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INTRODUCTION
POSAONE contains Posaconazole which belongs to the group of medicines called Antifungals. It is used in children (from 2 years of age and weighing more than 40 kg) and adult to treat various fungal infections such as chromoblastomycosis (infection of skin and subcutaneous tissue) and mycetoma (chronic infection of the skin) (when other antifungal medicines such as amphotericin B or itraconazole are ineffective or when these medicines have to be stopped in treating the infection).
Also, POSAONE prevents fungal infections in patients with weak immune system due to chemotherapy for acute myelogenous leukemia (cancer of the blood and bone marrow) or myelodysplastic syndromes (disorder where the formation of blood cells are disrupted) and patients receiving high-dose immunosuppressive therapy after hematopoietic stem cell transplant (bone marrow or stem cell transplantation used to treat certain cancers).
Before taking POSAONE inform your doctor if you have liver, kidney or heart problems, severe diarrhea and vomiting, problem with potassium, magnesium or calcium levels in the blood. Your doctor might want you to take certain blood tests prior to the treatment with POSAONE to understand the existing condition.
POSAONE is not recommended for use in pregnant women unless advised by the doctor and it is not recommended for use in breastfeeding women. POSAONE is not recommended for use in children (less than 2 years of age) and should be used with caution in elderly patients. The most common side effects of taking POSAONE are headache, fever, rash, itching, constipation and tiredness. Consult your doctor immediately if any of the side effect worsens.
USES OF POSAONE
Used in children (from 2 years of age and weighing more than 40 kg) and adult
- To treat various fungal infections (when anti-fungal medicines such as amphotericin B or itraconazole are ineffective or when it has to be stopped)
- Prevent fungal infection in patients with weak immune system (due to chemotherapy or high immunosuppressive therapy)
HOW POSAONE WORKS
POSAONE works by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, thus results in killing or stopping the growth of fungi causing infection.
DIRECTIONS FOR USE
Take POSAONE as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the right dose and duration of POSAONE for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF POSAONE
COMMON
- abnormal skin sensations (numbness, tingling, itching, creeping, pricking or burning)
- high blood pressure, headache
- loss of appetite, stomach pain or upset stomach, passing wind, dry mouth, changes in taste
- heartburn (burning sensation in the chest which rises up to throat)
- fever, weakness
- dizzy, tired or sleepy
- rash, itching
- constipation, rectal discomfort
UNCOMMON
- anemia (headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of hemoglobin)
- inflammation of the blood vessels, fits
- nerve damage (neuropathy)
- abnormal heart rhythm, low blood pressure, palpitation, slow or fast heartbeat
- inflammation of the pancreas (pancreatitis) (causes severe stomach pain)
- oxygen supply to the spleen is interrupted characterized by severe stomach pain
- severe kidney problems (passing more or less urine, that is a different colour than usual)
- cough, hiccups, nose bleeds
- severe sharp chest pain when breathing in
- swelling of lymph glands (lymphadenopathy)
- reduced feeling of sensitivity especially on the skin
- tremor
- high or low blood sugar levels
- blurred vision, sensitivity to light
- hair loss, mouth ulcers
- shivering, feeling generally unwell
- pain, back or neck pain, in arms or legs
- water retention (oedema)
- menstrual problems (abnormal vaginal bleeding)
- being completely or partially unable to talk, inability to sleep
- swelling of the mouth
- abnormal dreams or difficulty sleeping
- problems with co-ordination or balance
- mucosal inflammation, stuffy nose
- difficulty breathing, chest discomfort
- feeling bloated, mild to severe nausea, vomiting, cramps and diarrhea, belching
- confusion, feeling jittery
RARE
- pneumonia (feeling short of breath and producing discolored phlegm)
- high blood pressure in the blood vessels in the lungs (pulmonary hypertension)
- blood problems such as unusual blood clotting or prolonged bleeding
- severe allergic reactions (widespread blistering rash and skin peeling)
- mental problems such as hallucination
- fainting
- having problems thinking or talking, having jerking movements, in hands
- stroke (signs include pain, weakness, numbness, or tingling in the limbs)
- having a blind or dark spot in field of vision
- heart failure or heart attack
- blood clots in the legs (intense pain or swelling of the legs)
- blood clots in the lungs (pain while breathing, shortness of breath)
- bleeding into the stomach or gut (vomiting blood or passing blood in stool)
- intestinal obstruction (feeling bloated, vomiting, severe constipation, loss of appetite, and cramps)
- large purple discoloration on the skin
- swelling of the face or tongue
- depression, double vision
- breast pain
- adrenal glands not working properly (cause weakness, tiredness, loss of appetite, skin discoloration)
- hearing problems
Stop taking POSAONE and contact your doctor immediately if you experience any of the following side effects:
- severe nausea or vomiting and diarrhea
- signs of liver problems (jaundice (yellow skin or white of the eyes), unusually dark urine or pale feces, unusual sickness, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests)
- allergic reactions
HOW TO MANAGE SIDE EFFECTS
Headache:
Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.
Dry mouth:
Sip water regularly and other sugar free liquids. Do not use mouthwashes that contain alcohol because they can make your mouth dry, use mouthwash that is used only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco products. Consult your doctor if the symptom does not improve.
Stomach pain:
Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.
