GENERIC NAME: RITONAVIR SOLUTION - ORAL (rye-TAWN-uh-veer)
BRAND NAME(S): Norvir
WARNING: Ritonavir may interact with many different types of medicines, in some cases causing severe (sometimes fatal) reactions. Consult your doctor or pharmacist about which medications should not be taken with ritonavir. (See also Drug Interactions section.)
USES: This drug 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.Ritonavir belongs to a class of drugs known as protease inhibitors. It increases ("boosts") the levels of other protease inhibitors, which helps these medications 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 one month of age, unless your doctor thinks it is right for your baby. Discuss the risks and benefits with your doctor.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 medication 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 Patient Information Leaflet provided by your pharmacist before you start taking ritonavir and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Shake the bottle well before each dose. Take this medication by mouth with food or up to 2 hours after food, as directed by your doctor, usually 1 to 2 times daily. Take ritonavir at the same time(s) as your other protease inhibitor. Carefully measure the dose using 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 weight, liver function, medical condition, other medications, and response to treatment.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.It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. 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. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat, or worsen side effects.
SIDE EFFECTS: Diarrhea, nausea, vomiting, heartburn, stomach pain, loss of appetite, headache, dizziness, tiredness, weakness, changes in taste, or tingling/numbness of mouth area 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 immediately if any of these unlikely but serious side effects occur: persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin, mental/mood changes (such as depression, anxiety), increased urination (especially at night), increased thirst.Seek immediate medical attention if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding, fainting, fast/irregular heartbeat.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.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 ritonavir, tell your doctor or pharmacist if you are allergic to it; 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: diabetes, heart problems (coronary artery disease, heart attack), hemophilia, high cholesterol/triglycerides, gout/high uric acid in the blood, liver problems (such as hepatitis B, hepatitis C), pancreatitis.This medication may cause dizziness. 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.This medication contains alcohol. Caution is advised if you have alcohol dependence or any other condition that requires you to limit/avoid alcohol.If you have diabetes, this product may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar, such as increased thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. Your doctor may need to adjust your diabetes medication(s).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 effects of this product. 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 one month old.During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Ritonavir 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.
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DRUG INTERACTIONS: Ritonavir interacts with many medications. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: alfuzosin, certain antiarrhythmics (amiodarone, flecainide, propafenone, quinidine), certain benzodiazepines (midazolam, triazolam), bosentan, conivaptan, disulfiram, eletriptan, ergot alkaloids (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine), lurasidone, pimozide, quinine, ranolazine, certain "statin" cholesterol drugs (simvastatin, lovastatin), St John's wort, voriconazole.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting ritonavir.Other medications can affect the removal of ritonavir from your body, which may affect how ritonavir works. Examples include boceprevir, rifampin, among others.Ritonavir can slow down or speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include cisapride, digoxin, fluticasone, salmeterol, theophylline, certain antiarrhythmics (including disopyramide, mexiletine), antidepressants (such as fluoxetine, nefazodone, trazodone), certain beta blockers (metoprolol, timolol), certain "blood thinners" (such as rivaroxaban, warfarin), calcium channel blockers (such as nifedipine, felodipine), some cancer drugs (such as dasatinib, sunitinib, vincristine), certain azole fungal medications (ketoconazole, itraconazole), anti-seizure drugs (including carbamazepine, phenytoin), drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil), certain "statin" cholesterol drugs (atorvastatin, rosuvastatin), narcotic pain medications (such as fentanyl, methadone, meperidine), among others.If any of these medications are taken with ritonavir, your doctor may change your dose of ritonavir or the other drug(s), or your doctor may monitor you specially. Consult your doctor or pharmacist for more 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.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
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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.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as liver tests, viral load, T-cell counts, blood sugar, triglycerides/cholesterol) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Keep all medical and laboratory appointments.
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 this medication in the original bottle between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.