Patient Support 2018-09-10T18:24:51+00:00

Ritonavir Tablets: HIV-1 Infection Treatment and You

Why ritonavir tablets?

If you’re living with HIV, you know your daily treatment is very important to staying healthy. HIV is usually treated with a combination of drugs and your doctor may prescribe generic ritonavir tablets as part of your drug therapy. Ritonavir is a protease inhibitor that is a pharmacokinetic booster in combination with other antiretroviral medications.1 Ritonavir tablets are a prescription medicine used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection.

Antiretroviral treatment works to decrease the amount of HIV in your body (your viral load).2 Decreasing the level of HIV infection helps your immune system work better and lowers your chance for HIV complications.2 If HIV is left untreated, it can advance to a life-threatening stage—AIDS (acquired immune deficiency syndrome).2

Before starting any HIV treatment, it is important for you to talk with your doctor. Your doctor can tell you if ritonavir is right for you.

Take generic ritonavir with confidence

Hikma Pharmaceuticals USA Inc.’s ritonavir is the first AB-rated generic medicine to Norvir® tablets.3 This generic HIV drug is FDA-approved to provide the same clinical benefits as Norvir®.3 In order to receive FDA approval, generic medications must have the same active ingredients, same safety, same effectiveness, same strength, same quality and same benefits as its name-brand counterparts. Ask your doctor if generic ritonavir is right for you.

Frequently asked questions about ritonavir

When starting a new HIV-1 infection treatment, you’re bound to have questions. Get the answers to a few commonly asked questions about generic ritonavir tablets here. This information is not a substitute for talking to your doctor or pharmacist. They are your best resources for information about HIV treatments and ritonavir. In addition, please review the complete prescribing information for the product, including the Patient Counseling Information.

What conditions does ritonavir treat? 2018-02-19T17:52:45+00:00

Ritonavir is used with other antiretroviral medicines to treat HIV-1 infection, the virus that causes AIDS.1

Is ritonavir FDA-approved? 2018-06-21T15:14:32+00:00

In January 2015, West-Ward Pharmaceuticals Corp (now known as Hikma Pharmaceuticals USA Inc.) obtained FDA approval for ritonavir 100mg tablets, the only AB-rated generic prescription to Norvir®.

What is the recommended ritonavir dosage? 2018-02-19T17:53:50+00:00

In adults, the full dose of ritonavir is 600 mg taken twice a day with meals.1

Can I take ritonavir whenever I want? 2018-02-19T17:54:14+00:00

Ritonavir should be taken with food as directed by your doctor, usually 2 times a day.1 Ritonavir should be taken at the same time as your other HIV protease inhibitors.1 The tablets should be swallowed whole, never crushed, chewed or broken.1

How do I take ritonavir? 2018-02-22T09:51:31+00:00

Ritonavir tablets should be taken at the same time as your other HIV protease inhibitors.1 The tablets should be swallowed whole, never crushed, chewed or broken.1 Ritonavir tablets should be taken with food as directed by your doctor, usually 2 times a day.1

Can I take ritonavir with other medications? 2018-02-23T15:53:05+00:00

There are many medicines, vitamins and herbal supplements that can interact with ritonavir, some causing life-threatening side effects and events. It is important to share a list of all the prescription drugs, over-the-counter medications, vitamins and herbal products you use with your doctor and pharmacist. Do not start, stop or change the dosage of any medications without your doctor’s approval. See prescribing information.

What should I know about ritonavir side effects? 2018-02-23T12:35:44+00:00

Ritonavir can cause unwanted symptoms such as diarrhea, nausea, vomiting, upper and lower stomach (abdominal) pain, tingling feeling or numbness in hands or feet or around the lips, rash, and feeling weak or tired.1 These are not all the risks and side effects associated with ritonavir.1 This information does not replace talking with your doctor about your medical conditions and treatment before taking ritonavir. Read the important safety information and prescribing information  for warnings and side effects.

