Noxafil

DRUG DESCRIPTION

NOXAFIL (posaconazole oral suspension) is a triazole antifungal agent available as a suspension for oral administration.

Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5- (2,4-difluorophenyl)tetrahydro-5-(1H-1,2,4-triazol-1-ylmethyl)-3furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[ (1S,2S)-1-ethyl-2-hydroxypropyl]-2,4-dihydro-3H-1,2,4-triazol-3-one with an empirical formula of C37H42F2N8O4 and a molecular weight of 700.8. The chemical structure is:

NOXAFIL® (Posaconazole) Structural Formula Illustration

Posaconazole is a white powder and is insoluble in water.

NOXAFIL (posaconazole oral suspension) Oral Suspension is a white, cherry-flavored immediate-release suspension containing 40 mg of posaconazole per mL and the following inactive ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate, citric acid monohydrate, glycerin, xanthan gum, liquid glucose, titanium dioxide, artificial cherry flavor, and purified water.

What are the possible side effects of posaconazole (Noxafil)?

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

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, cough, body aches, flu symptoms;
  • slow, fast, or pounding heartbeats;
  • feeling light-headed, fainting;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle...

Read All Potential Side Effects and See Pictures of Noxafil »

What are the precautions when taking posaconazole oral suspension (Noxafil)?

Before taking posaconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart disease (e.g., irregular heartbeat).

Posaconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT...

Read All Potential Precautions of Noxafil »


Noxafil Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, abdominal pain, dizziness, trouble sleeping, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of infection (e.g., fever, persistent sore throat), unusual tiredness, weakness, swelling of the ankles/feet, muscle cramps, easy bruising/bleeding, vaginal bleeding, shortness of breath, increased thirst/urination.

Seek immediate medical attention if any of these rare but very serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting, trouble breathing, chest pain, change in the amount of urine, confusion, weakness on one side of the body, seizures.

Posaconazole has rarely caused very serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking posaconazole and tell your doctor immediately: yellowing eyes/skin, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Posaconazole can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking posaconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (e.g., ketoconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart disease (e.g., irregular heartbeat).

Posaconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using posaconazole, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using posaconazole safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages because they can increase the effects of dizziness and also increase the risk of serious liver problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Noxafil Patient Information Including Side Effects

Brand Names: Noxafil

Generic Name: posaconazole (Pronunciation: poe sa KONE a zole)

  • What is posaconazole (Noxafil)?
  • What are the possible side effects of posaconazole (Noxafil)?
  • What is the most important information I should know about posaconazole (Noxafil)?
  • What should I discuss with my healthcare provider before using posaconazole (Noxafil)?
  • How should I take posaconazole (Noxafil)?
  • What happens if I miss a dose (Noxafil)?
  • What happens if I overdose (Noxafil)?
  • What should I avoid while taking posaconazole (Noxafil)?
  • What other drugs will affect posaconazole (Noxafil)?
  • Where can I get more information?

What is posaconazole (Noxafil)?

Posaconazole is an antifungal medication that fights certain infections caused by fungus.

Posaconazole is used to prevent fungal infections in people with weak immune systems resulting from chemotherapy or stem cell transplantation.

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

What are the possible side effects of posaconazole (Noxafil)?

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

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, cough, body aches, flu symptoms;
  • slow, fast, or pounding heartbeats;
  • feeling light-headed, fainting;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;
  • confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling;
  • swelling of your ankles or feet;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • mild headache, tired feeling;
  • joint or muscle pain;
  • sleep problems (insomnia);
  • mild nausea, vomiting, diarrhea, constipation, or stomach pain; or
  • skin rash.

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 FDA at 1-800-FDA-1088.

What is the most important information I should know about posaconazole (Noxafil)?

Do not use this medication if you are allergic to posaconazole, or if you are using any of the following drugs:

  • halofantrine (Halfan);
  • pimozide (Orap);
  • quinidine (Cardioquin, Quinidex, Quinaglute); or
  • ergot medicine such as methysergide (Sansert), ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), methylergonovine (Methergine).

Take posaconazole for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Posaconazole will not treat a viral infection such as the common cold or flu.

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

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