ritonavir

Pronunciation

Generic Name: ritonavir (rit OH na vir)
Brand Name: Norvir, Norvir Soft Gelatin

What is ritonavir?

Ritonavir is an antiviral medicine that 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 purposes not listed in this medication guide.

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

Many other drugs can interact with ritonavir. There are certain medicines that can cause life-threatening drug interactions with ritonavir, and should not be used at the same time. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Slideshow: Flashback: FDA Drug Approvals 2013

What should I discuss with my healthcare provider before taking ritonavir?

You should not take ritonavir if you are allergic to it.

There are certain medicines that can cause life-threatening drug interactions with ritonavir, and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • alfuzosin;

  • cisapride;

  • pimozide;

  • St. John's wort;

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

  • voriconazole;

  • cholesterol-lowering medicine--lovastatin, simvastatin;

  • ergot medicine--dihydroergotamine, ergotamine, ergonovine, methylergonovine;

  • heart rhythm medicine--amiodarone, flecainide, propafenone, quinidine; or

  • a sedative--oral midazolam or triazolam.

To make sure ritonavir is safe for you, tell your doctor if you have:

  • liver disease (especially hepatitis B or C);

  • pancreas disorder;

  • diabetes;

  • heart disease or heart rhythm disorder;

  • a bleeding disorder such as hemophilia; or

  • high cholesterol or triglycerides.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Ritonavir can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy while taking ritonavir.

How should I take ritonavir?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ritonavir tablets must be taken with meals. Ritonavir capsules or liquid should be taken with food if possible.

Do not crush, chew, or break a ritonavir tablet. Swallow it whole.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Liquid ritonavir can be mixed with chocolate milk or a nutrition drink such as Ensure. Drink the mixture within 1 hour after mixing.

If a child is using this medicine, tell your doctor if the child has any changes in weight or height. Ritonavir doses are based on body surface area in children.

Use ritonavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Your blood will need to be tested on a regular basis. Your liver function may also need to be tested.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. 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.

Store ritonavir capsules in the refrigerator or at room temperature, away from heat or moisture. If you store the capsules at room temperature you must use them within 30 days. Protect from light.

Store ritonavir tablets at room temperature away from heat or moisture.

Store ritonavir liquid at room temperature with the cap tightly closed. Do not refrigerate.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking ritonavir?

Ritonavir capsules and oral liquid contain alcohol. Avoid drinking alcoholic beverages while using this medicine, and do not take disulfiram (Antabuse) or you could have an alcohol reaction.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share 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.

Ritonavir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives, skin sores, mouth sores; joint or muscle pain; wheezing, difficulty breathing, fast or pounding heartbeats; sweating, feeling light-headed; swelling of your face, lips, tongue, or throat.

Stop taking ritonavir and call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • irregular heartbeats;

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

  • pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Ritonavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with ritonavir. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

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

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;

  • numbness or tingling, especially around your mouth;

  • weakness, tired feeling;

  • mild 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.

See also: Side effects (in more detail)

Ritonavir dosing information

Usual Adult Dose for HIV Infection:

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

Comments:
-Ritonavir is most frequently used and recommended as a PK enhancer of more potent and better tolerated protease inhibitors.
-This use is not specifically approved by the FDA in the ritonavir labeling.
-The labeling of the boosted protease inhibitor should be consulted for dosage recommendations.

FDA-approved dose (sole protease inhibitor):
Initial dose: 300 mg orally twice a day
Maintenance dose: Increase by 100 mg twice daily every 2 to 3 days to the full dose of 600 mg orally twice a day

Comments: Use of ritonavir as the sole protease inhibitor is not recommended by US Department of Health and Human Services (HHS) guidelines.

Usual Pediatric Dose for HIV Infection:

As a PK booster for other protease inhibitors: The labeling of the boosted protease inhibitor should be consulted for dosage recommendations.

Comments:
-Ritonavir is most frequently used and recommended as a PK enhancer of more potent and better tolerated protease inhibitors.
-This use is not specifically approved by the FDA in the ritonavir labeling.

FDA-approved dose (sole protease inhibitor):
Greater than 1 month:
Initial dose: 250 mg/m2 orally twice a day
Maintenance dose: Increase by 50 mg/m2 twice daily every 2 to 3 days to the full dose of 350 to 400 mg/m2 orally twice a day
Maximum dose: 600 mg/dose

Comments:
-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.
-Ritonavir oral solution should not be given to neonates before a postmenstrual age of 44 weeks has been reached.
-Use of ritonavir as the sole protease inhibitor is not recommended by HSS guidelines.

What other drugs will affect ritonavir?

Many drugs can interact with ritonavir. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with ritonavir, especially:

  • other drugs to treat HIV or AIDS;

  • an antibiotic or antifungal medicine;

  • an antidepressant or anti-psychotic medicine;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • cancer medicine;

  • cholesterol-lowering medicine;

  • heart or blood pressure medicine;

  • medicine to prevent organ transplant rejection;

  • medicine to prevent or treat nausea and vomiting;

  • medicine to treat a breathing disorder;

  • narcotic medicine;

  • a sedative;

  • seizure medicine;

  • steroid medicine; or

  • Viagra and other erectile dysfunction medicines.

This list is not complete and many other drugs can interact with ritonavir. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about ritonavir.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 17.01. Revision Date: 2014-03-17, 7:58:14 AM.

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