Digihaler FB 400mcg Inhaler 120Md Allschoolabs -

Specification

INTRODUCTION
DIGIHALER FB 400MCG INHALER contains Budesonide and Formoterol, which belong to theroup of medicines called Inhaled corticosteroids, long-acting beta-adrenergic agonists. DIGIHALER FB 400MCG INHALER is used in adults and children above 6 years for the regular treatment 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 airwaysets narrower, swell, and produce extra mucus.?COPD is a chronic inflammatory disease of lung that causes obstructed airflow from the lungs. Symptoms of these diseases includes difficulty to breath, coughing, wheezing, sputum production etc.
Your doctor will regularly monitor therowth pattern of your child using DIGIHALER FB 400MCG INHALER. Before using this medicine, your doctor might advise you to perform certain respiratory tests to assess the severity of respiratory disorder and flow in the lungs.
DIGIHALER FB 400MCG INHALER is not recommended to use if you are allergic to any of its ingredients. DIGIHALER FB 400MCG INHALER isenerally not recommended to use during pregnancy or breast feeding unless it is clearly necessary. Before using DIGIHALER FB 400MCG INHALER, 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 aslaucoma (increased pressure inside eyes), cataracts (cloudy lens) and viral, bacterial, fungal, parasitic infections, exposed to measles or chicken pox, etc.
DIGIHALER FB 400MCG INHALER is not recommended for use by children below 6 years of age. Most common side effects of using DIGIHALER FB 400MCG INHALER in adults includes muscle pain, difficulty to sleep, palpitations, increased heartrate, increased levels of blood sugar, decreased levels of potassium etc. Consult your doctor if any of your symptomset worse or persist.
USES OF DIGIHALER FB 400MCG INHALER
It is used in adults and children above 6 years for the regular treatment of:
Asthma

Moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

HOW DIGIHALER FB 400MCG INHALER WORKS
DIGIHALER FB 400MCG INHALER 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 prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath due to asthma and chronic obstructive pulmonary diseases.
DIRECTIONS FOR USE
Use DIGIHALER FB 400MCG INHALER 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 DIGIHALER FB 400MCG INHALER

COMMON

Muscle pain and cramps

Difficulty to sleep

Palpitations

Increased heartrate

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 stomach and intestine)

Rashes

Conjunctivitis

UNCOMMON

Increased heartrate

Blurred vision

Cataract

Glaucoma (increased pressure in eyes)

Cramps in muscle

Nausea

RARE

Weakness

Rashes

Hives, urticaria

Dermatitis

Itching

Weightain

Taste disturbances

Increased heartrate, atrial fibrillation (irregular, rapid heartbeat which leads to blood clot in heart)

Growth retardation in children

Decreased bone density

Adrenal suppression (adrenalland fails to produce adequate hormones)
Stop using DIGIHALER FB 400MCG INHALER and contact doctor if you experience any of the following:
Depression

Changes in behaviour (mainly in children)

Retardedrowth in children

Angina pectoris (pain or heaviness in 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
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 symptomets 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 symptomets worse or persist.
Loose stool
Drink plenty of water, fluids, and electrolytes such as ORS and stay hydrated. Consult your doctor if your symptomets worse or persist.
Fungal infection of the mouth (thrush):
Rinse your mouth with water each time after using the medicine. Do not swallow the water. Try to maintainood oral hygiene by brushing twice a day, using mouthwash, etc. Consult your doctor if your symptomets worse or persist.
Nausea, 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 symptomets worse or persist.
Throat pain:
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 symptomets 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 symptomets worse or persist.
WARNING & PRECAUTIONS

PREGNANCY
DIGIHALER FB 400MCG INHALER isenerally not recommended for use during pregnancy or for those who are planning pregnancy due to a lack of safety data. Inform your doctor if youet pregnant in between the course of treatment with DIGIHALER FB 400MCG INHALER before discontinuing the medicine.
BREASTFEEDING
DIGIHALER FB 400MCG INHALER is not recommended to use in breastfeeding mothers unless the expected benefit to the mother isreater than any possible risk to the child. Consult your doctor before using DIGIHALER FB 400MCG INHALER.
DRIVING AND USING MACHINES
DIGIHALER FB 400MCG INHALER has no or negligible effect on your efficiency to drive and operate machines. Consult your doctor before using DIGIHALER FB 400MCG INHALER.
KIDNEY
DIGIHALER FB 400MCG INHALER is not recommended to use in patients with kidney diseases?due to a lack of safety data. However, consult your doctor before using DIGIHALER FB 400MCG INHALER.
LIVER
DIGIHALER FB 400MCG INHALER should be used with caution in patients diagnosed with liver diseases. Consult your doctor before using DIGIHALER FB 400MCG INHALER.
ALLERGY
Do not use DIGIHALER FB 400MCG INHALER if you are allergic to budesonide, formoterol, or any other ingredients in this medicine. Consult your doctor before receiving DIGIHALER FB 400MCG INHALER.
LUNGS
DIGIHALER FB 400MCG INHALER is not recommended to use for treating 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 DIGIHALER FB 400MCG INHALER.
HEART DISEASE
DIGIHALER FB 400MCG INHALER 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 DIGIHALER FB 400MCG INHALER.
OTHERS
Before using DIGIHALER FB 400MCG INHALER, inform your doctor if you have:
Fits