What risks are associated with ritonavir? 2018-09-10T18:35:47+00:00

Ritonavir tablets can interact with other medicines and cause serious and life-threatening side effects and adverse events. It is important to know the medicines that should not be taken with ritonavir tablets. Do not take ritonavir tablets if you or your child take any of the following medicines: alfuzosin (UROXATRAL®); amiodarone (CORDARONE®, NEXTERONE®, PACERONE®); cisapride (PROPULSID®, PROPULSID QUICKSOLV®); colchicine (COLCRYS®, COL-PROBENECID®, Probenecid and Colchicine and others); dronedarone (MULTAQ®); ergot-containing medicines, including: dihydroergotamine (D.H.E. 45®, MIGRANAL®), ergotamine tartrate (CAFERGOT®, MIGEROT®, ERGOSTAT®, MEDIHALER ERGOTAMINE®, WIGRAINE®, WIGRETTES®), methylergonovine maleate (ERGOTRATE®, METHERGINE®); flecainide (TAMBOCOR®); lovastatin (ADVICOR®, ALTOPREV®, MEVACOR®); lurasidone (LATUDA®); midazolam, when taken by mouth; pimozide (ORAP®); propafenone (RYTHMOL®); quinidine (NUEDEXTA®, QUINAGLUTE®, CARDIOQUIN®, QUINIDEX® and others); ranolazine (RANEXA®); sildenafil (REVATIO®), only when used for treating the lung problem, pulmonary arterial hypertension (PAH); simvastatin (SIMCOR®, VYTORIN®, ZOCOR®); St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort; triazolam (HALCION®) or voriconazole (VFEND®) if your ritonavir tablets dose is 400 mg every 12 hours or greater.  Serious problems can happen if you or your child takes any of these medicines with ritonavir tablets. Please see the Important Safety Information below and the full Prescribing Information for ritonavir tablets for complete product information including contraindications, warnings, precautions and adverse reactions.

What should I tell my doctor? 2018-02-19T17:58:19+00:00

Share a list of all the prescription and over the counter medicines, vitamins, and herbal supplements you take with your doctor and pharmacist. Tell your doctor and pharmacist if you are allergic to ritonavir or any of the ingredients in ritonavir tablets. See the ritonavir patient information for a complete list of ingredients in ritonavir tablets.

People with liver disease (including hepatitis B or C), heart problems, high blood sugar (diabetes), bleeding problems, hemophilia, who are pregnant, plan to become pregnant or are breastfeeding should talk to their doctor about their medical condition(s) before taking ritonavir.1

1. Ritonavir tablets [prescribing information]. Columbus, OH: West-Ward Columbus Inc.; 2018.
2. US Department of Health and Human Services AIDSinfo website. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV/Initiation of Antiretroviral Therapy. Available at: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/10/initiation-of-antiretroviral-therapy. Accessed February 16, 2018.
3. U.S. Food & Drug Administration website. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed February 15, 2018.

What is generic ritonavir?

LEARN MORE ABOUT IT

Use and Important Safety Information you should know about ritonavir tablets

What is ritonavir tablets?
Ritonavir tablets is a prescription medicine that is used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

Important Safety Information

What is the most important information I should know about ritonavir tablets?
Ritonavir tablets can interact with other medicines and cause serious side effects. It is important to know the medicines that should not be taken with ritonavir tablets. See the section titled, “Who should not take ritonavir tablets?”

Who should not take ritonavir tablets?
Do not take ritonavir tablets if you or your child are allergic to ritonavir or any of the ingredients in ritonavir tablets.

Drug Interactions:

Do not take ritonavir tablets if you or your child take any of the following medicines: alfuzosin (UROXATRAL®); amiodarone (CORDARONE®, NEXTERONE®, PACERONE®); cisapride (PROPULSID®, PROPULSID QUICKSOLV®); colchicine (COLCRYS®, COL-PROBENECID®, Probenecid and Colchicine and others); dronedarone (MULTAQ®); ergot-containing medicines, including: dihydroergotamine (D.H.E. 45®, MIGRANAL®), ergotamine tartrate (CAFERGOT®, MIGEROT®, ERGOSTAT®, MEDIHALER ERGOTAMINE®, WIGRAINE®, WIGRETTES®), methylergonovine maleate (ERGOTRATE®, METHERGINE®); flecainide (TAMBOCOR®); lovastatin (ADVICOR®, ALTOPREV®, MEVACOR®); lurasidone (LATUDA®); midazolam, when taken by mouth; pimozide (ORAP®); propafenone (RYTHMOL®); quinidine (NUEDEXTA®, QUINAGLUTE®, CARDIOQUIN®, QUINIDEX® and others); ranolazine (RANEXA®); sildenafil (REVATIO®), only when used for treating the lung problem, pulmonary arterial hypertension (PAH); simvastatin (SIMCOR®, VYTORIN®, ZOCOR®); St. John’s Wort (Hypericum perforatum) or a product that contains St. John’s Wort; triazolam (HALCION®) or voriconazole (VFEND®) if your ritonavir tablets dose is 400 mg every 12 hours or greater.

