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Posaconazole delayed-release tablet

Generic Name: posaconazole (POE-sa-KON-a-zole)
Brand Name: Noxafil

Posaconazole delayed-release tablet is used for:

Preventing certain types of fungal infections in patients with severely weakened immune systems. It may also be used for other conditions as determined by your doctor.

Posaconazole delayed-release tablet is an azole antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane.

Do NOT use posaconazole delayed-release tablet if:

  • you are allergic to any ingredient in posaconazole delayed-release tablet or to other azole antifungals (eg, fluconazole, ketoconazole, itraconazole, voriconazole)
  • you are taking atorvastatin, an ergot alkaloid (eg, ergotamine, dihydroergotamine), lovastatin, pimozide, quinidine, simvastatin, or sirolimus

Contact your doctor or health care provider right away if any of these apply to you.

Before using posaconazole delayed-release tablet:

Some medical conditions may interact with posaconazole delayed-release tablet. 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 a history of liver problems, kidney problems, blood vessel problems (eg, in the heart), or heart problems (eg, irregular heartbeat, abnormal heart function tests)
  • if you have blood electrolyte problems (eg, low blood potassium, magnesium, or calcium levels)
  • if you have severe diarrhea or vomiting
  • If you have low blood platelet or neutrophil levels, HIV, or a weakened immune system, or you take medicine that may weaken your immune system (eg, cyclosporine, tacrolimus)
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with posaconazole delayed-release tablet. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for allergies, anxiety, asthma or other lung or breathing problems, birth control, blood thinning, cancer, cystic fibrosis, depression or other mental or mood problems, diabetes, enlarged prostate gland, erectile dysfunction, gout, heartburn, high blood pressure, high blood prolactin levels, high cholesterol, HIV infection, immune system suppression, infections, irregular heartbeat or other heart problems, migraine headaches, overactive bladder, overactive parathyroid gland, pain, seizures, sleep, stomach or bowel problems, Tourette disorder), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with posaconazole delayed-release tablet. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with posaconazole delayed-release tablet.

This may not be a complete list of all interactions that may occur. Ask your health care provider if posaconazole delayed-release tablet 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 posaconazole delayed-release tablet:

Use posaconazole delayed-release tablet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with posaconazole delayed-release tablet. Talk to your pharmacist if you have questions about this information.
  • Take posaconazole delayed-release tablet by mouth with food.
  • Swallow posaconazole delayed-release tablet whole. Do not break, crush, dissolve, or chew before swallowing. If you cannot swallow posaconazole delayed-release tablet whole, tell your doctor. You may need a different medicine.
  • Take posaconazole delayed-release tablet on a regular schedule to get the most benefit from it.
  • Taking posaconazole delayed-release tablet at the same time each day will help you remember to take it.
  • Continue to take posaconazole delayed-release tablet even if you feel well. Do not miss any doses.
  • If you miss a dose of posaconazole delayed-release tablet, take it as soon as possible. If it is within 12 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use posaconazole delayed-release tablet.

Important safety information:

  • Serious and sometimes fatal liver problems have been reported with the use of posaconazole delayed-release tablet. Contact your doctor right away if you develop symptoms of liver problems, such as nausea, vomiting, loss of appetite, fever, stomach pain, yellowing of the skin or eyes, dark urine, pale stools, itching, or unusual tiredness or achiness. Discuss any questions or concerns with your doctor.
  • Contact your doctor if you experience severe diarrhea or vomiting. The effectiveness of posaconazole delayed-release tablet may be decreased.
  • Posaconazole delayed-release tablet only works against fungi; it does not treat viral infections (eg, the common cold) or bacterial infections.
  • Be sure to use posaconazole delayed-release tablet for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
  • Long-term or repeated use of posaconazole delayed-release tablet may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
  • Diabetes patients - Posaconazole delayed-release tablet may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Tell your doctor or dentist that you take posaconazole delayed-release tablet before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver function and heart function, may be performed while you use posaconazole delayed-release tablet. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Posaconazole delayed-release tablet should be used with extreme caution in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is not known if posaconazole delayed-release tablet can cause harm to the fetus. If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using posaconazole delayed-release tablet while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking posaconazole delayed-release tablet.

Possible side effects of posaconazole delayed-release tablet:

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:

Constipation; cough; diarrhea; headache; mild fever; mild stomach pain; nausea; stomach upset; tiredness; vomiting; weakness.

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); burning, numbness, or tingling; chest pain; decreased urination; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; mouth inflammation or sores; muscle aches, pain, spasms, weakness, or cramping; nosebleeds; seizures; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; sluggishness; swelling of the ankles, feet, hands, arms, or legs; tremor; unusual bruising or bleeding.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of posaconazole delayed-release tablet:

Store posaconazole delayed-release tablet at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep posaconazole delayed-release tablet out of the reach of children and away from pets.

General information:

  • If you have any questions about posaconazole delayed-release tablet, please talk with your doctor, pharmacist, or other health care provider.
  • Posaconazole delayed-release tablet 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take posaconazole delayed-release tablet or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about posaconazole delayed-release tablet. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to posaconazole delayed-release tablet. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using posaconazole delayed-release tablet.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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