Diabetes

Thyroid problems

Pheochromocytoma (adrenalland tumour)

Osteoporosis (bone disease)

Immune system diseases

Eye problems such aslaucoma (increased pressure inside eyes), cataracts (cloudy lens)

Viral, bacterial, fungal, parasitic infections

Exposed to measles or chicken pox, etc.

Decreased potassium levels and untreated

Aneurism (bulge in blood vessel)
Use in pediatrics:
DIGIHALER FB 400MCG INHALER is not recommended to use in children below 6 years of age due to lack of safety data. Consult your doctor before receiving DIGIHALER FB 400MCG INHALER. DIGIHALER FB 400MCG INHALER should be used with caution in children above 6 years of age. Your doctor will monitor the height androwth of children while using DIGIHALER FB 400MCG INHALER. Consult your doctor for advice.
Use ineriatrics:
DIGIHALER FB 400MCG INHALER is used with caution in elderly people with heart diseases. Consult doctor before using DIGIHALER FB 400MCG INHALER.
INTERACTIONS
A. Drug-Drug Interactions:
Before using DIGIHALER FB 400MCG INHALER, inform your doctor if you are taking any of the following medicines:
Ketoconazole, itraconazole, voriconazole, posaconazole (medicines used to treat fungal infection)

Clarithromycin, telithromycin (medicines used to treat bacterial infection)

Nefazodone (medicine used to treat depression)

HIV protease inhibitors such as indinavir, ritonavir (medicines used to treat HIV)

Monoamine oxidase inhibitors such as isocarboxazid, phenelzine and tricyclic antidepressants such as amitriptyline, desipramine (medicines used to treat depression)

Beta blockers (Ex. atenolol, labetalol, propranolol), loop diuretics (Ex. bumetanide, furosemide) thiazide diuretics (Ex. chlorothiazide, chlorthalidone, hydrochlorothiazide) (medicines used to treat high blood pressure)

Terfenadine (medicine used to treat allergy)

Quinidine, disopyramide, procainamide (medicines used to treat heart diseases)

Phenothiazines (EX. Chlorpromazine) (medicine used to treat mental disorders)

Salmeterol, formoterol fumarate, arformoterol tartrate (medicines used to treat 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 DIGIHALER FB 400MCG INHALER, 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 treat Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Dosage Forms :
Capsules, Inhaler, Rota cap, Respicap, Octacap, nexhaler, Respule, Smartules, Pulmules, Turboinhaler
MORE INFORMATION

Keep DIGIHALER FB 400MCG INHALER out of reach from children

Store DIGIHALER FB 400MCG INHALER at room temperature

FAQs ABOUT DIGIHALER FB 400MCG INHALER
What is DIGIHALER FB 400MCG INHALER used for?
DIGIHALER FB 400MCG INHALER is used in adults and children above 6 years for the regular treatment 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 DIGIHALER FB 400MCG INHALER.
How does DIGIHALER FB 400MCG INHALER work?
DIGIHALER FB 400MCG INHALER 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 prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath due to asthma and chronic obstructive pulmonary diseases.
What are the most common side effects of using DIGIHALER FB 400MCG INHALER?
The most common side effects of using DIGIHALER FB 400MCG INHALER 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 effectset worse or persist.
Is it safe to use DIGIHALER FB 400MCG INHALER during pregnancy?
DIGIHALER FB 400MCG INHALER is not recommended to use in pregnancy due to the lack of safety data. Consult a doctor before using DIGIHALER FB 400MCG INHALER.
Is it safe to use DIGIHALER FB 400MCG INHALER for the treatment of asthma in children?
DIGIHALER FB 400MCG INHALER is not recommended to use in children below 6 years of age due to a lack of safety data. Consult your doctor before receiving DIGIHALER FB 400MCG INHALER. DIGIHALER FB 400MCG INHALER should be used with caution in children above 6 years of age. Your doctor will monitor the height androwth of children while using DIGIHALER FB 400MCG INHALER. Consult your doctor for advice.
How to preventetting a fungal infection (thrush) in the mouth and throat while using DIGIHALER FB 400MCG INHALER?
Use DIGIHALER FB 400MCG INHALER only when advised by your doctor. Do not self-medicate. Rinse your mouth with water and spit the water out after each dose of DIGIHALER FB 400MCG INHALER. Do not swallow the water.argle regularly and maintainood 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