Description
INTRODUCTION
SYMBICORT TURBUHALER 4.5+160MCG is a combination of Budesonide and Formoterol which belongs to the group of medicines called Inhaled Corticosteroids and Long-acting Beta-adrenergic agonists respectively. It is used to prevent and control symptoms of asthma (condition in which the airways become narrow and swell and may produce extra mucus and causes breathing difficulty) such as wheezing in adults and in children (above 6 years of age).
SYMBICORT TURBUHALER 4.5+160MCG is also used to treat symptoms such as breathing difficulties as well as to reduce the number of flare ups in patients suffering from chronic obstructive pulmonary disease (COPD) (including chronic bronchitis and emphysema). Chronic obstructive pulmonary disease (COPD) is a group of diseases that causes airflow blockage and breathing-related problems. SYMBICORT TURBUHALER 4.5+160MCG should not be used as rescue therapy for the treatment of acute episodes of bronchospasm or for the relief of acute symptoms.
SYMBICORT TURBUHALER 4.5+160MCG is not recommended to treat sudden severe symptoms of asthma or chronic obstructive pulmonary disease (COPD) or in cases when asthma is adequately controlled on low or medium dose inhaled corticosteroids. SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in patients with liver impairment, fits, thyroid problems or diabetes. Before using SYMBICORT TURBUHALER 4.5+160MCG, inform your doctor if you are pregnant or breastfeeding.
SYMBICORT TURBUHALER 4.5+160MCG is not recommended for use in children (less than 6 years of age) and it should be used with caution in children (above 6 years of age). Also, caution should be exercised in elderly patients (aged 65 years and above) particularly with heart diseases.
Before using SYMBICORT TURBUHALER 4.5+160MCG, your doctor might advise you to perform certain respiratory tests to assess the severity of respiratory disorder and airflow in the lungs. The common side effects associated with the use of SYMBICORT TURBUHALER 4.5+160MCG are throat pain and irritation, flu, nasal congestion, fungal infection (thrush) in the mouth and throat, headache, and vomiting. Consult your doctor if any of the symptom worsens.
USES OF SYMBICORT TURBUHALER 4.5+160MCG
- Prevents and control symptoms of asthma
- Used as maintenance treatment of chronic obstructive pulmonary disease (COPD) (to improve breathing difficulties and to reduce the number of flare-ups)
HOW SYMBICORT TURBUHALER 4.5+160MCG WORKS
SYMBICORT TURBUHALER 4.5+160MCG is a combination of 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 SYMBICORT TURBUHALER 4.5+160MCG as advised by the doctor. It is for inhalation use only. Shake SYMBICORT TURBUHALER 4.5+160MCG well for 5 seconds before using. Just before using, breathe out and then put the mouthpiece gently between your lips. Close your lips over the mouthpiece and inhale forcefully and deeply through the mouthpiece. Hold it for a few seconds. Then take the mouthpiece out of your mouth before you breathe out again. Rinse your mouth with water and spit the water after each dose of SYMBICORT TURBUHALER 4.5+160MCG. Do not swallow the water. Avoid contact with your eyes. Your doctor will decide the correct dose, time and duration for you depending upon your age and severity of the disease condition.
SIDE EFFECTS OF SYMBICORT TURBUHALER 4.5+160MCG
COMMON
- Throat pain and irritation
- Upper respiratory tract infection
- Flu
- Nasal congestion
- Inflammation of mucous membrane of the sinuses (sinusitis)
- Infection and inflammation of the mucous membranes of the bronchial tubes (bronchitis)
- Back pain
- Fungal infection (thrush) in the mouth and throat
- Stomach discomfort
- Headache
- Vomiting
RARE
Stop using SYMBICORT TURBUHALER 4.5+160MCG and consult your doctor immediately if you experience any of the following side effects:
- Worsening of your breathing problems or have sudden wheezing
- Signs of heart problems such as chest pain, increased blood pressure, fast and irregular heartbeat
- Severe headache
- Tremor and nervousness
- 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
- Slow growth in children
- Eye problems including glaucoma and cataracts
- Signs of swelling of blood vessels in patients suffering from asthma such as feeling of tingling or pricking sensation or numbness in your arms or legs, flu like symptoms, rashes, pain and swelling of the sinuses
- Signs of decreased blood potassium levels (hypokalemia) such as constipation, muscle damage, tiredness
- Increased blood sugar levels (hyperglycemia)
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and relax. Drink plenty of fluids such as water. Apply a pain-relieving balm on the forehead if necessary. Consult your doctor if the symptom does not improve.
