INTRODUCTION
FLUTIBEX RESPULES contains Fluticasone which belongs to theroup of medicines called Corticosteroids (glucocorticoids). It is used to prevent asthma attacks in people who require regular treatment. Asthma is a condition in which airways become inflamed, narrow, and swollen and produce extra mucus, making it difficult to breathe. The other symptoms are chest pain, cough and wheezing.
Before using FLUTIBEX RESPULES tell your doctor if you have had tuberculosis and were treated for the same. FLUTIBEX RESPULES should be used with caution in pregnant and breastfeeding women. Contact your doctor before using.
FLUTIBEX RESPULES is not recommended for use in children below 4 years of age and should be used with caution in children between 4 to 16 years of age. Your doctor will decide the correct dose and duration of FLUTIBEX RESPULES for your child and will keep a check of the child?s height and modify the doses as required. Therefore, contact your child?s doctor before using FLUTIBEX RESPULES for your child.
The most common side effects of using FLUTIBEX RESPULES include candidiasis of mouth and tongue, hoarseness of voice, and sore tongue, or throat. Contact your doctor if any of these worsen or doesn?t improve.
USES OF FLUTIBEX RESPULES
It is used in prevention of asthma attacks in people who require regular treatment
HOW FLUTIBEX RESPULES WORKS
FLUTIBEX RESPULES causes vasoconstriction (constriction of blood vessels) and has an anti-inflammatory activity. It directly decreases the cells that cause inflammation such as eosinophils, monocytes, mast cells, macrophages, and dendritic cells. FLUTIBEX RESPULES also decreases mucusland secretions. Therefore, helping in reducing the inflammation and making it easier to breathe.
DIRECTIONS FOR USE
Use FLUTIBEX RESPULES as advised by your physician. It is for inhalational use only. It is administered by nebulisation using a nebuliser (with a face mask or mouthpiece) which is connected to an air compressor. Your doctor willuide on how to use the nebuliser. Do not exceed the recommended dose of FLUTIBEX RESPULES. Your doctor will decide the correct dose and duration of FLUTIBEX RESPULES for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF FLUTIBEX RESPULES
COMMON
Candidiasis of mouth and throat
Pneumonia (in patients having Chronic obstructive pulmonary disease)
Hoarseness of voice
Bruising
Sore tongue or throat
RARE
Oesophageal candidiasis
Stop using FLUTIBEX RESPULES and contact your doctor immediately if you experience any of the following side effects:
Bronchospasm
Worsening of breathing or wheezing
Blurred vision or visual disturbances
Severe allergic reactions (symptoms include skin rashes, redness, itching, hives, swelling of face, lips, mouth, tongue or throat causing difficulty in breathing, itchy rash, feeling faint and light-headedness)
Symptoms such as tummy ache, diarrhoea, nausea, headache or drowsiness
HOW TO MANAGE SIDE EFFECTS
Hoarseness and candidiasis of mouth:
Brush your teeth, rinse your mouth orargle using water and spit it out. Tell your doctor if these problems with your mouth or throat worsens or doesn?t improve.
WARNING & PRECAUTIONS
PREGNANCY
FLUTIBEX RESPULES should be used with caution in pregnant women only if the expected benefit to the mother isreater than any possible risk to the foetus. Contact your doctor before using.
BREASTFEEDING
FLUTIBEX RESPULES should be used with caution in breastfeeding women only if the expected benefit to the mother isreater than any possible risk to the child. Contact your doctor before using.
DRIVING AND USING MACHINES
FLUTIBEX RESPULES is unlikely to affect your ability to drive and use machines.
ALLERGY
Do not use FLUTIBEX RESPULES if you are allergic to Fluticasone or any of the other ingredients of this medicine.
OTHERS
Before using FLUTIBEX RESPULES tell your doctor if you have:
Been treated for tuberculosis
Use in Paediatrics:
FLUTIBEX RESPULES is not recommended for use in children below 4 years of age and should be used with caution in children between 4 to 16 years of age. Your doctor will decide the correct dose and duration of FLUTIBEX RESPULES for your child and will keep a check of the child?s height and modify the doses as required. Therefore, contact your child?s doctor before using FLUTIBEX RESPULES for your child.
Use ineriatrics:
FLUTIBEX RESPULES can be used in elderly patients. Consult with your doctor before using.
INTERACTIONS
A. Drug-Drug Interactions:
Before using FLUTIBEX RESPULES, tell your doctor if you are taking, or have recently taken any of the following medicines:
Medicines used to treat HIV (Ex. ritonavir, cobicistat)
Medicine used to treat fungal infections (Ex. ketoconazole)
Overdosage:
If you or anyone else accidentally uses too much of FLUTIBEX RESPULES, consult your doctor immediately or visit the nearby hospital. Symptoms include temporary suppression of adrenal function.
