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Introduction About FOMTIDE 400MCG+12MCG DISKETTE
GBNKEYWORD] contains Budesonide and Formoterol, which belong to the group of medicines called Inhaled corticosteroids, long-acting beta-adrenergic agonists. FOMTIDE 400MCG+12MCG DISKETTE is used in adults and children above 6 years for the regular management of asthma and moderate to severe Chronic Obstructive Pulmonary Disease (COPD) with frequent symptoms and a history of recurrent exacerbations.
Asthma is a respiratory disease in which airways get narrower, swell, and produce extra mucus. COPD is a chronic inflammatory disease of the lung that causes obstructed airflow from the lungs. Symptoms of these diseases include difficulty to breathe, coughing, wheezing, sputum production etc.
Your doctor will regularly monitor the growth pattern of your child using FOMTIDE 400MCG+12MCG DISKETTE. Before using this medicine, your doctor might advise you to perform certain respiratory tests to assess the severity of the respiratory disorders and flow in the lungs.
FOMTIDE 400MCG+12MCG DISKETTE is not recommended to use if you are allergic to any of its ingredients. FOMTIDE 400MCG+12MCG DISKETTE is generally not recommended to use during pregnancy or breastfeeding unless it is clearly necessary. Before using FOMTIDE 400MCG+12MCG DISKETTE, inform your doctor if you have heart problems, increased blood pressure, fits, diabetes, thyroid problems, liver problems, osteoporosis (bone disease), immune system diseases, eye problems such as glaucoma (increased pressure inside eyes), cataracts (cloudy lens) and viral, bacterial, fungal, parasitic infections, exposed to measles or chickenpox, etc.
FOMTIDE 400MCG+12MCG DISKETTE is not recommended for use by children below 6 years of age. The most common side effects of using FOMTIDE 400MCG+12MCG DISKETTE in adults includes muscle pain, difficulty to sleep, palpitations, increased heart rate, increased levels of blood sugar, decreased levels of potassium etc. Consult your doctor if any of your symptoms get worse or persist.
Uses Of FOMTIDE 400MCG+12MCG DISKETTE
It is used in adults and children above 6 years for the management of
- asthma
- moderate to severe Chronic Obstructive Pulmonary Disease
How FOMTIDE 400MCG+12MCG DISKETTE Works
FOMTIDE 400MCG+12MCG DISKETTE contains Budesonide and Formoterol. Budesonide helps to decrease inflammation in the lungs whereas formoterol acts as a bronchodilator that helps the muscles around the airways in the lungs to relax. Together they help to ease breathing problems as well as manage symptoms such as wheezing, cough, chest tightness, and shortness of breath due to asthma and chronic obstructive pulmonary diseases.
How to use FOMTIDE 400MCG+12MCG DISKETTE
Use FOMTIDE 400MCG+12MCG DISKETTE exactly as advised by your doctor. It is for inhalational use only. Check the label carefully for directions before use. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and severity of condition.
Side Effects Of FOMTIDE 400MCG+12MCG DISKETTE
Common
- muscle pain and cramps
- difficulty to sleep
- palpitations
- increased heart rate
- increased levels of blood sugar
- decrease in plasma levels of potassium
- rhinitis
- cough
- ear infection
- nausea, vomiting
- headache
- backpain
- nasopharyngitis
- sinusitis
- upper respiratory tract infections (sneezing, cold, nasal stiffness etc)
- dizziness
- dry mouth
- loose stools
- throat irritation
- hoarseness of voice
- stomach pain
- candidiasis (fungal infection)
- viral infections
- bleeding from nose
- gastroenteritis (inflammation of the stomach and intestine)
- rashes
- conjunctivitis
Uncommon
- increased heart rate
- blurred vision
- cataract
- glaucoma (increased pressure in eyes)
- cramps in muscle
- nausea
Rare
- weakness
- rashes
- hives, urticaria
- dermatitis
- itching
- weight gain
- taste disturbances
- increased heart rate, atrial fibrillation (irregular, rapid heartbeat which leads to a blood clots in the heart)
- growth retardation in children
- decreased bone density
- adrenal suppression (adrenal gland fails to produce adequate hormones)
Stop using FOMTIDE 400MCG+12MCG DISKETTE and contact your doctor if you experience any of the following
- depression
- changes in behaviour (mainly in children)
- retarded growth in children
- angina pectoris (pain or heaviness in the chest)
- variation in blood pressure
- airway constriction (paradoxical bronchospasm)
- ECG variation (prolonged QTc interval)
- worsening of fungal infection in your mouth or throat
- signs of pneumonia or other lung diseases such as, increase in sputum production, change in mucus colour, fever, chills, increased cough, and increased breathing problems
- signs of serious allergic reactions such as rashes, hives, swelling of the face, mouth, and tongue along with breathing problems
- signs of swelling of blood vessels in patients suffering from asthma such as feeling tingling or pricking sensation or numbness in your arms or legs, flu like symptoms, rashes, pain and swelling of the sinuses
How To Manage Side Effects
Diarrhea
Drink plenty of water, fluids, and electrolytes such as ORS and stay hydrated. Consult your doctor if your symptom gets worse or persist.
Dry Mouth
Drink plenty of water and fruit juices and consume soft foods with higher water and fibre content. Artificial saliva can be used in case you feel extreme dryness in your mouth. Consult your doctor if your symptom gets worse or persist.
Headache
Rest and relax. Drink plenty of fluids such as water. Apply a pain balm on your forehead if needed. Consult your doctor if your symptom gets worse or persist.
Mouth Ulcers
Rinse your mouth with water each time after using the medicine. Do not swallow the water. Try to maintain good oral hygiene by brushing twice a day, using mouthwash, etc. Consult your doctor if your symptom gets worse or persist.
Nausea And Vomiting
Drink lots of electrolytes such as coconut water and fruit juices. Eat simple and light meals throughout the day. Stay away from oil-rich and spicy foods. Consult your doctor if your symptom gets worse or persist.
Sore Throat
Do warm saline or betadine irrigation(gargle) at regular intervals throughout the day. Avoid eating food items that are difficult to swallow. Consult your doctor if your symptom gets worse or persist.
Stomach Pain
Stick to simple meals. Drink enough fluids. Avoid eating oily, fried, or spicy foods. Take adequate rest. Consult your doctor if your symptom gets worse or persist.
Warning & Precautions
Pregnancy
Consult your doctorFOMTIDE 400MCG+12MCG DISKETTE is generally not recommended for use during pregnancy or for those who are planning pregnancy due to a lack of safety data. Inform your doctor if you get pregnant in between the course of management with FOMTIDE 400MCG+12MCG DISKETTE before discontinuing the medicine.
Breastfeeding
Consult your doctorFOMTIDE 400MCG+12MCG DISKETTE is not recommended to use in breastfeeding mothers unless the expected benefit to the mother is greater than any possible risk to the child. Consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Driving and Using Machines
Use with CautionFOMTIDE 400MCG+12MCG DISKETTE has no or negligible effect on your efficiency to drive and operate machines. Consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Kidney
ContraindicatedFOMTIDE 400MCG+12MCG DISKETTE is not recommended to use in patients with kidney diseases due to a lack of safety data. However, consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Liver
Use with CautionFOMTIDE 400MCG+12MCG DISKETTE should be used with caution in patients diagnosed with liver diseases. Consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Allergy
ContraindicatedDo not use FOMTIDE 400MCG+12MCG DISKETTE if you are allergic to budesonide, formoterol, or any other ingredients in this medicine. Consult your doctor before receiving FOMTIDE 400MCG+12MCG DISKETTE.
Lungs
ContraindicatedFOMTIDE 400MCG+12MCG DISKETTE is not recommended to use for managing asthma, bronchospasm and COPD induced by exercise as well as for acute episodes of asthma or COPD where intensive measures are required. Consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Heart Disease
Consult your doctorFOMTIDE 400MCG+12MCG DISKETTE should be used with caution in patients with heart diseases such as coronary insufficiency (coronary artery fails to pump enough blood), irregular heartbeat, increased blood pressure, hypertrophic obstructive cardiomyopathy (thickened heart muscles), heart valve disease, the low blood supply to heart, heart failure. Consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Use In Pediatrics
Consult your doctorFOMTIDE 400MCG+12MCG DISKETTE is not recommended to use in children below 6 years of age due to lack of safety data. Consult your doctor before receiving FOMTIDE 400MCG+12MCG DISKETTE. FOMTIDE 400MCG+12MCG DISKETTE should be used with caution in children above 6 years of age. Your doctor will monitor the height and growth of children while using FOMTIDE 400MCG+12MCG DISKETTE. Consult your doctor for advice.
Use In Geriatrics
Use with CautionFOMTIDE 400MCG+12MCG DISKETTE is used with caution in elderly people with heart diseases. Consult doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Others
Before using FOMTIDE 400MCG+12MCG DISKETTE inform your doctor if you have
- fits
- diabetes
- thyroid problems
- pheochromocytoma (adrenal gland tumour)
- osteoporosis (bone disease)
- immune system diseases
- eye problems such as glaucoma (increased pressure inside eyes), cataracts (cloudy lens)
- viral, bacterial, fungal, parasitic infections
- exposed to measles or chicken pox, etc.
- decreased potassium levels and unmanageed
- aneurism (bulge in blood vessel)
Interactions
A. Drug-Drug Interactions:
Before using FOMTIDE 400MCG+12MCG DISKETTE, inform your doctor if you are taking any of the following medicines
- ketoconazole, itraconazole, voriconazole, posaconazole (medicines used to manage fungal infection)
- clarithromycin, telithromycin (medicines used to manage bacterial infection)
- nefazodone (medicine used to manage depression)
- HIV protease inhibitors such as indinavir, ritonavir (medicines used to manage HIV)
- monoamine oxidase inhibitors such as isocarboxazid, phenelzine and tricyclic antidepressants such as amitriptyline, desipramine (medicines used to manage depression)
- beta blockers (Ex. atenolol, labetalol, propranolol), loop diuretics (Ex. bumetanide, furosemide) thiazide diuretics (Ex. chlorothiazide, chlorthalidone, hydrochlorothiazide) (medicines used to manage high blood pressure)
- terfenadine (medicine used to manage allergy)
- quinidine, disopyramide, procainamide (medicines used to manage heart diseases)
- phenothiazines (EX. Chlorpromazine) (medicine used to manage mental disorders)
- salmeterol, formoterol fumarate, arformoterol tartrate (medicines used to manage asthma and chronic obstructive pulmonary disease)
- any other vitamin supplements, herbal medicines, over the counter medicines
Overdosage:
If you or anyone else accidentally use more FOMTIDE 400MCG+12MCG DISKETTE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are fits, pain in chest, variation in blood pressure, increased heart rate, nervousness, headache, tremor, palpitations, muscle pain, nausea, dizziness, sleep disturbances, metabolic acidosis, increased blood sugar and decreased potassium levels and in extreme rare conditions it may cause cardiac arrest and even death.
Synopsis
| Drug | : | Budesonide, Formoterol |
| Pharmacological Category | : | Inhaled corticosteroids, long-acting beta-adrenergic agonists |
| Therapeutic Indication | : | Used to manage Asthma, COPD (Chronic Obstructive Pulmonary Disease) |
| Dosage Forms | : | Capsules, Inhaler, Rota cap, Octacap, nexhaler, Nexcap, Respule, Smartules, Pulmules, Turboinhaler |
More Information
- Keep FOMTIDE 400MCG+12MCG DISKETTE out of reach from children
- Store FOMTIDE 400MCG+12MCG DISKETTE at room temperature
FAQs About FOMTIDE 400MCG+12MCG DISKETTE
Q: What is FOMTIDE 400MCG+12MCG DISKETTE used for?