Loss of appetite:
Eat when you are hungry. Eat a nutritious snack rich in calories and protein, such as dried fruit and nuts. If the symptom does not show improvement, consult your doctor.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly. If the symptom does not improve, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
POSAONE is not recommended for use in pregnant women unless advised by the doctor. If you are a woman of childbearing age, use effective contraception to avoid pregnancy during treatment with this medicine. Consult your doctor before taking POSAONE.
BREASTFEEDING
POSAONE is not recommended for use in breastfeeding women as small amount of this medicine is excreted in the breastmilk. Consult your doctor before taking POSAONE.
DRIVING AND USING MACHINES
Do not drive or use machines if you feel sleepy, dizzy or blurring of vision after taking POSAONE.
LIVER
POSAONE should be used with caution in patients with liver problems. Consult your doctor before taking POSAONE.
ALLERGY
Do not take POSAONE if you are allergic to Posaconazole or any other ingredients of this medicine. POSAONE should be used with caution if you are allergic to other antifungal medicines such as ketoconazole, fluconazole or itraconazole.
HEART DISEASE
POSAONE should be used with caution in patients with abnormal heart rhythm, weakness of the heart muscle or heart failure and very slow heartbeat. Consult your doctor before taking POSAONE.
OTHERS
Before taking POSAONE, inform your doctor if you:
- have any problem with potassium, magnesium or calcium levels in the blood
- develop severe diarrhea or vomiting
Use in pediatrics:
POSAONE is not recommended for use in children (less than 2 years of age). Consult child’s doctor for advice.
Use in geriatrics:
POSAONE should be used with caution in elderly patients. Consult your doctor before taking POSAONE.
INTERACTIONS
Before taking POSAONE, inform your doctor if you are taking any of the following medicines:
- terfenadine, astemizole (used to treat allergies)
- cisapride (used to treat stomach problems)
- pimozide (used to treat symptoms of tourette’s and mental illness)
- halofantrine (to treat malaria)
- quinidine (to treat abnormal heart rhythms), diltiazem, verapamil, nifedipine, nisoldipine or other calcium channel blockers (used to treat high blood pressure), digoxin (to treat heart failure)
- any medicines that contain ergot alkaloids (Ex. ergotamine or dihydroergotamine) (used to treat migraines)
- statins (Ex. simvastatin, atorvastatin or lovastatin) (used to treat high cholesterol)
- rifabutin and rifampicin (used to treat certain infections)
- medicines used to prevent or treat fits (Ex. phenytoin, carbamazepine, phenobarbital or primidone)
- efavirenz and fosamprenavir, protease inhibitors such as lopinavir and atazanavir, which are given with ritonavir)
- vincristine, vinblastine and other vinca alkaloids, venetoclax (used to treat cancer), tretinoin (used to treat certain blood cancers)
- ciclosporin, tacrolimus and sirolimus (used during or after transplant surgery to prevent organ rejection)
- midazolam, triazolam, alprazolam or other benzodiazepines (used as sedatives or muscle relaxants)
- glipizide or other sulfonylureas (used to treat high blood sugar)
Overdosage:
If you or anyone else accidentally take too much of POSAONE, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Posaconazole |
| Pharmacological Category | : | Azole antifungals |
| Therapeutic Indication | : | Prevent and treat various fungal infections |
| Dosage Forms | : | Injection, Suspension, Syrup, Tablet |
MORE INFORMATION
- Keep POSAONE out of reach of children
- Store POSAONE at room temperature
FAQs ABOUT POSAONE
Can POSAONE be used in pregnant women?
POSAONE is not recommended for use in pregnant women unless advised by the doctor. If you are a woman of childbearing age, use effective contraception to avoid pregnancy during treatment with this medicine. Consult your doctor before taking POSAONE.
Is POSAONE an antibiotic?
No, POSAONE is an antifungal medicine which acts by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, and kills or stops the growth of fungi causing infection.
Can POSAONE be used in children?
POSAONE is not recommended for use in children (less than 2 years of age) and it should be used with caution in children (from 2 years of age and weighing more than 40 kg) to prevent or treat various fungal infections. Consult child’s doctor for advice before administering POSAONE to your child.
What if I miss to take a dose of POSAONE?
If you forget to take a dose of POSAONE take it as soon as you remember it. However, if it is time for your next dose of POSAONE, skip the missed dose and go back to the regular schedule. Do not take a double dose of POSAONE to make up for the forgotten one.
Does POSAONE affects my ability to drive or use machines?
Do not drive or use machines if you feel sleepy, dizzy or blurring of vision after taking POSAONE. You can resume doing your activities once you feel normal again. Consult your doctor for advice before taking POSAONE.
REFERENCES
1. KD Tripathi. Antifungal Drugs. Essentials of medical pharmacology. Eighth Edition. 2019. Page – 847
2. Lu Chen, Elke H. J. Krekels, Paul. E. Verweij, Jochem B. Buil, Catherijne A. J. Knibbe, and Roger J. M. Bruggemann. Pharmacokinetics and Pharmacodynamics of Posaconazole. April 2020 [Accessed on 4th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183491/
3. Nickie D. Greer. Posaconazole (Noxafil): a new triazole antifungal agent. April 2007. [Accessed on 4th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1849883/
4. Delorbis Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 4th August 2022]. https://www.medicines.org.uk/emc/files/pil.12017.pdf
USEFUL DIAGNOSTIC TESTS
- Complete Blood count
- Fungal Culture Test
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