Norvir

DRUG DESCRIPTION

NORVIR (ritonavir) is an inhibitor of HIV protease with activity against the Human Immunodeficiency Virus (HIV).

Ritonavir is chemically designated as 10-Hydroxy-2-methyl-5-(1-methylethyl)-1- [2-(1-methylethyl)-4thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-2,4,7,12- tetraazatridecan-13-oic acid, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C37H48N6O5S2, and its molecular weight is 720.95. Ritonavir has the following structural formula:

NORVIR (ritonavir) Structural Formula Illustration

Ritonavir is a white-to-light-tan powder. Ritonavir has a bitter metallic taste. It is freely soluble in methanol and ethanol, soluble in isopropanol and practically insoluble in water.

NORVIR tablets are available for oral administration in a strength of 100 mg ritonavir with the following inactive ingredients: copovidone, anhydrous dibasic calcium phosphate, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate. The following are the ingredients in the film coating: hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, talc, polyethylene glycol 3350, colloidal silicon dioxide, and polysorbate 80.

NORVIR oral solution is available for oral administration as 80 mg/mL of ritonavir in a peppermint and caramel flavored vehicle. Each 8-ounce bottle contains 19.2 grams of ritonavir. NORVIR oral solution also contains 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.

What are the possible side effects of ritonavir (Norvir)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ritonavir and call your doctor at once if you have any of these serious side effects:

  • slow heart rate, feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • increased urination or extreme thirst;
  • easy bruising or bleeding;
  • signs of a new infection,...

Read All Potential Side Effects and See Pictures of Norvir

What are the precautions when taking ritonavir capsules, oral solution (Norvir)?

Before taking ritonavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), hemophilia, high cholesterol/triglycerides, gout/high uric acid in the blood, liver problems (such as hepatitis B, hepatitis C), pancreatitis.

This medication may cause dizziness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This...

Read All Potential Precautions of Norvir


Norvir Consumer (continued)

SIDE EFFECTS: Diarrhea, nausea, vomiting, heartburn, stomach pain, loss of appetite, headache, dizziness, tiredness, weakness, changes in taste, or tingling/numbness of hands/feet/mouth area may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as depression, anxiety), joint pain, muscle weakness/cramps/aches, increased urination (especially at night), increased thirst.

Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, fainting, fast/irregular heartbeat.

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

If you are taking HIV medications for the first time, you may experience symptoms of an old infection. This may happen as your immune system begins to work better. Contact your doctor immediately if you notice any of the following symptoms: new cough, trouble breathing, fever, new vision problems, new headaches, new skin problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ritonavir, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (coronary artery disease, heart attack), hemophilia, high cholesterol/triglycerides, gout/high uric acid in the blood, liver problems (such as hepatitis B, hepatitis C), pancreatitis.

This medication may cause dizziness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication contains alcohol. Caution is advised if you have alcohol dependence or any other condition that requires you to limit/avoid alcohol.

If you have diabetes, this product may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. Your doctor may need to adjust your diabetes medication(s).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Ritonavir may be part of that treatment. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Norvir Patient Information Including Side Effects

Brand Names: Norvir

Generic Name: ritonavir (Pronunciation: rit OH na vir)

  • What is ritonavir (Norvir)?
  • What are the possible side effects of ritonavir (Norvir)?
  • What is the most important information I should know about ritonavir (Norvir)?
  • What should I discuss with my healthcare provider before taking ritonavir (Norvir)?
  • How should I take ritonavir (Norvir)?
  • What happens if I miss a dose (Norvir)?
  • What happens if I overdose (Norvir)?
  • What should I avoid while taking ritonavir (Norvir)?
  • What other drugs will affect ritonavir (Norvir)?
  • Where can I get more information?

What is ritonavir (Norvir)?

Ritonavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Ritonavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Ritonavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Ritonavir is not a cure for HIV or AIDS.

Ritonavir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ritonavir (Norvir)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ritonavir and call your doctor at once if you have any of these serious side effects:

  • slow heart rate, feeling like you might pass out;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • increased urination or extreme thirst;
  • easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
  • low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, stomach pain;
  • numbness or tingling, especially around your mouth;
  • headache, mood changes; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ritonavir (Norvir)?

Do not take ritonavir with alfuzosin (Uroxatral), amiodarone (Cordarone, Pacerone), bepridil (Vascor), flecainide (Tambocor), propafenone (Rythmol), quinidine (Quinaglute, Quinidex), voriconazole (Vfend), cisapride (Propulsid), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, Methergine.

These drugs can cause life-threatening side effects if you use them while you are taking ritonavir.

There are many other medicines that can interact with ritonavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Related Drug Centers
  • Norvir


Related Drugs Index: