Lopinavir and ritonavir (Oral route)
- Capsule, Liquid Filled
Uses of This Medicine:
Lopinavir and ritonavir combination is used in the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all.
Lopinavir and ritonavir combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Lopinavir and ritonavir combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of lopinavir and ritonavir combination in infants younger than 14 days of age. Safety and efficacy have not been established. Kaletra® should not be used once a day in children. Kaletra® oral liquid should not be given to premature infants.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lopinavir and ritonavir combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving lopinavir and ritonavir combination.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Doxorubicin Hydrochloride Liposome
- Ergoloid Mesylates
- Ethinyl Estradiol
- Isavuconazonium Sulfate
- St John's Wort
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Ado-Trastuzumab Emtansine
- Arsenic Trioxide
- Dabigatran Etexilate
- Doxorubicin Hydrochloride Liposome
- Fusidic Acid
- Irinotecan Liposome
- Isavuconazonium Sulfate
- Morphine Sulfate Liposome
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Vincristine Sulfate Liposome
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Estradiol Cypionate
- Estradiol Valerate
- Ethynodiol Diacetate
- Medroxyprogesterone Acetate
- Tenofovir Disoproxil Fumarate
- Valproic Acid
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cirrhosis (liver disease) or
- Diabetes mellitus or
- Hemophilia (a bleeding problem) or
- Hyperglycemia (high blood sugar) or
- Hyperlipidemia (high cholesterol or fat in the blood) or
- Liver disease (eg, hepatitis B or C) or
- Pancreatitis, history of Use with caution. May make these conditions worse.
- Heart attack, history of or
- Heart disease (eg, cardiomyopathy, ischemic heart disease), history of or
- Heart rhythm problems (eg, prolonged PR or QT interval, congenital long QT syndrome), history of or
- Hypokalemia (low potassium in the blood) Use with caution. May increase risk for more serious side effects.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
This medicine comes with a Medication Guide. Read and follow the instructions carefully before starting treatment and each time you refill your prescription. Ask your doctor if you have any questions.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.
Lopinavir and ritonavir combination will always be given with other medicines for HIV. Take all of the medicines your doctor has prescribed as part of your combination treatment. Do not stop using your medicine unless your doctor tells you to.
It is important that lopinavir and ritonavir oral liquid be taken with food. Use a calibrated dosing syringe or medicine cup to measure the dose for the oral liquid.
Lopinavir and ritonavir tablets may be taken with or without food. Swallow the tablets whole. Do not crush, break, or chew them.
If you are also using didanosine (Videx®), take it 1 hour before or 2 hours after taking Kaletra® oral liquid. Didanosine can be taken (without food) at the same time as Kaletra® tablets.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For treatment of HIV infection:
- For oral dosage form (solution):
- Adults 400 milligrams (mg) of lopinavir and 100 mg of ritonavir (5 milliliters [mL]) two times a day with food or 800 mg of lopinavir and 200 mg of ritonavir (10 mL) once a day with food. Your doctor may adjust your dose as needed.
- Children 6 months and older Dose is based on body weight or body size and must be determined by your child's doctor. The recommended dose is 10 to 12 milligrams per kilogram (mg/kg) of body weight or 230 milligrams per square meter (mg/m) of body size for lopinavir and 2.5 to 3 mg/kg or 57.5 (mg/m) for ritonavir two times a day with food. Your doctor may adjust your dose as needed.
- Children 14 days to 6 months of age Dose is based on body weight or body size and must be determined by your child's doctor. The recommended dose is 16 milligrams per kilogram (mg/kg) of body weight or 300 milligrams per square meter (mg/m) of body size for lopinavir and 4 mg/kg or 75 (mg/m) for ritonavir two times a day with food.
- Children younger than 14 days of age Use is not recommended, unless your doctor determines it is safe to administer.
- For oral dosage form (tablets):
- Adults 400 milligrams (mg) of lopinavir and 100 mg of ritonavir (2 tablets) two times a day or 800 mg of lopinavir and 200 mg of ritonavir (4 tablets) once a day. Your doctor may adjust your dose as needed.
- Children 6 months and older The child must be able to swallow a tablet whole. Dose is based on body weight and must be determined by your child's doctor. The recommended dose is 200 to 400 milligrams (mg) of lopinavir and 50 to 100 mg of ritonavir (2 to 4 tablets) two times a day. Your doctor may adjust your dose as needed.
- Children 14 days to 6 months of age This dosage form is usually not used for infants. Please refer to the oral solution dosage form.
- Infants younger than 14 days of age Use is not recommended, unless your doctor determines it is safe to administer.
- For oral dosage form (solution):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is best to store the Kaletra® oral liquid in a closed container in the refrigerator. Do not freeze. If you must store the liquid at room temperature, use the medicine within 2 months and keep it away from excessive heat.
The Kaletra® tablets should be stored in a closed container at room temperature, away from heat, moisture, and direct light.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Methergine®, or Migranal®), lovastatin (Advicor®, Altoprev®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®), sildenafil (Revatio®, simvastatin (Simcor®, Vytorin®, Zocor®), or triazolam (Halcion®).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (eg, St. John's wort) or vitamin supplements.
Pancreatitis may occur while you are using this medicine. Check with your doctor right away if you or your child have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.
This medicine can cause changes in heart rhythms, such as a condition called PR or QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
This medicine may increase the level of cholesterol and fats in your blood. If this condition occurs, your doctor may give you a medicine to lower the cholesterol and fats. Talk to your doctor if you or your child have concerns.
If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor as soon as possible.
If you are taking the oral liquid, you should limit the amount of alcohol you drink. The Kaletra® oral liquid contains 42% alcohol. Talk to your doctor if you or your child are taking, or plan to take, metronidazole (Flagyl®) or disulfiram (Antabuse®).
Birth control pills that contain estrogen may not work as well while you are using this medicine. To keep from getting pregnant, use a second type of birth control together with the pills. Other forms of birth control include condoms, a diaphragm, or contraceptive foam or jelly.
When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.
Side Effects of This Medicine:
- Less common
- blurred vision
- darkened urine
- dry mouth
- fast heartbeat
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- loss of consciousness
- pains in the stomach, side, or abdomen, possibly moving to the back
- troubled breathing
- unexplained weight loss
- yellow eyes or skin
- Incidence not known
- Blistering, peeling, or loosening of the skin
- chest pain or discomfort
- joint or muscle pain
- lightheadedness, dizziness, or fainting
- red skin lesions, often with a purple center
- red, irritated eyes
- slow or irregular heartbeat
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- unusual tiredness
- Less common
- Abnormal stools
- acid or sour stomach
- lack or loss of strength
- skin rash
- stomach discomfort, upset, or pain
- trouble with sleeping
- Incidence not known
- Redistribution of body fat
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 10/12/2016