Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Do not take Viramune - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section 6). - if you have taken Viramune before and had to stop the treatment because you suffered from: - severe skin rash - skin rash with other symptoms for example: - fever - blistering - mouth sores - inflammation of the eye - swelling of the face - general swelling - shortness of breath - muscle or joint pain - general feelings of illness - abdominal pain - hypersensitivity (allergic) reactions - inflammation of the liver (hepatitis) - if you have severe liver disease - if you have had to stop Viramune treatment in the past because of changes in your liver function - if you are taking a medicine containing the herbal substance St. John's Wort (Hypericum perforatum). This herbal substance may stop Viramune from working properly.
Warnings and precautions
Talk to your doctor or pharmacist before taking Viramune. During the first 18 weeks of treatment with Viramune it
is very important that you and your doctor watch out for
~ \ Boehringer lll Ingelheim
signs of liver or skin reactions. These can become severe and even life threatening. You are at greatest risk of such a reaction during the first 6 weeks of treatment.
If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash) accompanied by other side effects such as
- fever,
- _ blistering,
- mouth sores,
- inflammation of the eye,
- swelling of the face,
- general swelling,
- shortness of breath,
- muscle or joint pain,
- general feelings of illness,
- or abdominal pain
YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death. If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking Viramune.
If you experience symptoms suggesting damage of the liver, such as
- loss of appetite,
- feeling sick (nausea),
- vomiting,
- yellow skin (jaundice),
- abdominal pain
you should discontinue taking Viramune and must contact your doctor immediately.
If you develop severe liver, skin or hypersensitivity reactions whilst taking Viramune, NEVER TAKE VIRAMUNE again without referring to your doctor. You must take the dose of Viramune as prescribed by your doctor. This is especially important within the first 14 days of treatment (see more information in
"How to take Viramune").
The following patients are at increased risk of developing
liver problems:
- women
- patients infected with hepatitis B or C
- patients with abnormal liver function tests
- treatment-naive patients with higher CD4+ cell counts at the start of Viramune therapy (women more than 250 cells/mm, men more than 400 cells/mm?)
- pre-treated patients with detectable HIV-1 plasma viral load and higher CD4+ cell counts at the start of Viramune therapy (women more than 250 cells/mm?, men more than 400 cells/mm').
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS-defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection
or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Changes of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat (see section 4 "Possible side effects").
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and higher body mass index may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.
If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells. Do not take Viramune after an exposure to HIV unless you have been diagnosed with HIV and instructed to do so by your doctor.
Prednisone should not be used to treat a rash related to Viramune.
If you are taking oral contraceptives (e.g. "pill") or other hormonal methods of birth control during treatment with Viramune, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission.
If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.
If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune.
Children and adolescents: Viramune oral suspension can be taken by children of all age groups. Always follow the exact instructions given by your child's doctor. Viramune is also available as tablets. Viramune tablets can be taken by: - children 16 years of age or older - children under 16 years of age who:
- weigh 50 kg or more
- or have a body surface area above 1.25 square
metres.
Other medicines and Viramune
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Inform your doctor about all other medicines you are taking before you start taking Viramune. Your doctor might need to monitor whether your other medicines are still working and adjust doses. Carefully read the package leaflet of all other HIV medicines you are taking in combination with Viramune.
It is particularly important that you tell your doctor if you
are taking or have recently taken:
- St. John's Wort (Hypericum perforatum, medicine to treat depression)
- rifampicin (medicine to treat tuberculosis)
- _ rifabutin (medicine to treat tuberculosis)
- macrolides e.g. clarithromycin (medicine to treat bacterial infections)
- fluconazole (medicine to treat fungal infections)
- ketoconazole (medicine to treat fungal infections)
- itraconazole (medicine to treat fungal infections)
- methadone (medicine used for treatment of opiate addicts)
- warfarin (medicine to reduce blood clotting)
- hormonal contraceptives (e.g. the "pill")
- atazanavir (another medicine to treat HIV-infection)
- lopinavir/ritonavir (another medicine to treat HIV-infection)
- fosamprenavir (another medicine to treat HIV-infection)
- efavirenz (another medicine to treat HIV-infection)
- etravirine (another medicine to treat HIV-infection)
- rilpivirine (another medicine to treat HIV-infection)
- zidovudine (another medicine to treat HIV-infection)
- elvitegravir/cobicistat (another medicine to treat HIV-infection).
Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them together.
If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Viramune. This is because Viramune can be partly washed out of your blood by dialysis.
Taking Viramune with food and drink There are no restrictions on taking Viramune with food and drink.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.
If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.
Driving and using machines
You may experience fatigue when taking Viramune.
Use caution when engaging in activities such as driving, using any tools or machines. If you experience fatigue you should avoid potentially hazardous tasks such as driving or using any tools or machines.
Viramune contains sucrose, sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate and sodium
Viramune oral suspension contains 150 mg sucrose per mL. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
Viramune oral suspension contains 162 mg sorbitol per mL. Sorbitol is a source of fructose. If your doctor has told
you that you (or your child) have an intolerance to some sugars or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. These excipients can cause allergic reactions over time.
