Generic Name: Posaconazole Brand Name(s): .

Uses

What is Posaconazole used for?

Posaconazole is used to prevent certain fungal infections in patients 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.

How should I take Posaconazole?

Take this medication by mouth as directed by your doctor, usually once daily with food. Do not crush or chew delayed-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The length of treatment is based on your medical condition.

This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

The tablet and suspension forms of posaconazole may deliver different amounts of medication. 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.

How do I store Posaconazole?

Posaconazole is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Posaconazole in the bathroom or the freezer. There may be different brands of Posaconazole that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Posaconazole down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Posaconazole?

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.

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 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. 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.

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 breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Posaconazole during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Posaconazole. Posaconazole is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Posaconazole?

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 right away if you have any serious side effects, including: unusual tiredness, easy bruising/bleeding, weakness, muscle cramps, mental/mood changes, swelling of the ankles/feet, signs of infection (such as chills, fever), 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, including: yellowing eyes/skin, dark urine, persistent nausea/vomiting, severe stomach/abdominal pain.

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. Therefore, get medical help right away if you develop any rash.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Posaconazole?

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 atorvastatin, lovastatin, simvastatin), among others.

Posaconazole may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Posaconazole?

Posaconazole may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Posaconazole?

Posaconazole may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Posaconazole.

What is the dose of Posaconazole for an adult?

Usual Adult Dose for Aspergillosis – Invasive

IV:

Loading dose: 300 mg IV twice a day on the first day

Maintenance dose: 300 mg IV once a day, starting on the second day

Oral:

Delayed-release tablets:

-Loading dose: 300 mg orally twice a day on the first day

-Maintenance dose: 300 mg orally once a day, starting on the second day

Oral suspension: 200 mg orally three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:

-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus host disease (GVHD) or patients with hematologic malignancies with prolonged neutropenia from chemotherapy

Usual Adult Dose for Candidemia

IV:

Loading dose: 300 mg IV twice a day on the first day

Maintenance dose: 300 mg IV once a day, starting on the second day

Oral:

Delayed-release tablets:

-Loading dose: 300 mg orally twice a day on the first day

-Maintenance dose: 300 mg orally once a day, starting on the second day

Oral suspension: 200 mg orally three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:

-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as hematopoietic stem cell transplant (HSCT) recipients with graft versus host disease (GVHD) or patients with hematologic malignancies with prolonged neutropenia from chemotherapy

Usual Adult Dose for Oral Thrush

Oral suspension:

Oropharyngeal candidiasis:

-Loading dose: 100 mg orally twice a day on the first day

-Maintenance dose: 100 mg orally once a day for 13 days

Oropharyngeal candidiasis refractory to itraconazole and/or fluconazole: 400 mg orally twice a day

Duration of therapy: Should be based on severity of patient’s underlying disease and clinical response

Renal Dose Adjustments

IV:

Moderate or severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 50 mL/min): The injection should be avoided unless benefit justifies risk.

Comments: Serum creatinine levels should be monitored closely; if levels increase, switching to oral posaconazole therapy should be considered.

Oral:

Mild to moderate renal dysfunction (eGFR 20 to 80 mL/min/1.73 m2): No adjustment recommended.

Severe renal dysfunction (eGFR less than 20 mL/min/1.73 m2): No adjustment recommended; patients should be monitored closely for breakthrough fungal infections.

Liver Dose Adjustments

Mild to severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended.

Dialysis

This drug is not removed by hemodialysis.

Other Comments

Administration advice:

-Administer the injection through a 0.22 micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter.

-Administer the injection via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow IV infusion over about 90 minutes; never administer as an IV bolus injection.

-If a central venous catheter is not available, the injection may be administered through a peripheral venous catheter by slow IV infusion over about 30 minutes only as a single dose before central venous line placement or to bridge the period when a central venous line is replaced or in use for other IV therapy; when multiple dosing is needed, infuse via a central venous line.

