Lopinavir and Ritonavir: Uses, Side Effects and Dosage

What is lopinavir and ritonavir?

Lopinavir and ritonaviris a prescription medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and children 14 days of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if lopinavir and ritonaviris safe and effective in children under 14 days old.

Who should not take lopinavir and ritonavir ?

Do not take lopinavir and ritonavir if you or your child:

•are allergic to lopinavir, ritonavir, or any of the ingredients in lopinavir and ritonavir. See the end of this Medication Guide for a complete list of ingredients in lopinavir and ritonavir .

• take any of the following medicines:
• alfuzosin
• suzetrigine
• apalutamide
• ranolazine
• dronedarone
• colchicine, if you have kidney or liver problems.
• rifampin
• lurasidone
• pimozide
• ergot containing medicines including:
• dihydroergotamine mesylate
• ergotamine tartrate
• methylergonovine
• cisapride
• elbasvir/grazoprevir
• lovastatin
• simvastatin
• lomitapide
• sildenafil (Revatio®), when used for the treatment of pulmonary arterial hypertension
• triazolam
• midazolam when taken by mouth
• St. John’s Wort (Hypericum perforatum®)

Serious problems can happen if you or your child takes any of the medicines listed above with lopinavir and ritonavir.

Before taking lopinavir and ritonavir , tell your healthcare provider about all of your medical conditions, including if you:

•have ever had a serious skin rash or an allergic reaction to medicines that contain lopinavir or ritonavir.

•have or had pancreas problems.

•have liver problems, including Hepatitis B or Hepatitis C.

•have any heart problems, including if you have a condition called Congenital Long QT Syndrome.

•have low potassium in your blood.

•have diabetes.

•have high cholesterol in your blood.

•have hemophilia. Lopinavir and ritonavir may cause increased bleeding.

•are pregnant or plan to become pregnant. It is not known if lopinavir and ritonavir tablets will harm your unborn baby.

Lopinavir and ritonavir oral solution contains alcohol (ethanol) and propylene glycol. You should not take lopinavir and ritonavir oral solution during pregnancy because there is no safe level of alcohol exposure during pregnancy. Tell your healthcare provider if you become pregnant during treatment with lopinavir and ritonavir

oLopinavir and ritonavir 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 lopinavir and ritonavir.

oPregnancy Registry: There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of the pregnancy registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

• are breastfeeding or plan to breastfeed. Do not breastfeed if you take lopinavir and ritonavir.

Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with lopinavir and ritonavir:

• The HIV-1 virus may pass to your baby if your baby does not have HIV-1.
• The HIV-1 virus may become harder to treat if your baby has HIV-1.
• Your baby may get side effects from lopinavir and ritonavir.

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

You can ask your healthcare provider or pharmacist for a list of medicines that interact with lopinavir and ritonavir.

Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take lopinavir and ritonavir with other medicines. Your healthcare provider may need to change the dose of other medicines during treatment with lopinavir and ritonavir.

How should I take lopinavir and ritonavir ?

•Take lopinavir and ritonavir every day exactly as prescribed by your healthcare provider.

•Stay under the care of your healthcare provider during treatment with lopinavir and ritonavir.

•It is important to set up a dosing schedule and follow it every day.

•Do not change your treatment or stop treatment without first talking with your healthcare provider.

•Swallow lopinavir and ritonavir tablets whole. Do not chew, break, or crush lopinavir and ritonavir tablets.

•lopinavir and ritonavir tablets can be taken with or without food.

•If you are taking both didanosine and lopinavir and ritonavir:

oDidanosine can be taken at the same time as lopinavir and ritonavir tablets, without food.

•Take didanosine either 1 hour before or 2 hours after taking lopinavir and ritonavir oral solution.

•If you are pregnant:

oYou should not take lopinavir and ritonavir tablets on a 1 time each day dose schedule.

•Avoid use of lopinavir and ritonavir oral solution.

• If your child is prescribed lopinavir and ritonavir:

oTell your healthcare provider if your child’s weight changes.

•Lopinavir and ritonavir should not be given to children on a 1 time each day dose schedule. When giving lopinavir and ritonavir to your child, give lopinavir and ritonavir exactly as prescribed.