Viramune oral suspension contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
You should not use Viramune on its own. You must take it with at least two other antiretroviral medicines. Your doctor will recommend the best medicines for you.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is the same for all adults (20 mL).
Your child's doctor will calculate the dose for your child. The calculation will include your child's age and body weight, or body surface area. Make sure that your child's doctor clearly tells you what dose you must give to your child.
For adults
The dose for adults is 20 mL (200 mg) once a day for the first 14 days of treatment ("lead in" period). After 14 days, the usual dose is 20 mL (200 mg) twice a day.
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It is very important that you take only 20 mL of Viramune a day for the first 14 days ("lead-in" period). If you have any rash during this period, do not increase the dose but consult your doctor.
Viramune is also available as 200 mg tablets for adults (16 years of age and older).
For children
The dose for children is 4 mg/kg body weight or 150 mg/m? body surface area once a day for the first 14 days of treatment ("lead-in period"). Thereafter your child will be switched to a twice daily dosing schedule and your child's doctor will decide the right dose based either on your child's weight or body surface area.
It is very important that your child takes Viramune
only once a day for the first 14 days ("lead-in" period).
If your child develops any rash during this period, do not increase the dose but consult your child's doctor.
Viramune is also available as 200 mg tablets for older children, particularly adolescents, weighing more than 50 kg or having a body surface of more than 1.25 m'. Your child's doctor will inform you exactly of the correct dose for your child. Your child's doctor will continually check your child's weight or body surface area to ensure the correct dose.
If you are uncertain please be sure to ask your child's doctor or pharmacist.
Viramune oral suspension should be shaken gently prior to administration. Measure the exact dose using a measuring syringe.
If you are an adult and choose to use another measuring device (e.g. cup or teaspoon) please make sure that you take the whole dose. This is because some Viramune can remain in the cup or spoon. To do so, rinse the used device thoroughly with water and drink it.
The oral dosing syringe, and dosing cup are not provided with Viramune oral suspension. Ask your pharmacist for a syringe or cup if you do not have one.
The 14-day "lead-in" period has been shown to lower the risk of skin rash.
As Viramune must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully. These are supplied in the package leaflets for those medicines.
You should continue to take Viramune for as long as instructed by your doctor.
As explained in 'Warnings and precautions', above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome your
doctor may decide to interrupt or stop Viramune treatment. Your doctor might then decide to restart you on a lower dose.
Viramune oral suspension is in a liquid suspension form and should only be taken by mouth. Shake the bottle gently before you take your medicine.
If you take more Viramune than you should
Do not take more Viramune than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Viramune overdose. Consult your doctor if you have taken more Viramune than you should.
If you forget to take Viramune
Try not to miss a dose. If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible. If it has been more than 8 hours since the dose was due only take the next dose at the usual time.
If you stop taking Viramune
Taking all doses at the appropriate times:
- greatly increases the effectiveness of your combination antiretroviral medicines
- reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.
It is important that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop.
If you stop taking Viramune for more than 7 days your doctor will instruct you to start the 14-day 'lead in' period (described above) once again, before returning to the twice daily dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As mentioned in 'Warnings and precautions', above, the most important side effects of Viramune are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Viramune. This is therefore an important period which requires close monitoring by your doctor.
If you ever observe any rash symptoms, inform your doctor immediately.
When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as
a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.
If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately. Pay special attention to any rashes that your child develops. Although these may appear normal (for example nappy rash), they might be rashes due to Viramune. If in doubt ask your child's doctor.
Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:
- rash
- swelling of the face
- difficulty breathing (bronchial spasm)
- anaphylactic shock.
Hypersensitivity reactions can also occur as rash with
other side effects such as:
- fever
- blistering of your skin
- mouth sores
- inflammation of the eye
- swelling of the face
- general swelling
- shortness of breath
- muscle or joint pain
- areduction in the number of your white blood cells (granulocytopenia)
- general feelings of illness
- severe problems with liver or kidneys (liver or kidney failure).
Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction. Such reactions can be life-threatening.
Abnormal liver functioning has been reported with the use of Viramune. This includes some cases of inflammation
of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal.
Tell your doctor if you experience any of the following clinical symptoms of liver damage:
- loss of appetite
- feeling sick (nausea)
- vomiting
- yellow skin (jaundice)
- abdominal pain.
The side effects described below have been experienced by patients given Viramune:
Very common (may affect more than 1 in 10 people): - rash.
Common (may affect up to 1 in 10 people):
- decreased number of white blood cells (granulocytopenia)
- allergic reactions (hypersensitivity)
6. Contents of the pack and other information
What Viramune contains
- The active substance is nevirapine. Each 5 mL
- headache tains 50 f the acti bst was - feeling sick (nausea) contains me of the active substance nevirapine - vomiting (as hemihydrate).
- The other ingredients are: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
- abdominal pain
- loose stools (diarrhoea)
- inflammation of the liver (hepatitis) - feeling tired (fatigue)
- fever sorbitol, - abnormal liver function tests. sucrose, polysorbate 80, Uncommon (may affect up to 1 in 100 people): sodium hydroxide and water.
- allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock
- decreased numbers of red blood cells (anaemia)
- yellow skin (jaundice)
- severe and life-threatening skin rashes (Stevens- Johnson syndrome/ toxic epidermal necrolysis)
- hives (urticaria)
- fluid under the skin (angioedema)
- joint pain (arthralgia)
- muscle pain (myalgia)
- decreased blood phosphorus
- increased blood pressure.
What Viramune looks like and contents of the pack
Viramune oral suspension is a white to off-white homogenous suspension.
Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 mL suspension per bottle.
Viramune is also supplied as 200 mg tablets for older children and adults.
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Rare (may affect up to 1 in 1 000 people):
- sudden and intense inflammation of the liver (fulminant hepatitis)
- drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms).
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
55216 Ingelheim am Rhein
Germany
The following events have also been reported when Viramune has been used in combination with other antiretroviral agents:
- decreased numbers of red blood cells or platelets - inflammation of the pancreas
- decrease in or abnormal skin sensations.
These events are commonly associated with other antiretroviral agents and may be expected to occur when Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Additional side effects in children and adolescents
A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects.
This leaflet was last revised in 05/2026.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Viramune Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the carton and on the bottle after "EXP".
The expiry date refers to the last day of that month. Viramune should be used within 6 months of opening the bottle.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
C50001297/03
For children
The dose for children is 4 mg/kg body weight or 150 mg/m? body surface area once a day for the first 14 days of treatment ("lead-in period"). Thereafter your child will be switched to a twice daily dosing schedule and your child's doctor will decide the right dose based either on your child's weight or body surface area.
It is very important that your child takes Viramune
only once a day for the first 14 days ("lead-in" period).
If your child develops any rash during this period, do not increase the dose but consult your child's doctor.
Viramune is also available as 200 mg tablets for older children, particularly adolescents, weighing more than 50 kg or having a body surface of more than 1.25 m'. Your child's doctor will inform you exactly of the correct dose for your child. Your child's doctor will continually check your child's weight or body surface area to ensure the correct dose.
If you are uncertain please be sure to ask your child's doctor or pharmacist.
Viramune oral suspension should be shaken gently prior to administration. Measure the exact dose using a measuring syringe.
If you are an adult and choose to use another measuring device (e.g. cup or teaspoon) please make sure that you take the whole dose. This is because some Viramune can remain in the cup or spoon. To do so, rinse the used device thoroughly with water and drink it.
The oral dosing syringe, and dosing cup are not provided with Viramune oral suspension. Ask your pharmacist for a syringe or cup if you do not have one.
The 14-day "lead-in" period has been shown to lower the risk of skin rash.
As Viramune must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully. These are supplied in the package leaflets for those medicines.
You should continue to take Viramune for as long as instructed by your doctor.
As explained in 'Warnings and precautions', above, your doctor will monitor you with liver tests or for undesirable effects such as rash. Depending on the outcome your
doctor may decide to interrupt or stop Viramune treatment. Your doctor might then decide to restart you on a lower dose.
Viramune oral suspension is in a liquid suspension form and should only be taken by mouth. Shake the bottle gently before you take your medicine.
If you take more Viramune than you should
Do not take more Viramune than prescribed by your doctor and described in this leaflet. There is at present little information on the effects of Viramune overdose. Consult your doctor if you have taken more Viramune than you should.
If you forget to take Viramune
Try not to miss a dose. If you notice that you have missed a dose within 8 hours of when it was due, take the missed dose as soon as possible. If it has been more than 8 hours since the dose was due only take the next dose at the usual time.
If you stop taking Viramune
Taking all doses at the appropriate times:
- greatly increases the effectiveness of your combination antiretroviral medicines
- reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.
It is important that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop.
If you stop taking Viramune for more than 7 days your doctor will instruct you to start the 14-day 'lead in' period (described above) once again, before returning to the twice daily dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As mentioned in 'Warnings and precautions', above, the most important side effects of Viramune are severe and life threatening skin reactions and serious liver damage. These reactions occur mainly in the first 18 weeks of treatment with Viramune. This is therefore an important period which requires close monitoring by your doctor.
If you ever observe any rash symptoms, inform your doctor immediately.
When rash occurs it is normally mild to moderate. However, in some patients a rash, which appears as
a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded. Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.
If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately. Pay special attention to any rashes that your child develops. Although these may appear normal (for example nappy rash), they might be rashes due to Viramune. If in doubt ask your child's doctor.
Hypersensitivity (allergic) reactions can occur. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:
- rash
- swelling of the face
- difficulty breathing (bronchial spasm)
- anaphylactic shock.
Hypersensitivity reactions can also occur as rash with
other side effects such as:
- fever
- blistering of your skin
- mouth sores
- inflammation of the eye
- swelling of the face
- general swelling
- shortness of breath
- muscle or joint pain
- areduction in the number of your white blood cells (granulocytopenia)
- general feelings of illness
- severe problems with liver or kidneys (liver or kidney failure).
Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction. Such reactions can be life-threatening.
Abnormal liver functioning has been reported with the use of Viramune. This includes some cases of inflammation
of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal.
Tell your doctor if you experience any of the following clinical symptoms of liver damage:
- loss of appetite
- feeling sick (nausea)
- vomiting
- yellow skin (jaundice)
- abdominal pain.
