KALETRA (Brand for LOPINAVIR-RITONAVIR)

LOPINAVIR; RITONAVIR (loe PIN a veer; ri TOE na veer) is 2 antiretroviral medicines in 1 solution. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. This medicine can lower, but not fully prevent, the risk of spreading HIV to others.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Use a specially marked spoon or container to measure the dose. Household spoons are not accurate. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.
 
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
 
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for infants as young as 14 days old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Do not take this medicine with any of the following medications:
-alfuzosin
-certain medicines for anxiety or sleep like midazolam, triazolam
-certain medicines for cancer like apalutamide, enzalutamide
-certain medicines for cholesterol like lomitapide, lovastatin, simvastatin
-certain medicines for fungal infections like fluconazole, posaconazole
-certain medicines for hepatitis C like elbasvir; grazoprevir, boceprevir, dasabuvir; ombitasvir; paritaprevir; ritonavir
-cisapride
-dronedarone
-eletriptan
-ergot alkaloids like dihydroergotamine, ergonovine, ergotamine, methylergonovine
-lurasidone
-meperidine
-naloxegol
-pimozide
-ranolazine
-red yeast rice
-ribociclib
-rifampin
-silodosin
-St. John's wort
-thioridazine
-ubrogepant
 
This medicine may also interact with the following medications:
-atovaquone
-bedaquiline
-birth control pills
-bosentan
-bupropion
-certain medicines for blood pressure like felodipine, nicardipine, nifedipine
-certain medicines for cancer like abemaciclib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine
-certain medicines for cholesterol like atorvastatin
-certain medicines for erectile dysfunction like sildenafil, tadalafil, vardenafil
-certain medicines for fungal infections like isavuconazonium, itraconazole, ketoconazole, voriconazole
-certain medicines for irregular heartbeat like amiodarone, bepridil, lidocaine, quinidine
-certain medicines for seizures like carbamazepine, lamotrigine, phenobarbital, phenytoin, valproate
-certain medicines that treat or prevent blood clots like rivaroxaban, warfarin
-clarithromycin
-colchicine
-cyclosporine
-disulfiram
-elagolix
-fentanyl
-fostamatinib
-methadone
-metronidazole
-other medicines for HIV or AIDS
-other medicines that prolong the QT interval (cause an abnormal heart rhythm) like dofetilide, ziprasidone
-quetiapine
-rifabutin
-rifapentine
-salmeterol
-sirolimus
-steroid medicines like budesonide, dexamethasone, fluticasone, prednisone, triamcinolone
-tacrolimus
-trazodone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

Visit your doctor or healthcare provider for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.
 
HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.
 
Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control. Women who can still have children must use a reliable form of barrier contraception, like a condom or diaphragm.
 
This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.
 
Some products may contain alcohol. Ask your pharmacist or healthcare provider if this medicine contains alcohol. Be sure to tell all healthcare providers you are taking this medicine. Certain medicines, like metronidazole and disulfiram, can cause an unpleasant reaction when taken with alcohol. The reaction includes flushing, headache, nausea, vomiting, sweating, and increased thirst. The reaction can last from 30 minutes to several hours.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Side effects that you should report to your doctor or health care professional as soon as possible:
-allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
-fast, irregular heart rate
-feeling faint or lightheaded, falls
-nausea, vomiting, abdominal pain
-red, hot, painful spot on leg
-redness, blistering, peeling or loosening of the skin, including inside the mouth
-signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
 
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
-diarrhea
-difficulty sleeping
-headache
-heartburn
-unusually weak
-weight gain around waist, back, or thinning of face, arms, legs

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children.

Store in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Throw away any unused medicine after the expiration date. If stored at room temperature, up to 25 degrees C (77 degrees F), you must throw the medicine away after 2 months.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.