Darunavir (By mouth)
Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). Darunavir does not cure HIV or AIDS. It will be used with another drug called ritonavir (Norvir®) to slow the progress of the disease.
PrezistaThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:You should not use this medicine if you or your child have had an allergic reaction to darunavir or ritonavir. Do not use this medicine if you or your child are also using alfuzosin (Uroxatral®), cisapride (Propulsid®), pimozide (Orap®), oral midazolam (Versed®), triazolam (Halcion®), rifampin (Rifadin®, Rifater®), lovastatin (Advicor®, Altoprev®, Mevacor®), simvastatin (Simcor®, Vytorin®, Zocor®), sildenafil (Revatio®), ergot medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Ergomar®, Ergostat®, Migranal®, or Wigraine®), or St John's wort. Do not give this medicine to children younger than 3 years of age.
How to Use This Medicine:
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
- This medicine should always be taken together with ritonavir (Norvir®).
- It is best to take this medicine with food or milk.
- Swallow the tablet whole with water or milk. Do not crush, break, or chew it.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
If a dose is missed:
- If you take this medicine once a day and you miss a dose or forget to use it, and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
- If you take this medicine two times a day and you miss a dose or forget to use it, and it is more than 6 hours since your last dose, wait and take your next dose at the normal time. If you miss a dose or forget to use it, and it is less than 6 hours since your last dose, take it as soon as you can and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- You must avoid many other medicines while you are using darunavir. Tell your doctor if you are using a medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®) or a medicine to lower cholesterol (such as atorvastatin, pravastatin, rosuvastatin, Lipitor®, or Pravachol®). Make sure your doctor knows if you are also using other medicines to treat HIV or AIDS (such as atazanavir, didanosine, efavirenz, indinavir, lopinavir/ritonavir, maraviroc, saquinavir, Crixivan®, Invirase®, Kaletra®, Sustiva®, or Videx®).
- Tell your doctor if you are using a medicine for heart rhythm problems (such as amiodarone, bepridil, digoxin, flecainide, lidocaine, propafenone, quinidine, Cardioquin®, Cordarone®, Lanoxin®, or Tambocor®), a blood thinner (such as warfarin, Coumadin®), clarithromycin (Biaxin®), a medicine to treat a fungus infection (such as itraconazole, ketoconazole, voriconazole, Nizoral®, Sporanox®, or Vfend®), rifabutin (Mycobutin®), certain blood pressure medicines (such as felodipine, nicardipine, nifedipine, metoprolol, Adalat®, Cardene®, Lopressor®, or Plendil®), or medicine to treat glaucoma (such as timolol or Timoptic®).
- Make sure your doctor knows if you are using a steroid medicine (such as dexamethasone, fluticasone, or Decadron®), cyclosporine (Gengraf®, Neoral®, or Sandimmune®), sirolimus (Rapamune®), tacrolimus (Prograf®), bosentan (Tracleer®), buprenorphine (Buprex®, Suboxone®), colchicine (Colcrys®), methadone (Dolophine®), midazolam given by injection, birth control pills (such as Femhrt®, Loestrin®, Ortho-Novum®, or Ovcon®), risperidone (Risperdal®), thioridazine (Mellaril®), salmeterol (Advair®, Serevent®), sildenafil (Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), or a medicine to treat depression (such as desipramine, paroxetine, sertraline, trazodone, Desyrel®, Norpramin®, Paxil®, or Zoloft®).
Warnings While Using This Medicine:
- Make sure your doctor knows if you are pregnant, or if you have diabetes, liver disease (including hepatitis B or C), or a bleeding disorder known as hemophilia. Tell your doctor if you or your child are allergic to sulfa medicines (such as Bactrim® or Septra®).
- You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
- 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.
- This medicine may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.
- When you start taking HIV medicines, your immune system may get stronger. If you or your child 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.
- Serious skin reactions can occur with this medicine. Stop using this medicine and 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; chills; cough; diarrhea; itching; fever; joint or muscle pain; red skin lesions, often with a purple center; skin rash; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.
- This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
- Birth control pills may not work as well while you are using darunavir. To keep from getting pregnant, use an additional form of birth control with your pills. Other forms include condoms, diaphragms, or a contraceptive foam or jelly.
- 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.
- Do not stop using this medicine unless your doctor tells you to do so.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Blistering, peeling, or red skin rash.
- Change in how much or how often you urinate.
- Chest pain or fast heartbeat.
- Confusion, weakness, and muscle twitching.
- Dark-colored urine or pale stools.
- Excessive hunger or thirst.
- Fever, chills, cough, sore throat, runny or stuffy nose, and body aches.
- Muscle pain, tenderness, or weakness.
- Nausea, vomiting, loss of appetite, or pain in your upper stomach.
- Numbness or weakness in your arm or leg, or on one side of your body.
- Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
- Rapid weight gain.
- Sudden or severe headache, or problems with vision, speech, or walking.
- Swelling in your hands, ankles, or feet.
- Trouble breathing.
- Unusual bleeding or bruising.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Diarrhea, constipation, stomach pain, or upset stomach.
- Gaining weight around your neck, upper back, breast, face, or waist.
- Mild headache or dizziness.
- Mild skin rash.
- Mood changes or memory problems.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Last Updated: 1/4/2011
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