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Norvir

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Norvir

Norvir

PATIENT INFORMATION

NORVIR®
(NOR-VEER)
(ritonavir) Tablet

NORVIR®
(NOR-VEER)
(ritonavir) Oral Solution

Read this Patient Information before you start taking NORVIR and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about NORVIR?

  • NORVIR can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with NORVIR. See the section “Who should not take NORVIR?”

What is NORVIR?

NORVIR is a prescription anti-HIV medicine used with other anti-HIV medicines to treat people with human immunodeficiency virus (HIV) infection. NORVIR is a type of anti-HIV medicine called a protease inhibitor. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

When used with other HIV medicines, NORVIR may reduce the amount of HIV in your blood (called “viral load”). NORVIR may also help to increase the number of CD4 (T) cells in your blood which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections). Patients who took NORVIR in clinical studies had significant reductions in both death and AIDS defining diseases; however NORVIR may not have these effects in all patients.

NORVIR does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using NORVIR.

Avoid doing things that can spread HIV-1 infection.

  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

Who should not take NORVIR?

Do not take NORVIR if you are allergic to ritonavir or any of the ingredients in NORVIR. See the end of this leaflet for a complete list of ingredients in NORVIR.

Do not take NORVIR with any of the following medicines:

  • alfuzosin (Uroxatral)
  • amiodarone (Cordarone, Nexterone, Pacerone), flecainide (Tambocor), propafenone (Rhythmol) or quinidine (Nuedext, Quinaglute, Cardioquin, Quinidex, and others)
  • voriconazole (VFend) if NORVIR dose is 400 mg every 12 hours or greater
  • dihydroergotamine (D.H.E. 45, Embolex, Migranal), ergonovine, ergotamine (Cafergot, Ergomar) methylergonovine (Methergine)
  • cisapride (Propulsid)
  • St. John's Wort (Hypericum perforatum)
  • the cholesterol lowering medicines lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin)
  • pimozide (Orap)
  • sildenafil (Revatio) only when used for the treatment of pulmonary arterial hypertension • oral midazolam or triazolam (Halcion)

Serious problems can happen if you or your child takes any of these medicines with NORVIR.

What should I tell my doctor before taking NORVIR?

Before taking NORVIR, tell your doctor if you:

  • have liver problems, including Hepatitis B or Hepatitis C.
  • have heart problems.
  • have high blood sugar (diabetes).
  • have bleeding problems or hemophilia.
  • are pregnant or plan to become pregnant. It is not known if NORVIR can harm your unborn baby.
    Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
  • are breastfeeding. Do not breastfeed if you take NORVIR
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if NORVIR passes into your breast milk.
    • Talk to your doctor about the best way to feed your baby.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking NORVIR and certain other medicines may affect each other causing serious side effects. NORVIR may affect the way other medicines work and other medicines may affect how NORVIR works.

Especially tell your doctor if you take:

  • medicine to treat HIV
  • estrogen-based contraceptives (birth control). NORVIR might reduce the effectiveness of estrogen-based contraceptives. You must take additional precautions for birth control such as a condom.
  • medicine for pain such as tramadol (Ryzolt, Ultracet, Conzip, Ultram), propoxyphene, or meperidine (Demerol)
  • medicine to treat alcohol abuse such as disulfiram (Antabuse)
  • medicine for your heart such as disopyramide (Norpace), lidocaine (Xylocaine Viscous), mexiletine, digoxin (Lanoxin), nifedipine (Procardia, Adalat, Afeditab CR), diltiazem (Cardizem, Dilacor, Cartia, Diltzac, Dilt, Taztia, Tiazac) or verapamil (Calan, Covera, Isoptin, Tarka, Verelan)
  • medicines for panic disorder or anxiety such as buspirone, clorazepate, diazepam, estazolam, flurazepam, and zolpidem
  • medicine for cancer such as dasatinib (Sprycel), nilotinib (Tasigna) vincristine, or vinblastine
  • warfarin (Coumadin, Jantoven), rivaroxaban (Xarelto)
  • medicine for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol, Epitol), clonazepam (Klonopin), ethosuximide (Zarontin, Ethosuximide), divalproex (Depakote, Divalproex Sodium), lamotrigine (Lamictal) or phenytoin (Dilantin, Phenytek)
  • medicine for depression such as nefazodone, bupropion (Wellbutrin, Aplenzin, Zyban), desipramine (Norpramin) or trazadone, fluoxetine (Prozac), paroxetine (Paxil), amitriptyline, or nortriptyline
  • medicine for nausea and vomiting such as dronabinol (Marinol) or perphenazine
  • medicine for fungal infections such as ketoconazole (Nizoral), itraconazole (Sporanox, Onmel) or voriconazole (VFend)
  • colchicine (Colcrys, Col-Probenecid, Probenecid and Colchine)
  • medicine for infections such as clarithromycin (Prevpac, Biaxin), rifabutin (Mycobutin), rifampin (Rimactane, Rifadin, Rifater, Rifamate), atovaquone (Mepron, Malarone), quinine (Qualaquin) or metronidazole (Flagyl, Helidac, Metrocream)
  • medicine used to treat blood pressure, a heart attack, heart failure, or to lower pressure in the eye such as metoprolol (Lopressor, Toprol-XL), timolol (Cosopt, Betimol, Timoptic, Isatolol, Combigan)
  • medicine for lung disease such as theophylline and salmeterol (Serevent)
  • bosentan (Tracleer)
  • medicine to prevent organ transplant failure such as cyclosporine (Gengraf, Sandimmune, Neoral), tacrolimus (Prograf,) sirolimus (Rapamune)
  • steroids such as dexamethasone, fluticasone (Advair Diskus, Veramyst, Flovent, Flonase), budesonide (Entocort EC, Pulmicort, Rhinocort), or prednisone
  • a narcotic medicine such as methadone (Methadose, Dolophine Hydrochloride) or fentanyl (Abstral, Actiq, Fentora, Lazanda, Onsolis, Duragesic)
  • medicine to treat schizophrenia such as risperidone (Risperdal) or thioridazine
  • medicine to treat erectile dysfunction or pulmonary hypertension such as avanafil (Stendra), sildenafil (Viagra, Revatio), vardenafil (Levitra, Staxyn), tadalafil (Cialis, Adcirca). If you are taking avanafil (Stendra), your doctor may need to change it to a different medicine.
  • midazolam by injection
  • methamphetamine (Desoxyn)
  • cholesterol lowering medicine such as atorvastatin (Lipitor) or rosuvasatin (Crestor)

This is not a complete list of medicines that you should tell your doctor that you are taking. Ask your doctor, provider or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine. Do not start any new medicines while you are taking NORVIR without first talking with your doctor.

How should I take NORVIR?

  • Take NORVIR exactly as prescribed by your doctor.
  • You should stay under a doctor's care when taking NORVIR. Do not change your dose of NORVIR or stop your treatment without talking with your doctor first.
  • If your child is taking NORVIR, your child's doctor will decide the right dose based on your child's height and weight. Tell your doctor if your child's weight changes. Your child should take NORVIR with food. If your child does not tolerate NORVIR Oral Solution, ask your child's doctor for advice.
  • Swallow NORVIR tablets whole. Do not chew, break, or crush tablets before swallowing. If you cannot swallow NORVIR tablets whole, tell your doctor. You may need a different medicine.
  • Take NORVIR with meals.
  • NORVIR Oral Solution is peppermint or caramel flavored. You can take it alone, or may improve the taste by mixing it with 8 ounces of chocolate milk, Ensure®, or Advera®. NORVIR Oral Solution should be taken within 1 hour if mixed with these fluids. Ask your doctor, nurse or pharmacist about other ways to improve the taste of NORVIR Oral Solution.
  • Do not run out of NORVIR. Get your NORVIR prescription refilled from you doctor or pharmacy before you run out.
  • If you miss a dose of NORVIR, take it as soon as possible and then take your next scheduled dose at its regular time. If it is almost time for your next dose, wait and take the next dose at the regular time. Do not double the next dose.
  • If you take too much NORVIR, call your local poison control center or go to the nearest hospital emergency room right away.

What are the possible side effects of NORVIR?