The side effects described below have been experienced by patients given Viramune:
Very common (may affect more than 1 in 10 people): - rash.
Common (may affect up to 1 in 10 people):
- decreased number of white blood cells (granulocytopenia)
- allergic reactions (hypersensitivity)
Do not use this medicine after the expiry date which
is stated on the carton and on the bottle after "EXP".
The expiry date refers to the last day of that month. Viramune should be used within 6 months of opening the bottle.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
C50001297/03
What Viramune contains
- The active substance is nevirapine. Each 5 mL
- headache tains 50 f the acti bst was - feeling sick (nausea) contains me of the active substance nevirapine - vomiting (as hemihydrate).
- The other ingredients are: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
- abdominal pain
- loose stools (diarrhoea)
- inflammation of the liver (hepatitis) - feeling tired (fatigue)
- fever sorbitol, - abnormal liver function tests. sucrose, polysorbate 80, Uncommon (may affect up to 1 in 100 people): sodium hydroxide and water.
- allergic reaction characterized by rash, swelling of the face, difficulty breathing (bronchial spasm) or anaphylactic shock
- decreased numbers of red blood cells (anaemia)
- yellow skin (jaundice)
- severe and life-threatening skin rashes (Stevens- Johnson syndrome/ toxic epidermal necrolysis)
- hives (urticaria)
- fluid under the skin (angioedema)
- joint pain (arthralgia)
- muscle pain (myalgia)
- decreased blood phosphorus
- increased blood pressure.
What Viramune looks like and contents of the pack
Viramune oral suspension is a white to off-white homogenous suspension.
Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 mL suspension per bottle.
Viramune is also supplied as 200 mg tablets for older children and adults.
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Rare (may affect up to 1 in 1 000 people):
- sudden and intense inflammation of the liver (fulminant hepatitis)
- drug reaction with systemic symptoms (drug reaction with eosinophilia and systemic symptoms).
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
55216 Ingelheim am Rhein
Germany
The following events have also been reported when Viramune has been used in combination with other antiretroviral agents:
- decreased numbers of red blood cells or platelets - inflammation of the pancreas
- decrease in or abnormal skin sensations.
These events are commonly associated with other antiretroviral agents and may be expected to occur when Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
Additional side effects in children and adolescents
A reduction in white blood cells (granulocytopenia) can occur, which is more common in children. A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children. As with rash symptoms, please inform your doctor of any side effects.
This leaflet was last revised in 05/2026.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Viramune 50mg/5ml oral Suspension comes as suspension containing 50mg/5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Viramune 50mg/5ml oral Suspension is nevirapine hemihydrate.
This leaflet reproduces the patient information leaflet approved for Viramune 50mg/5ml oral Suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV‑1 infected adults, adolescents, and children of any age (see section 4.2).
Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Viramune should be administered by physicians who are experienced in the treatment of HIV infection.
Posology
Patients 16 years and older
The recommended dose for Viramune is 20 mL (200 mg) oral suspension once daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by 20 mL (200 mg) oral suspension twice daily, in combination with at least two additional antiretroviral agents.
Viramune is also available as a 200 mg tablet for patients 16 years and older, or for older children, particularly adolescents, weighing 50 kg or more or whose BSA is above 1.25 m2.
If a dose is recognized as missed within 8 hours of when it was due, the patient should take the missed dose as soon as possible. If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time.
Dose management considerations
Patients experiencing rash during the 14‑day lead-in period of 200 mg/day (4 mg/kg/day or 150 mg/m2/day for paediatric patients) should not have their Viramune dose increased until the rash has resolved. The isolated rash should be closely monitored (see section 4.4). The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.
Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period.
There are toxicities that require interruption of Viramune therapy (see section 4.4).
Elderly
Nevirapine has not been specifically investigated in patients over the age of 65.
Renal impairment
For patients with renal dysfunction requiring dialysis an additional 200 mg dose of nevirapine following each dialysis treatment is recommended. Patients with CLcr ≥ 20 mL/min do not require a dose adjustment, see section 5.2.
Hepatic impairment
Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3). No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
Paediatric population
The total daily dose should not exceed 400 mg for any patient. Viramune may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows:
By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m2 once daily for two weeks followed by 150 mg/m2 twice daily thereafter.
Calculation of the volume of Viramune oral suspension (50 mg/5 mL) required for paediatric dosing on a body surface basis of 150 mg/m2:
| BSA range (m2) | Volume (mL) |
| 0.08‑0.25 | 2.5 |
| 0.25‑0.42 | 5 |
| 0.42‑0.58 | 7.5 |
| 0.58‑0.75 | 10 |
| 0.75‑0.92 | 12.5 |
| 0.92‑1.08 | 15 |
| 1.08‑1.25 | 17.5 |
| 1.25+ | 20 |
By weight the recommended oral dose for paediatric patients up to 8 years of age is 4 mg/kg once daily for two weeks followed by 7 mg/kg twice daily thereafter. For patients 8 years and older the recommended dose is 4 mg/kg once daily for two weeks followed by 4 mg/kg twice daily thereafter.
