with the unchanged compound, ie, renal excretion plays a small role in the induction of nevirapine.
It was shown that nevirapine is the inducer of the enzymes of the system of cytochrome P450 in the liver.
As a result of autoinduction of metabolism, the terminal T1/2 nevirapine from the plasma: approximately 45 hours (with a single dose) to about 25-30 hours (with repeated administration of the drug in doses of 200-400 mg / day).
Clearance in women is 13.8% lower than in men.

In adults aged 19-68 years and in different races, there are no significant differences in pharmacokinetics [parameters are not noted.

Special patient groups

Impaired renal function

Comparison of pharmacokinetics after single administration of nevirapine in patients with mild (Child-Pugh class A), medium (Child-Pugh class B), or severe severity (Child-Pugh class C), noted for kidney disease or in the terminal stage of renal failure requiring dialysis, and in patients with normal renal function (CK> 80 mL / min).
Renal failure (mild, moderate or severe) did not lead to significant changes in the pharmacokinetics of nevirapine. However, in patients with end-stage renal failure requiring dialysis, a reduction of 43.5% of nevirapine AUC was observed during the 1-week exposure period. There was also an accumulation of hydroxylated nevirapine metabolites in plasma. Auxiliary therapy with nevirapine with the use of an additional dose of 200 mg after each dialysis session could compensate for the effect of dialysis on the clearance of the drug.
Impaired liver function

Comparison of pharmacokinetics after single administration of nevirapine in patients with hepatic insufficiency and in patients with normal liver function was compared.
In patients with mild or moderate severity, liver function deficiency does not require an individual dose selection.
However, the results of studying the pharmacokinetics in one patient with moderate expressed ascites indicate the possibility of nevirapine accumulation in systemic circulation in patients with severe impairment of liver function.

Pregnant women

It was found that nevirapine rapidly penetrates the placental barrier.
The concentration of nevirapipa in the blood of the umbilical cord after the mother's intake of the dose of 200 mg was more than 100 ng / ml, and the ratio of blood concentrations in the umbilical cord and in the mother's blood was 0.84 ± 0.19 (n = 36, range 0.37-1.22).
Mothers breastfeeding

Nevirapine is excreted in breast milk.
After a single intake of the drug in the daughter of 200 mg, the average ratio of concentrations in breast milk and in the mother's plasma was 60.5% (25-122%).
INDICATIONS

- Treatment of HIV infection in combination with other antiretroviral drugs used to treat HIV-1 infection.
With monotherapy with nevirapine, resistant strains of the virus quickly and practically always occur. Therefore, nevirapine should always be used in combination with at least two other antiretroviral drugs;
- to prevent mother-to-child transmission of HIV-1, in pregnant women who do not receive antiretroviral therapy during labor, nevirapine is indicated and can be used by the mother as monotherapy, as a single dose taken orally during labor.
In order to minimize the risk of HIV-1 transmission to a child, it is recommended that a combination therapy be provided in the mother before delivery, where this is possible.
DOSING MODE

For oral administration, regardless of food intake.
Tablets should be washed down with water, not crushing or chewing them.
Adults

The recommended dose of nevirapine is 200 mg (1 tab.) 1 time / day for the first 14 days (this introductory period is necessary because it has been determined that the incidence of the rash decreases), then 200 mg 2 times / day, and combination with at least two additional antiretroviral drugs.
In the case of combined therapy, it is necessary to follow the dosing and monitoring rules recommended by the manufacturers.
General recommendations

Patients should be informed about the need to take nevirapine daily, because
it is prescribed to them. If the patient misses the medication, the patient should not double the next dose, the next dose should be taken as soon as possible. Prior to taking nevirapine and at appropriate intervals during therapy, biochemical studies should be carried out, incl. research of liver function.
Patients who have a rash during the 14-day initial period of daily dosing at a dose of 200 mg / day should not increase the dose until the rash disappears.

Patients who stopped taking Nevirapine for a period of more than 7 days, with the resumption of therapy should again use the recommended mode of use, i.e.
take the drug at a dose of 200 mg 1 time / day for 14 days, and then 1 tab. 200 mg 2 times / day.
Prevention of mother-to-child transmission of HIV

The following dosing regimen for women in labor and their newborns is recommended.

Dosing in mothers: a single dose of 200 mg as soon as possible after the onset of labor.

If the mother received nevirapine less than 2 hours before the birth, the newborn should be given the first dose of nevirapine (2 mg / kg) immediately after birth, and the second dose (2 mg / kg) - within 24-72 hours after the first.

