Description
Nevirapine is used in combination with other medicines to treat human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by lowering the amount of HIV in the blood.
Nevirapine will not cure HIV infection or AIDS, however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Nevirapine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Tablet
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine oral liquid in children. However, safety and efficacy have not been established in infants younger than 15 days of age.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nevirapine extended-release tablets in children 6 years of age and older with a body surface area of 1.17 square meter (m2) or greater. However, use is not recommended in children younger than 6 years of age. Safety and efficacy have not been established in children younger than 6 years of age with a body surface area of less than 1.17 m2.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nevirapine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving nevirapine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Atazanavir
- Dasabuvir
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Amiodarone
- Amprenavir
- Artemether
- Atidarsagene Autotemcel
- Atogepant
- Avanafil
- Benzhydrocodone
- Buprenorphine
- Bupropion
- Cabotegravir
- Carbamazepine
- Clarithromycin
- Clonazepam
- Cobicistat
- Codeine
- Cyclophosphamide
- Cyclosporine
- Daclatasvir
- Darunavir
- Delavirdine
- Desogestrel
- Dexamethasone
- Dienogest
- Dihydrocodeine
- Diltiazem
- Dolutegravir
- Doravirine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Drospirenone
- Efavirenz
- Enzalutamide
- Ergotamine
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethosuximide
- Ethynodiol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Caspofungin
- Cisapride
- Dalfopristin
- Indinavir
- Lopinavir
- Ospemifene
- Quinupristin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Hepatitis B or
- Hepatitis C—Use with caution. May cause side effects to become worse.
- Liver disease, moderate or severe—Should not be used in patients with this conditions.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
This medicine comes with a Medication Guide. Read and follow these instructions carefully before starting nevirapine treatment and each time you refill your prescription. Ask your doctor if you have any questions.
Nevirapine may be taken with or without food, and with water, milk, or soda.
If you or your child are taking the oral liquid, shake it gently before use. Measure the oral liquid with a marked oral syringe or dosing cup. The average household teaspoon may not hold the right amount of liquid. After taking the medicine, drink water to make sure you get all the medicine. If the dose is less than 1 teaspoon (5 mL), use an oral syringe.
Swallow the extended-release tablet whole. Do not crush, break, or chew it.
Keep taking nevirapine for the full time of treatment, even if you begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.
It is important to take nevirapine as part of a combination treatment. Take all other medicines your doctor has prescribed at the right time of the day. This will make your medicines work better.
This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. For example, if you or your child are taking one dose per day, try to take it at the same time each day. If you are taking two doses per day, the doses should be spaced about 12 hours apart. If you need help planning the best times to take your medicine, check with your doctor.
Do not take more than one dosage form of nevirapine at the same time. Talk to your doctor if you have any questions.
If you stop taking this medicine for more than 7 days, ask your doctor how much to use before you start taking it again.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For HIV infection:
- For oral dosage form (extended-release tablets):
- Adults—At first, one 200 milligram (mg) Viramune® immediate-release tablet once a day for the first 14 days. This is followed by one 400 mg Viramune XR® tablet once a day, together with other HIV medicines.
- Children 6 to 17 years of age with a body surface area of 1.17 square meter (m2) or greater—Dose is based on body size and must be determined by your doctor. The starting dose is usually 150 milligrams (mg) per square meter (m2) of Viramune® oral suspension or tablets for the first 14 days. This is followed by 400 mg of Viramune XR® once a day, together with other HIV medicines.
- Children younger than 6 years of age with a body surface area of less than 1.17 m2—Use is not recommended.
- For oral dosage forms (suspension):
- Adults—200 milligrams (mg) or 20 milliliters (mL) once a day for 2 weeks, followed by 200 mg 2 times per day, together with other medicines. However, the dose is usually not more than 400 mg per day.
- Children and infants 15 days of age and older—Dose is based on body surface area (BSA) and must be determined by your doctor. The dose is usually 150 milligrams per square meter (mg/m[2]) of BSA, once a day for 14 days, followed by 150 mg/m2 2 times a day. However, the dose is usually not more than 400 mg per day.
- BSA of 1.25 meter squared (m2) or more—20 milliliters (mL) once a day for 14 days.
- BSA of 1.08 to 1.25 m2—17.5 mL once a day for 14 days.
- BSA of 0.92 to 1.08 m2—15 mL once a day for 14 days.
- BSA of 0.75 to 0.92 m2—12.5 mL once a day for 14 days.
- BSA of 0.58 to 0.75 m2—10 mL once a day for 14 days.
- BSA of 0.42 to 0.58 m2—7.5 mL once a day for 14 days.
- BSA of 0.25 to 0.42 m2—5 mL once a day for 14 days.
- BSA of 0.12 to 0.25 m2—2.5 mL once a day for 14 days.
- BSA of 0.06 to 0.12 m2—1.25 mL once a day for 14 days.
- Infants younger than 15 days of age—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your or your child's progress to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
Your immune system may get stronger, when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves disease, polymyositis, and Guillain-Barré syndrome) may also occur.
This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, including an increased amount of body fat in your neck or upper back, face, around your chest, or stomach area. You might also lose fat from your legs, arms, or face.
It is important to continue to practice safe sex. Make sure you understand and practice safe sex such as using latex condoms, even if your partner also has HIV. Do not share needles, toothbrushes, and razor blades with anyone.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Decreased appetite
- swelling of the feet or lower legs
Rare
- Pain, numbness, or tingling of the hands, arms, legs, or feet
- sleepiness or unusual drowsiness
- stomach pain
- tingling, burning, or prickly sensations
Incidence not known
- Black, tarry stools
- blistering, peeling, or loosening of the skin
- bone pain
- chest pain or tightness
- chills
- clay-colored stools
- cough
- dark urine
- diarrhea
- difficulty swallowing
- dizziness
- fast heartbeat
- fever
- general tiredness and weakness
- headache
- hives, itching, skin rash
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- lower back or side pain
- muscle cramps, spasms, pain, or stiffness
- nausea
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain, continuing
- swollen glands
- trouble breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- vomiting of blood
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Chest pain
- cough
- decrease in weight
- dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- headache
- pain in the ankles or knees
- painful, red lumps under the skin, mostly on the legs
- sensation of spinning
- trouble sleeping
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Difficulty with moving
- joint pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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