Budetrol 400mcg+12Mcg Capsule 30’S

INTRODUCTION

BUDETROL 400MCG 12MCG CAPSULE contains Budesonide and Formoterol which belong to theroup of medicines called Inhaled corticosteroids and long-acting beta-adrenergic agonists respectively. BUDETROL 400MCG 12MCG CAPSULE is used in adults and children above 12 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 airwayset 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 breathing, coughing, wheezing, sputum production etc.

Your doctor may regularly monitor therowth pattern of children using BUDETROL 400MCG 12MCG CAPSULE. Before using this medicine, your doctor may advise you to do some blood tests, and respiratory tests to assess the severity of the respiratory disorder and flow in the lungs.

BUDETROL 400MCG 12MCG CAPSULE is not recommended to use if you are allergic to any of its ingredients. Before using BUDETROL 400MCG 12MCG CAPSULE, inform your doctor if you have heart problems, lung infections, liver diseases, increased blood pressure, fits, diabetes, thyroid problems, low levels of potassium in the blood or adrenalland tumours.

BUDETROL 400MCG 12MCG CAPSULE isenerally not recommended for use during pregnancy and breastfeeding unless it is necessary. BUDETROL 400MCG 12MCG CAPSULE is not recommended for use by children below 12 years of age. BUDETROL 400MCG 12MCG CAPSULE should be used with caution in children and adolescents from 13-17 years of age. The common side effects of using BUDETROL 400MCG 12MCG CAPSULE include headache, throat pain, hoarseness of voice, coughing, oral thrush, palpitations etc. Consult your doctor if any of your symptomset worse or persist.

USES OF BUDETROL 400MCG 12MCG CAPSULE

It is used in adults and children above 12 years for the regular treatment of:

Asthma
Moderate to severe Chronic Obstructive Pulmonary Disease
HOW BUDETROL 400MCG 12MCG CAPSULE WORKS

BUDETROL 400MCG 12MCG CAPSULE contains Budesonide and Formoterol. Budesonide helps to decrease inflammation in the lungs. Formoterol acts as a bronchodilator that helps in relaxing the muscles around the airways in the lungs. Together they help to ease breathing problems as well as to prevent symptoms of asthma and chronic obstructive pulmonary diseases such as wheezing, cough, chest tightness, and shortness of breath.

DIRECTIONS FOR USE

Use BUDETROL 400MCG 12MCG CAPSULE exactly as advised by your doctor. It is for inhalational use only. Do not swallow the medicine. Check the instructions label carefully before use to know the directions for 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 BUDETROL 400MCG 12MCG CAPSULE
COMMON
Headache
Throat pain
Hoarseness of voice
Coughing
Oral thrush (fungal infection)
Palpitations
Pneumonia in patients with Chronic Obstructive Pulmonary Disease
Shaking
Dizziness
UNCOMMON
Tiredness
Nausea
Blurred vision
Increased heartrate
Bleeding
Muscle pain
Restlessness,etting nervous, agitated
Sleep disturbances
RARE
Rashes
Hives
Itching
Dermatitis
Decreased potassium levels
Increased blood sugar
Taste disturbances
Bronchospasm (tightening of airways)

Stop using BUDETROL 400MCG 12MCG CAPSULE and contact your doctor if you experience any of the following

Depression
Changes in behaviour such as anxiety, restlessness, sleeplessness etc (mainly in children)
Retardedrowth in children
Decrease in bone mineral density
Weightain or cushings’syndrome (increased adrenal hormones)
Angina pectoris (pain or heaviness in chest)
Variation in blood pressure
Airway constriction (paradoxical bronchospasm)
ECG variation (prolonged QTc interval)
Eye diseases like cataract (cloudy eyes),laucoma (increased pressure inside eyes)
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
Fall in blood pressure, increased heartrate, difficulty to stand up, loss of consciousness (anaphylactic shock)
HOW TO MANAGE SIDE EFFECTS

Nausea, Vomiting:

Drink electrolytes such as coconut water and fruit juices. Eat simple and light meals at frequent intervals 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.

Fungal infection of the mouth (thrush):

Wash (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 before taking any medication.

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.

WARNING & PRECAUTIONS
PREGNANCY

BUDETROL 400MCG 12MCG CAPSULE isenerally not recommended for use in pregnant or those who are planning pregnancy due to a lack of safety data. Consult your doctor before using BUDETROL 400MCG 12MCG CAPSULE.

BREASTFEEDING

BUDETROL 400MCG 12MCG CAPSULE 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 BUDETROL 400MCG 12MCG CAPSULE.

DRIVING AND USING MACHINES

BUDETROL 400MCG 12MCG CAPSULE has no or negligible effect on your efficiency to drive and operate machines. Consult your doctor before using BUDETROL 400MCG 12MCG CAPSULE.

KIDNEY

BUDETROL 400MCG 12MCG CAPSULE is not recommended to use in patients with kidney diseases due to a lack of safety data. However, consult your doctor before using BUDETROL 400MCG 12MCG CAPSULE.