Renal insufficiency

Patients with impaired renal function who are on dialysis to compensate for nevirapine's clearance are recommended taking an additional dose of nevirapine 200 mg after each dialysis session.
Patients with a CC of> 20 ml / min do not need to adjust the dose.
Dosing in mothers: a single dose of 200 mg as soon as possible after the onset of labor.

If the mother received nevirapine less than 2 hours before the birth, the newborn should be given the first dose of nevirapine (2 mg / kg) immediately after birth, and the second dose (2 mg / kg) - within 24-72 hours after the first.

Renal insufficiency

Patients with impaired renal function who are on dialysis to compensate for nevirapine's clearance are recommended taking an additional dose of nevirapine 200 mg after each dialysis session.
Patients with a CC of> 20 ml / min do not need to adjust the dose.
SIDE EFFECT

The most common adverse events associated with nevirapine therapy were rash, allergic reactions, changes in liver function indicators, nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain and myalgia.
Postmarketing experience has shown that the most serious side effects are Stevens-Johnson syndrome, toxic epidermal necrolysis, severe hepatitis / hepatic insufficiency, and hypersensitivity syndrome characterized by a rash, common symptoms (such as fever, arthralgia, myalgia and lymphadenopathy) and signs of internal organ damage (such as hepatitis, eosinophilia, granulocytopenia and renal dysfunction). The critical period during which careful monitoring is required is the first 18 weeks of treatment. The following are undesirable events likely associated with nevirapine therapy, according to the generally accepted frequency classification: very often (> 1/10), often (> 1/100. <1/10), infrequently (> 1/1000, <1 / 100), rarely (> 1/10000, <1/1000), very rarely (<1/10000).
On the part of laboratory indicators: often - changes in liver function (increased activity of ALT, ACT, gamma-glutamyltranspeptidase (GGT), increased total bilirubin, alkaline phosphatase);
infrequently - hypophosphatemia.
On the part of blood and blood-forming organs: often - granulocytopenia;
infrequently - anemia:
From the nervous system: often - a headache.

From the skin, subcutaneous fat: very often - a rash;
infrequently - Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, hives;
From the musculoskeletal system: infrequently - myalgia, arthralgna.

From the side. ZHKT: often - nausea, vomiting, diarrhea, abdominal pain.

From the liver and bile ducts: often - hepatitis, incl.
serious and life-threatening hepatotoxicity; infrequently - jaundice; rarely - fulminant hepatitis (including fatal).
From the side of the cardiovascular system: infrequently - increased blood pressure.

From the immune system: often - allergic reactions (including angioedema, urticaria): rarely - a drug rash, accompanied by eosinophilia and general symptoms, anaphylaxis.

Other: often - fatigue, fever.

Patients who received combined antiretroviral therapy had lipodystrophy, including central obesity, an increase in fatty tissue in the dorso-cervical region ("buffalo buffalo"), a decrease in the volume of peripheral adipose tissue, reduced not subcutaneous fat in the facial area, hypertrophy of the mammary glands.

Against the background of combined antiretroviral therapy, metabolic disorders such as hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, gnperlactatemia were observed.

Cases of pancreatitis, peripheral neuropathy, and thrombocytopenia have been reported with the use of nevirapine in combination with other antiretroviral drugs.

Postmarketing experience: there are reports of cases of severe hepatitis, liver failure and kidney failure.

CONTRAINDICATIONS

- clinically significant hypersensitivity to nevirapine or any other component of the drug;

- hereditary intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption;

- simultaneous use of nevirapine with efavirenz, delavirdine, etravirine, rilpivirin, fosamprenavir, saquinavir, atazanavir (when not used in conjunction with low-dose ritonavir), elvitegravir (together with cobicystate), bocepivir, rifampicin, ketoconazole;

- simultaneous use of nevirapine with preparations based on St. John's wort perforated (due to the risk of reducing the concentration of nevirapine in
plasma and reduce its clinical effect);
- Nevirapine should not be given to patients with severe liver dysfunction (Child-Pugh class C), as well as to patients with an initial increase in ACT or ALT activity more than 5 times the upper limit of the norm, until ACT / ALT does not stabilize at a level that does not exceed the upper limit of the norm by 5 times;

- Nevirapine should not be re-used in patients who needed to be withdrawn because of severe rash or rash accompanied by general symptoms of hypersensitivity reactions or development of a clinically significant

hepatitis caused by nevirapine;

- Nevirapine should not be re-assigned to patients who had previously been treated with nevirapine for an increase in ACT or ALT activity exceeding the upper limit of the norm by more than 5 times, or for patients who, after repeated use of nevirapine,

liver function;

- nevirapine should not be given to patients weighing less than 50 kg or body surface area less than 1.25 square meters;

- Children under 18 years of age (for this dosage form).