Stomach discomfort:
Stick to simple meals. Drink sufficient amount of fluids. Avoid eating oily, fried or spicy foods. Take adequate rest. Consult your doctor if the symptom does not improve
Fungal infection of the mouth and throat (thrush):
Rinse your mouth with water each time after using the medicine. Do not swallow the water. Maintain good oral hygiene. Consult your doctor if the symptom worsens.
Vomiting:
Stick to simple meals. Drink sufficient amount of fluids. Avoid eating oily, fried and spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Throat pain:
Gargle with warm saline water or betadine solution at regular intervals throughout the day. Avoid eating spicy and hard solid food items which are difficult to swallow. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in pregnant women only if considered clearly necessary. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
BREASTFEEDING
SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in breastfeeding women as it may pass into breast milk. Your doctor may advice you to use SYMBICORT TURBUHALER 4.5+160MCG if considered clearly necessary. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
LIVER
SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in patients with liver impairment. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
ALLERGY
Do not use SYMBICORT TURBUHALER 4.5+160MCG if you are allergic to budesonide or formoterol or any other ingredients of this medicine.
LUNGS
SYMBICORT TURBUHALER 4.5+160MCG is not recommended for use in patients with sudden severe symptoms of asthma or COPD (chronic obstructive pulmonary disease). Also, do not use SYMBICORT TURBUHALER 4.5+160MCG in patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids and for relief of acute symptoms (bronchospasm). It should be used with caution in patients with active or quiescent tuberculosis infections of the respiratory tract. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
HEART DISEASE
SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in patients with heart problems especially coronary insufficiency (insufficient blood flow through one or more coronary arteries), irregular heartbeat and high blood pressure. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
OTHERS
Before using SYMBICORT TURBUHALER 4.5+160MCG, inform your doctor if you have:
- Fits (seizures)
- Thyroid problems
- Diabetes
- Osteoporosis, poor nutrition, or immobilized for long period
- Immune system problem
- Eye problems such as increased pressure in the eye, glaucoma or cataract
- Any type of viral, bacterial, fungal or parasitic infection
- Exposed to chicken pox and measles
Use in Pediatrics:
SYMBICORT TURBUHALER 4.5+160MCG is not recommended for use in children (below 6 years of age) due to lack of safety and effectiveness and it should be used with caution in children and adolescents (above 6 years of age). Child’s doctor may monitor the growth of children while using this medicine. Consult child’s doctor for advice regarding the use of SYMBICORT TURBUHALER 4.5+160MCG in children.
Use in Geriatrics:
SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in elderly patients (aged 65 years and above) with heart diseases. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
INTERACTIONS
A. Drug-Drug Interactions:
Before using SYMBICORT TURBUHALER 4.5+160MCG, inform your doctor if you are taking any of the following medicines:
- Medicines used to treat asthma and chronic obstructive pulmonary disease (COPD) such as long-acting beta agonists (LABAs) (Ex. salmeterol, arformoterol)
- Medicines used to reduce inflammation such as oral corticosteroids (Ex. prednisolone, cortisone)
- Monoamine oxidase inhibitors such as isocarboxazid, phenelzine and tricyclic antidepressants such as amitriptyline, desipramine (used to treat depression)
- Medicines used to treat high blood pressure such as beta blockers (Ex. atenolol, labetalol, propranolol), loop diuretics (Ex. bumetanide, furosemide) thiazide diuretics (Ex. chlorothiazide, chlorthalidone, hydrochlorothiazide)
- Ketoconazole, itraconazole (used to treat fungal infections)
- Clarithromycin, erythromycin and telithromycin (used to treat bacterial infections)
- Ritonavir, indinavir, atazanavir, nefazodone, nelfinavir, saquinavir (used to treat HIV infection)
Overdosage:
If you or anyone else accidentally use more SYMBICORT TURBUHALER 4.5+160MCG, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are fits, chest pain, fluctuation in blood pressure (high or low), increased heart rate, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, increased blood sugar and decreased potassium levels and in extreme rare conditions it causes cardiac arrest and even death.
