Posaconazole 40 mg/ml Oral Suspension

Posaconazole 40 mg/ml Oral Suspension

Posaconazole is used to prevent fungal infections in patients with severely compromised immune systems (such as patients who have had chemotherapy). It is also employed in the treatment of fungal infections of the mouth and throat. It belongs to the azole antifungals class of drugs. It works by inhibiting fungi growth.

Posaconazole Oral Administration

Before you begin taking posaconazole, and each time you get a refill, read the Patient Information Leaflet provided by your pharmacist. If you have any concerns, consult your doctor or pharmacist.

As directed by your doctor, take this medication by mouth with a full meal. If you are unable to take this medication with a full meal, combine it with a liquid nutritional supplement or a carbonated beverage (such as ginger ale). Before using, thoroughly shake the medication. Use the provided dose-measuring spoon to carefully measure the medication. If you use a regular spoon, you may not get the correct dose.

The duration and dosage of treatment are determined by your medical condition and response to treatment.

Take this antifungal at regular intervals for the best results. Take this medication at the same time(s) every day to help you remember.

Even if your symptoms go away after a few days, keep taking this medication until the full prescribed amount is gone. Stopping the medication too soon may result in the infection reappearing.

Posaconazole tablets and suspensions may contain different amounts of medication. Do not change the forms of this medication without your doctor’s permission and instructions.

If you have severe diarrhoea or vomiting, contact your doctor. Posaconazole may not be as effective.

Inform your doctor if your condition does not improve or worsens, or if you are unable to take this medication with a full meal, a carbonated beverage, or a liquid nutritional supplement.

Adverse Effects

Nausea, vomiting, diarrhoea, headache, abdominal pain, dizziness, difficulty sleeping, or stomach upset are all possible side effects. Inform your doctor or pharmacist right away if any of these effects persist or worsen.

Remember that your doctor has prescribed this medication because the benefit to you outweighs the risk of side effects. Many people who take this medication have no serious side effects.

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 should all be reported to your doctor right away.

If you experience any of the following very serious side effects, seek medical attention immediately: fast/irregular heartbeat, severe dizziness, or fainting.

Posaconazole has rarely caused potentially fatal liver disease. If you experience persistent nausea/vomiting, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, or dark urine, contact your doctor right away.

It is uncommon for this drug to cause a severe allergic reaction. However, seek medical attention immediately if you notice any of the following symptoms of a severe allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or difficulty breathing.

Posaconazole may cause a mild rash, which is usually not serious. However, you may be unable to distinguish it from a rare rash that could indicate a severe allergic reaction. If you develop a rash, seek medical attention immediately.

This is not an exhaustive list of potential side effects. Contact your doctor or pharmacist if you notice any other side effects not listed above.

In the United States, contact your doctor for medical advice about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088 or visiting www.fda.gov/medwatch.

In Canada, contact your doctor if you are experiencing side effects. You can contact Health Canada at 1-866-234-2345 to report side effects.

Precautions

Tell your doctor or pharmacist if you are allergic to posaconazole or any other azole antifungals (such as ketoconazole), or if you have any other allergies. Inactive ingredients in this product may cause allergic reactions or other problems. For more information, consult your pharmacist.

Before taking this medication, inform your doctor or pharmacist of your medical history, particularly if you have: liver disease or kidney disease.

Posaconazole has been linked to a heart rhythm disorder (QT prolongation). QT prolongation can cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness and fainting) that require immediate medical attention.

If you have certain medical conditions or are taking other drugs that may cause QT prolongation, your risk of QT prolongation may be increased. Before taking posaconazole, inform your doctor or pharmacist of all the medications you are currently taking, as well as if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), a family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low potassium and magnesium levels in the blood may also increase your risk of QT prolongation. This risk may increase if you take certain medications (such as diuretics/”water pills”) or have conditions such as excessive sweating, diarrhoea, or vomiting. Consult your doctor about how to use posaconazole safely.

This medication may cause dizziness. You may become dizzy if you consume alcohol or marijuana (cannabis). Do not drive, operate machinery, or do anything else that requires alertness until you are sure you can do it safely. Consume no alcoholic beverages. If you use marijuana, talk to your doctor (cannabis). Alcohol may also increase the likelihood of developing serious liver problems.

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

Older adults may be more sensitive to the drug’s side effects, particularly QT prolongation (see above).

This medication should be used only when clearly necessary during pregnancy. Consult your doctor about the risks and benefits.

It is unknown whether this medication passes into breast milk. Before you start breast-feeding, talk to your doctor.

Interactions

Drug interactions can alter the way your medications work or put you at risk for serious side effects. This document does not include every possible drug interaction. Maintain a list of all the products you use (including prescription and nonprescription drugs, as well as herbal supplements) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medications without first consulting your doctor.

Other medications may interfere with the removal of posaconazole from your body, affecting how posaconazole works. Cimetidine, efavirenz, proton pump inhibitors (such as esomeprazole and pantoprazole), rifamycins (such as rifabutin), and certain seizure medications (such as phenytoin) are examples.

This medication can slow the removal of other medications from your body, which may affect how they work. Certain alpha blockers (e.g., alfuzosin, silodosin, tamsulosin), certain benzodiazepines (e.g., midazolam), dronedarone, ergot alkaloids (e.g., ergotamine, dihydroergotamine), pimozide, quinidine, rivaroxaban, sirolimus, certain “statin” drugs (e.g.

Overdose

Call 911 if someone has overdosed and is experiencing serious symptoms such as passing out or difficulty breathing. Otherwise, contact a poison control centre immediately. Residents in the United States can contact their local poison control centre at 1-800-222-1222. Residents of Canada can contact a provincial poison control centre.

Notes Do not give this medication to anyone else.

This medication has been prescribed specifically for your current condition. Unless your doctor instructs you otherwise, do not use it to treat or prevent another infection.

Before and during treatment, lab and/or medical tests (such as liver function and blood mineral levels such as calcium, magnesium, and potassium) should be performed. Maintain all medical and laboratory appointments. For more information, speak with your doctor.

Dose Omitted

If you forget to take a dose, take it as soon as you remember. If the next dose is approaching, skip the missed dose. Take your next dose at your usual time. To catch up, do not double the dose.

Storage

Store away from light and moisture at room temperature. Do not become paralysed. Keep out of the bathroom. Keep all medications out of the reach of children and pets.

Unless otherwise directed, do not flush medications or pour them down the drain. When this product has expired or is no longer needed, properly dispose of it. Consult your pharmacist or a waste disposal company in your area.