Description
Posaconazole delayed-release tablets, oral suspension, and delayed-release oral suspension are used to prevent certain fungus (yeast) infections (eg, invasive Aspergillus or Candida infections) in patients who have a weakened immune system (eg, hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers).
Posaconazole delayed-release tablets is also used to treat invasive aspergillosis.
Posaconazole oral suspension is also used to treat a fungus infection of the mouth or throat called oral thrush (candidiasis). Posaconazole oral suspension may be used as an initial treatment or after treatment with other antifungal medicines (eg, itraconazole or fluconazole) have failed.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Delayed Release
- Suspension
- Powder for Suspension, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of posaconazole delayed-release tablets, oral suspension, and delayed-release oral suspension in children 2 years of age and older to prevent fungus infections. However, safety and efficacy have not been established in children younger than 2 years of age. Use of delayed-release oral suspension in children weighing more than 40 kilograms (kg) is not recommended.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of posaconazole delayed-release tablets in children 13 years of age and older to treat invasive aspergillosis. Safety and efficacy have been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of posaconazole oral suspension in children 13 years of age and older to treat oral thrush (candidiasis). Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of posaconazole in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alfuzosin
- Alprazolam
- Amiodarone
- Aripiprazole
- Astemizole
- Atorvastatin
- Bedaquiline
- Bepridil
- Buprenorphine
- Cisapride
- Citalopram
- Clarithromycin
- Clozapine
- Colchicine
- Conivaptan
- Crizotinib
- Dabrafenib
- Dasatinib
- Dihydroergotamine
- Disopyramide
- Dofetilide
- Domperidone
- Donepezil
- Dronedarone
- Eletriptan
- Encorafenib
- Entrectinib
- Eplerenone
- Ergonovine
- Ergotamine
- Erythromycin
- Etrasimod
- Fexinidazole
- Finerenone
- Flibanserin
- Fluvastatin
- Fostemsavir
- Gepirone
- Glasdegib
- Halofantrine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acalabrutinib
- Adagrasib
- Ado-Trastuzumab Emtansine
- Alfentanil
- Amitriptyline
- Amprenavir
- Anagrelide
- Apalutamide
- Apixaban
- Apomorphine
- Aprepitant
- Arsenic Trioxide
- Asciminib
- Asenapine
- Atogepant
- Avacopan
- Avanafil
- Avapritinib
- Axitinib
- Azithromycin
- Benzhydrocodone
- Berotralstat
- Bictegravir
- Bosutinib
- Brentuximab Vedotin
- Brexpiprazole
- Brigatinib
- Bromocriptine
- Budesonide
- Buserelin
- Cabazitaxel
- Cabozantinib
- Calcifediol
- Capivasertib
- Capmatinib
- Carbamazepine
- Cariprazine
- Ceritinib
- Chloroquine
- Chlorpromazine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
- Aripiprazole Lauroxil
- Lorazepam
- Topiramate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Diarrhea, severe or
- Vomiting, severe—Use with caution. May increase the risk for other fungal infections.
- Heart disease, history of or
- Heart rhythm problems (eg, arrhythmia, QT prolongation) or
- Liver disease or
- Mineral imbalance (low potassium, magnesium, or calcium in the blood)—Use with caution. May cause side effects to become worse.
- Fructose intolerance, hereditary—The delayed-release oral suspension should not be used in patients with this condition.
- Kidney disease, moderate to severe—May cause the medicine to not work as well.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Swallow the delayed-release tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.
If you are using the oral liquid:
- Shake the oral liquid well before measuring the dose. Use the dosing spoon in the package to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the measuring spoon with water after using and before storage.
- Take this medicine during or right after (within 20 minutes) a full meal or liquid nutritional supplement. This medicine may also be taken with an acidic beverage (eg, ginger ale).
If you are using the delayed-release oral liquid:
- Do not open the pack until ready to prepare the medicine.
- Remove the cap from the mixing liquid and push the bottle adapter into the neck of the bottle. Remove 9 milliliters (mL) of mixing liquid using the provided blue syringe and put back the cap on the bottle. Use only the provided mixing liquid and syringes.
- Mix the 9 mL liquid and the entire contents of 1 packet in the provided mixing cup. Shake the cup for 45 seconds and make sure the powder is mixed. The mixture should look cloudy and free from clumps.
- Take the liquid within 1 hour of mixing. Throw away any unused liquid.
- Take this medicine with food.
Measure the oral liquid or delayed-release oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. You may hand wash and reuse the provided mixing cup and syringes.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicine, check with your doctor.
