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Ritonavir is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.
Ritonavir is used together with other antiviral medicines to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Ritonavir is not a cure for HIV or AIDS.
Ritonavir may also be used for purposes not listed in this medication guide.
Serious drug interactions can occur when certain medicines are used with ritonavir. Tell your doctor about all your current medicines and any you start or stop using.
Serious drug interactions can occur when certain medicines are used with ritonavir. Your doctor may need to change your treatment plan if you use any of the following drugs:
alfuzosin, cisapride, colchicine, St. John's wort, voriconazole;
sildenafil (Revatio) when used to treat pulmonary arterial hypertension (PAH);
antipsychotic medicine--lurasidone, pimozide;
cholesterol-lowering medicine--lovastatin, simvastatin;
ergot medicine--dihydroergotamine, ergotamine, methylergonovine;
heart medicine--amiodarone, dronedarone, flecainide, propafenone, quinidine, ranolazine; or
a sedative--oral midazolam or triazolam.
Tell your doctor if you have ever had:
liver disease (especially hepatitis B or C);
heart disease or heart rhythm disorder;
diabetes; or
a bleeding disorder such as hemophilia.
Ritonavir liquid contains alcohol and propylene glycol, and should not be used by pregnant women or premature babies.
Tell your doctor if you become pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.
Ritonavir can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.
Women with HIV or AIDS should not breast feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Ritonavir must be given in combination with other antiviral medications and it should not be used alone. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Ritonavir tablets must be taken with meals. Ritonavir capsules or liquid should be taken with food if possible.
Swallow the tablet whole and do not crush, chew, or break it.
Shake the oral solution (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Liquid ritonavir can be mixed with chocolate milk or a nutrition drink such as Ensure. Drink the mixture within 1 hour after mixing.
Ritonavir oral powder should be mixed with soft food such as applesauce or pudding. You may also mix the powder with water, chocolate milk, or infant formula.
Follow your doctor's dosing instructions very carefully when giving ritonavir to an infant. Tell your doctor when the child has changes in weight or height. Ritonavir doses are based on body surface area in children.
Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.
You will need frequent medical tests.
If you've ever had hepatitis B, using ritonavir can cause this virus to become active or get worse. You may need frequent liver function tests while using ritonavir and for several months after you stop.
Store ritonavir capsules in the refrigerator or at room temperature, away from heat or moisture. If you store the capsules at room temperature you must use them within 30 days. Protect from light.
Store the tablets, liquid, or powder at room temperature away from heat or moisture. Store the liquid with the cap tightly closed. Do not refrigerate.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Get your prescription refilled before you run out of medicine completely.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of ritonavir oral liquid could be fatal to a child.
Ritonavir capsules and liquid contain alcohol. Avoid drinking alcoholic beverages while using ritonavir, and do not take disulfiram (Antabuse) or you could have an alcohol reaction.
Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Get emergency medical help if you have signs of an allergic reaction (hives, skin sores, difficult breathing, fast or pounding heartbeats, sweating, mouth sores, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
irregular heartbeats, or a light-headed feeling (like you might pass out);
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes).
Ritonavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:
signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.
Common side effects may include:
nausea, vomiting, stomach pain, diarrhea;
numbness or tingling in your hands or feet or around your mouth;
feeling weak or tired;
rash; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can affect ritonavir, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Ritonavir (www.drugs.com/mtm/ritonavir.html).
Commonly reported side effects of ritonavir include: asthenia, diarrhea, hypertriglyceridemia, increased gamma-glutamyl transferase, nausea, vomiting, and unpleasant taste. Other side effects include: abdominal pain, dyspepsia, fever, hyperlipidemia, increased serum alanine aminotransferase, peripheral paresthesia, dysgeusia, and oral paresthesia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to ritonavir: oral capsule liquid filled, oral powder, oral solution, oral tablet
Oral route (Capsule, Liquid Filled; Solution; Tablet)
Coadministration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir.
Along with its needed effects, ritonavir 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 while taking ritonavir:
Less common
Rare
Incidence not known
Some side effects of ritonavir 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
Less common
Incidence not known
For Healthcare Professionals
Applies to ritonavir: oral capsule, oral powder for reconstitution, oral solution, oral tablet
GeneralThe most frequently reported side effects associated with this drug alone and in combination with other antiretrovirals were gastrointestinal (including nausea, diarrhea, vomiting, upper and lower abdominal pain), neurological disturbances (including paresthesia, oral paresthesia), rash, and fatigue/asthenia.
