Norvir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Norvir is used together with other antiviral medicines to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS).

Norvir is not a cure for HIV or AIDS.

Serious drug interactions can occur when certain medicines are used with Norvir. Tell your doctor about all your current medicines and any you start or stop using.

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

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Norvir should not be used without other antiviral medication. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take with meals.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

Swallow the tablet whole and do not crush, chew, or break it.

Shake the oral solution (liquid). Measure a dose with the supplied syringe or a dose-measuring device (not a kitchen spoon).

Follow your doctor's dosing instructions very carefully when giving Norvir to an infant. Doses are based on body surface area (height and weight) in children. The dose may change if the child grows or gains weight.

Use all HIV medications as directed. Do not change your dose or stop using a medicine without your doctor's advice. Remain under the care of a doctor.

You will need frequent medical tests.

If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using Norvir and for several months after you stop.

Store the tablets, liquid, or powder at room temperature away from heat or moisture. Do not refrigerate. Keep tightly closed when not in use.

Store the capsules in the refrigerator or at room temperature away from moisture, heat, and light. Or store at room temperature and use the capsules within 30 days.

Usual Adult Dose for HIV Infection:

Use as a pharmacokinetic (PK) booster for other protease inhibitors: 100 to 400 mg/day orally in 1 or 2 divided doses

Use as an antiretroviral agent (sole protease inhibitor):
-Initial dose: 300 mg orally twice a day; increase by 100 mg twice a day every 2 to 3 days to the full maintenance dose
-Maintenance dose: 600 mg orally twice a day

-According to experts, this drug should not be used as the sole protease inhibitor for initial therapy.

Usual Pediatric Dose for HIV Infection:

Use as a PK booster for other protease inhibitors: The manufacturer product information of the boosted protease inhibitor should be consulted for dose recommendations.

Use as an antiretroviral agent (sole protease inhibitor):
Greater than 1 month:
-Initial dose: 250 mg/m2 orally twice a day; increase by 50 mg/m2 twice a day every 2 to 3 days to the full maintenance dose
-Maintenance dose: 350 to 400 mg/m2 orally twice a day
Maximum dose: 600 mg/dose

Comments:
-This drug is most often used and recommended as a PK enhancer of more potent and better tolerated protease inhibitors.
-Use as a PK enhancer for other protease inhibitors is not specifically approved by the US FDA in the manufacturer product information for Norvir.
-If 400 mg/m2 twice a day is intolerable, the highest tolerated dose may be used for maintenance therapy in combination with other antiretrovirals; however, alternative therapy should be considered.
-The oral solution should not be given to neonates before a postmenstrual age of 44 weeks has been reached.
-According to experts, this drug should not be used as the sole protease inhibitor for initial therapy.
-Special attention should be given to accurate calculation of dose, transcription of medication order, dispensing information, and dosing instructions to reduce risk for medication errors and overdose; particularly important for infants and young children.
-Total amounts of alcohol and propylene glycol from all medications (including the oral solution) to be given to pediatric patients 1 to 6 months of age should be considered to avoid toxicity from these excipients.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Some drugs should not be used with Norvir. Your treatment plan may change if you also use:

• alfuzosin, apalutamide, cisapride, colchicine, St. John's wort, voriconazole;

• sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);

• antipsychotic medicine - lurasidone, pimozide;

• cholesterol-lowering medicine - lovastatin, simvastatin, lomitapide;

• ergot medicine - dihydroergotamine, ergotamine, methylergonovine;

• heart medicine - amiodarone, dronedarone, flecainide, propafenone, quinidine, ranolazine; or

• a sedative - oral midazolam or triazolam.

To make sure Norvir is safe for you, tell your doctor if you have ever had:

• liver disease (especially hepatitis B or C);

• heart problems;

• diabetes; or

• a bleeding disorder such as hemophilia.

Norvir liquid contains alcohol and propylene glycol, and should not be used by pregnant women or premature babies.

To prevent HIV in a newborn baby, use all medications to control your infection during pregnancy. Your name may be listed on an antiviral pregnancy registry.

Norvir can make birth control pills or skin patches less effective. Ask your doctor about other birth control options such as an injection, implant, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

Women with HIV should not breastfeed. The virus can pass to your baby in your breast milk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Norvir oral liquid could be fatal to a child.

Drinking alcohol or taking disulfiram (Antabuse) while taking Norvir capsules or liquid may cause unpleasant side effects.

Using Norvir will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction to Norvir (hives, skin sores, difficult breathing, fast or pounding heartbeats, sweating, mouth sores, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• irregular heartbeats, or a light-headed feeling (like you might pass out);

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• signs of a kidney stone - pain in your side or lower back, blood in your urine, painful or difficult urination;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or

• signs of liver or pancreas problems - loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes).

Norvir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Norvir side effects may include:

• nausea, vomiting, stomach pain, diarrhea;

• numbness or tingling in your hands or feet or around your mouth;

• feeling weak or tired;

• rash; 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ritonavir, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.