SYNOPSIS
Drug :?? Fluticasone
Pharmacological Category :?? Corticosteroid
Therapeutic Indication :?? Asthma
Dosage Forms :?? Capsule, Cream, Inhaler, Innospray, Lotion, Nasal Spray, Nasal Drops, Ointment, Respules, Rotacaps, Spray
MORE INFORMATION
Keep FLUTIBEX RESPULES out of sight and reach of children.
Store FLUTIBEX RESPULES at room temperature below 30?C
FAQs ABOUT FLUTIBEX RESPULES
What is FLUTIBEX RESPULES and why is it prescribed?
FLUTIBEX RESPULES contains Fluticasone which belongs to theroup of medicines called Corticosteroids (glucocorticoids). It is used to prevent asthma attacks in people who require regular treatment.
Is FLUTIBEX RESPULES a steroid?
Yes, FLUTIBEX RESPULES is corticosteroid which causes vasoconstriction (constriction of blood vessels) and has an anti-inflammatory activity. It directly decreases the cells that cause inflammation such as eosinophils, monocytes, mast cells, macrophages, and dendritic cells. FLUTIBEX RESPULES also decreases mucusland secretions. Therefore, helping in reducing the inflammation and making it easier to breathe.
What conditions should be informed to the doctor before starting use of FLUTIBEX RESPULES?
Before taking FLUTIBEX RESPULES tell your doctor if you have had been treated for tuberculosis (TB).
Can I stop using FLUTIBEX RESPULES on my own if I start to feel better?
Do not stop using FLUTIBEX RESPULES until and unless your doctor asks you to. It is important that FLUTIBEX RESPULES is not stopped suddenly as this could make your asthma worse, make you feel unwell and may cause symptoms such as vomiting, nausea, drowsiness, headache, tiredness, loss of appetite and low blood sugar level and could also cause problems with the body?s hormones.
What are the things I need to take care while using FLUTIBEX RESPULES?
FLUTIBEX RESPULES is administered by nebulisation using a nebuliser (with a face mask or mouthpiece) which is connected to an air compressor. It produces a mist, do not let the liquid, or the mist produced by the nebuliser,et into your eyes by wearinglasses oroggles to protect them. Use your nebuliser in a well-ventilated room as some of the mist will be released into the air which may be inhaled by others.
Can FLUTIBEX RESPULES be used in children?
FLUTIBEX RESPULES is not recommended for use in children below 4 years of age and should be used with caution in children between 4 to 16 years of age. Your doctor will decide the correct dose and duration of FLUTIBEX RESPULES for your child and will keep a check of the child?s height and modify the doses as required. Therefore, contact your child?s doctor before using FLUTIBEX RESPULES for your child. If you or your child is on high doses of FLUTIBEX RESPULES and become unwell with symptoms such as tummy ache, sickness, diarrhoea, headache or drowsiness, talk to your doctor as soon as possible.
REFERENCES
1. K.D. Tripathi. Respiratory System Drugs. Essentials of Medical Pharmacology. Eighth Edition. 2019. Page 250.
2. Beyza Poplata Demirca, Hasret Cagan, Ayca Kiykim, Ulku Arig, Medeni Arpa, Aysin Tulunay, Ahmet Ozen, Elif Karakoc-Aydiner, Safa Baris, I.B. Barlan. Nebulized fluticasone propionate, a viable alternative to systemic route in the management of childhood moderate asthma attack: A double-blind, double-dummy study. Science Direct. September 2015. [Accessed on 30th Oct 2022] https://www.sciencedirect.com/science/article/pii/S0954611115300226
3. Kailey Remien,?Andy Bowman. Fluticasone. NIH National Library of Medicine, National center for biotechnology information. StatPearls. June 2022. [Accessed on 30th Oct 2022] https://www.ncbi.nlm.nih.gov/books/NBK542161/
4. Ashley Woodcock,?Eric D Bateman, William W Busse,?Jan L?tvall,?Neil Snowise,?Richard Forth,?Loretta Jacques,?Brett Haumann, Eugene R Bleecker.?Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial. Biomed Central. December 2011. [Accessed on 30th Oct 2022] https://respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-12-132
5. Cipla Ltd. Flohale Respules (Fluticasone). [Revised in Sep 2020] [Accessed on 30th Oct 2022] https://www.ciplamed.com/content/flohale-respules
USEFUL DIAGNOSTIC TESTS
Percutaneous skin test
Allergen-specific immunoglobulin E (IgE) antibody test
Chest Xray
PRODUCT DETAILS
Country Of Origin
India
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