Carefully

Pregnancy, violations of liver function of moderate severity (class B according to the Child-Pugh classification), simultaneous use with telaprevir, fluconazole.

PREGNANCY AND LACTATION

Comprehensive controlled studies of treatment in HIV-1-infected pregnant women have not been carried out to date.
Nevirapine should be used during pregnancy only in cases where the potential benefit exceeds the potential risk to the fetus.
The safety and efficacy of nevirapine, used to prevent mother-to-child transmission of HIV-1, was established when the drug was used as part of a treatment regimen that included a single oral dose of 200 mg by the mother during labor and an oral dose of 2 mg / kg to a newborn within 72 hours after birth.

Nevirapine easily penetrates the placental barrier and is determined in breast milk.
According to existing recommendations, HIV-infected mothers should not breast-feed newborns to avoid the risk of postnatal HIV transmission.
Mothers who receive nevirapine should stop breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function who are on dialysis to compensate for nevirapine's clearance are recommended taking an additional dose of nevirapine 200 mg after each dialysis session.
Patients with a CC of> 20 ml / min do not need to adjust the dose.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with mild or moderate severity, liver function deficiency does not require an individual dose selection.

The use of the drug in patients is shown with severe severity of liver dysfunction (class C in Child-Pyo), as well as patients with an initial increase in ACT or ALT activity more than 5 times the upper limit of the norm, until the ACT / ALT activity is stabilizes at a level that does not exceed the upper limit of the norm by 5 times.

APPLICATION FOR CHILDREN

The use of the drug for children and adolescents under the age of 18 (for a given dosage form) is contraindicated.