-Do not use the delayed-release tablets and oral suspension interchangeably; dosing is different for each formulation.

-Take delayed-release tablets with food to enhance absorption and optimize plasma levels; swallow whole (do not divide, crush, or chew); use only for the prophylaxis indication.

-Take each dose of the oral suspension during or within 20 minutes after a full meal to enhance absorption and optimize plasma levels; shake well before use.

-In patients unable to eat a full meal, and the delayed-release tablets or injection are not options, give each dose of the oral suspension with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale).

-For patients unable to eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage, and the delayed-release tablets or injection are not options, consider alternative antifungal therapy or monitor patients closely for breakthrough fungal infections.

-If this drug is administered via a nasogastric tube, monitor patients closely for breakthrough fungal infections.

-In general, avoid concomitant use of agents that can decrease plasma levels of this drug unless benefit outweighs risk; if such agents are needed, monitor patients closely for breakthrough fungal infections.

-The manufacturer product information should be consulted regarding missed doses.

Storage requirements:

-Injection: Store refrigerated at 2C to 8C (36F to 46F); once admixed, may store refrigerated up to 24 hours.

-Delayed-release tablets: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

-Oral suspension: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F); do not freeze.

Reconstitution/preparation techniques:

-The manufacturer product information should be consulted.

IV compatibility:

-Compatible diluents: 5% dextrose in water, sodium chloride 0.9%

-Compatible drug products (if prepared in a compatible diluent): Amikacin sulfate, caspofungin, ciprofloxacin, daptomycin, dobutamine hydrochloride (HCl), famotidine, filgrastim, gentamicin sulfate, hydromorphone HCl, levofloxacin, lorazepam, meropenem, micafungin, morphine, norepinephrine bitartrate, potassium chloride, vancomycin HCl

Monitoring:

-General: For breakthrough fungal infections (e.g., patients with severe diarrhea or vomiting using an oral formulation, patients weighing more than 120 kg)

-Hepatic: Liver function tests (start of and during therapy); for more severe liver injury in patients with abnormal liver function tests (during therapy); hepatic function (especially liver function tests and bilirubin) for patient management (during therapy)

-Renal: Serum creatinine levels in patients with moderate or severe renal dysfunction using the injection

What is the dose of Posaconazole for a child?

Usual Pediatric Dose for Aspergillosis – Invasive

13 years or older:

Delayed-release tablets:

-Loading dose: 300 mg orally twice a day on the first day

-Maintenance dose: 300 mg orally once a day, starting on the second day

Oral suspension: 200 mg orally three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:

-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as HSCT recipients with GVHD or patients with hematologic malignancies with prolonged neutropenia from chemotherapy

Usual Pediatric Dose for Candidemia

13 years or older:

Delayed-release tablets:

-Loading dose: 300 mg orally twice a day on the first day

-Maintenance dose: 300 mg orally once a day, starting on the second day

Oral suspension: 200 mg orally three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:

-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as HSCT recipients with GVHD or patients with hematologic malignancies with prolonged neutropenia from chemotherapy

Usual Pediatric Dose for Oral Thrush

13 years or older:

Oral suspension:

Oropharyngeal candidiasis:

-Loading dose: 100 mg orally twice a day on the first day

-Maintenance dose: 100 mg orally once a day for 13 days

Oropharyngeal candidiasis refractory to itraconazole and/or fluconazole: 400 mg orally twice a day

Duration of therapy: Should be based on the severity of the patient’s underlying disease and clinical response

Precautions

Safety and efficacy of the delayed-release tablets and oral suspension have not been established in patients younger than 13 years. Safety and efficacy of the injection have not been established in patients younger than 18 years; it should not be used.

How is Posaconazole available?

Posaconazole is available in the following dosage forms and strengths:

  • Oral suspension,
  • Oral delayed release tablet,
  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Posaconazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 11, 2018 | Last Modified: April 11, 2018

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