When used as a pharmacokinetic enhancer, side effects were dependent on the coadministered protease inhibitor. The manufacturer product information for the coadministered protease inhibitor should be consulted.
GastrointestinalPancreatitis (including some fatalities) has been reported in patients using this drug, including those who developed hypertriglyceridemia.
Limit for high chemistry included amylase greater than 2 times the upper limit of normal (2 x ULN).
Very common (10% or more): Diarrhea (including severe with electrolyte imbalance; up to 67.9%), nausea (up to 57.4%), vomiting (up to 31.9%), upper and lower abdominal pain (up to 26.4%), dyspepsia (up to 11.5%)
Common (1% to 10%): Flatulence, gastrointestinal (GI) hemorrhage, gastroesophageal reflux disease, mouth ulcer, pancreatitis, increased amylase, constipation, circumoral paresthesia, local throat irritation
Frequency not reported: Abnormal stools, bloody diarrhea, cheilitis, colitis, dry mouth, dysphagia, eructation, esophagitis, esophageal ulcer, fecal incontinence, gastritis, gastroenteritis, GI disorder, GI symptoms, gingivitis, ileitis, ileus, melena, oral moniliasis, periodontal abscess, pseudomembranous colitis, rectal disorder, rectal hemorrhage, sialadenitis, stomatitis, tenesmus, tongue edema, ulcerative colitis
MetabolicVery common (10% or more): Increased cholesterol (up to 65.2%), increased triglycerides (up to 33.6%)
Common (1% to 10%): Increased fasting triglycerides, hypertriglyceridemia, increased uric acid, hypercholesterolemia, increased glucose, gout, dehydration, anorexia, increased alkaline phosphatase, decreased potassium, decreased calcium
Uncommon (0.1% to 1%): Diabetes mellitus, increased magnesium, increased LDH, increased chloride, increased potassium, decreased sodium, decreased chloride, decreased magnesium
Rare (0.01% to 0.1%): Hyperglycemia
Frequency not reported: Alcohol intolerance, avitaminosis, enzymatic abnormality, xanthomatosis, redistribution/accumulation of body fat
Antiretroviral therapy:
-Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), increased blood lipid levels, increased glucose levels
Protease inhibitor therapy:
-Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia, diabetic ketoacidosis
Limits for high chemistry included cholesterol greater than 240 mg/dL, triglycerides greater than 800 mg/dL, triglycerides greater than 1500 mg/dL (greater than 16.9 mmol/L), fasting triglycerides greater than 1500 mg/dL (greater than 16.9 mmol/L), uric acid greater than 12 mg/dL (greater than 0.7 mmol/L), glucose greater than 13.8 mmol/L, alkaline phosphatase greater than 550 units/L, LDH greater than 1170 units/L, chloride greater than 122 mmol/L, and potassium greater than 6 mmol/L. Limits for low chemistry included potassium 3 mmol/L, calcium less than 3.45 mmol/L, chloride less than 84 mmol/L, magnesium less than 1 mmol/L, and sodium less than 123 mmol/L.
Increases of 30% to 40% from baseline have been reported for cholesterol levels and 200% to 300% for triglycerides.
Dehydration (usually associated with GI symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency) has been reported (including during postmarketing experience); orthostatic hypotension, syncope, and renal insufficiency have also been reported without known dehydration.
Hyperglycemia has also been reported during postmarketing experience in patients with and without known history of diabetes.
New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported in HIV-infected patients receiving protease inhibitors; in some cases, diabetic ketoacidosis occurred. No causal relationship has been established.
Nervous systemVery common (10% or more): Paresthesia (including oral and peripheral paresthesia; up to 50.7%), dysgeusia (16.2%), dizziness (up to 15.6%), taste perversion (up to 15.5%), peripheral neuropathy (10.1%), headache
Common (1% to 10%): Syncope, seizure, somnolence
Frequency not reported: Abnormal gait, amnesia, aphasia, ataxia, coma, convulsion, dementia, grand mal convulsion, hearing impairment, hyperesthesia, hyperkinesia, hypoesthesia, incoordination, migraine, neuralgia, neuropathy, paralysis, peripheral neuropathic pain, peripheral sensory neuropathy, sleep disorder, speech disorder, stupor, subdural hematoma, tinnitus, tremor, vertigo, vestibular disorder, cerebral ischemia, cerebral venous thrombosis, taste loss
Postmarketing reports: Neurologic events
Syncope and seizure have also been reported during postmarketing experience.