Posaconazole oral liquid works differently than the delayed-release tablet or delayed-release oral liquid, even at the same dose. Do not switch from one form to another unless your doctor tells you to.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For prevention of fungus infections:
- For oral dosage form (delayed-release tablets):
- Adults and children 2 years of age and older weighing more than 40 kilograms (kg)—300 milligrams (mg) (three 100 mg delayed-release tablets) 2 times a day on the first day, then 300 mg once a day.
- Children younger than 2 years of age or weighing 40 kg or less—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
- Adults and children 13 years of age and older—200 milligrams (mg) or 5 milliliters (mL) 3 times a day.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (delayed-release suspension):
- Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
- Weighing 36 to 40 kilograms (kg)—240 milligrams (mg) or 8 milliliters (mL) 2 times a day on the first day, then 240 mg or 8 mL once a day.
- Weighing 26 to less than 36 kg—210 mg or 7 mL 2 times a day on the first day, then 210 mg or 7 mL once a day.
- Weighing 21 to less than 26 kg—180 mg or 6 mL 2 times a day on the first day, then 180 mg or 6 mL once a day.
- Weighing 17 to less than 21 kg—150 mg or 5 mL 2 times a day on the first day, then 150 mg or 5 mL once a day.
- Weighing 12 to less than 17 kg—120 mg or 4 mL 2 times a day on the first day, then 120 mg or 4 mL once a day.
- Weighing 10 to less than 12 kg—90 mg or 3 mL 2 times a day on the first day, then 90 mg or 3 mL once a day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- Adults and children 2 years of age and older—Dose is based on body weight and must be determined by your doctor.
- For oral dosage form (delayed-release tablets):
- For treatment of invasive aspergillosis:
- For oral dosage form (delayed-release tablets):
- Adults and children 13 years of age and older—300 milligrams (mg) (three 100 mg delayed-release tablets) 2 times a day on the first day, then 300 mg once a day for 6 to 12 weeks.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (delayed-release tablets):
- For initial treatment of oral candidiasis:
- For oral dosage form (suspension):
- Adults and children 13 years of age and older—100 milligrams (mg) or 2.5 milliliters (mL) 2 times a day on the first day, then 100 mg or 2.5 mL once a day for 13 days.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
- For treatment of oral candidiasis after failed treatment with itraconazole or fluconazole:
- For oral dosage form (suspension):
- Adults and children 13 years of age and older—400 milligrams (mg) or 10 milliliters (mL) 2 times a day.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Do not take the delayed-release tablet if it has been more than 12 hours since you missed your last dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.
You should not use atorvastatin (Lipitor®), lovastatin (Mevacor®), pimozide (Orap®), quinidine (Quinaglute®), simvastatin (Zocor®), sirolimus (Rapamune®), venetoclax (Venclexta®), or ergotamine medicines (eg, bromocriptine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, methysergide, Cafergot®, Ergomar®, Wigraine®). Using any of them together with this medicine may increase the chance of unwanted effects.
This medicine can cause changes in heart rhythms, including QT prolongation and torsades de pointes. Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow skin or eyes. These could be symptoms of a serious liver problem.
Check with your doctor right away if you have severe diarrhea or vomiting while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Black, tarry stools
- bleeding in the gums
- blood in the urine or stools
- bloody nose
- blurred vision
- body aches or pain
- chest tightness
- confusion
- cough
- decreased urine
- diarrhea
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dry mouth
- fever or chills
- fruit-like breath odor
- heavy non-menstrual vaginal bleeding
- increased thirst or urination
- irregular heartbeats
- loss of appetite
- loss of voice
- mood changes
- muscle pain, cramps, spasms, or twitching
- nausea or vomiting
- numbness or tingling in the hands, feet, lips, mouth, or fingertips
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- seizures
- slow or fast heartbeat
- small red or purple spots on the skin
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- stomach pain
- sweating
- swelling of the ankles or hands
- tender, swollen glands in the neck
- trembling
- trouble swallowing
- unexplained weight loss
- unusual bleeding or bruising
- yellow eyes or skin
Less common
- Fainting
- irregular heartbeat, recurrent
Incidence not known
- Anxiety
- change in mental status
- chest pain or discomfort
- darkening of the skin
- itching or skin rash
- mental depression
- seizures
- swelling of the eyes or eyelids
- swelling of the face, fingers, feet, or lower legs
- trouble breathing
- weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- back pain
- belching
- difficulty having a bowel movement (stool)
- heartburn
- lack or loss of strength
- muscle stiffness
- pain in the joints
- trouble sleeping
Less common
- Bad, unusual, or unpleasant (after) taste
- change in taste
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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