Posaconazole (oral/injection)

Posaconazole is an antifungal medicine that treats or prevents fungal infections that can spread throughout the body. posaconazole is sometimes used in people with weakened immune systems due to treatments like chemotherapy or stem cell transplantation.

Posaconazole injection or delayed-release tablets are used to treat infections in adults and children who are at least 13 years old.

To prevent infections, posaconazole is given in the following ways:

• The injection is used in adults and children who are at least 2 years old.
• Delayed-release tablets are used in adults and children 2 years and older who weigh more than 88 pounds (40 kg).
• The oral suspension is used in people who are at least 13 years old.
• The PowderMix is used in adults and children 2 years and older who weigh 88 pounds (40 kg) or less.

The oral suspension liquid form of posaconazole is also used to treat oral thrush (yeast infection of the mouth).

Posaconazole may also be used for other purposes not listed in this medication guide.

Tell your doctor about all your other medicines. Some drugs must not be used with posaconazole.

You should not use posaconazole if you are allergic to posaconazole or similar antifungals such as fluconazole, itraconazole, ketoconazole, or voriconazole.

Some drugs should not be used with posaconazole. Your treatment plan may change if you also use:

• midazolam;
• pimozide;
• quinidine;
• sirolimus;
• cholesterol lowering medicines--atorvastatin, lovastatin, simvastatin, and others; or
• ergot medicine--dihydroergotamine, ergotamine, ergonovine, or methylergonovine.

You should not use PowderMix for oral suspension if you have hereditary fructose intolerance.

Tell your doctor if you have ever had:

• heart problems;
• blood circulation problems;
• liver or kidney disease; or
• an electrolyte imbalance (such as high or low blood levels of calcium, potassium, magnesium, or sodium).

May harm an unborn baby. Tell your doctor if you are pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Posaconazole may cause serious side effects. Call your doctor right away if you have:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might faint);
• swelling in an arm or leg;
• shortness of breath;
• liver problems--nausea, vomiting, itching, feeling tired, jaundice (yellowing of the skin or eyes); or
• signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle pain or weakness, numbness or tingling, confusion, feeling jittery, irregular heartbeats.

Common side effects of posaconazole may include:

• diarrhea, nausea, vomiting;
• low potassium (an electrolyte);
• headache;
• fever; or
• cough.

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 the FDA at 1-800-FDA-1088.

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.

Posaconazole oral is taken by mouth. The liquid and tablet forms are not equivalent and may not have the same dose or schedule. Ask your pharmacist if you have questions about the medicine you receive at the pharmacy.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

You may take the delayed-release tablet with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Prepare the PowderMix for oral suspension when it is time for the dose. Shake well for 45 seconds and measure a dose with the supplied dosing spoon. Rinse the spoon with water and wash the mixing cup after each use. Throw away the medicine if not used within 1 hour after mixing.

Take prepared PowderMix with food.

Take posaconazole oral suspension during or within 20 minutes after eating a full meal. If you cannot eat a full meal, take the medicine with a nutritional supplement or acidic carbonated drink such as ginger ale.

Tell your doctor if you cannot swallow a posaconazole tablet whole or cannot take posaconazole liquid with food or beverages as directed.

Posaconazole injection is given in a vein and must be given slowly over 30 to 90 minutes.

Prepare an injection only when you are ready to give it. Be sure you understand how to properly mix this medicine with a liquid (diluent) and how to store the mixture. Call your pharmacist if the medicine has particles in it.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Posaconazole will not treat a viral infection (flu or a common cold).

Call your doctor if you have ongoing vomiting or diarrhea. Posaconazole may not work as well while during this time.

You may need frequent medical tests.

Store posaconazole oral at room temperature away from moisture and heat. Do not freeze the liquid medicine. Do not open a packet of PowderMix until you are ready to prepare a dose.

Store posaconazole injection in the refrigerator. Take the vial out of the refrigerator and let it reach room temperature before mixing with a diluent. If you cannot give the injection right away, place the mixed medicine in the refrigerator and use it within 24 hours.

Throw away a vial, bottle, or IV bag after one use even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

For delayed-release tablets: Take the medicine as soon as you remember, but skip the missed dose if your next dose is due in less than 12 hours. Do not take two doses at once.

For all other forms: Take the medicine as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol while you are taking posaconazole (oral).

Posaconazole can lead to a serious heart issue. Your risk might be higher if you also take certain other medicines for infections, asthma, heart issues, high blood pressure, depression, mental health conditions, cancer, malaria, or HIV.

Inform your doctor about all the medicines you are currently taking. Many drugs can influence how posaconazole works, especially:

• cimetidine;
• cyclosporine;
• esomeprazole;
• rifabutin;
• phenytoin;
• tacrolimus;
• some cancer treatments--vinblastine, vincristine, vinorelbine; or
• HIV medicines--atazanavir, efavirenz, fosamprenavir, ritonavir.

This is not a complete list, and there are many other drugs that may interact with posaconazole. This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Not all potential drug interactions are mentioned here.