A: FOMTIDE 400MCG+12MCG DISKETTE is used in adults and children above 6 years for the regular management of asthma (narrowing of airways with coughing, wheezing, difficulty to breath etc.) and moderate to severe Chronic Obstructive Pulmonary Disease (COPD- inflammation of lung) with frequent symptoms and a history of recurrent exacerbations. Consult your doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Q: How does FOMTIDE 400MCG+12MCG DISKETTE work?
A: FOMTIDE 400MCG+12MCG DISKETTE contains Budesonide and Formoterol. Budesonide helps to decrease inflammation in the lungs whereas formoterol acts as a bronchodilator that helps the muscles around the airways in the lungs to relax. Together they help to ease breathing problems as well as manage symptoms such as wheezing, cough, chest tightness, and shortness of breath due to asthma and chronic obstructive pulmonary diseases.
Q: What are the most common side effects of using FOMTIDE 400MCG+12MCG DISKETTE?
A: The most common side effects of using FOMTIDE 400MCG+12MCG DISKETTE in adults include muscle pain, difficulty sleeping, palpitations, increased heart rate, increased levels of blood sugar, decreased levels of potassium etc. Consult your doctor if any of your side effects get worse or persist.
Q: Is it safe to use FOMTIDE 400MCG+12MCG DISKETTE during pregnancy?
A: FOMTIDE 400MCG+12MCG DISKETTE is not recommended to use in pregnancy due to the lack of safety data. Consult a doctor before using FOMTIDE 400MCG+12MCG DISKETTE.
Q: Is it safe to use FOMTIDE 400MCG+12MCG DISKETTE for the management of asthma in children?
A: FOMTIDE 400MCG+12MCG DISKETTE is not recommended to use in children below 6 years of age due to a lack of safety data. Consult your doctor before receiving FOMTIDE 400MCG+12MCG DISKETTE. FOMTIDE 400MCG+12MCG DISKETTE should be used with caution in children above 6 years of age. Your doctor will monitor the height and growth of children while using FOMTIDE 400MCG+12MCG DISKETTE. Consult your doctor for advice.
Q: How to manage getting a fungal infection (thrush) in the mouth and throat while using FOMTIDE 400MCG+12MCG DISKETTE?
A: Use FOMTIDE 400MCG+12MCG DISKETTE only when advised by your doctor. Do not self-medicate. Rinse your mouth with water and spit the water out after each dose of FOMTIDE 400MCG+12MCG DISKETTE. Do not swallow the water. Gargle regularly and maintain good oral hygiene.
References
1. KD Tripathi. Drugs for bronchial asthma and cough. Essentials of Medical Pharmacology. Seventh edition Page-224, 230 and 231.
2. O’Byrne, Paul M., J. Mark F, Eric D. Bateman, Peter J. Barnes, Nanshan Zhong, Christina Keen, Carin Jorup, Rosa Lamarca, Stefan I and Helen K. R. Inhaled combined budesonide–formoterol as needed in mild asthma. The New England Journal of Medicine. [Published on 17th May 2018] [Accessed on 29th October 2022] https://www.nejm.org/doi/full/10.1056/nejmoa1715274
3. Budesonide+ Formoterol. Cipla Med. [Revised in July 2022] [Accessed on 29th October 2022] https://ciplamed.com/content/foracort-inhaler
4. Budesonide+ Formoterol. Cipla Med. [Revised in October 2019] [Accessed on 29th October 2022] https://ciplamed.com/content/foracort-respules
5. Budesonide+ Formoterol. Cipla Med. [Revised in July 2022] [Accessed on 29th October 2022] https://ciplamed.com/content/foracort-rotacaps
6. Budesonide+ Formoterol. Cipla Med. [Revised in February 2022] [Accessed on 29th October 2022] https://ciplamed.com/content/foracort-synchrobreathe
7. Budesonide+ Formoterol. Leeford pharma. [Accessed on 29th October 2022] https://www.leeford.in/product/484/weldinide-f-respule
Useful Diagnostic Tests
- Absolute Eosinophil Count
- Complete Blood Count