Calculation of the volume of Viramune oral suspension (50 mg/5 mL) required for paediatric dosing after the two weeks lead-in period.
| Weight Range (kg) for patients < 8 yrs of age on a body weight basis receiving 7 mg/kg. | Weight Range (kg) for patients ≥ 8 years of age on a body weight basis receiving 4 mg/kg. | Volume (mL) |
| 1.79‑5.36 | 3.13‑9.38 | 2.5 |
| 5.36‑8.93 | 9.38‑15.63 | 5 |
| 8.93‑12.50 | 15.63‑21.88 | 7.5 |
| 12.50‑16.07 | 21.88‑28.12 | 10 |
| 16.07‑19.64 | 28.12‑34.37 | 12.5 |
| 19.64‑23.21 | 34.37‑40.62 | 15 |
| 23.21‑26.79 | 40.62‑46.88 | 17.5 |
| 26.79+ | 46.88+ | 20 |
All patients less than 16 years of age receiving Viramune oral suspension should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
Method of administration
It is important that the entire measured dose of Viramune oral suspension is administered. This is assisted by the use of a dispensing syringe. If an alternative measuring device is used (e.g. a dispensing cup or teaspoon for larger doses) it should be thoroughly rinsed with water and the rinse should also be administered to the patient. Viramune may be taken with or without food.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Readministration to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Patients with severe hepatic impairment (Child-Pugh C) or pre-treatment ASAT or ALAT > 5 ULN until baseline ASAT/ALAT are stabilised < 5 ULN.
Readministration to patients who previously had ASAT or ALAT > 5 ULN during nevirapine therapy and had recurrence of liver function abnormalities upon readministration of nevirapine (see section 4.4).
Coadministration with herbal preparations containing St. John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2‑4 weeks of initiating multiple-dose therapy.
Compounds using this metabolic pathway may have decreased plasma concentrations when co-administered with nevirapine. Careful monitoring of the therapeutic effectiveness of P450 metabolised medicinal products is recommended when taken in combination with nevirapine.
The absorption of nevirapine is not affected by food, antacids or medicinal products which are formulated with an alkaline buffering agent.
The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available. ND = Not Determined, ↑= Increased, ↓ = Decreased, ↔ = No Effect
| Medicinal products by therapeutic areas | Interaction | Recommendations concerning co-administration |
| ANTI-INFECTIVES | ||
| ANTIRETROVIRALS | ||
| NRTIs | ||
| Didanosine 100‑150 mg BID | Didanosine AUC ↔ 1.08 (0.92‑1.27) Didanosine Cmin ND Didanosine Cmax ↔ 0.98 (0.79‑1.21) | Didanosine and Viramune can be co-administered without dose adjustments. |
| Emtricitabine | Emtricitabine is not an inhibitor of human CYP 450 enzymes. | Viramune and emtricitabine may be coadministered without dose adjustments. |
| Abacavir | In human liver microsomes, abacavir did not inhibit cytochrome P450 isoforms. | Viramune and abacavir may be coadministered without dose adjustments. |
| Lamivudine 150 mg BID | No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of nevirapine on lamivudine clearance. | Lamivudine and Viramune can be co-administered without dose adjustments. |
| Stavudine: 30/40 mg BID | Stavudine AUC ↔ 0.96 (0.89‑1.03) Stavudine Cmin ND Stavudine Cmax ↔ 0.94 (0.86‑1.03) Nevirapine: compared to historical controls, levels appeared to be unchanged. | Stavudine and Viramune can be co-administered without dose adjustments. |
| Tenofovir 300 mg QD | Tenofovir plasma levels remain unchanged when co-administered with nevirapine. Nevirapine plasma levels were not altered by co-administration of tenofovir. | Tenofovir and Viramune can be co-administered without dose adjustments. |
| Zidovudine 100‑200 mg TID | Zidovudine AUC ↓ 0.72 (0.60‑0.96) Zidovudine Cmin ND Zidovudine Cmax ↓ 0.70 (0.49‑1.04) Nevirapine: Zidovudine had no effect on its pharmacokinetics. | Zidovudine and Viramune can be co-administered without dose adjustments Granulocytopenia is commonly associated with zidovudine. Therefore, patients who receive nevirapine and zidovudine concomitantly and especially paediatric patients and patients who receive higher zidovudine doses or patients with poor bone marrow reserve, in particular those with advanced HIV disease, have an increased risk of granulocytopenia. In such patients haematological parameters should be carefully monitored. |
| NNRTIs | ||
| Efavirenz 600 mg QD | Efavirenz AUC ↓ 0.72 (0.66‑0.86) Efavirenz Cmin ↓ 0.68 (0.65‑0.81) Efavirenz Cmax ↓ 0.88 (0.77‑1.01) | It is not recommended to co-administer efavirenz and Viramune (see section 4.4), because of additive toxicity and no benefit in terms of efficacy over either NNRTI alone (for results of 2NN study, see section 5.1). |
| Etravirine | Concomitant use of etravirine with nevirapine may cause a significant decrease in the plasma concentrations of etravirine and loss of therapeutic effect of etravirine. | The concomitant administration of Viramune with NNRTIs is not recommended (see section 4.4). |
| Rilpivirine | Interaction has not been studied. | The concomitant administration of Viramune with NNRTIs is not recommended (see section 4.4). |
| PIs | ||
| Atazanavir/ritonavir 300/100 mg QD 400/100 mg QD | Atazanavir/r 300/100 mg: Atazanavir/r AUC ↓ 0.58 (0.48‑0.71) Atazanavir/r Cmin ↓ 0.28 (0.20‑0.40) Atazanavir/r Cmax ↓ 0.72 (0.60‑0.86) Atazanavir/r 400/100 mg: Atazanavir/r AUC ↓ 0.81 (0.65‑1.02) Atazanavir/r Cmin ↓ 0.41 (0.27‑0.60) Atazanavir/r Cmax ↔ 1.02 (0.85‑1.24) (compared to 300/100 mg without nevirapine) Nevirapine AUC ↑1.25 (1.17‑1.34) Nevirapine Cmin ↑1.32 (1.22‑1.43) Nevirapine Cmax ↑1.17 (1.09‑1.25) | It is not recommended to co-administer atazanavir/ritonavir and Viramune (see section 4.4). |
| Darunavir/ritonavir 400/100 mg BID | Darunavir AUC ↑1.24 (0.97‑1.57) Darunavir Cmin ↔ 1.02 (0.79‑1.32) Darunavir Cmax ↑1.40 (1.14‑1.73) Nevirapine AUC ↑1.27 (1.12‑1.44) Nevirapine Cmin ↑1.47 (1.20‑1.82) Nevirapine Cmax ↑1.18 (1.02‑1.37) | Darunavir and Viramune can be co-administered without dose adjustments. |
| Fosamprenavir 1 400 mg BID | Amprenavir AUC ↓ 0.67 (0.55‑0.80) Amprenavir Cmin ↓ 0.65 (0.49‑0.85) Amprenavir Cmax ↓ 0.75 (0.63‑0.89) Nevirapine AUC ↑1.29 (1.19‑1.40) Nevirapine Cmin ↑1.34 (1.21‑1.49) Nevirapine Cmax ↑1.25 (1.14‑1.37) | It is not recommended to co-administer fosamprenavir and Viramune if fosamprenavir is not co-administered with ritonavir (see section 4.4). |
| Fosamprenavir/ritonavir 700/100 mg BID | Amprenavir AUC ↔ 0.89 (0.77‑1.03) Amprenavir Cmin ↓ 0.81 (0.69‑0.96) Amprenavir Cmax ↔ 0.97 (0.85‑1.10) Nevirapine AUC ↑1.14 (1.05‑1.24) Nevirapine Cmin ↑1.22 (1.10‑1.35) Nevirapine Cmax ↑1.13 (1.03‑1.24) | Fosamprenavir/ritonavir and Viramune can be co-administered without dose adjustments |
| Lopinavir/ritonavir (capsules) 400/100 mg BID | Adult patients: Lopinavir AUC ↓ 0.73 (0.53‑0.98) Lopinavir Cmin ↓ 0.54 (0.28‑0.74) Lopinavir Cmax ↓ 0.81 (0.62‑0.95) | An increase in the dose of lopinavir/ritonavir to 533/133 mg (4 capsules) or 500/125 mg (5 tablets with 100/25 mg each) twice daily with food is recommended in combination with Viramune. Dose adjustment of Viramune is not required when co-administered with lopinavir. |
| Lopinavir/ritonavir (oral solution) 300/75 mg/m2 BID | Paediatric patients: Lopinavir AUC ↓ 0.78 (0.56‑1.09) Lopinavir Cmin ↓ 0.45 (0.25‑0.82) Lopinavir Cmax ↓ 0.86 (0.64‑1.16) | For children, increase of the dose of lopinavir/ritonavir to 300/75 mg/m2 twice daily with food should be considered when used in combination with Viramune, particularly for patients in whom reduced susceptibility to lopinavir/ritonavir is suspected. |
| Ritonavir 600 mg BID | Ritonavir AUC↔ 0.92 (0.79‑1.07) Ritonavir Cmin ↔ 0.93 (0.76‑1.14) Ritonavir Cmax ↔ 0.93 (0.78‑1.07) Nevirapine: Co-administration of ritonavir does not lead to any clinically relevant change in nevirapine plasma levels. | Ritonavir and Viramune can be co-administered without dose adjustments. |
| Saquinavir/ritonavir | The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and nevirapine | Saquinavir/ritonavir and Viramune can be co-administered without dose adjustments. |
| Tipranavir/ritonavir 500/200 mg BID | No specific drug-drug interaction study has been performed. The limited data available from a phase IIa study in HIV‑infected patients have shown a clinically non significant 20% decrease of TPV Cmin. | Tipranavir and Viramune can be co-administered without dose adjustments. |
| ENTRY INHIBITORS | ||
| Enfuvirtide | Due to the metabolic pathway no clinically significant pharmacokinetic interactions are expected between enfuvirtide and nevirapine. | Enfuvirtide and Viramune can be co-administered without dose adjustments. |
| Maraviroc 300 mg QD | Maraviroc AUC ↔ 1.01 (0.6‑1.55) Maraviroc Cmin ND Maraviroc Cmax ↔ 1.54 (0.94‑2.52) compared to historical controls Nevirapine concentrations not measured, no effect is expected. | Maraviroc and Viramune can be co-administered without dose adjustments. |
| INTEGRASE INHIBITORS | ||
