posaconazole 300 mg oral suspension,delayed release in a packet

Generic name:
Posaconazole delayed-release packet - oral

Pronunciation
(POE-sa-KON-a-zole)

Brand name(s)
Noxafil PowderMix

Posaconazole is used to prevent certain fungal infections in children who have severely weakened immune systems (such as patients who have had chemotherapy). It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

This form of posaconazole is not recommended for use by children who weigh more than 88 pounds (40 kilograms) since this dosage form will not provide the right dose.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start taking posaconazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually twice daily for the first day, and then once daily after that. Do not take this medication at the same time with alcohol or with medications that contain alcohol. Doing so can release all of the drug at once, increasing the risk of side effects.

Follow instructions on how to prepare and mix the suspension. Do not open the powder packet until you are ready to prepare the medication. Only use the mixing liquid provided in the kit to mix the powder. Do not use any other liquid to mix. Shake the medication well before using. The suspension should look cloudy and free of clumps. Carefully measure the dose using the provided measuring syringe. Do not use a household spoon because you may not get the correct dose. After mixing, the medication should be used within 1 hour. Discard any unused suspension.

The dosage and length of treatment are based on your medical condition and weight.

For the best effect, take this antifungal at evenly spaced times. To help you remember, take this medication at the same time every day.

Continue to take this medication until the full prescribed amount is finished. Stopping the medication too early may result in the medication not working well.

This form of posaconazole may deliver different amounts of medication than the tablet and regular-release suspension forms. Do not switch between the different forms of this medication without your doctor's permission and directions.

Tell your doctor if you have severe diarrhea or vomiting. Posaconazole may not work as well. If you are giving this medication to a small child, tell the doctor if the child is unable to take the full dose or is spitting out the medication.

Nausea, vomiting, diarrhea, mouth sores, headache, abdominal pain, dizziness, or stomach upset may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• swelling hands/ankles/feet
• signs of infection (such as fever, chills)
• unusual tiredness
• weakness
• muscle cramps
• mental/mood changes
• easy bruising/bleeding
• vaginal bleeding
• shortness of breath
• increased thirst/urination

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

Posaconazole has rarely caused very serious (possibly fatal) liver disease. Tell your doctor right away if you develop symptoms of liver disease, such as:

• nausea/vomiting that doesn't stop
• loss of appetite
• stomach/abdominal pain
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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. Get medical help right away 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 or at www.fda.gov/medwatch.

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

Before taking posaconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (such as 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
• a certain genetic enzyme problem (hereditary fructose intolerance)

Posaconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using posaconazole, tell your doctor or pharmacist of all the drugs you take and 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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may also increase the risk of serious liver problems.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

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

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of posaconazole from your body, which may affect how posaconazole works. Examples include efavirenz, rifamycins (such as rifabutin), certain drugs used to treat seizures (such as phenytoin), among others.

This drug can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, silodosin, tamsulosin), certain benzodiazepines (such as midazolam), dronedarone, ergot alkaloids (such as ergotamine, dihydroergotamine), pimozide, quinidine, rivaroxaban, sirolimus, certain "statin" drugs (such as lovastatin, simvastatin), venetoclax, among others.

Many drugs besides posaconazole may affect the heart rhythm (QT prolongation), such as pacritinib, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later to prevent another infection unless your doctor tells you to.

Lab and/or medical tests (such as liver function, blood pressure, blood mineral levels such as calcium, magnesium, potassium) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.