INTRODUCTION
IT MAC ORAL SOLUTION contains Itraconazole which belongs to group of medicines called Antifungals. It is used to treat fungal infections in patients (with poor immune system) which includes yeast infections of mouth, throat or gullet. It is also used to prevent fungal infections in patients with poor immunity system that occurs due to major blood disorder or bone marrow transplantation.
Yeast infection is a type of fungal infection that occurs when excess yeast (fungi) grows on the skin or other areas, it is generally characterized by symptoms such as white patches on the tongue, redness, soreness or difficulty while swallowing.
IT MAC ORAL SOLUTION is not recommended for use in patients who are allergic to Itraconazole. Before taking IT MAC ORAL SOLUTION, inform your doctor if you have heart problems (including congestive heart failure), kidney disorders or liver problems (such as jaundice).
IT MAC ORAL SOLUTION is not recommended for use in pregnant women unless it is clearly advised by the doctor and it is not recommended for use in breast-feeding women. It is also not recommended for use in children and adolescents (aged below 18 years) and elderly patients unless it is clearly advised by the doctor.
The most common side effects of taking IT MAC ORAL SOLUTION are headache, stomach-ache, nausea, vomiting, diarrhea, unpleasant taste and rash. Consult your doctor if any of the side effects worsen.
USES OF IT MAC ORAL SOLUTION
Treats yeast infections of mouth, throat or gullet (in individuals with poor immune system)
Prevents fungal infections in patients with poor immunity system that occurs due to major blood disorder or bone marrow transplantation
HOW IT MAC ORAL SOLUTION WORKS
IT MAC ORAL SOLUTION works by inhibiting ergosterol synthesis (an organic compound responsible for maintaining cell membrane integrity of fungi cell) that leads to fungal cell membrane abnormalities (marked with increased permeability and disruption of fungi cell) thus causing destruction to the fungi cell and preventing the occurrence of fungal infections in affected individuals.
DIRECTIONS FOR USE
Take IT MAC ORAL SOLUTION as advised by your physician. Shake well before use. Use a graduated measuring cup to properly measure the dose. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF IT MAC ORAL SOLUTION
COMMON
Headache
Stomach-ache
Nausea, vomiting, diarrhea
Unpleasant taste
Rash
Fever/high temperature
Shortness of breath
UNCOMMON
Certain blood disorders which may increase the risk of bleeding, bruising or infections
Signs of low potassium level in blood such as muscle weakness
Dizziness
Indigestion
Constipation
Inflammation of the liver, yellowing of the skin (jaundice)
Itching
General swelling
RARE
Stop taking IT MAC ORAL SOLUTION and contact your doctor immediately if you experience any of the following side effects:
Have signs of severe liver problems (such as severe lack of appetite, nausea, vomiting, unusual tiredness, abdominal/stomach pain, unusually dark urine, and/or pale stools)
Have unusual feelings of tingling, numbness or weakness in the hands or feet
Experience any hearing loss symptoms which can become temporary/permanent hearing loss
Have signs of heart failure (such as shortness of breath, unexpected weight gain, swelling of the legs/stomach, feel unusually tired, shortness of breath at night)
Have signs of serious allergic reactions such as sudden wheeziness, difficulty in breathing, swelling of the face, rash, itching (especially affecting the whole body)
Have signs of severe skin disorder such as widespread rashes with peeling skin and blisters in the mouth, eyes and genitals, and/or rashes with small pustules/blisters
Experience blurred/double vision, ringing in ears, lose the ability to control urine or increased urge to pass urine
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.
Nausea and vomiting:
Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Diarrhoea:
Drink lot of fluids, such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables, and cereals and drink plenty of water. Exercise more regularly (such as daily walk). Consult your doctor if the symptom does not improve.
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.
WARNING & PRECAUTIONS
PREGNANCY
IT MAC ORAL SOLUTION is generally not recommended for use during pregnancy and in women planning for pregnancy unless it is considered clearly necessary. Women with childbearing potential should use contraceptives to avoid pregnancy during treatment with this medicine. Consult your doctor before taking IT MAC ORAL SOLUTION.
BREASTFEEDING
IT MAC ORAL SOLUTION is not recommended for use in breastfeeding women since it may pass through the breast milk. Consult your doctor before taking IT MAC ORAL SOLUTION.
DRIVING AND USING MACHINES
Do not drive or operate any machines after taking IT MAC ORAL SOLUTION since it may cause dizziness, blurred/double vision, and/or hearing loss. Consult your doctor before taking IT MAC ORAL SOLUTION.
ALCOHOL
Avoid consumption of alcohol while taking IT MAC ORAL SOLUTION since it may reduce the absorption of this medicine. Consult your doctor before taking IT MAC ORAL SOLUTION.
KIDNEY
IT MAC ORAL SOLUTION should be used with caution in patients with kidney disorders. Consult your doctor before taking IT MAC ORAL SOLUTION.
LIVER
IT MAC ORAL SOLUTION should be used with caution in patients with liver problems such as jaundice (yellowing of the skin). Consult your doctor before taking IT MAC ORAL SOLUTION.
ALLERGY
Do not take IT MAC ORAL SOLUTION if you are allergic to Itraconazole or any other ingredients of this medicine.
HEART DISEASE
IT MAC ORAL SOLUTION should be used with caution in patients with heart problems including congestive heart failure. Consult your doctor before taking IT MAC ORAL SOLUTION.
OTHERS
Before taking IT MAC ORAL SOLUTION, inform your doctor if you:
Had an allergic reaction to any other antifungal medicines
Use in Pediatrics:
IT MAC ORAL SOLUTION is generally not recommended for use in children and adolescents (aged below 18 years) unless it is considered clearly necessary. Consult your child’s doctor for advice.