SYNOPSIS
| Drug | : | Budesonide, Formoterol |
| Pharmacological Category | : | Inhaled corticosteroids and Long acting beta-adrenergic agonists |
| Therapeutic Indication | : | Asthma and Chronic obstructive pulmonary disease (COPD) |
| Dosage Forms | : | Turbuhaler |
MORE INFORMATION
- Keep SYMBICORT TURBUHALER 4.5+160MCG out of reach of children
- Store at room temperature
FAQs ABOUT SYMBICORT TURBUHALER 4.5+160MCG
What is SYMBICORT TURBUHALER 4.5+160MCG used for?
SYMBICORT TURBUHALER 4.5+160MCG is a combination of budesonide and formoterol which is used to prevent and control symptoms of asthma (in adults and in children above 6 years of age). Also, it is used to treat symptoms such as breathing difficulties as well as to reduce the number of flare ups in patients suffering from chronic obstructive pulmonary disease (COPD). Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG.
What are the common side effects of using SYMBICORT TURBUHALER 4.5+160MCG?
The common side effects of using SYMBICORT TURBUHALER 4.5+160MCG are throat irritation, pain, flu, nasal congestion, inflammation of mucous membrane of the sinuses (sinusitis), back pain, fungal infection (thrush) in the mouth and throat, stomach discomfort, headache and vomiting. Consult your doctor if any symptom worsens or persists for long period of time.
Is SYMBICORT TURBUHALER 4.5+160MCG safe to use in children?
SYMBICORT TURBUHALER 4.5+160MCG is not recommended for use in children (below 6 years of age) due to lack of safety and effectiveness and it should be used with caution in children and adolescents (above 6 years of age). Child’s doctor may monitor the growth of children while using this medicine. Consult child’s doctor for advice regarding the use of SYMBICORT TURBUHALER 4.5+160MCG in children.
Can I use SYMBICORT TURBUHALER 4.5+160MCG during pregnancy?
SYMBICORT TURBUHALER 4.5+160MCG should be used with caution in pregnant women only if clearly advised by your doctor. Consult your doctor before using SYMBICORT TURBUHALER 4.5+160MCG if you are pregnant or planning to get pregnant.
How to prevent getting fungal infection (thrush) in the mouth and throat while using SYMBICORT TURBUHALER 4.5+160MCG?
Use SYMBICORT TURBUHALER 4.5+160MCG only when advised by your doctor. Do not self-medicate. Rinse your mouth with water and spit the water out after each dose of SYMBICORT TURBUHALER 4.5+160MCG. Do not swallow the water. Gargle and maintain good oral hygiene to prevent fungal infection in the mouth while using SYMBICORT TURBUHALER 4.5+160MCG.
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. May 2018. [Accessed on 1st August 2022] https://www.nejm.org/doi/full/10.1056/nejmoa1715274
3. Sharafkhaneh, Amir, John G, Mitchell G, Tom U, and J. Martin. Effect of budesonide/formoterol pMDI on COPD exacerbations: a double-blind, randomized study. Respiratory medicine. 2012. [Accessed on 1st August 2022] https://www.resmedjournal.com/action/showPdf?pii=S0954-6111%2811%2900255-1
4. AstraZeneca Pharmaceuticals LP. Symbicort (budesonide 80/160 mcg and formoterol 4.5mcg). [Revised in December 2017] [Accessed on 1st August 2022] https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/a4b62ab8-1314-4583-91b4-294ec239f790/a4b62ab8-1314-4583-91b4-294ec239f790_pi_med_guide_rendition__c.pdf
5. AstraZeneca Pharmaceuticals LP. U.S Food and Drug Administration, [Revised in January 2017] [Accessed on 1st August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Absolute Eosinophil Count
- Complete Blood Count
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