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INTRODUCTION
POCONAL ORAL SUSPENSION contains Posaconazole which belongs to the group of medicines called Antifungals. It is used in adults and pediatric patients of 13 years of age and older as a prophylaxis to prevent fungal infections such as invasive aspergillus and candida infections in severely immunocompromised patients such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low count of a type of white blood cell (neutrophils) due to chemotherapy.
It is also used to treat oropharyngeal candidiasis (fungal infections of the mouth and throat) including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients of 13 years of age and older.
Before taking POCONAL ORAL SUSPENSION inform your doctor if you have liver, kidney or heart problems, 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 POCONAL ORAL SUSPENSION to understand the existing condition.
POCONAL ORAL SUSPENSION is not recommended for use in pregnant women unless advised by the doctor and it is not recommended for use in breastfeeding women. Safety and effectiveness of POCONAL ORAL SUSPENSION have not been established in pediatric patients younger than 2 years of age and it should be used with caution in elderly patients. Consult your doctor before taking POCONAL ORAL SUSPENSION.
The most common side effects of taking POCONAL ORAL SUSPENSION are headache, fever, rash, itching and constipation. Inform your doctor immediately if any of the side effect worsens.
USES OF POCONAL ORAL SUSPENSION
Treats or prevent fungal infections, such as:
- Used as prophylaxis to prevent invasive aspergillus and candida infections (in severely immunocompromised patients)
- Treats oropharyngeal candidiasis (also including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole)
HOW POCONAL ORAL SUSPENSION WORKS
POCONAL ORAL SUSPENSION 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 POCONAL ORAL SUSPENSION as advised by your physician. Shake well before use. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF POCONAL ORAL SUSPENSION
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 (pleuritic pain)
- 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)
- haemolytic uraemic syndrome (small blood vessels in the kidneys become damaged and inflamed)
- 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)
- pituitary gland not working properly (may cause low blood levels of some hormones that affect the male or female sex organs)
- pseudoaldosteronism (high blood pressure with a low potassium level)
- hearing problems
Stop taking POCONAL ORAL SUSPENSION and contact your doctor immediately if you experience any of the following side effects:
- severe nausea or vomiting (feeling or being sick), diarrhea
- signs of liver problems (jaundice, unusually dark urine or pale feces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests)
- allergic reaction
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
POCONAL ORAL SUSPENSION 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 POCONAL ORAL SUSPENSION. Consult your doctor before taking POCONAL ORAL SUSPENSION.
BREASTFEEDING
POCONAL ORAL SUSPENSION is not recommended for use in breastfeeding women as small amount of this medicine is excreted in the breastmilk. Consult your doctor before taking POCONAL ORAL SUSPENSION.
DRIVING AND USING MACHINES
Do not drive or use machines if you feel sleepy, dizzy or blurring of vision after taking POCONAL ORAL SUSPENSION.
LIVER
POCONAL ORAL SUSPENSION should be used with caution in patients with liver problems. Consult your doctor before taking POCONAL ORAL SUSPENSION.
ALLERGY
Do not take POCONAL ORAL SUSPENSION if you are allergic to Posaconazole or any other ingredients of this medicine. POCONAL ORAL SUSPENSION should be used with caution if you are allergic to other antifungal medicines such as ketoconazole, fluconazole or itraconazole.
HEART DISEASE
POCONAL ORAL SUSPENSION 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 POCONAL ORAL SUSPENSION.
OTHERS
Before taking POCONAL ORAL SUSPENSION, 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:
Safety and effectiveness of POCONAL ORAL SUSPENSION have not been established in pediatric patients younger than 2 years of age. It should be used with caution in pediatric patients. Consult your child’s doctor for advice.
Use in geriatrics:
POCONAL ORAL SUSPENSION should be used with caution in elderly patients. Consult your doctor before taking POCONAL ORAL SUSPENSION.
INTERACTIONS
A. Drug - Drug interactions:
Before taking POCONAL ORAL SUSPENSION, inform your doctor if you are taking any of the following medicines:
- terfenadine, astemizole (used to treat allergies)
- cisapride, cimetidine, ranitidine, proton pump inhibitors such as omeprazole (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 (used to treat HIV infection)
- 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 (Ex. clonazepam) (used as sedatives or muscle relaxants)
- glipizide or other sulfonylureas (Ex. glibenclamide) (used to treat high blood sugar)
Overdosage:
If you or anyone else accidentally takes too much of POCONAL ORAL SUSPENSION, 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 POCONAL ORAL SUSPENSION out of reach of children
- Store POCONAL ORAL SUSPENSION at room temperature
FAQs ABOUT POCONAL ORAL SUSPENSION
Can POCONAL ORAL SUSPENSION be used in pregnant women?
POCONAL ORAL SUSPENSION 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 POCONAL ORAL SUSPENSION. Consult your doctor before taking POCONAL ORAL SUSPENSION.
Is POCONAL ORAL SUSPENSION an antibiotic?
No, POCONAL ORAL SUSPENSION 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.
What if I miss to take a dose of POCONAL ORAL SUSPENSION?
If you forget to take a dose of POCONAL ORAL SUSPENSION take it as soon as you remember it. However, if it is time for your next dose of POCONAL ORAL SUSPENSION, skip the missed dose and go back to the regular schedule. Do not take a double dose of POCONAL ORAL SUSPENSION to make up for the forgotten one.
Is POCONAL ORAL SUSPENSION safe to use in patients with heart problems?
POCONAL ORAL SUSPENSION 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 POCONAL ORAL SUSPENSION.
Does POCONAL ORAL SUSPENSION 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 POCONAL ORAL SUSPENSION. You can resume doing your activities once you feel normal again. Consult your doctor for advice before taking POCONAL ORAL SUSPENSION.
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 6th 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 6th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1849883/
4. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 6th August 2022] https://www.medicines.org.uk/emc/files/pil.11298.pdf
5. Merck & Co. Inc. U.S. Food & Drug Administration. [Revised in September 2022] [Accessed on 6th August 2022] https://www.merck.com/product/usa/pi_circulars/n/noxafil/noxafil_pi.pdf
USEFUL DIAGNOSTIC TESTS
- Complete blood count
- Fungal culture test
AUTHOR DETAILS
Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 28 Sep 2022 | 07:17 PM(IST)