Posaconazole (Oral)

Generic name: Posaconazole
Drug class: Azole antifungals

Usage of Posaconazole (Oral)

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.

Posaconazole (Oral) 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.

Before taking Posaconazole (Oral)

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.

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.

Interactions with 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

Alprazolam

Amiodarone

Aripiprazole

Astemizole

Atorvastatin

Bedaquiline

Bepridil

Buprenorphine

Cisapride

Citalopram

Clarithromycin

Clozapine

Colchicine

Conivaptan

Crizotinib

Dabrafenib

Dasatinib

Dihydroergotamine

Disopyramide

Dofetilide

Domperidone

Donepezil

Dronedarone

Eletriptan

Eliglustat

Encorafenib

Entrectinib

Eplerenone

Ergonovine

Ergotamine

Erythromycin

Etrasimod

Fexinidazole

Finerenone

Flibanserin

Fluvastatin

Fostemsavir

Gepirone

Glasdegib

Halofantrine

Haloperidol

Iloperidone

Isavuconazonium Sulfate

Itraconazole

Ivabradine

Ivosidenib

Lapatinib

Levoketoconazole

Lomitapide

Lopinavir

Lovastatin

Lumefantrine

Lurasidone

Macimorelin

Maraviroc

Mavacamten

Mefloquine

Mesoridazine

Methadone

Methylergonovine

Methysergide

Mifepristone

Mirtazapine

Mobocertinib

Naloxegol

Nelfinavir

Nilotinib

Nimodipine

Ondansetron

Osilodrostat

Pacritinib

Pazopanib

Pimozide

Piperaquine

Propafenone

Quetiapine

Quinidine

Quinine

Ranolazine

Relugolix

Ribociclib

Saquinavir

Selpercatinib

Simvastatin

Sirolimus

Solifenacin

Sorafenib

Sparfloxacin

Sunitinib

Tacrolimus

Tamoxifen

Telithromycin

Terfenadine

Thioridazine

Tolvaptan

Toremifene

Trazodone

Ubrogepant

Vardenafil

Vemurafenib

Venetoclax

Vilanterol

Voclosporin

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.

Acalabrutinib

Adagrasib

Ado-Trastuzumab Emtansine

Alfentanil

Amitriptyline

Amprenavir

Anagrelide

Apalutamide

Apixaban

Apomorphine

Aprepitant

Arsenic Trioxide

Asenapine

Atogepant

Avacopan

Avanafil

Avapritinib

Axitinib

Azithromycin

Benzhydrocodone

Bosutinib

Brentuximab Vedotin

Brexpiprazole

Brigatinib

Bromocriptine

Budesonide

Buserelin

Ceritinib

Chloroquine

Chlorpromazine

Cilostazol

Cimetidine

Ciprofloxacin

Clofazimine

Clomipramine

Clothiapine

Cobimetinib

Codeine

Copanlisib

Cyclobenzaprine

Cyclosporine

Daclatasvir

Daridorexant

Deflazacort

Degarelix

Delamanid

Desipramine

Deslorelin

Deutetrabenazine

Dexamethasone

Dexmedetomidine

Dihydrocodeine

Docetaxel

Dolasetron

Doxepin

Doxorubicin

Doxorubicin Hydrochloride Liposome

Droperidol

Duvelisib

Ebastine

Efavirenz

Elacestrant

Elagolix

Elexacaftor

Enzalutamide

Eribulin

Erlotinib

Escitalopram

Esomeprazole

Eszopiclone

Etravirine

Everolimus

Famotidine

Fedratinib

Felbamate

Fentanyl

Fesoterodine

Fingolimod

Flecainide

Fluconazole

Fluoxetine

Fluticasone

Formoterol

Fosamprenavir

Fosaprepitant

Foscarnet

Fosphenytoin

Galantamine

Gatifloxacin

Gemifloxacin

Gilteritinib

Gonadorelin

Goserelin

Granisetron

Histrelin

Hydrocodone

Hydroquinidine

Hydroxychloroquine

Hydroxyzine

Ibrexafungerp

Ibrutinib

Ibutilide

Idelalisib

Ifosfamide

Imipramine

Infigratinib

Inotuzumab Ozogamicin

Irinotecan

Irinotecan Liposome

Istradefylline

Ivacaftor

Ixabepilone

Larotrectinib

Lefamulin

Lemborexant

Leniolisib

Lenvatinib

Leuprolide

Levofloxacin

Levomilnacipran

Lofexidine

Lorlatinib

Lumacaftor

Lumateperone

Lurbinectedin

Macitentan

Manidipine

Meperidine

Methotrexate

Methotrimeprazine

Metronidazole

Midazolam

Midostaurin

Mirvetuximab Soravtansine-gynx

Mitapivat

Mizolastine

Moricizine

Moxifloxacin

Nafarelin

Neratinib

Nifedipine

Norfloxacin

Octreotide

Ofloxacin

Olanzapine

Olaparib

Omaveloxolone

Osimertinib

Oxaliplatin

Oxycodone

Ozanimod

Palbociclib

Paliperidone

Palovarotene

Panobinostat

Papaverine

Paroxetine

Pasireotide

Pemigatinib

Pentamidine

Pentazocine

Perphenazine

Pexidartinib

Phenobarbital

Phenytoin

Pimavanserin

Pipamperone

Pirtobrutinib

Pitolisant

Ponatinib

Ponesimod

Pralsetinib

Primidone

Probucol

Procainamide

Prochlorperazine

Promethazine

Protriptyline

Quizartinib

Reboxetine

Regorafenib

Retapamulin

Rifabutin

Rifampin

Rimegepant

Risperidone

Ritonavir

Rivaroxaban

Romidepsin

Ruxolitinib

Salmeterol

Selumetinib

Sertindole

Sertraline

Sevoflurane

Sildenafil

Simeprevir

Siponimod

Sirolimus Protein-Bound

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Sonidegib

Sotalol

Sparsentan

Sufentanil

Sulpiride

Sultopride

Suvorexant

Tadalafil

Tamsulosin

Tazemetostat

Telaprevir

Telavancin

Tetrabenazine

Tezacaftor

Thiotepa

Tolterodine

Trabectedin

Tramadol

Triclabendazole

Trimipramine

Triptorelin

Upadacitinib

Valbenazine

Vamorolone

Vandetanib

Venlafaxine

Vilazodone

Vinblastine

Vincristine

Vincristine Sulfate Liposome

Vinflunine

Vinorelbine

Vorapaxar

Vorinostat

Warfarin

Zanubrutinib

Zolpidem

Zotepine

Zuclopenthixol

Zuranolone

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

Interactions with Food/Tobacco/Alcohol

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

Relate drugs

How to use Posaconazole (Oral)

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.

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 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 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.

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.

Warnings

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Posaconazole (Oral)

Usage of Posaconazole (Oral)

Posaconazole (Oral) side effects

Before taking Posaconazole (Oral)

Allergies

Pediatric

Geriatric

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Relate drugs

How to use Posaconazole (Oral)

Dosing

Missed Dose

Storage

Warnings

Disclaimer

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