Ritonavir (Oral route)
- Capsule, Liquid Filled
Warnings:Oral route(Capsule, Liquid Filled;Solution;Tablet)
Coadministration of ritonavir with sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs .
Uses of This Medicine:
Ritonavir is used alone or in combination 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 HIV infection or prevent 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.
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 ritonavir in infants younger than 1 month old. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of ritonavir have not been performed in the geriatric population, geriatric-specific problems are not expected to 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.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
- Ergoloid Mesylates
- 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
- Brentuximab Vedotin
- Dabigatran Etexilate
- Doxorubicin Hydrochloride Liposome
- Eslicarbazepine Acetate
- Fusidic Acid
- Morphine Sulfate Liposome
- 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
- Ethinyl Estradiol
- 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:
- Diabetes mellitus or
- Hyperglycemia (high blood sugar)—May increase the amount of sugar in the blood.
- Heart disease or
- Heart rhythm problems (e.g., prolonged PR interval) or
- Hyperlipidemia (high cholesterol or fat in the blood) or
- Liver disease or other liver problems (e.g., hepatitis) 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 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.
It is important that ritonavir be taken with food.
Swallow the 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 (such as Ensure® or Advera®) to make it taste better. You should drink this medicine within one hour of mixing.
This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. It is best to take the doses at evenly spaced times, day and night. For example, if you are to take two doses each day, the doses should be spaced about 12 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.
Ritonavir must be taken with other medicines. Tell your doctor about all of the medications you are taking since the dose of ritonavir or other medications you take may need to be adjusted.
If you are taking ritonavir with a medication called didanosine (Videx®), take the ritonavir 2 hours and 30 minutes before or after the didanosine.
Read and carefully follow the patient information leaflet before starting ritonavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.
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, or tablets):
- Adults—600 milligrams (mg) two 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 two times per day. 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, or tablets):
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.
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 or tablets in a closed container at room temperature, away from heat and direct light. Do not refrigerate.
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 take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal (e.g., St. John's wort) or vitamin supplements.
Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), amiodarone (Cordarone®), astemizole (Hismanal®), bepridil (Vascor®), cisapride (Propulsid®), ergot medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, or Ergomar®), flecainide (Tambocor®), lovastatin (Altocor®, Mevacor®), oral midazolam (Versed®), pimozide (Orap®), propafenone (Rythmol®), quinidine (Quinaglute®), 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.
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. Stop using this medicine and 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 decrease the effects of some birth control pills. To avoid getting pregnant, use an additional form of birth control along with your pills. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
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 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.
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.
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 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.
Side Effects of This Medicine:
- Less common
- feeling faint, dizzy, or lightheaded
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- dry or itchy skin
- fruity mouth odor
- increased hunger
- increased thirst
- increased urination
- weight loss
- Incidence not known
- darkened urine
- decreased urination
- difficulty with breathing
- dry mouth
- fast heartbeat
- hives or welts
- increase in heart rate
- 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
- shortness of breath
- skin rash
- sudden loss of consciousness
- sunken eyes
- tightness in the chest
- unusual tiredness or weakness
- wrinkled skin
- yellow eyes or skin
- More common
- Acid or sour stomach
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in sense of taste
- general feeling of discomfort or illness
- lack or loss of strength
- sleepiness or unusual drowsiness
- trouble sleeping
- unable to sleep
- Less common
- Body aches or pain
- difficulty with moving
- dryness or soreness of the throat
- excess air or gas in the stomach or intestines
- feeling sad or empty
- full feeling
- increased urge to urinate during the night
- lack of appetite
- loss of interest or pleasure
- mood or mental changes
- muscle pain or stiffness
- pain in the joints or in unspecified location
- passing gas
- runny nose
- tender, swollen glands in the neck
- throat irritation
- trouble concentrating
- trouble with swallowing
- voice changes
- waking to urinate at night
- Incidence not known
- Gaining weight around your neck, upper back, breast, face, or waist
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: 11/4/2014