| Elvitegravir/ cobicistat | Interaction has not been studied. Cobicistat, a cytochrome P450 3A inhibitor significantly inhibits hepatic enzymes, as well as other metabolic pathways. Therefore coadministration would likely result in altered plasma levels of cobicistat and Viramune. | Coadministration of Viramune with elvitegravir in combination with cobicistat is not recommended (see section 4.4). |
| Raltegravir 400 mg BID | No clinical data available. Due to the metabolic pathway of raltegravir no interaction is expected. | Raltegravir and Viramune can be co-administered without dose adjustments. |
| ANTIBIOTICS | ||
| Clarithromycin 500 mg BID | Clarithromycin AUC ↓ 0.69 (0.62‑0.76) Clarithromycin Cmin ↓ 0.44 (0.30‑0.64) Clarithromycin Cmax ↓ 0.77 (0.69‑0.86) Metabolite 14‑OH clarithromycin AUC ↑1.42 (1.16‑1.73) Metabolite 14‑OH clarithromycin Cmin ↔ 0 (0.68‑1.49) Metabolite 14‑OH clarithromycin Cmax ↑1.47 (1.21‑1.80) Nevirapine AUC ↑1.26 Nevirapine Cmin ↑1.28 Nevirapine Cmax ↑1.24 compared to historical controls. | Clarithromycin exposure was significantly decreased, 14‑OH metabolite exposure increased. Because the clarithromycin active metabolite has reduced activity against Mycobacterium avium-intracellulare complex overall activity against the pathogen may be altered. Alternatives to clarithromycin, such as azithromycin should be considered. Close monitoring for hepatic abnormalities is recommended |
| Rifabutin 150 or 300 mg QD | Rifabutin AUC ↑1.17 (0.98‑1.40) Rifabutin Cmin ↔ 1.07 (0.84‑1.37) Rifabutin Cmax ↑1.28 (1.09‑1.51) Metabolite 25‑O‑desacetylrifabutin AUC ↑1.24 (0.84‑1.84) Metabolite 25‑O‑desacetylrifabutin Cmin ↑1.22 (0.86‑1.74) Metabolite 25‑O‑desacetylrifabutin Cmax ↑1.29 (0.98‑1.68) A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported. | No significant effect on rifabutin and Viramune mean PK parameters is seen. Rifabutin and Viramune can be co-administered without dose adjustments. However, due to the high interpatient variability some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity. Therefore, caution should be used in concomitant administration. |
| Rifampicin 600 mg QD | Rifampicin AUC ↔ 1.11 (0.96‑1.28) Rifampicin Cmin ND Rifampicin Cmax ↔ 1.06 (0.91‑1.22) Nevirapine AUC ↓ 0.42 Nevirapine Cmin ↓ 0.32 Nevirapine Cmax ↓ 0.50 compared to historical controls. | It is not recommended to co-administer rifampicin and Viramune (see section 4.4). Physicians needing to treat patients co-infected with tuberculosis and using a Viramune containing regimen may consider co-administration of rifabutin instead. |
| ANTIFUNGALS | ||
| Fluconazole 200 mg QD | Fluconazole AUC ↔ 0.94 (0.88‑1.01) Fluconazole Cmin ↔ 0.93 (0.86‑1.01) Fluconazole Cmax ↔ 0.92 (0.85‑0.99) Nevirapine: exposure: ↑100% compared with historical data where nevirapine was administered alone. | Because of the risk of increased exposure to Viramune, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely. |
| Itraconazole 200 mg QD | Itraconazole AUC ↓ 0.39 Itraconazole Cmin ↓ 0.13 Itraconazole Cmax ↓ 0.62 Nevirapine: there was no significant difference in nevirapine pharmacokinetic parameters. | A dose increase for itraconazole should be considered when these two agents are administered concomitantly. |
| Ketoconazole 400 mg QD | Ketoconazole AUC ↓ 0.28 (0.20‑0.40) Ketoconazole Cmin ND Ketoconazole Cmax ↓ 0.56 (0.42‑0.73) Nevirapine: plasma levels: ↑1.15‑1.28 compared to historical controls. | It is not recommended to co-administer ketoconazole and Viramune (see section 4.4). |
| ANTIVIRALS FOR CHRONIC HEPATITIS B AND C | ||
| Adefovir | Results of in vitro studies showed a weak antagonism of nevirapine by adefovir (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected. Adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renally. No clinically relevant drug-drug interaction is expected. | Adefovir and Viramune may be coadministered without dose adjustments. |
| Entecavir | Entecavir is not a substrate, inducer or an inhibitor of cytochrome P450 (CYP450) enzymes. Due to the metabolic pathway of entecavir, no clinically relevant drug-drug interaction is expected. | Entecavir and Viramune may be coadministered without dose adjustments. |
| Interferons (pegylated interferons alfa 2a and alfa 2b) | Interferons have no known effect on CYP 3A4 or 2B6. No clinically relevant drug-drug interaction is expected. | Interferons and Viramune may be coadministered without dose adjustments. |
| Ribavirin | Results of in vitro studies showed a weak antagonism of nevirapine by ribavirin (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected. Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes. No clinically relevant drug-drug interaction is expected. | Ribavirin and Viramune may be coadministered without dose adjustments.