SPECIAL INSTRUCTIONS

Critical is the first 18 weeks of therapy with nevirapine.
During this period, careful monitoring of patients is required to identify possible severe and life-threatening skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) or severe hepatitis / liver failure. The greatest risk of unwanted reactions from the liver and dermatological reactions exists in the first 6 weeks of therapy. The risk of adverse events on the part of the liver is increased in women and in patients with a higher number of CD4 + cells. It is necessary to strictly adhere to the recommended regimen, especially during the initial 14-day period.
Skin reactions
In patients treated with nevirapine, observed serious and life-threatening dermatological reactions, including fatal. There were cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity syndrome characterized by rash, general reactions and visceral. Careful observation of patients during the first 18 weeks of treatment. Careful monitoring is required in the case of an isolated rash. Nevirapine must be canceled in any patient in the event of severe rash and the rash, accompanied by general symptoms (fever, blistering, changes in oral cavity, conjunctivitis, swelling of the face, pain in the joints or muscles, malaise), with Stevens-Johnson syndrome or toxic epidermalpom necrolysis.Nevirapine must be canceled in any patient case and hypersensitivity reactions characterized by rash and general symptoms as well as internal organs changes, including hepatitis, eosinophilia, granulocytopenia, and renal dysfunction, or other signs of internal organ (see. the section "Side effect").
Patients should inform that the main manifestation of toxicity of nevirapine is rash. Should be used during the initial treatment, because It found that this reduces the incidence of rash (see. the section "Method of administration and dose"). In most cases, the rash associated with administration of NVP, occurs in the first 6 weeks of therapy. Therefore, during that period careful observation of patients in dermatological reactions. Patients should be informed that in case of any rash during the initial treatment period, the dose should not be increased as long as the rash disappears. It is shown that the simultaneous use of prednisone (40 mg / day for the first 14 days of nevirapine) does not reduce the incidence of rash, and contrast,may become more frequent dermatological reactions during the first 6 weeks of therapy. Among the risk factors for severe skin reactions include violation of the recommendations on the use of medication in a dose of 200 mg / day during the initial treatment period. The risk of more serious outcomes of dermatological reactions increases in the case of delay in seeking medical advice after the onset of symptoms. The risk of rash in women, apparently, more than men, as in the case of nevirapine, and treatment that does not contain nevirapine. The patient from whom there is expressed a rash or a rash, accompanied by general symptoms (fever, blistering, changes in oral cavity, conjunctivitis, swelling of the face, pain in the joints or muscles, malaise) must stop taking the drug, and to consult with a physician.Repeated use of nevirapine in these patients is not allowed. If the patient has a rash and is suspected connection with the administration of NVP should be studied liver function. In patients with moderate or severe impairment of gravity (ACT indicators of activity or ALT levels exceed the upper limit of normal in more than 5 times), nevipin should be abolished.
In the event of a hypersensitivity reaction. characterized by rash, which is accompanied by general symptoms (fever, arthralgia, myalgia and lymphadenopathy) in combination with the features of internal organ, such as hepatitis, eosinophilia, granulotsitopenisy and renal dysfunction, nevirapine should be canceled; re-use of nevirapine is not allowed.
Reaction of the liver
In patients treated with nevirapine, there is a serious or life-threatening hepatotoxicity, including fatal fulminant hepatitis. Are critical first 18 weeks of treatment, during which careful monitoring. The highest risk of reactions on the part of the liver observed in the first 6 weeks of therapy. Increased risk of adverse reactions on the part of the liver is seen in women and patients with higher CD4 + cell count. This risk persists in the future, so frequent monitoring should continue throughout the entire treatment. It is necessary to inform the patient that the reaction of the liver are the main type of the toxicity of nevirapine, and that the appearance of symptoms. pointing to the development of hepatitis, should be cause for immediate consultation with the doctor.
On serious hepatotoxicity, including the development of liver failure requiring liver transplantation was reported when using multiple doses of nevirapine for the purpose of PEP individuals who were not infected with HIV that is not among the approved indications for the use of this drug. A higher risk of adverse reactions by the liver during any antiretroviral therapy, including and during application modes including nevirapine, marked increase in the initial activity of AST or ALT more than 2.5 times compared with the upper limit of normal and / or in the presence of hepatitis B and / or C. The risk of adverse reactions in the liver associated with rash, women appear to 3 times higher than in men (4.6% versus 1.5%). The risk of adverse reactions in the liver,associated with a rash in the treatment of nevirapine, may also be higher in patients with higher numbers of CD4 + cells. According to a retrospective analysis, a number of women with CD4 + cells more than 250 cells / mm3 , the risk of hepatotoxic reactions associated with rash was 9 times higher than in women with the number of CD4 + cells less than 250 cells / mm 3 (8.4%versus 0.9%). Increased risk was also observed in men with the number of CD4 + cells more than 400 cells / mm 3 compared to men with the number of CD4 + cells less than 400 cells / mm 3 (4.5% versus 0.7%).
The control state of the liver
When using nevirapine reported changes in liver function, sometimes occurring in the first weeks of therapy. Asymptomatic increased activity of liver enzymes is described frequently and is not an absolute contraindication for nevirapine. Asymptomatic increase of gamma-glutamyl transferase is not a contraindication to continue therapy. It recommended strict control of the liver function at short intervals, depending on the clinical condition of patients, particularly during the first 18 weeks of treatment. Clinical and laboratory monitoring should continue throughout the period of treatment with nevirapine. Physicians and patients should be wary of such prodromal signs or symptoms of hepatitis, as anorexia, nausea, jaundice, bilirubinemia, aholichny chairhepatomegaly or hepatic tenderness. Patients should be informed of the need to seek medical advice in such cases.
In case of increase of ALT activity ACT or more than 2.5 times compared with the upper limit of normal before or during treatment, liver function tests should be inspected more frequently during regular clinic visits. Nevirapine should not be administered to patients in whom baseline ACT ALT activity or more than 5 times the upper limit of normal (as long as it is stable not decrease to a value less than 5 times the upper limit of the norm).
