Wednesday, October 5, 2016

posaconazole


poe-sa-KON-a-zole


Commonly used brand name(s)

In the U.S.


  • Noxafil

Available Dosage Forms:


  • Suspension

Therapeutic Class: Antifungal


Chemical Class: Triazole


Uses For posaconazole


Posaconazole is used to prevent certain fungus infections in patients 13 years of age and older, who have a weakened immune system (e.g., hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers). Posaconazole is also used to treat a fungus infection of the mouth or throat called oral thrush (candidiasis). posaconazole may be used as an initial treatment or after treatment with other antifungal medicines (e.g., itraconazole or fluconazole) have failed.


posaconazole is available only with your doctor's prescription.


Before Using posaconazole


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 posaconazole, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to posaconazole 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 in children and teenagers 13 to 17 years of age. However, safety and efficacy have not been established in children younger than 13 years of age.


Geriatric


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.


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 posaconazole, 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 posaconazole 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

  • Amiodarone

  • Astemizole

  • Cisapride

  • Clarithromycin

  • Clozapine

  • Crizotinib

  • Dasatinib

  • Dihydroergotamine

  • Disopyramide

  • Dofetilide

  • Dronedarone

  • Ergoloid Mesylates

  • Ergonovine

  • Ergotamine

  • Erythromycin

  • Halofantrine

  • Iloperidone

  • Lapatinib

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Mesoridazine

  • Methadone

  • Methylergonovine

  • Methysergide

  • Nilotinib

  • Ondansetron

  • Pazopanib

  • Pimozide

  • Propafenone

  • Quetiapine

  • Quinidine

  • Quinine

  • Ranolazine

  • Salmeterol

  • Saquinavir

  • Simvastatin

  • Sirolimus

  • Solifenacin

  • Sorafenib

  • Sparfloxacin

  • Sunitinib

  • Telithromycin

  • Terfenadine

  • Thioridazine

  • Toremifene

  • Trazodone

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

Using posaconazole 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.


  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Atorvastatin

  • Azithromycin

  • Boceprevir

  • Chloroquine

  • Chlorpromazine

  • Cimetidine

  • Ciprofloxacin

  • Citalopram

  • Clomipramine

  • Cyclosporine

  • Desipramine

  • Dolasetron

  • Droperidol

  • Efavirenz

  • Etravirine

  • Everolimus

  • Flecainide

  • Fluconazole

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Haloperidol

  • Ibutilide

  • Imipramine

  • Levofloxacin

  • Lovastatin

  • Midazolam

  • Moxifloxacin

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Paliperidone

  • Perflutren Lipid Microsphere

  • Phenytoin

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Protriptyline

  • Rifabutin

  • Rifampin

  • Rivaroxaban

  • Ruxolitinib

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Sotalol

  • Tacrolimus

  • Telavancin

  • Tetrabenazine

  • Trifluoperazine

  • Trimipramine

  • Vandetanib

  • Vinblastine

  • Vincristine

  • Vincristine Liposome

  • Vinorelbine

Using posaconazole 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.


  • Atazanavir

  • Digoxin

  • Esomeprazole

  • Metoclopramide

  • Ritonavir

  • 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.


Other Medical Problems


The presence of other medical problems may affect the use of posaconazole. Make sure you tell your doctor if you have any other medical problems, especially:


  • Heart disease, history of or

  • Heart rhythm problems (e.g., 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 posaconazole


posaconazole comes with a patient information leaflet. Read and follow these instructions carefully. Talk to your doctor if you have any questions.


Shake the oral suspension 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 posaconazole during or right after (within 20 minutes) a full meal or liquid nutritional supplement. posaconazole may also be taken with an acidic beverage (e.g., ginger ale).


posaconazole 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 posaconazole 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 posaconazole. 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 (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 posaconazole, 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.


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 posaconazole


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 ergotamine medicines (e.g., bromocriptine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, methysergide, Ergomar®, Ergotrate®, Methergine®, Migranal®, Parlodel®, or Sansert®), pimozide (Orap®), quinidine (Quinaglute®), simvastatin (Zocor®), or sirolimus (Rapamune®). Using any of them together with posaconazole may increase the chance of unwanted effects.


posaconazole 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.


Stop using posaconazole and 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 eyes or skin. These could be symptoms of a serious liver problem.


Check with your doctor right away if you have severe diarrhea or vomiting while using posaconazole.


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.


posaconazole 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
  • abdominal or stomach pain

  • black, tarry stools

  • bleeding gums

  • bloody nose

  • blurred vision

  • body aches or pain

  • burning or stinging of the skin

  • chills

  • confusion

  • cough

  • cracked lips

  • decreased urine

  • diarrhea

  • difficult or labored breathing

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • drowsiness

  • dry mouth

  • dry or sore throat

  • ear congestion

  • feeling unusually cold

  • fever

  • flushed, dry skin

  • fruit-like breath odor

  • headache

  • heavy non-menstrual vaginal bleeding

  • increased hunger

  • increased thirst

  • increased urination

  • irregular heartbeats

  • loss of appetite

  • loss of voice

  • mood changes

  • muscle pain

  • muscle spasms or twitching

  • nasal congestion

  • 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

  • pounding in the ears

  • runny nose

  • shivering

  • slow or fast heartbeat

  • small red or purple spots on the skin

  • sneezing

  • sores, ulcers, or white spots on the lips, tongue, or inside mouth

  • sweating

  • tender, swollen glands in the neck

  • tightness in the chest

  • trembling

  • trouble with 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

  • difficulty speaking

  • itching

  • mental depression

  • seizures

  • skin rash

  • 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

  • bone pain

  • difficulty having a bowel movement (stool)

  • difficulty with moving

  • heartburn

  • indigestion

  • muscle stiffness

  • pain in the joints

  • sleeplessness

  • stomach discomfort or upset

  • trouble sleeping

  • unable to sleep

  • weight loss

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.

See also: posaconazole side effects (in more detail)



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More posaconazole resources


  • Posaconazole Side Effects (in more detail)
  • Posaconazole Use in Pregnancy & Breastfeeding
  • Posaconazole Drug Interactions
  • Posaconazole Support Group
  • 1 Review for Posaconazole - Add your own review/rating


  • Posaconazole Professional Patient Advice (Wolters Kluwer)

  • Posaconazole Monograph (AHFS DI)

  • Posaconazole Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Noxafil Prescribing Information (FDA)

  • Noxafil Consumer Overview



Compare posaconazole with other medications


  • Aspergillosis, Invasive
  • Candida Infections, Systemic
  • Oral Thrush

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