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Posaconazole (Oral route)

Pronunciation:

poe-sa-KON-a-zole

Brand Names:

  • Noxafil

Dosage Forms:

  • Suspension
  • Tablet, Delayed Release

Classifications:

Therapeutic—

Antifungal

Chemical—

Triazole

Uses of This Medicine:

Posaconazole delayed-release tablets and oral suspension are used to prevent certain fungus (yeast) infections in patients 13 years of age and older, who have a weakened immune system (eg, hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers). 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.

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of posaconazole in teenagers 13 to 17 years of age. However, safety and efficacy have not been established in children younger than 13 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of posaconazole in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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
  • Amifampridine
  • Amiodarone
  • Aripiprazole
  • Astemizole
  • Atazanavir
  • Atorvastatin
  • Bedaquiline
  • Cisapride
  • Citalopram
  • Clarithromycin
  • Clozapine
  • Conivaptan
  • Crizotinib
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Dihydroergotamine
  • Disopyramide
  • Dofetilide
  • Domperidone
  • Dronedarone
  • Eletriptan
  • Ergoloid Mesylates
  • Ergonovine
  • Ergotamine
  • Erythromycin
  • Escitalopram
  • Eszopiclone
  • Halofantrine
  • Haloperidol
  • Iloperidone
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Lomitapide
  • Lopinavir
  • Lovastatin
  • Lumefantrine
  • Lurasidone
  • Maraviroc
  • Mefloquine
  • Mesoridazine
  • Methadone
  • Methylergonovine
  • Methysergide
  • Mifepristone
  • Nilotinib
  • Nimodipine
  • Ondansetron
  • Pazopanib
  • Pimozide
  • Piperaquine
  • Propafenone
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Rilpivirine
  • Ritonavir
  • Salmeterol
  • Saquinavir
  • Simvastatin
  • Sirolimus
  • Solifenacin
  • Sorafenib
  • Sparfloxacin
  • Sunitinib
  • Suvorexant
  • Tacrolimus
  • Tamoxifen
  • Telithromycin
  • Terfenadine
  • Thioridazine
  • Tolvaptan
  • Toremifene
  • Trazodone
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Vorapaxar
  • Voriconazole
  • Ziprasidone

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.

  • Ado-Trastuzumab Emtansine
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Arsenic Trioxide
  • Asenapine
  • Avanafil
  • Axitinib
  • Azithromycin
  • Boceprevir
  • Bosutinib
  • Buserelin
  • Cabozantinib
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Cimetidine
  • Ciprofloxacin
  • Clomipramine
  • Cyclosporine
  • Daclatasvir
  • Desipramine
  • Deslorelin
  • Dolasetron
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Droperidol
  • Efavirenz
  • Enzalutamide
  • Erlotinib
  • Esomeprazole
  • Etravirine
  • Everolimus
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Fluticasone
  • Fosamprenavir
  • Fosphenytoin
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Histrelin
  • Hydrocodone
  • Ibrutinib
  • Ibutilide
  • Idelalisib
  • Ifosfamide
  • Imipramine
  • Ivacaftor
  • Leuprolide
  • Levofloxacin
  • Levomilnacipran
  • Macitentan
  • Metronidazole
  • Midazolam
  • Moxifloxacin
  • Nafarelin
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Oxycodone
  • Paliperidone
  • Perflutren Lipid Microsphere
  • Phenytoin
  • Pomalidomide
  • Ponatinib
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Protriptyline
  • Regorafenib
  • Retapamulin
  • Rifabutin
  • Rifampin
  • Rivaroxaban
  • Romidepsin
  • Ruxolitinib
  • Sevoflurane
  • Simeprevir
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sotalol
  • Tamsulosin
  • Telaprevir
  • Telavancin
  • Tetrabenazine
  • Tizanidine
  • Tocophersolan
  • Trabectedin
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Ulipristal
  • Vilazodone
  • Vinblastine
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinorelbine
  • Warfarin

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.

  • Digoxin
  • Lorazepam
  • Metoclopramide
  • 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.

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:

  • 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)—These conditions may cause side effects to become worse.
  • Kidney disease, severe—May cause the medicine to not work as well.

Proper Use of This Medicine:

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. Take this medicine with 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).

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.

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 oral dosage form (delayed-release tablets):
    • For prevention of fungus infections:
      • Adults and teenagers—300 milligrams (mg) (three 100 mg delayed-release tablets) two times a day on the first day, then 300 mg once a day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (suspension):
    • For prevention of fungus infections:
      • Adults and teenagers—200 milligrams (mg) or 5 milliliters (mL) three times a day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    • For initial treatment of oral candidiasis:
      • Adults and teenagers—100 milligrams (mg) or 2.5 milliliters (mL) two 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 treatment of oral candidiasis after failed treatment with itraconazole or fluconazole:
      • Adults and teenagers—400 milligrams (mg) or 10 milliliters (mL) two times a day.
      • Children younger than 13 years of age—Use and dose must be determined by your doctor.

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 this medicine 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 While Using This Medicine:

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®), 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, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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 of This Medicine:

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
Abdominal or stomach pain
black, tarry stools
bloody nose
blurred vision
body aches or pain
confusion
cough
diarrhea
difficult or labored breathing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
fever or chills
fruit-like breath odor
heavy non-menstrual vaginal bleeding
increased thirst or urination
irregular heartbeats
loss of voice
muscle pain, 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
pounding in the ears
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
sweating
tender, swollen glands in the neck
tightness in the chest
trembling
trouble swallowing
unexplained weight loss
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
sudden shortness of breath or troubled breathing
swelling of the eyes or eyelids
swelling of the face, fingers, feet, or lower legs
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
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.


Last Updated: 11/4/2014

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