INTRODUCTION

SPIROFORM B 1MG RESPULES contains Budesonide and Formoterol, which belong to the group of medicines called Inhaled corticosteroids, long-acting beta-adrenergic agonists. SPIROFORM B 1MG RESPULES 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 airways gets 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 the growth pattern of your child using SPIROFORM B 1MG RESPULES. 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.

SPIROFORM B 1MG RESPULES is not recommended to use if you are allergic to any of its ingredients. SPIROFORM B 1MG RESPULES is generally not recommended to use during pregnancy or breast feeding unless it is clearly necessary. Before using SPIROFORM B 1MG RESPULES, 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 chicken pox, etc.

SPIROFORM B 1MG RESPULES is not recommended for use by children below 6 years of age. Most common side effects of using SPIROFORM B 1MG RESPULES 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 symptoms get worse or persist.

USES OF SPIROFORM B 1MG RESPULES

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 SPIROFORM B 1MG RESPULES WORKS

SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES

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 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.

Loose stool

Drink plenty of water, fluids, and electrolytes such as ORS and stay hydrated. Consult your doctor if your symptom gets 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 maintain good oral hygiene by brushing twice a day, using mouthwash, etc. Consult your doctor if your symptom gets 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 symptom gets 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 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.

WARNING & PRECAUTIONS

PREGNANCY

SPIROFORM B 1MG RESPULES 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 treatment with SPIROFORM B 1MG RESPULES before discontinuing the medicine.

BREASTFEEDING

SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES.

DRIVING AND USING MACHINES

SPIROFORM B 1MG RESPULES has no or negligible effect on your efficiency to drive and operate machines. Consult your doctor before using SPIROFORM B 1MG RESPULES.

KIDNEY

SPIROFORM B 1MG RESPULES is not recommended to use in patients with kidney diseases due to a lack of safety data. However, consult your doctor before using SPIROFORM B 1MG RESPULES.

LIVER

SPIROFORM B 1MG RESPULES should be used with caution in patients diagnosed with liver diseases. Consult your doctor before using SPIROFORM B 1MG RESPULES.

ALLERGY

Do not use SPIROFORM B 1MG RESPULES if you are allergic to budesonide, formoterol, or any other ingredients in this medicine. Consult your doctor before using SPIROFORM B 1MG RESPULES.

LUNGS

SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES.

HEART DISEASE

SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES.

INTERACTIONS

A. Drug-Drug Interactions:

Before using SPIROFORM B 1MG RESPULES, 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 SPIROFORM B 1MG RESPULES, 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

MORE INFORMATION

• Keep SPIROFORM B 1MG RESPULES out of reach from children
• Store SPIROFORM B 1MG RESPULES at room temperature

FAQs ABOUT SPIROFORM B 1MG RESPULES

What is SPIROFORM B 1MG RESPULES used for?

SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES.

How does SPIROFORM B 1MG RESPULES work?

SPIROFORM B 1MG RESPULES 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 SPIROFORM B 1MG RESPULES?

The most common side effects of using SPIROFORM B 1MG RESPULES 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.

Is it safe to use SPIROFORM B 1MG RESPULES during pregnancy?

SPIROFORM B 1MG RESPULES is not recommended to use in pregnancy due to the lack of safety data. Consult a doctor before using SPIROFORM B 1MG RESPULES.

Is it safe to use SPIROFORM B 1MG RESPULES for the treatment of asthma in children?

SPIROFORM B 1MG RESPULES is not recommended to use in children below 6 years of age due to a lack of safety data. Consult your doctor before receiving SPIROFORM B 1MG RESPULES. SPIROFORM B 1MG RESPULES should be used with caution in children above 6 years of age. Your doctor will monitor the height and growth of children while using SPIROFORM B 1MG RESPULES. Consult your doctor for advice.

How to prevent getting a fungal infection (thrush) in the mouth and throat while using SPIROFORM B 1MG RESPULES?

Use SPIROFORM B 1MG RESPULES only when advised by your doctor. Do not self-medicate. Rinse your mouth with water and spit the water out after each dose of SPIROFORM B 1MG RESPULES. 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

AUTHOR DETAILS

Written By Dr. Dhivakaran R, BDS
Last updated on 11 Nov 2022 | 01:07 PM(IST)