•You may have a greater chance of getting diarrhea if you take lopinavir and ritonavir 1 time each day than if you take it 2 times each day.

• Do not miss a dose of lopinavir and ritonavir. This could make the virus harder to treat. If you forget to take lopinavir and ritonavir, take the missed dose right away. If it is almost time for your next dose, do not take the missed dose. Instead, follow your regular dosing schedule by taking your next dose at its regular time. Do not take more than one dose of lopinavir and ritonavir at one time.

If you or your child take more than the prescribed dose of lopinavir and ritonavir , call your healthcare provider or go to the nearest emergency room right away.

What are the possible side effects of lopinavir and ritonavir ?

Lopinavir and ritonavir can cause serious side effects, including:

•See “What is the most important information I should know about lopinavir and ritonavir?”

•Diabetes and high blood sugar (hyperglycemia). You may develop new or worsening diabetes or high blood sugar during treatment with lopinavir and ritonavir. Tell your healthcare provider if you get any of the following signs or symptoms:

• urinate more often than usual o unusual weight loss
• increased hunger or thirst o increase in your blood sugar levels

Your healthcare provider may need to start you on medicine to treat high blood sugar or change your diabetes medicines.

•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.

•Increases in certain fat (triglycerides and cholesterol) levels in your blood. Large increases of triglycerides and cholesterol can be seen in blood test results of some people who take lopinavir and ritonavir. Your healthcare provider should do blood tests to check your cholesterol and triglyceride levels before you start taking lopinavir and ritonavir and during your treatment.

•Changes in body fat can happen in some people who take antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle 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 at this time.

•Increased bleeding in people with hemophilia. Some people with hemophilia have increased bleeding with lopinavir and ritonaviror similar medicines.

•Skin rash, which can be severe, can happen in people who take lopinavir and ritonavir. Tell your healthcare provider if you have a history of skin rash with other medicine used to treat your HIV-1 infection or if you get any skin rash during treatment with lopinavir and ritonavir.

• Kidney stones

Common side effects of lopinavir and ritonavir include:

•diarrhea• vomiting

•nausea•increased fats in blood (trigkycerides or cholesterol)

These are not all of the possible side effects of lopinavir and ritonavir. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store lopinavir and ritonavir ?

Lopinavir and ritonavir tablets:

•Store lopinavir and ritonavir tablets at room temperature, between 68°F to 77°F (20°C to 25°C).

•Store lopinavir and ritonavir tablets in the original container.

•Do not keep lopinavir and ritonavir tablets out of the container it comes in for longer than 2 weeks, especially in areas where there is a lot of humidity.

•Keep the container closed tightly.

Keep lopinavir and ritonavir tablets and all medicines out of the reach of children.

General information about the safe and effective use of lopinavir and ritonavir.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lopinavir and ritonavir tablets for a condition for which it was not prescribed. Do not give lopinavir and ritonavir tablets to other people, even if they have the same condition you have. It may harm them. You can ask your pharmacist or healthcare provider for information about lopinavir and ritonavir tablets that is written for health professionals.

What are the ingredients in lopinavir and ritonavir tablets ?

Active ingredients: lopinavir and ritonavir

Inactive ingredients:

The yellow, 200 mg lopinavir and 50 mg ritonavir, tablets contain the following inactive ingredients: copovidone, sorbiton monolaurate, colloidal silicon dioxide, anhydrous dibasic calcium phosphate, sodium stearyl fumarate. The coating consists of titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow.

The pale yellow, 100 mg lopinavir and 25 mg ritonavir, tablets contain the following inactive ingredients: copovidone, sorbiton monolaurate, colloidal silicon dioxide, anhydrous dibasic calcium phosphate, sodium stearyl fumarate. The coating consists of titanium dioxide, polyethylene glycol 3350, talc, iron oxide yellow.

For more information about lopinavir and ritonavir tablets call 1-888-943-3210 1-855-926-3384

The brands listed herewith are the trademarks of their own properties.

Manufactured for:

Macleods Pharma USA, Inc.

Princeton, NJ 08540

Manufactured by:

Macleods Pharmaceuticals Ltd.

Baddi, Himachal Pradesh-174101, INDIA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: August 2026