Use in Geriatrics:
IT MAC ORAL SOLUTION is generally not recommended for use in elderly patients unless it is considered clearly necessary. Consult your doctor before taking IT MAC ORAL SOLUTION.
INTERACTIONS
A. Drug-Drug interactions:
Before taking IT MAC ORAL SOLUTION, inform your doctor if you are taking any of the following medicines:
Terfenadine, astemizole, mizolastine, ebastine (antihistaminic medicines used for allergies)
Bepridil (used to treat angina)
Nisoldipine (used for high blood pressure)
Cisapride (used for stomach upsets)
Midazolam, alprazolam, brotizolam, triazolam and buspirone (used to help you sleep or for anxiety)
Lovastatin, simvastatin, atorvastatin (used to lower cholesterol)
Pimozide, sertindole (antipsychotic medicines used to treat conditions affecting thoughts, feelings, behavior)
Levacetylmethadol (used to treat opioid drug abuse)
Dihydroergotamine, ergotamine, eletriptan (used for migraine headaches)
Ergometrine, methyl-ergometrine (medicines used after giving birth)
Quinidine, dofetilide (medicine used for irregular heartbeat rhythms)
Clarithromycin, erythromycin (antibiotics used to treat infections)
Medicines that act on the heart and blood vessels Ex. digoxin, calcium channel-blockers (Ex. dihydropyridines, verapamil), cilostazol, disopyramide
Drugs that slow down blood clotting/thin the blood (Ex. warfarin)
Methylprednisolone, budesonide, fluticasone, dexamethasone (medicines used to treat inflammation, asthma and allergies)
Ciclosporin, tacrolimus, rapamycin (medicines that are given after an organ transplantation to prevent rejection)
Medicines used in HIV-infected patients (Ex. ritonavir, indinavir, saquinavir)
Medicines for cancer (Ex. busulphan, docetaxel, vinca alkaloids (Ex. vinblastine, vinorelbine), trimetrexate
Alfentanil, fentanyl (medicines used for pain)
Reboxetine (used for depression)
Loperamide (used for diarrhoea)
Halofantrine (medicine used to treat malaria)
Repaglinide (medicine used to treat diabetes)
B. Drug-Food interaction:
Avoid taking IT MAC ORAL SOLUTION with food since it reduces the absorption of this medicine. Consult your doctor before taking IT MAC ORAL SOLUTION.
Overdosage:
If you or anyone else accidentally takes too much of IT MAC ORAL SOLUTION, Consult your doctor immediately or visit the nearby hospital to manage the overdosage symptoms.
SYNOPSIS
Drug :
Itraconazole
Pharmacological Category :
Triazole antifungals
Therapeutic Indication :
Fungal infection which includes yeast infections of mouth, Throat or gullet
Dosage Forms :
Oral Solution, Suspension, Capsule, Tablet, Cream, Dusting Powder, Eye Drops, Eye Ointment, Gel, Ointment, Powder, Soap
MORE INFORMATION
Keep IT MAC ORAL SOLUTION out of reach of children
Do not store IT MAC ORAL SOLUTION above 25°C
FAQs ABOUT IT MAC ORAL SOLUTION
What is IT MAC ORAL SOLUTION used for?
[GBNKEWYORD] is used to treat fungal infections in patients (with poor immune system) which includes yeast infections of mouth, throat or gullet. It is also used to prevent fungal infections in patients with poor immunity system that occurs due to major blood disorder or bone marrow transplantation.
What are the common side effects of IT MAC ORAL SOLUTION?
The most common side effects of taking IT MAC ORAL SOLUTION are headache, stomach-ache, nausea, vomiting, diarrhea, unpleasant taste, rash, and/or shortness of breath. Consult your doctor if any of these side effects worsen.
Can IT MAC ORAL SOLUTION be used in pregnant and breastfeeding women?
No, IT MAC ORAL SOLUTION is generally not recommended for use during pregnancy and in women planning for pregnancy unless it is clearly advised by the doctor. It is also not recommended for use in breastfeeding women since it may pass through the breast milk. Consult your doctor before taking IT MAC ORAL SOLUTION.
How does IT MAC ORAL SOLUTION work?
IT MAC ORAL SOLUTION works by inhibiting ergosterol synthesis (an organic compound responsible for maintaining cell membrane integrity of fungi cell) that leads to fungal cell membrane abnormalities (marked with increased permeability and disruption of fungi cell) thus causing destruction to the fungi cell and preventing the occurrence of fungal infections in affected individuals.
Is IT MAC ORAL SOLUTION safe to use in patients with heart problems?
IT MAC ORAL SOLUTION should be used with caution in patients with heart problems including congestive heart failure as this medicine could make it worse. During treatment with this medicine if you experience any symptoms related to heart (such as shortness of breath, unexpected weight gain, swelling of the legs or stomach, unusual tiredness, etc.) inform your doctor immediately.
REFERENCES
1. K.D.Tripathi. Antifungal Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page 794.
2. Heidi Kurn; Roopma Wadhwa. Itraconazole. NIH National Library of Medicine. National Center for Biotechnology Information. StatPearls [Internet]. April 2022. [Accessed on 29th September 2022] https://www.ncbi.nlm.nih.gov/books/NBK557874/
3. Janssen Pharmaceuticals. Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis. ClinicalTrials.gov. [Revised in June 2005] [Accessed on 29th September 2022] https://clinicaltrials.gov/ct2/show/NCT00002132
4. SyriMed. Electronic Medicines Compendium (EMC). [Revised in May 2021] [Accessed on 29th September 2022] https://www.medicines.org.uk/emc/files/pil.10049.pdf
USEFUL DIAGNOSTIC TESTS
Complete blood count
Echocardiogram
Country Of Origin
India
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