Cardiac and neurologic events have been reported during postmarketing experience when this drug was used with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. Possible drug interaction could not be excluded.
OtherVery common (10% or more): Fatigue (including asthenia; 46.2%), asthenia (up to 14.2%), flushing/feeling hot (13.2%)
Common (1% to 10%): Edema, peripheral edema, peripheral coldness, fever, weight loss, malaise
Uncommon (0.1% to 1%): Decreased albumin
Frequency not reported: Breast pain, enlarged abdomen, accidental injury, cachexia, chest pain, chills, facial edema, facial pain, influenza syndrome, hypothermia, neck pain, neck rigidity, pain (unspecified), pelvic pain, substernal chest pain, ear pain, increased cerumen, parosmia, thirst
Postmarketing reports: Acute ergot toxicity (characterized by vasospasm, ischemia of extremities and other tissues [including the central nervous system])
Antiretroviral therapy:
-Frequency not reported: Increased weight
Limit for low chemistry included albumin less than 20 g/L.
Acute ergot toxicity has been reported when this drug was used with ergotamine or dihydroergotamine.
HematologicLimits for low hematology included WBCs less than 2.5 x 10(9)/L, RBCs less than 3 x 10(12)/L, hematocrit less than 30% (less than 0.3), neutrophils up to 0.5 x 10(9)/L, hemoglobin less than 8 g/dL, and platelet count less than 2 x 10(9)/L. Limits for high hematology included eosinophils greater than 1 x 10(9)/L, neutrophils greater than 20 x 10(9)/L, WBCs greater than 25 x 10(9)/L, and prothrombin time greater than 1.5 x ULN.
Increased bleeding (including spontaneous skin hematomas and hemarthrosis) in patients with hemophilia type A or B treated has been associated with protease inhibitors. In many of the reported cases, treatment with protease inhibitors was continued or restarted and some patients required additional factor VIII. A causal relationship between protease inhibitor therapy and these episodes has not been established.
Very common (10% or more): Decreased WBCs (up to 36.9%), decreased RBCs (up to 18.6%), decreased hematocrit (up to 17.3%)
Common (1% to 10%): Decreased neutrophils, decreased hemoglobin, thrombocytopenia, increased eosinophils, increased neutrophils, increased WBCs
Uncommon (0.1% to 1%): Increased prothrombin time, decreased platelet count
Frequency not reported: Acute myeloblastic leukemia, anemia, ecchymosis, leukopenia, lymphadenopathy, lymphocytosis, myeloproliferative disorder
Protease inhibitor therapy:
-Frequency not reported: Increased bleeding (including spontaneous skin hematomas, hemarthrosis) in hemophiliacs
DermatologicToxic epidermal necrolysis has also been reported during postmarketing experience.
Alopecia has been reported in patients using indinavir or atazanavir plus this drug.
Very common (10% or more): Rash (including erythematous rash, maculopapular rash; up to 27.1%), pruritus (up to 12.2%)
Common (1% to 10%): Acne, acquired lipodystrophy, sweating
Rare (0.01% to 0.1%): Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Contact dermatitis, dry skin, eczema, erythema multiforme, exfoliative dermatitis, folliculitis, fungal dermatitis, furunculosis, maculopapular rash, molluscum contagiosum, onychomycosis, photosensitivity reaction, psoriasis, pustular rash, seborrhea, skin discoloration, skin disorder, skin hypertrophy, skin melanoma, urticaria, vesiculobullous rash, alopecia
RespiratoryVery common (10% or more): Coughing (21.7%), oropharyngeal pain (15.9%), pharyngitis
Frequency not reported: Asthma, bronchitis, increased cough, dyspnea, epistaxis, hiccup, hypoventilation, interstitial pneumonia, larynx edema, lung disorder, rhinitis, sinusitis
HepaticLimits for high chemistry included GGT greater than 300 international units/L, AST greater than 180 international units/L, ALT greater than 215 international units/L, and total bilirubin greater than 61 mcmol/L.