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

What should I tell my healthcare provider before taking ritonavir tablets?
Before taking ritonavir tablets, tell your healthcare provider if you or your child have liver problems, including hepatitis B or hepatitis C; heart problems; high blood sugar (diabetes); or bleeding problems or hemophilia.

Before taking ritonavir tablets, tell your healthcare provider if you are pregnant or plan to become pregnant.

Tell your healthcare provider if you become pregnant during treatment with ritonavir tablets.

Ritonavir tablets may reduce how well hormonal birth control works. Females who may become pregnant should use another effective form of birth control or an additional barrier method of birth control during treatment with ritonavir tablets.

Do not breastfeed if you take ritonavir tablets. Ritonavir tablets may pass into your breastmilk. Also, mothers with HIV-1 should not breastfeed because of the risk of passing HIV-1 to the baby. Talk to your healthcare provider about the best way to feed your baby.

If you take ritonavir tablets during pregnancy, talk to your healthcare provider about how you can take part in an Antiretroviral Pregnancy Registry.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with ritonavir tablets. Keep a list of your medicines to show your healthcare provider and pharmacist.

Ask your healthcare provider or pharmacist for a list of medicines that interact with ritonavir tablets.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ritonavir tablets with other medicines.

What are the possible side effects of ritonavir tablets?
Liver problems. Some people taking ritonavir tablets in combination with other antiviral medicines have developed liver problems which may be life-threatening. Your healthcare provider should do regular blood tests during your combination treatment with ritonavir tablets. If you have chronic hepatitis B or hepatitis C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your healthcare provider right away if you have any of the following signs and symptoms of liver problems: loss of appetite, yellowing of your skin or whites of your eyes, pain or tenderness on your right side below your ribs or itchy skin.

Inflammation of your pancreas (pancreatitis). Ritonavir tablets can cause serious pancreas problems, which may lead to death. Tell your healthcare provider right away if you have nausea, vomiting, or stomach (abdomen) pain, as these may be signs of pancreatitis.

Allergic reactions. Sometimes these allergic reactions can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking ritonavir tablets and get medical help right away if you have any of the following symptoms of a severe allergic reaction: trouble breathing; sweating; wheezing; swelling of your face, lips or tongue; dizziness or fainting; muscle or joint pain; throat tightness or hoarseness; blisters or skin lesions; fast heartbeat or pounding in your chest (tachycardia) or mouth sores or ulcers.

Changes in the electrical activity of your heart called PR prolongation. PR prolongation can cause irregular heartbeats. Tell your healthcare provider right away if you have symptoms such as: dizziness, lightheadedness, feel faint or pass out or have an abnormal heartbeat.

Increase in cholesterol and triglyceride levels. Treatment with ritonavir tablets may increase your blood levels of cholesterol and triglycerides. Your healthcare provider should do blood tests before you start your treatment with ritonavir tablets and regularly to check for increases in your cholesterol and triglycerides levels.

Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors, including ritonavir tablets, can get high blood sugar, develop diabetes or their diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or urinate often during treatment with ritonavir tablets.

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 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 healthcare provider right away if you start having new symptoms after starting your HIV-1 medicine.

Change in body fat can happen in some people who are taking HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle part of your body (trunk). 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 ritonavir tablets.

The most common side effects of ritonavir tablets include: diarrhea, nausea, vomiting, upper and lower stomach (abdominal) pain, tingling feeling or numbness in hands or feet or around the lips, rash and feeling weak or tired.

These are not all of the possible side effects of ritonavir tablets. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Reference:

  1. RITONAVIR tablets [prescribing information]. Eatontown, NJ: West-Ward Pharmaceutical Corp; 2017

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information for ritonavir tablets.

For Patient Information CLICK HERE.

Manufactured by: Cipla Limited, Patalganga, Maharashtra, India
Manufactured for: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724

Use and Important Safety Information you should know about ritonavir tablets

What is ritonavir tablets?
Ritonavir tablets is a prescription medicine that is used with other antiviral medicines to treat people with human immunodeficiency virus (HIV-1) infection.