Posaconazole (poe-sa-KON-a-zole)

Treats or prevents fungus infections, especially in people who have a weak immune system.

Brand Name(s):

Noxafil

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Delayed Release Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Delayed-release tablet: Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.
• Oral liquid:
  • Shake the oral liquid well before using. Use the dosing spoon in the package to measure the dose. Rinse the measuring spoon with water after use and before storage.
  • Take this medicine with a full meal or within 20 minutes after a meal. If you cannot eat a full meal, take it with a liquid nutritional supplement or an acidic drink, including ginger ale.
• Delayed-release oral liquid:
  • Do not open the packet until you are ready to prepare the medicine.
  • Remove the cap from the mixing liquid and push the bottle adapter into the neck of the bottle. Remove 9 milliliters (mL) of mixing liquid using the provided blue syringe and put back the cap on the bottle. Use only the provided mixing liquid and syringes.
  • Mix the 9 mL liquid and the entire contents of 1 packet in the provided mixing cup. Shake the cup for 45 seconds and make sure the powder is mixed. The mixture should look cloudy and free from clumps.
  • Take the liquid within 1 hour of mixing. Throw away any unused liquid.
  • It is best to take this medicine with food or milk.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. You may hand wash and reuse the provided mixing cup and syringes.
• Posaconazole oral liquid works differently than the delayed-release tablet or delayed-release oral liquid, even at the same dose. Do not switch from one form to another unless your doctor tells you to.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Delayed-release tablet: Take your dose of medicine as soon as you remember. If it is less than 12 hours until your next dose, just skip the missed dose and go back to your regular schedule. Do not take extra medicine to make up for the missed dose.
  • Oral liquid: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze the oral liquid.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with atorvastatin, lovastatin, pimozide, quinidine, simvastatin, sirolimus, venetoclax, or an ergot medicine (including ergotamine, dihydroergotamine).
• Some foods and medicines can affect how posaconazole works. Tell your doctor if you are using any of the following:
  • Cimetidine, cyclosporine, digoxin, efavirenz, esomeprazole, glipizide, metoclopramide, phenytoin, rifabutin, tacrolimus
  • Benzodiazepine medicine (including alprazolam, triazolam)
  • Blood pressure medicine (including verapamil, diltiazem, felodipine, nifedipine, nicardipine)
  • Medicine to treat HIV/AIDS (including atazanavir, efavirenz, fosamprenavir, ritonavir)
  • Vinca alkaloids (including vinblastine, vincristine)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a history of heart disease, kidney disease, liver disease, or heart rhythm problems (including QT prolongation).
• This medicine can cause the following problems:
  • Heart rhythm problems, including QT prolongation, torsades de pointes
  • Liver problems
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps
• Fast, slow, pounding, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe diarrhea
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild diarrhea, constipation
• Sores or white patches on your lips, mouth, or throat

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