Kaletra

Brand Name

Kaletra

Common Name

lopinavir - ritonavir

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Lopinavir and ritonavir are two medications used in combination with other anti-HIV medications to help prevent the human immunodeficiency virus (HIV) from reproducing. The HIV virus is the virus responsible for acquired immune deficiency syndrome (AIDS).

Lopinavir and ritonavir belong to a class of medications known as protease inhibitors. Protease is an enzyme that is needed by HIV for reproduction. Lopinavir and ritonavir block the action of protease. Ritonavir also slows down the body's breakdown of lopinavir, making more lopinavir available to the body.

This medication does not cure AIDS and does not prevent it from being spread to others. It is used in combination with other anti-HIV medications to slow further growth or reproduction of HIV and seems to slow down the destruction of the immune system. This may help to delay the development of problems such as infections related to AIDS or HIV disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual recommended dose for adults is 400 mg lopinavir and 100 mg ritonavir taken twice daily. If recommended by a doctor, some people may be able to take this medication as a once-daily dose of 800 mg lopinavir and 200 mg ritonavir. People who are pregnant must take the recommended twice-daily dose.

The recommended dose for children between 6 months and 18 years of age is based on body weight or body surface area and will be calculated by the doctor using the child's weight and height. Children and adolescents less than 18 years of age should take this medication twice daily.

Doses may vary if other medications for HIV are used at the same time.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

The tablets can be taken with or without food and should be swallowed whole. Do not chew, crush, or break the tablets. The oral solution must be taken with food.

Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the tablets at room temperature. Store the solution in its original container. It may be kept in the fridge between 2°C and 8°C until the expiry date or for up to 42 days at room temperature. Avoid exposure to excessive heat. Keep the cap of the oral solution tightly closed. Keep all forms of this medication out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Film-coated tablets

100 mg/25 mg
Each pale yellow, film-coated tablet, embossed with the Abbott logo and the Abbo-Code "KC", contains 100 mg of lopinavir and 25 mg of ritonavir. Nonmedicinal ingredients: copovidone, sorbitan monolaurate, colloidal silicon dioxide, and sodium stearyl fumarate; film-coating: polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, and yellow ferric oxide E172.

200 mg/50 mg
Each yellow, film-coated tablet, embossed with the Abbott logo and the Abbo-Code "KA", contains 200 mg of lopinavir and 50 mg of ritonavir. Nonmedicinal ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, and sorbitan monolaurate; film-coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, yellow ferric oxide E172, and titanium dioxide.

Oral solution

Each mL of light yellow-to-orange liquid contains 80 mg of lopinavir and 20 mg of ritonavir. Nonmedicinal ingredients: acesulfame potassium, alcohol, artificial cotton candy flavour, citric acid, glycerin, high fructose corn syrup, Magnasweet-110 flavour, menthol, natural and artificial vanilla flavour, peppermint oil, polyoxyl 40 hydrogenated castor oil, povidone, propylene glycol, saccharin sodium, sodium chloride, sodium citrate, and water.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to lopinavir, ritonavir, or any ingredients of the medication
• are taking any of the following medications:
• alfuzosin
• apalutamide
• cisapride
• colchicine
• dihydroergotamine
• dronedarone
• elbasvir - grazoprevir
• ergonovine
• ergotamine
• lomitapide
• lovastatin
• lurasidone
• methylergonovine
• midazolam
• neratinib
• pimozide
• ranolazine
• rifampin
• salmeterol
• sildenafil
• simvastatin
• St. John's wort
• triazolam
• vardenafil
• venetoclax

Do not take the liquid form of this medication if you:

• are pregnant
• have decreased liver function or liver disease
• have decreased kidney function or kidney disease
• are taking disulfiram or metronidazole

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• diarrhea
• headache
• nausea
• skin rash
• tingling feeling in hands, feet, and around lips
• tiredness
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• chest pain
• increased blood cholesterol levels
• signs of bleeding, e.g.:
• blood in stools
• blood in urine
• bloody nose
• coughing blood
• cuts that don't stop bleeding
• signs of infections, symptoms may include:
• fever or chills
• headache
• listlessness
• prolonged dizziness
• severe diarrhea
• shortness of breath
• stiff neck
• weight loss
• signs of liver problems, e.g.:
• dark urine
• diarrhea
• loss of appetite
• nausea
• pale stools
• vomiting
• weight loss
• yellowing of the skin or whites of the eyes
• symptoms of high blood sugar such as frequent urination or increased thirst

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (swelling of face or throat, hives, or difficulty breathing)
• signs of pancreatitis, e.g.:
• abdominal pain on the upper left side
• back pain
• chills
• fever
• nausea
• rapid heartbeat
• swollen abdomen
• signs of a severe skin reaction, e.g.:
• a rash combined with fever or discomfort
• a rash covering a large area of the body
• a rash that spreads quickly
• blistering
• peeling

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, pentamidine, probucol, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with lopinavir - ritonavir. You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are female
• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have diabetes
• have had a stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications (e.g., verapamil, atazanavir), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Alcohol content: The liquid form of lopinavir - ritonavir contains alcohol. If you have decreased kidney or liver function, a history of alcoholism, epilepsy or a brain injury, or are pregnant or a child, this medication may not be appropriate for you. Talk to your doctor if you have concerns.

