Description
Ritonavir is used together with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Ritonavir 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 problems that are usually related to AIDS or HIV disease from occurring. Ritonavir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
- Tablet
- Powder
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ritonavir powder in children younger than 1 month old. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ritonavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ritonavir.
Breastfeeding
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.
Drug Interactions
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.
- Alfuzosin
- Amiodarone
- Apalutamide
- Astemizole
- Atorvastatin
- Bepridil
- Carbamazepine
- Cisapride
- Colchicine
- Conivaptan
- Crizotinib
- Dihydroergotamine
- Dronedarone
- Efavirenz
- Elbasvir
- Eletriptan
- Eliglustat
- Encainide
- Enzalutamide
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Estetrol
- Ethinyl Estradiol
- Etonogestrel
- Everolimus
- Finerenone
- Flecainide
- Flibanserin
- Fluconazole
- Fosphenytoin
- Gepirone
- Grazoprevir
- Isavuconazole
- Isavuconazonium
- Ivabradine
- Ivacaftor
- Ketoconazole
- Levoketoconazole
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.
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Afatinib
- Alfentanil
- Alpelisib
- Alprazolam
- Amisulpride
- Amlodipine
- Anagrelide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asciminib
- Atazanavir
- Atidarsagene Autotemcel
- Atogepant
- Atovaquone
- Atrasentan
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azathioprine
- Bedaquiline
- Benzhydrocodone
- Betamethasone
- Betrixaban
- Bictegravir
- Boceprevir
- Bosentan
- Bosutinib
- Brexpiprazole
- Brigatinib
- Bromocriptine
- Budesonide
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.
- Acenocoumarol
- Amitriptyline
- Amprenavir
- Cerivastatin
- Clonazepam
- Dalfopristin
- Delavirdine
- Desipramine
- Didanosine
- Dutasteride
- Fosamprenavir
- Imipramine
- Indinavir
- Lamotrigine
- Levothyroxine
- Mexiletine
- Nefazodone
- Prasugrel
- Quinupristin
- Risperidone
- Tenofovir Disoproxil Fumarate
- Theophylline
Other Interactions
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:
- Diabetes or
- Hyperglycemia (high blood sugar)—May increase the amount of sugar in the blood.
- Heart disease (eg, cardiomyopathy, ischemic heart disease) or
- Heart rhythm problems (eg, prolonged PR interval) or
- Hyperlipidemia (high cholesterol or fat in the blood) or
- Liver disease (eg, hepatitis B or C) or
- Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.
- Hemophilia (a bleeding problem)—May increase the chance of bleeding.
Proper Use
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 patient information leaflet and patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor or pharmacist if you have any questions.
Ritonavir must be taken with other medicines that are used to treat HIV infection. Take all of the medicines your doctor has prescribed at the right time of day and in correct order. Do not stop using your medicine unless your doctor tells you to.
It is important that ritonavir be taken with food.
Swallow the capsule or tablet whole. Do not break, crush, or chew it.
For patients taking the oral liquid:
- Shake the bottle well before using.
- Use a specially marked measuring syringe or cup to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.
- You can mix the oral liquid with chocolate milk or nutritional drinks (eg, Ensure® or Advera®) to make it taste better. You should drink this medicine within 1 hour of mixing.
- This form of ritonavir contains alcohol and propylene glycol. Do not use a polyurethane feeding tube to give this medicine.
For patients taking the oral powder:
- Check the label on the carton for the number of packets that you need to prepare a dose. Do not open a packet until you are ready to use it.
- Mix the oral powder with food (eg, applesauce, vanilla pudding) or liquid (eg, water, infant formula, chocolate milk). If you will use a feeding tube to take this medicine, use water to mix the powder.
- Use the mixture within 2 hours of preparing the dose. Be sure to drink or swallow all of it. Throw away the mixture if not used within 2 hours and prepare a new dose.
Dosing
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 forms (capsules, solution, powder, or tablets):
- Adults—600 milligrams (mg) 2 times per day.
- Children 1 month of age and older—Dose is based on body size and must be determined by your doctor. The dose is usually 350 to 400 milligrams per square meter (mg/[m]2) of body size 2 times per day. The doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 600 mg two times per day.
- Children younger than 1 month of age—Use and dose must be determined by your doctor.
- For oral dosage forms (capsules, solution, powder, or tablets):
Missed Dose
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.
Storage
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.
Store the capsules in the refrigerator or at room temperature in a closed container. If stored at room temperature, use the medicine within 30 days. Keep away from heat and direct light.
Store the oral liquid in a closed container at room temperature, away from heat and direct light. Do not refrigerate.
Store the oral powder in its packet container at room temperature or in a cool, dry place, away from heat and direct light.
Store the tablets in a closed container at room temperature or in a cool, dry place, away from heat and direct light. Do not store this medicine out of the original container in places with high humidity for more than 2 weeks.
Precautions
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 and urine tests may be needed to check for unwanted effects.
Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), amiodarone (Cordarone®), apalutamide (Erleada®), astemizole (Hismanal®), bepridil (Vascor®), cisapride (Propulsid®), colchicine (Colcrys®), dronedarone (Multaq®), ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, or Ergomar®), flecainide (Tambocor®), lomitapide (Juxtapid®), lovastatin (Altocor®, Mevacor®), lurasidone (Latuda®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), quinidine (Quinaglute®), ranolazine (Ranexa®), sildenafil (Revatio®), simvastatin (Simcor®, Vytorin®, Zocor®), terfenadine (Seldane®), triazolam (Halcion®), or voriconazole (Vfend®). Using these medicines together with ritonavir may increase your chance of having serious side effects.
This medicine may decrease the effects of some birth control pills. Use an additional form of birth control along with your pills to keep from getting pregnant. Other forms of birth control include condoms, a diaphragm, or a contraceptive foam or jelly.
Ritonavir oral liquid contains alcohol, which should not be given to pregnant women and preterm babies.
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.
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.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin, fever, chills, cough, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swelling of your hands, face, tongue, or throat, or unusual tiredness or weakness.
This medicine may cause heart rhythm problems. Tell your doctor right away if you or your child gets dizzy or lightheaded, have fast or irregular heart beats, or feels like fainting.
This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood. Talk to your doctor if you or your child have concerns.
This medicine may increase your blood sugar levels. Check with your doctor right away if you or your child have the following symptoms: confusion, nausea or vomiting, increased hunger, thirst or urination, or unusual tiredness or weakness.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder such as Graves disease, polymyositis, or Guillain-Barré syndrome.
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 may increase the risk of bleeding in patients with hemophilia (a bleeding disorder). Talk with your doctor about this risk.
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 also 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.
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.
Side Effects
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:
Less common
- Fainting
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- headache
- sweating
Rare
- Confusion
- dehydration
- dry or itchy skin
- fruity mouth odor
- increased hunger
- increased thirst
- increased urination
- nausea
- vomiting
- weight loss
Incidence not known
- Bloating
- chills
- constipation
- convulsions
- cough
- darkened urine
- decreased urination
- difficulty with breathing
- dry mouth
- fast heartbeat
- fever
- hives or welts, itching, skin rash
- increase in heart rate
- indigestion
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of bladder control
- muscle spasm or jerking of all extremities
- noisy breathing
- pains in the stomach, side, or abdomen, possibly radiating to the back
- rapid breathing
- redness of the skin
- sudden loss of consciousness
- sunken eyes
- thirst
- tightness in the chest
- unusual tiredness or weakness
- wrinkled skin
- yellow eyes or skin
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:
More common
- Belching
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in sense of taste
- diarrhea
- dizziness
- general feeling of discomfort or illness
- heartburn
- lack or loss of strength
- sleepiness or unusual drowsiness
- trouble sleeping
- weakness
Less common
- Body aches or pain
- congestion
- delusions
- dementia
- difficulty with moving
- discouragement
- dryness or soreness of the throat
- excess air or gas in the stomach or intestines
- fear
- feeling sad or empty
- full feeling
- hoarseness
- increased urge to urinate during the night
- irritability
- lack of appetite
- loss of interest or pleasure
- mood or mental changes
- muscle pain or stiffness
- nervousness
- pain in the joints or in an unspecified location
- passing gas
- runny nose
- tender, swollen glands in the neck
- throat irritation
- tiredness
- trouble concentrating
- trouble swallowing
- voice changes
- waking to urinate at night
Incidence not known
- Gaining weight around your neck, upper back, breast, face, or waist
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.
DRG-20067063
