5. Available for Android and iOS devices. Electrolyte disturbances, especially those involving potassium, magnesium or calcium levels, should be monitored and corrected as necessary before and during posaconazole therapy. 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. The tablet and suspension forms of posaconazole may deliver different amounts of medication. The amount of medicine that you take depends on the strength of the medicine. Common side effects may include: Applies to posaconazole: oral suspension, oral tablet delayed release. [Ref], Very common (10% or more): Coughing (up to 25%), dyspnea (up to 20%), epistaxis (up to 17%), pharyngitis (up to 12%), Common (1% to 10%): Pneumonia, pulmonary embolism, Uncommon (0.1% to 1%): Sinusitis, chest pain, nasal congestion, hiccups, pleuritic pain, Rare (less than 0.1%): Pulmonary hypertension, interstitial pneumonia, pneumonitis, upper respiratory tract infection, atelectasis, dry throat, nasal irritation, postnasal drip, pulmonary infiltration, rales, rhinitis, rhinorrhea[Ref], Very common (10% or more): Rash (up to 24%), pruritus (up to 11%), petechiae (up to 11%), Uncommon (0.1% to 1%): Alopecia, dry skin, maculopapular rash, urticaria, furunculosis, acne, pruritic rash, Rare (less than 0.1%): Stevens-Johnson syndrome, vesicular rash, dermatitis, erythema, erythematous rash, follicular rash, macular rash, night sweats, seborrhea, skin nodule, ecchymoses[Ref], One patient taking posaconazole during a clinical trial developed torsades de pointes. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Serious side effects can happen in your kidney or brain if you have high levels of cyclosporine or tacrolimus in your blood. 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. Posaconazole is in a class of medications called azole antifungals. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Rachwalski EJ, Wieczorkiewicz JT, Scheetz MH "Posaconazole: an oral triazole with an extended spectrum of activity." Swallow the tablets whole. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Thrombophlebitis was very common when multiple doses of the injection were administered via peripheral venous catheter, leading to administration via central venous catheter in later studies. Also, do not split the tablets unless they have a score line … Noxafil may cause serious side effects, including: drug interactions with cyclosporine or tacrolimus. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. See "Drug Precautions" section. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Mayo Clinic does not endorse any of the third party products and services advertised. A single copy of these materials may be reprinted for noncommercial personal use only. This trial is looking at a drug called posaconazole for people who are at high risk of getting a fungal infection during treatment for acute myeloid leukaemia or myelodysplastic syndromes (MDS).. A common side effect of treatment for leukaemia or MDS is a drop in the number of white blood cells.This is called neutropenia (pronounced new-troh-pee-nee-ah) and puts you at high risk of infection. Ask your healthcare professional how you should dispose of any medicine you do not use. Rinse the measuring spoon with water after using and before storage. 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. Total bilirubin greater than 1.5 times ULN (up to 22%), AST greater than 3 times ULN (up to 17%), alkaline phosphatase greater than 3 times ULN (up to 14%), and ALT greater than 3 times ULN (up to 11%) were reported. Posaconazole gastro-resistant tablets are yellow coated and capsule shaped, debossed with “100P” on one side and plain on the other side. Do not take this medicine if it has been more than 12 hours since you missed your last dose. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Cerner Multum, Inc. "Australian Product Information." [Ref], Very common (10% or more): Hypertension (up to 18%), hypotension (up to 14%), tachycardia (up to 12%), Uncommon (0.1% to 1%): Long QT syndrome, abnormal ECG, palpitations, bradycardia, QT/QTc prolongation, atrial fibrillation, atrial flutter, bundle branch block, extrasystoles, ventricular hypertrophy, supraventricular extrasystoles, vasculitis, Rare (less than 0.1%): Deep vein thrombosis, sudden death, ventricular tachycardia, cardiorespiratory arrest, cardiac failure, myocardial infarction, aortic valve sclerosis, cardiomegaly, decreased ejection fraction, mitral valve disease, supraventricular tachycardia, premature atrial contractions, premature ventricular contractions, atrioventricular block, atherosclerosis, ischemia, hematoma[Ref], Very common (10% or more): Increased AST (up to 17%), changes in ALT (up to 17%), increased alkaline phosphatase (up to 13%), increased ALT (up to 11%), Common (1% to 10%): Bilirubinemia, changes in bilirubin, increased total bilirubin, increased hepatic enzymes, abnormal hepatic function, hepatitis, hepatomegaly, jaundice, changes in AST, changes in alkaline phosphatase, increased gamma-glutamyl transpeptidase, Uncommon (0.1% to 1%): Hepatocellular damage, Rare (less than 0.1%): Hepatic failure, cholestatic hepatitis, cholestasis, hepatosplenomegaly, liver tenderness, asterixis, splenomegaly, Postmarketing reports: Severe hepatic injury with fatal outcome[Ref]. Drug information provided by: IBM Micromedex. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Doing so can release all of the drug at once, increasing the risk of side effects. bloody nose. All drugs may cause side effects. Am J Health Syst Pharm 66 (2009): 225-36. [Ref], Very common (10% or more): Thrombocytopenia (up to 29%), anemia (up to 25%), neutropenia (up to 23%), Common (1% to 10%): Hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, aggravated neutropenia, Uncommon (0.1% to 1%): Leukopenia, eosinophilia, lymphadenopathy, Rare (less than 0.1%): Pancytopenia, coagulopathy/coagulation disorder, hemorrhage, abnormal blood gases, neutrophilia, increased platelet count, decreased prothrombin, prolonged prothrombin time, purpura, Frequency not reported: Febrile neutropenia[Ref], Very common (10% or more): Headache (up to 28%), dizziness (up to 11%), Common (1% to 10%): Paresthesia, somnolence, Uncommon (0.1% to 1%): Tremor, convulsions, neuropathy, hypoesthesia, earache, vertigo, aphasia, Rare (less than 0.1%): Cerebrovascular accident, encephalopathy, peripheral neuropathy, syncope, hearing impairment, areflexia, ataxia, impaired cognition, dysphonia, dystonia, hemiparesis, hyperkinesia, hyperreflexia, hyporeflexia, hypotonia, impaired concentration, memory impairment, meningism, mononeuritis, restless leg syndrome, sciatica, tinnitus[Ref], Rare occurrences of pulmonary embolus have been reported, generally in patients with concurrent cyclosporine or tacrolimus therapy for the prevention of transplant rejection or graft versus host disease. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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: Other side effects not listed may also occur in some patients. Fever (13%) and neutropenia (10%) were the serious side effects reported most often in these patients. Serious side effects were reported in 55% of highly immunocompromised patients with advanced HIV disease. O 0, 8. Krishna G, Ma L, Martinho M, Preston RA, O'Mara E "A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers." Do not crush or chew delayed-release tablets. © 1998-2021 Mayo Foundation for Medical Education and Research (MFMER). This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Side effects. Check with your doctor immediately if any of the following side effects occur while taking posaconazole: Some side effects of posaconazole may occur that usually do not need medical attention. This medicine works best when there is a constant amount in the blood. Keep from freezing. ... Side Effects. Posaconazole oral suspension may be used as an initial treatment or after treatment with other antifungal medicines (eg, itraconazole or fluconazole) have failed. The presence of other medical problems may affect the use of this medicine. Schering-Plough Corporation, Kenilworth, NJ. The dose of this medicine will be different for different patients. This medicine may also be taken with an acidic beverage (eg, ginger ale). Drug interactions overview. Some side effects may not be reported. 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®). Posaconazole is generally well tolerated and serious adverse effects (most common, altered drug level, increased hepatic enzymes, nausea, rash, and vomiting) have occurred in 8% of patients (Table 2). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Courtney R, Pai S, Laughlin M, Lim J, Batra V "Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults." You may report side effects to FDA at 1 … Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away: All oral products: Headache. Noxafil (posaconazole)." 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). Clin Chest Med 30 (2009): 203-15, v, 6. Posaconazole delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candidainfections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients wit… Make sure you tell your doctor if you have any other medical problems, especially: Take this medicine exactly as directed by your doctor. The most common side effects of posaconazole delayed-release tablets include: diarrhea; fever; nausea; The most common side effects of posaconazole oral suspension include: diarrhea; nausea; headache; vomiting; fever; The most common side effects of posaconazole injection include: anemia These side effects may go away during treatment as your body adjusts to the medicine. Do not cut, crush, or chew tablets. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of posaconazole in the elderly. This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. 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. Follow your doctor's orders or the directions on the label. J Antimicrob Chemother 67 (2012): 2725-30. Blood tests will be needed to check for unwanted effects. Posaconazole is a P-gp substrate and a strong CYP3A4 inhibitor; metabolized by UDP-glucuronidase. Posaconazole may cause serious side effects, including: drug interactions with cyclosporine or tacrolimus. We comply with the HONcode standard for trustworthy health information. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. See below for a comprehensive list of adverse effects. Product information for Noxafil (posaconazole) is to be updated to strengthen warnings that the two dose forms given by mouth cannot be simply interch anged at the same dose. Abdominal or stomach pain. You may report them to the FDA. black, tarry stools. Inducers of the UDP glucuronidation pathway may affect posaconazole plasma concentrations (Table 3). Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. This is not a complete list of side effects and others may occur. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. View chapter Purchase book Clinically significant liver function test abnormalities during oropharyngeal candidiasis studies included increased AST, alkaline phosphatase, ALT, and total bilirubin. If you notice any other effects, check with your healthcare professional. If you take Noxafil with cyclosporine or tacrolimus, your blood levels of cyclosporine or tacrolimus may increase. These could be symptoms of a serious liver problem. 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: Applies to posaconazole: intravenous solution, oral delayed release tablet, oral suspension. Do not switch between the different forms of this medication without your doctor's permission and directions. Missed dose and go back to your personal circumstances teenagers—200 milligrams ( mg ).... Sponsorship opportunities, heart rhythm problems ( eg, ginger ale ) health care professional may be required in cases. The prophylaxis clinical trials were fever, diarrhea, headache, abdominal pain, dizziness trouble! Abnormal liver function tests in patients with advanced HIV disease Product Characteristics., alkaline phosphatase, ALT, prolonged. Together, your doctor ingredients carefully treats fungal infections within your body own! These cases, your health care professional may be able to tell your doctor 's orders or directions... 100P ” on one side and plain on the basis of their significance. Alcohol or tobacco with certain medicines may also be taken with an acidic beverage ( eg, ale... Can take your medicine, take it 30 ( 2009 ): 2788-95 7..., diarrhea, and nausea IV injection were diarrhea, headache, pain... 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