Blood tests: Lopinavir - ritonavir can cause changes in your blood test results, such as red blood cell count, platelet count, cholesterol level, and sugar level. Your doctor will explain these to you and monitor your blood levels.

Diabetes: Antiretroviral medications such as lopinavir - ritonavir may cause diabetes or increase blood sugar levels. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.

If you experience symptoms of diabetes, such as frequent urination or increased thirst, contact your doctor.

Heart conditions: People with heart disease or people who are taking certain medications (e.g., verapamil, atazanavir) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hemophilia: Lopinavir - ritonavir may put people with hemophilia at a higher risk of bleeding while taking this medication. If you have hemophilia, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

High cholesterol: Lopinavir - ritonavir may increase cholesterol and triglyceride levels. If you have high cholesterol or are taking medication to control your cholesterol level, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Immune reconstitution inflammatory syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or tuberculosis). Report any new symptoms to your doctor immediately.

Liver problems: Decreased liver function or liver disease can cause lopinavir - ritonavir to build up in the body and may cause side effects. This medication may also cause liver problems. People with liver disease or decreased liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Pancreatitis (inflammation of the pancreas): Lopinavir - ritonavir may cause or worsen pancreatitis. If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the potential benefits outweigh risks. If you become pregnant while taking this medication, contact your doctor immediately. The oral solution should not be used during pregnancy due to the alcohol and propylene glycol content.

Breast-feeding: It is not known if lopinavir - ritonavir passes into breast milk. People who have HIV infection should not breast-feed because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of this medication have not been established for children younger than 6 months. This medication is not recommended for this age group.

What other drugs could interact with this medication?

There may be an interaction between lopinavir - ritonavir and any of the following:

• aliskiren
• alitretinoin
• alpha-blockers (e.g., alfuzosin, doxazosin, silodosin, tamsulosin)
• antiarrhythmic medications (e.g., amiodarone, disopyramide, flecainide, lidocaine, procainamide, propafenone, sotalol)
• anticancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
• anticonvulsants (e.g., carbamazepine, lamotrigine, phenobarbital, phenytoin, valproic acid)
• antipsychotics (e.g., aripiprazole, cariprazine, chlorpromazine, haloperidol, olanzapine, quetiapine, risperidone)
• apalutamide
• apixaban
• aprepitant
• atogepant
• atovaquone
• avacopan
• "azole" antifungal agents (e.g., itraconazole, ketoconazole, voriconazole)
• benzodiazepines (e.g., alprazolam, diazepam, midazolam, triazolam)
• bilastine
• birth control pills
• bosentan
• bromocriptine
• buprenorphine
• bupropion
• buspirone
• butorphanol
• calcitriol
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• cannabis
• CF transmembrane regulators (e.g., elexacaftor, ivacaftor, lumacaftor, tezacaftor)
• cinacalcet
• clindamycin
• clopidogrel
• cobicistat
• colchicine
• cyclosporine
• daridorexant
• darifenacin
• deferasirox
• desiccated thyroid
• diabetes medications (e.g., acarbose, canagliflozin, gliclazide, insulin, metformin, repaglinide, sitagliptin)
• digoxin
• disulfiram
• domperidone
• dutasteride
• edoxaban
• elagolix
• eliglustat
• enzalutamide
• ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• everolimus
• fesoterodine
• flibanserin
• galantamine
• garlic
• grapefruit juice
• guanfacine
• hepatitis C antivirals (e.g., glecaprevir, voxilaprevir)
• HIV integrase inhibitors (e.g., bictegravir, cabotegravir, elvitegravir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine, rilpivirine)
• HIV protease inhibitors (e.g., atazanavir, ritonavir, tipranavir)
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• intranasal corticosteroids (e.g., fluticasone, mometasone)
• ivabradine
• lemborexant
• lenacapavir
• letermovir
• leuprolide
• levomilnacipran
• lomitapide
• macitentan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• mavacamten
• mebendazole
• mefloquine
• methadone
• metronidazole
• mifepristone
• mirtazapine
• modafinil
• certain monoclonal antibodies (e.g., brentuximab, enfortumab, polatuzumab, sacituzumab)
• nadolol
• naloxegol
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tramadol)
• nirmatrelvir and ritonavir
• oral corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, prednisone)
• orlistat
• ospemifene
• oxybutynin
• phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• praziquantel
• progestins (e.g., dienogest, medroxyprogesterone)
• proguanil
• quinine
• ranolazine
• rifabutin
• rifampin
• riociguat
• rivaroxaban
• roflumilast
• rupatadine
• St. John's wort
• salmeterol
• sirolimus
• solifenacin
• sotalol
• "statin" cholesterol reducing medications (e.g., atorvastatin, lovastatin, rosuvastatin, simvastatin)
• tacrolimus
• temsirolimus
• tenofovir
• theophyllines (e.g., aminophylline, theophylline)
• ticagrelor
• tofacitinib
• tolterodine
• trazodone
• tretinoin
• "triptan" migraine medications (e.g., almotriptan, eletriptan)
• tyrosine kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
• ubrogepant
• upadacitinib
• ulipristal
• vilanterol
• vilazodone
• warfarin
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Kaletra