|
| Telbivudine | Telbivudine is not a substrate, inducer or inhibitor of the cytochrome P450 (CYP450) enzyme system. Due to the metabolic pathway of telbivudine, no clinically relevant drug-drug interaction is expected. | Telbivudine and Viramune may be coadministered without dose adjustments. |
| ANTACIDS | ||
| Cimetidine | Cimetidine: no significant effect on cimetidine PK parameters is seen. Nevirapine Cmin ↑1.07 | Cimetidine and Viramune can be co-administered without dose adjustments. |
| ANTITHROMBOTICS | ||
| Warfarin | The interaction between nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly. | Close monitoring of anticoagulation levels is warranted. |
| CONTRACEPTIVES | ||
| Depo-medroxyprogesterone acetate (DMPA) 150 mg every 3 months | DMPA AUC ↔ DMPA Cmin ↔ DMPA Cmax ↔ Nevirapine AUC ↑1.20 Nevirapine Cmax ↑1.20 | Viramune co-administration did not alter the ovulation suppression effects of DMPA. DMPA and Viramune can be co-administered without dose adjustments. |
| Ethinyl estradiol (EE) 0.035 mg | EE AUC ↓ 0.80 (0.67‑0.97) EE Cmin ND EE Cmax ↔ 0.94 (0.79‑1.12) | Oral hormonal contraceptives should not be used as the sole method of contraception in women taking Viramune (see section 4.4). Appropriate doses for hormonal contraceptives (oral or other forms of application) other than DMPA in combination with Viramune have not been established with respect to safety and efficacy. |
| Norethindrone (NET) 1.0 mg QD | NET AUC ↓ 0.81 (0.70‑0.93) NET Cmin ND NET Cmax ↓ 0.84 (0.73‑0.97) | |
| ANALGESICS/OPIOIDS | ||
| Methadone Individual Patient Dosing | Methadone AUC ↓ 0.40 (0.31‑0.51) Methadone Cmin ND Methadone Cmax ↓ 0.58 (0.50‑0.67) | Methadone-maintained patients beginning Viramune therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly. |
| HERBAL PRODUCTS | ||
| St. John's Wort | Serum levels of nevirapine can be reduced by concomitant use of the herbal preparation St. John's Wort (Hypericum perforatum). This is due to induction of medicinal product metabolism enzymes and/or transport proteins by St. John's Wort. | Herbal preparations containing St. John's Wort and Viramune must not be co-administered (see section 4.3). If a patient is already taking St. John's Wort check nevirapine and if possible viral levels and stop St. John's Wort. Nevirapine levels may increase on stopping St. John's Wort. The dose of Viramune may need adjusting. The inducing effect may persist for at least 2 weeks after cessation of treatment with St. John's Wort. |
Other information:
Nevirapine metabolites: Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/sulfamethoxazole. Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Women of childbearing potential / Contraception in males and females
Women of childbearing potential should not use oral contraceptives as the sole method for birth control, since nevirapine might lower the plasma concentrations of these medicinal products (see sections 4.4 & 4.5).
Pregnancy
Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity. To date no other relevant epidemiological data are available. No observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits (see section 5.3). There are no adequate and well-controlled studies in pregnant women. Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4). As hepatotoxicity is more frequent in women with CD4+ cell counts above 250 cells/mm3 with detectable HIV‑1 RNA in plasma (50 or more copies/mL), these conditions should be taken in consideration on therapeutic decision (see section 4.4). There is not enough evidence to substantiate that the absence of an increased risk for toxicity seen in pre-treated women initiating nevirapine with an undetectable viral load (less than 50 copies/mL of HIV‑1 in plasma) and CD4+ cell counts above 250 cells/mm3 also applies to pregnant women. All the randomised studies addressing this issue specifically excluded pregnant women, and pregnant women were under-represented in cohort studies as well as in meta-analyses.
Breast-feeding
It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV.
Fertility
In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
There are no specific studies about the ability to drive vehicles and use machinery.
However, patients should be advised that they may experience adverse reactions such as fatigue during treatment with Viramune. Therefore, caution should be recommended when driving a car or operating machinery. If patients experience fatigue they should avoid potentially hazardous tasks such as driving or operating machinery.
There is no known antidote for nevirapine overdose. Cases of Viramune overdose at doses ranging from 800 to 6 000 mg per day for up to 15 days have been reported. Patients have experienced oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases and weight decrease. All of these effects subsided following discontinuation of nevirapine.
Paediatric population
One case of massive accidental overdose in a newborn was reported. The ingested dose was 40 times the recommended dose of 2 mg/kg/day. Mild isolated neutropenia and hyperlactataemia was observed, which spontaneously disappeared within one week without any clinical complications. One year later, the child's development remained normal.
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