NORVIR can cause serious side effects including:

  • See “What is the most important information I should know about NORVIR?”
  • Liver disease. Some people taking NORVIR in combination with other anti-HIV medicines have developed liver problems which may be life-threatening. Your doctor should do regular blood tests during your combination treatment with NORVIR. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Tell your doctor if you have any of the below signs and symptoms of liver problems:
    • loss of appetite
    • pain or tenderness on your right side below your ribs
    • yellowing of your skin or whites of your eyes
    • itchy skin
  • Swelling of your pancreas (Pancreatitis). NORVIR can cause serious pancreas problems, which may lead to death. Tell your doctor right away if you have signs or symptoms of pancreatitis such as:
    • nausea
    • vomiting
    • stomach (abdomen) pain
  • Allergic Reactions. Sometimes these allergic reactions can become severe and require treatment in a hospital. You should call your doctor right away if you develop a rash. Stop taking NORVIR and get medical help right away if you have any of the following symptoms of a severe allergic reaction:
    • trouble breathing
    • wheezing
    • dizziness or fainting
    • throat tightness or hoarseness
    • fast heartbeat or pounding in your chest (tachycardia)
    • sweating
    • swelling of your face, lips or tongue
    • muscle or joint pain
    • blisters or skin lesions
    • mouth sores or ulcers
  • Changes in the electrical activity of your heart called PR prolongation. PR prolongation can cause irregular heartbeats. Tell your doctor right away if you have symptoms such as:
    • dizziness
    • lightheadedness
    • feel faint or pass out
    • abnormal heart beat
  • Increase in cholesterol and triglyceride levels. Treatment with NORVIR may increase your blood levels of cholesterol and triglycerides. Your doctor should do blood tests before you start your treatment with NORVIR and regularly to check for an increase in your cholesterol and triglycerides levels.
  • Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including NORVIR can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your doctor if you notice an increase in thirst or urinate often while taking NORVIR.
  • Changes in your immune system (Immune reconstitution syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your doctor right away if you start having new symptoms after starting your HIV medicine.
  • Change in body fat. These changes can happen in people who take antiretroviral therapy. The changes may include an increase amount of fat in the upper back and neck (“buffalo hump”), breast, and around the back and stomach area. Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known.
  • Increased bleeding for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors including NORVIR.

The most common side effects of NORVIR include:

  • diarrhea
  • nausea
  • vomiting
  • upper and lower stomach (abdomen) pain
  • tingling feeling or numbness in hands or feet or around the lips
  • rash
  • feeling weak or tired

NORVIR liquid contains a large amount of alcohol. If a toddler or young child accidentally drinks more than the recommended dose of NORVIR, it could make him/her sick from too much alcohol. Contact your local poison control center or emergency room immediately if this happens.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of NORVIR. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store NORVIR?

  • Store NORVIR Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store NORVIR tablets below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted.
  • Do not refrigerate NORVIR Oral Solution.
  • Shake NORVIR Oral Solution well before each use.
  • Keep NORVIR Oral Solution away from heat.
  • Store NORVIR tablets and NORVIR oral solution in the original container given to you by the pharmacist.
  • Exposure of NORVIR tablets to high humidity outside the original container for longer than 2 weeks is not recommended.
  • Use NORVIR tablets and NORVIR Oral Solution by the expiration date on the bottle.

Keep NORVIR and all medicines out of the reach of children.

General information about NORVIR

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not share this medicine with other people.

This leaflet summarizes the most important information about NORVIR. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about NORVIR that is written for healthcare professionals.

For more information, call 1-800-633-9110.

What are the ingredients in NORVIR?

Active ingredient: ritonavir

Inactive ingredients:

NORVIR Tablet: copovidone, anhydrous dibasic calcium phosphate, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The film coating contains: hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, talc, polyethylene glycol 3350, colloidal silicon dioxide, and polysorbate 80.

NORVIR Oral Solution: ethanol, water, polyoxyl 35 castor oil, propylene glycol, anhydrous citric acid to adjust pH, saccharin sodium, peppermint oil, creamy caramel flavoring, and FD&C Yellow No. 6.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 11/22/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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