Hepatic dysfunction (including some fatalities) has been reported, generally in patients taking multiple concurrent medications and/or with advanced AIDS.
Very common (10% or more): Increased GGT (up to 19.6%)
Common (1% to 10%): Increased AST, increased ALT, hepatitis (including increased AST, ALT, GGT), increased blood bilirubin (including jaundice), increased total bilirubin
Frequency not reported: Exacerbation of chronic liver disease, cholangitis, cholestatic jaundice, hepatic coma, hepatomegaly, hepatosplenomegaly, liver damage, liver function tests abnormal, hepatic transaminase elevations exceeding 5 x ULN, clinical hepatitis, jaundice
Postmarketing reports: Hepatic dysfunction (including some fatalities)
MusculoskeletalVery common (10% or more): Arthralgia and back pain (18.6%), increased creatine phosphokinase (CPK; up to 12.1%)
Common (1% to 10%): Myalgia, myopathy/increased CPK, myositis, rhabdomyolysis
Frequency not reported: Arthritis, arthrosis, bone disorder, bone pain, extraocular palsy, joint disorder, leg cramps, muscle cramps, muscle weakness, twitching, osteonecrosis
Limit for high chemistry included CPK greater than 1000 international units/L.
Osteonecrosis has been reported, particularly in patients with advanced HIV disease, long-term combination antiretroviral therapy, or other risk factors (including corticosteroid use, alcohol use, severe immunosuppression, higher body mass index).
HypersensitivityCommon (1% to 10%): Hypersensitivity (including urticaria, face edema)
Rare (0.01% to 0.1%): Anaphylaxis
Frequency not reported: Allergic reactions (including urticaria, mild skin eruptions, bronchospasm, angioedema)
OcularCommon (1% to 10%): Blurred vision
Frequency not reported: Abnormal electrooculogram, abnormal electroretinogram, abnormal vision, amblyopia/blurred vision, blepharitis, conjunctivitis, diplopia, eye disorder, eye pain, iritis, photophobia, uveitis, visual field defect, vitreous disorder
GenitourinaryCommon (1% to 10%): Increased urination, menorrhagia
Frequency not reported: Albuminuria, cystitis, dysuria, glycosuria, hematuria, impotence, nocturia, penis disorder, polyuria, urethritis, urinary frequency, urinary retention, urinary tract infection, vaginitis
Menorrhagia has also been reported during postmarketing experience.
CardiovascularCommon (1% to 10%): Hypertension, hypotension (including orthostatic hypotension), vasodilation
Uncommon (0.1% to 1%): Myocardial infarction
Frequency not reported: PR interval prolonged, cardiovascular disorder, palpitation, peripheral vascular disorder, phlebitis, postural hypotension, tachycardia, vasospasm, hemorrhage
Postmarketing reports: Orthostatic hypotension, first-degree atrioventricular (AV) block, second-degree AV block, third-degree AV block, right bundle branch block, cardiac events
Myocardial infarction has also been reported during postmarketing experience.
Cardiac and neurologic events have been reported during postmarketing experience when this drug was used with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. Possible drug interaction could not be excluded.
PsychiatricCommon (1% to 10%): Confusion, disturbance in attention, insomnia, anxiety, abnormal thinking
Frequency not reported: Abnormal dreams, depression, depersonalization, emotional lability, euphoria, agitation, hallucinations, decreased libido, manic reaction, nervousness, personality disorder
RenalCommon (1% to 10%): Renal impairment (e.g., oliguria, elevated creatinine)
Uncommon (0.1% to 1%): Acute renal failure, increased creatinine
Frequency not reported: Renal calculus, renal failure, abnormal kidney function, kidney pain, pyelonephritis, increased BUN
Postmarketing reports: Renal insufficiency
Limit for high chemistry included creatinine greater than 0.3 mmol/L.
Renal insufficiency was reported in 3 AIDS patients receiving this drug. All cases occurred within 10 to 15 days after starting this drug and all were reversible upon discontinuation.
ImmunologicFrequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
EndocrineCushing's syndrome and adrenal suppression have been reported when this drug was used with fluticasone or budesonide.
Common (1% to 10%): Decreased free and total thyroxin
Frequency not reported: Adrenal cortex insufficiency, hormone level altered
Postmarketing reports: Cushing's syndrome, adrenal suppression
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Ritonavir (www.drugs.com/mtm/ritonavir.html).
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