Darunavir Generic Name:
Darunavir (dar-UE-na-vir)Brand Name:
Darunavir is used for:
Treating HIV infection in certain patients along with other antiretroviral medicines. Darunavir must always be taken along with another medicine called ritonavir.
Darunavir is an HIV protease inhibitor. It works by blocking the growth activity of an enzyme (HIV protease) that the HIV virus needs to reproduce in the body.
Do NOT use Darunavir if:
- you are allergic to any ingredient in Darunavir
- you have severe liver problems
- you are taking astemizole, carbamazepine, certain benzodiazepines (eg, oral midazolam, triazolam), certain other HIV protease inhibitors (eg, lopinavir, saquinavir), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, an ergot derivative (eg, ergonovine, ergotamine), phenobarbital, phenytoin, pimozide, rifampin, St. John's wort, or terfenadine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Darunavir :
Some medical conditions may interact with Darunavir . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
- if you have a history of liver problems (eg, hepatitis, cirrhosis), high blood cholesterol or triglycerides, infection, bleeding problems (eg, hemophilia), diabetes, or a family history of diabetes
Some MEDICINES MAY INTERACT with Darunavir . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Astemizole, cisapride, ergot derivatives (eg, ergonovine, ergotamine), pimozide, or terfenadine because the risk of severe blood vessel problems or serious and possibly life-threatening irregular heartbeat may be increased
- Certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin) because the risk of severe muscle and kidney problems may be increased
- Certain benzodiazepines (eg, oral midazolam, triazolam) because the risk of severe or prolonged nervous system depression or breathing problems may be increased
- Certain HIV protease inhibitors (eg, lopinavir, saquinavir) because they may increase the risk of Darunavir 's side effects
- Carbamazepine, phenobarbital, phenytoin, rifampin, or St. John's wort because they may decrease Darunavir 's effectiveness
- Many other prescription and nonprescription medicines (eg, used for asthma, birth control, blood thinning, heart problems, heartburn, high blood pressure, high cholesterol, HIV infection, immune system suppression, impotence, infections, irregular heartbeat, mental or mood problems, migraine headaches, pain, seizures), and herbs found in multivitamin products, herbal teas, and dietary supplements may interact with Darunavir and increase the risk of side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Darunavir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Darunavir :
Use Darunavir as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Darunavir . Talk to your pharmacist if you have questions about this information.
- Take Darunavir by mouth with food. Ritonavir should also be taken at the same time as Darunavir .
- Swallow Darunavir whole with a drink such as water or milk. Do not break, crush, or chew before swallowing.
- If you also take didanosine, do not take it within 1 hour before or 2 hours after taking Darunavir . Check with your doctor if you have questions.
- Taking Darunavir at the same time each day will help you remember to take it.
- Take Darunavir on a regular schedule to get the most benefit from it.
- Continue to take Darunavir even if you feel well. Do not miss any doses.
- If you take Darunavir 1 time per day and you miss a dose by less than 12 hours, take it as soon as possible and go back to your regular dosing schedule. If you miss a dose by more than 12 hours, skip the missed dose and go back to your regular dosing schedule. If you take Darunavir 2 times per day and miss a dose by less than 6 hours, take it as soon as possible and go back to your regular dosing schedule. If you miss a dose of Darunavir by more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses of Darunavir at once.
Ask your health care provider any questions you may have about how to use Darunavir .
Important safety information:
- Keep a list of all the medicines that you take. Make a new list each time a medicine is added or stopped. Find out about medicines that should not be taken while you are taking Darunavir . Be sure that each of your health care providers knows all the medicines that you are taking.
- Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Darunavir . The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor. Do not stop taking Darunavir or change your dose without talking with your doctor.
- Darunavir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Darunavir .
- Darunavir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor. The long-term effects of taking Darunavir are unknown.
- Darunavir does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
- Do NOT take more than the recommended dose, change the dose, or stop taking Darunavir or ritonavir without checking with your doctor.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Darunavir , even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Darunavir . To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Hemophilia patients - Report all bleeding episodes to your doctor.
- Darunavir may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Darunavir may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Darunavir may increase triglyceride and lipid levels. The long-term chance of complications from this, such as heart attack and stroke, are not known at this time.
- Lab tests, including liver function, blood cholesterol or triglyceride levels, blood glucose levels, blood electrolyte levels, and complete blood cell counts, may be performed while you use Darunavir . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Darunavir with caution in the ELDERLY; they may be more sensitive to its effects.
- Darunavir should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- Darunavir should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Darunavir while you are pregnant. It is not known if Darunavir is found in breast milk. Do not breast-feed while taking Darunavir . Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Darunavir to the baby.
Possible side effects of Darunavir :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; nausea; stomach pain.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in the amount of urine produced; chest pain; dark urine; fast heartbeat; fever, chills, or persistent sore throat; loss of appetite; pale stools; red, swollen, or blistered skin; severe headache or dizziness; severe or persistent nausea, vomiting, or stomach pain; symptoms of high blood sugar (eg, confusion, flushing, rapid breathing, unusual hunger or thirst); unusual bleeding or bruising; unusual drowsiness, tiredness, or weakness; unusual swelling of the arms or legs; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Darunavir :
Store Darunavir at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Darunavir out of the reach of children and away from pets.
- If you have any questions about Darunavir , please talk with your doctor, pharmacist, or other health care provider.
- Darunavir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Darunavir . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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