If ACT indicators of activity or ALT levels increase to more than 5 times the upper limit of normal during treatment, nevirapine should be immediately repealed. If indicators ACT activity n ALT returned to baseline values ​​and if the patient does not experience any clinical signs or symptoms of hepatitis, common symptoms or other phenomena, indicating dysfunction of internal organs, nevirapine use may be resumed (if there is a clinical need). This decision should be taken in each case based on clinical considerations. Reassignment nevirapine must be in conditions of increased clinical and laboratory alertness in an initial dose of 200 mg / day (14 days}, followed by its increase up to 400 mg / day. If liver function abnormalities are renewed,Nevirapine should be permanently repealed.
If hepatitis occurs, accompanied by such clinical symptoms as anorexia, nausea, vomiting, jaundice, and laboratory abnormalities (moderate or significant changes in liver function, excluding GGT), nevirapine must be canceled completely. Nevirapine should not be assigned again for those patients who have required its cancellation due to differences in clinical hepatitis caused by nevirapine.
Liver disease
results of pharmacokinetic studies indicate the need for caution in the appointment compliance nevirapine patients with a mean severity of liver failure (class classification Child-Pyo). Nevirapine should not be administered to patients with severe hepatic impairment (P classification Child-Pyo).
The risk of hepatotoxicity of antiretroviral drugs in patients co-infected with HIV and hepatitis B or C higher than when only HIV. Therefore, patients with chronic hepatitis B or C, which simultaneously receive antiretrovirals are at increased risk of adverse effects on the liver which can be fatal. For such patients should be closely monitored, both clinical and laboratory.
A higher risk of adverse reaction by the liver during any antiretroviral therapy, including and during application modes including nevirapine, seen in patients with baseline liver diseases, including with chronic active hepatitis. Patients with liver disease receiving nevirapine as part of combination therapy aitiretrovirusnoy should be closely monitored; when the signs of worsening liver function should be to consider the possibility of interruption or discontinuation.
rhabdomyolysis
In rare cases, patients with reactions of the skin and liver related to the use of nevirapine was observed rhabdomyolysis. Patients should be warned that at the first sign of muscle pain and weakness, or darkening of the urine have to stop taking the drug and contact your doctor to determine ativnost creatine kinase in the blood.
osteonecrosis
Although ethnology ostsonekroza considered multifactorial (eg, receiving corticosteroids, alcohol consumption, severe immunosuppression, higher BMI play an important role in the development of complications), there are reports of such cases, particularly in patients with advanced HIV infection / or duration of antiretroviral therapy . Patients should consult a doctor with the appearance of symptoms such as fatigue, stiffness, joint pain, or the appearance of difficulty in movement.
lipodystrophy
In patients receiving antiretroviral therapy, there was a redistribution / accumulation of body fat including central-type obesity, increased fat deposition in dorsotservikalyyuy area ( "buffalo hump"), a decrease in the volume of peripheral adipose tissue, reduction of subcutaneous fat in the face, hypertrophy of the mammary glands and "cushingoid appearance." The mechanism of development and long-term consequences of these effects are currently unknown, their causal connection with the use of certain antiretroviral drugs has not been established.
Immune reconstitution syndrome
In HIV-infected patients receiving combination antiretroviral therapy, observed the development of immune reconstitution syndrome. In patients with severe immunodeficiency inflammatory response may occur in response to asymptomatic or residual opportunistic infections that can lead to development of serious medical conditions or increase in severity of symptoms. Such reactions are usually in the first few weeks or months of antiretroviral therapy. Examples includecytomegalovirus retinitis, generalized and / or focal mycobacterial infection and pneumonia caused by Pneumocystis jirovecii.Any symptoms of an inflammatory nature and requires appropriate assessment. if necessary, the start of treatment. Patients should be under close clinical supervision of specialists who have experience treating patients with HIV zabolsvapnyami.
Autoimmune disorders (such as Graves' disease, Wagner's syndrome, polymyositis, and Guillain-Barré syndrome) have been observed on the background of immune reconstitution, but the time of the primary manifestations varied, and the disease may occur many months after initiation of therapy and have an atypical course.
granulocytopenia
Granulocytopenia is commonly associated with zidovudine. Increased risk of granulocytopenia in patients receiving the combination of nevirapine and zidovudine (especially in patients receiving zidovudine in high doses and in patients with reduced bone marrow reserve). In these patients, careful monitoring of hematological parameters.
Other warnings
In the case of nevirapine in combination with other antiretroviral drugs, and reported on the development of such undesirable reactions as pancreatitis, peripheral neuropathy and thrombocytopenia. These phenomena are often associated with other antiretroviral agents. Their occurrence can be expected when using nevirapine in combination with other drugs; Probability of these reactions with the use of nevirapine small.
Information about nevirapine ability to reduce the risk of horizontal transmission of HIV-1 to others is not available.
Despite the fact that the installed capacity of nevirapine to prevent transmission of HIV-1 from mother to child (in women not receiving other antiretrovirals) to minimize transmission of HIV-1, the child may recommend more intensive treatment of the mother before giving birth to the use of antiretroviral drug combinations (when it is possible).
Pharmacokinetic studies in patients with renal dysfunction who were on dialysis, have shown that adjuvant therapy with nevirapine by adding a dose of 200 mg after each dialysis session can help compensate for the effect of dialysis on nevirapine clearance. Thus, patients with CC more than 20 ml / min change nevirapine dosing is required.
In women taking nevirapine should not be used as a primary method of birth control pills and other hormonal methods, because Nevirapine may reduce the concentration of these drugs in plasma. Furthermore, in the case of during nevirapine therapy of oral contraception in order to hormonal regulation, requires control over the therapeutic effect of the hormonal treatment.
Existing pharmacokinetic data
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Rambler's Top100
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!