LIVER

BUDETROL 400MCG 12MCG CAPSULE should be used with caution in patients diagnosed with liver diseases. Consult your doctor before using BUDETROL 400MCG 12MCG CAPSULE.

ALLERGY

Do not use BUDETROL 400MCG 12MCG CAPSULE if you are allergic to budesonide, formoterol, or any other ingredients in this medicine. Consult your doctor before using BUDETROL 400MCG 12MCG CAPSULE.

LUNGS

BUDETROL 400MCG 12MCG CAPSULE should be used with caution in patients with lung disease. Consult your doctor before using BUDETROL 400MCG 12MCG CAPSULE.

HEART DISEASE

BUDETROL 400MCG 12MCG CAPSULE 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 BUDETROL 400MCG 12MCG CAPSULE.

OTHERS

Before using BUDETROL 400MCG 12MCG CAPSULE inform your doctor if you have:

Fits
Diabetes
Thyroid problems
Pheochromocytoma (adrenalland tumor)
Decreased potassium levels and untreated
Aneurism (bulge in blood vessel)

Use in pediatrics:

BUDETROL 400MCG 12MCG CAPSULE is not recommended to use in children below 12 years of age due to lack of safety data. BUDETROL 400MCG 12MCG CAPSULE should be used with caution in children and adolescents from 13-17 years of age. Your doctor will monitor the height androwth of children while using BUDETROL 400MCG 12MCG CAPSULE. Consult your doctor for advice.

Use ineriatrics:

BUDETROL 400MCG 12MCG CAPSULE is used with caution in elderly people with heart diseases. Consult doctor before using BUDETROL 400MCG 12MCG CAPSULE.

INTERACTIONS

A. Drug-Drug Interactions:

Before using BUDETROL 400MCG 12MCG CAPSULE, 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)
Indinavir, ritonavir, nelfinavir, saquinavir, atazanavir (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 BUDETROL 400MCG 12MCG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are nausea, vomiting, increased heartrate, increased blood sugar levels, decrease in levels of potassium, variations in ECG (prolonged QTc interval 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 BUDETROL 400MCG 12MCG CAPSULE out of reach from children
Store BUDETROL 400MCG 12MCG CAPSULE at room temperature
FAQs ABOUT BUDETROL 400MCG 12MCG CAPSULE

What is BUDETROL 400MCG 12MCG CAPSULE used for?

BUDETROL 400MCG 12MCG CAPSULE is used in adults and children above 12 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 doctor before using BUDETROL 400MCG 12MCG CAPSULE.

How BUDETROL 400MCG 12MCG CAPSULE works?

BUDETROL 400MCG 12MCG CAPSULE contains Budesonide and Formoterol. Budesonide helps to decrease inflammation in the lungs. Formoterol acts as a bronchodilator that aids in relaxing the muscles around the airways in the lungs. Together they help to ease breathing problems as well as to prevent symptoms of asthma and chronic obstructive pulmonary diseases such as wheezing, cough, chest tightness, and shortness of breath.

What are the common side effects of using BUDETROL 400MCG 12MCG CAPSULE?

Common side effects of using BUDETROL 400MCG 12MCG CAPSULE includes headache, throat pain, hoarseness of voice, coughing, oral thrush, palpitations etc. Consult doctor if any of these symptoms are worsening.

Is it safe to use BUDETROL 400MCG 12MCG CAPSULE during pregnancy?

BUDETROL 400MCG 12MCG CAPSULE is not recommended to use in pregnancy due to the lack of safety data. Consult doctor before using BUDETROL 400MCG 12MCG CAPSULE.

Is it safe to use BUDETROL 400MCG 12MCG CAPSULE for treatment of asthma in children?

BUDETROL 400MCG 12MCG CAPSULE is not recommended to use in children below 12 years of age due to lack of safety data. Consult your doctor before receiving BUDETROL 400MCG 12MCG CAPSULE. BUDETROL 400MCG 12MCG CAPSULE should be used with caution in children and adolescents from 13-17 years of age. Doctor will monitor the height androwth of children while using BUDETROL 400MCG 12MCG CAPSULE. Consult your doctor for advice.

How to avoidetting fungal infection in the mouth and throat while using BUDETROL 400MCG 12MCG CAPSULE?

Use BUDETROL 400MCG 12MCG CAPSULE only if it is prescribed by your doctor. Do not self-medicate. Wash your mouth with water and spit out the water after each dose of BUDETROL 400MCG 12MCG CAPSULE. Do not swallow the water. Try to 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 on 1st February 2021] [Accessed on 29th October 2022] https://ciplamed.com/content/foracort-forte-inhale

4. Budesonide Formoterol. Cipla med. [Revised on 11th January 2021] [Accessed on 29th October 2022] https://ciplamed.com/content/foracort-forte-rotacap

5. Budesonide Formoterol. MacLeod pharma. [Accessed on 29th October 2022] https://www.macleodspharma.com/products/

USEFUL DIAGNOSTIC TESTS
Absolute Eosinophil Count
Complete Blood Count
PRODUCT DETAILS
Net Qty
1 N
Item Weight
40
Ingredient
BUDESONIDE 400MCG FORMOTEROL 12MCG
Hsn Code
30049091
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