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ritonavir
The only AB-rated generic to Norvir®

Ritonavir is FDA-approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children older than 1 month.

Models throughout are for illustrative purposes only

Is ritonavir right for you?

Questions about ritonavir?

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.