GENERIC NAME: LOPINAVIR/RITONAVIR SOLUTION - ORAL (loe-PIN-a-vir/ri-TOE-na-vir)
BRAND NAME(S): Kaletra
USES: This combination product contains two medications: lopinavir and ritonavir. This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Both lopinavir and ritonavir belong to a class of drugs known as HIV protease inhibitors. Ritonavir increases ("boosts") the levels of lopinavir. This helps lopinavir work better.Because this solution contains other ingredients (alcohol and propylene glycol) that may cause side effects, it is not recommended for premature (pre-term) newborns right after birth or full-term newborns younger than 14 days of age, unless your doctor thinks it is right for your baby. Discuss the risks and benefits with your doctor.Lopinavir/ritonavir is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This product may also be used in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking lopinavir/ritonavir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually twice daily. Carefully measure the dose with a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).For children, the dosage is also based on age, weight, and height. Once-daily dosing of this medication is not recommended for children younger than 18 years of age.If you are taking didanosine in addition to this product, take it one hour before or two hours after taking this product.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses.This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
SIDE EFFECTS: Diarrhea, headache, nausea, vomiting, stomach upset, drowsiness, dizziness, a bad taste in the mouth, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).Tell your doctor right away if you have any serious side effects, including: increased thirst, increased urination, blurred vision, confusion, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, persistent fever.Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), severe dizziness, fainting, slow/fast/irregular heartbeat, severe drowsiness, difficulty breathing, seizures, muscle weakness, change in the amount of urine.Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.This medication may cause an increase in blood fat levels (cholesterol and triglycerides). Cholesterol and triglyceride testing should be done before and occasionally during treatment with this medication. Consult your doctor or pharmacist for more information.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either lopinavir or ritonavir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, diabetes, pancreatitis, high blood fat levels (cholesterol/triglycerides), heart problems (coronary artery disease, heart attack), bleeding problems (such as hemophilia), previous infection with certain diseases (such as hepatitis B infection, hepatitis C infection, tuberculosis).Lopinavir/ritonavir may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using lopinavir/ritonavir, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using lopinavir/ritonavir safely.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be more sensitive to the side effects of this drug, especially severe drowsiness and breathing changes. The alcohol in this product may cause an accidental overdose that could be serious. The propylene glycol in this product may also cause serious side effects in children, especially in premature (pre-term) newborns and full-term newborns less than 14 days old.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment can decrease the risk of passing the HIV infection to your baby. Lopinavir/ritonavir (in the tablet form) may be part of that treatment. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Lopinavir/ritonavir interacts with many medications. Before taking lopinavir/ritonavir, tell your doctor or pharmacist about all the medications and products you use, including: certain HIV medications (such as darunavir, fosamprenavir, tipranavir).Other medications can affect the removal of lopinavir/ritonavir from your body, which may affect how lopinavir/ritonavir works. Examples include boceprevir, rifampin, St. John's wort, among others.Lopinavir/ritonavir can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, tamsulosin), certain inhaled drugs to treat breathing problems (such as fluticasone, salmeterol), cisapride, drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), ergot drugs (such as ergotamine, dihydroergotamine), pimozide, rivaroxaban, certain sedatives (such as midazolam, triazolam), certain statins (such as lovastatin, simvastatin), among others.Because lopinavir/ritonavir solution contains alcohol, severe nausea and vomiting may occur if you are also taking certain drugs that interact with alcohol (such as disulfiram, metronidazole, tinidazole). Consult your doctor or pharmacist for details.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including other drugs that contain alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: numbness or tingling in the arms/hands/legs/feet, a change in amount of urine, severe drowsiness/dizziness, loss of consciousness, shallow breathing.Due to the high alcohol content of lopinavir/ritonavir solution, children accidentally drinking the medication may have a serious, possibly fatal reaction. If a child accidentally drinks this product, contact your poison control center or emergency room immediately.
NOTES: Do not share this medication with others.Keep all medical and laboratory appointments. Laboratory and/or medical tests (such as liver function, blood count, blood cholesterol/triglyceride levels, blood sugar) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Lopinavir/ritonavir is available in tablets, capsules, and oral solution. Do not switch types of this medication without instructions on how to do so by your doctor.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the refrigerator. If stored at room temperature, the US product should be used within 2 months and the Canadian product should be used within 6 weeks. Avoid exposure to high heat. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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