Symbicort 80/4.5 Tab

Here is a detailed product description for SYMBICORT 80/4.5 Turbuhaler:

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SYMBICORT 80/4.5 Turbuhaler

Name

• Common Name: Budesonide/Formoterol Fumarate Dihydrate
• Brand Name: SYMBICORT 80/4.5 Turbuhaler. Please note that while the request mentioned "TAB," Symbicort 80/4.5 is typically available as an inhaler (specifically a Turbuhaler or HFA aerosol inhaler), not a tablet.

Composition Each delivered dose from the SYMBICORT 80/4.5 Turbuhaler contains:

• Active Ingredients: Budesonide 80 micrograms (an inhaled corticosteroid) and Formoterol Fumarate Dihydrate 4.5 micrograms (a long-acting beta2-agonist).
• Excipient: Lactose monohydrate.

Uses SYMBICORT 80/4.5 Turbuhaler is indicated for the regular treatment of asthma and as a maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) in adults, aiming to improve lung function and prevent symptoms.

• Asthma: It is prescribed for patients whose asthma is not adequately controlled with inhaled corticosteroids and "as needed" short-acting beta2-agonists, or for those already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. It is suitable for patients aged 6 years and older.
• COPD: It helps alleviate symptoms like breathlessness and wheezing in COPD, though SYMBICORT 160/4.5 mcg is typically indicated for COPD maintenance treatment and reducing exacerbations.
• Important Note: SYMBICORT is not intended for the relief of acute bronchospasm or sudden severe symptoms and should not replace a rapid-acting rescue inhaler.

Dosage and Administration SYMBICORT is administered by inhalation. The dosage should be individualized based on disease severity and should be titrated to the lowest effective dose.

• Asthma (Adults and Adolescents 12 years and older): Typically, 1 to 2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
• Asthma (Children 6-11 years): Usually 2 inhalations twice daily.
• Maintenance and Reliever Therapy (SMART): In some cases, SYMBICORT can be used as both regular maintenance treatment and as needed in response to symptoms.
• Administration: Patients should rinse their mouth with water and spit it out after each maintenance dose to minimize the risk of oropharyngeal thrush.

Side Effects

• Common Side Effects: Headache, sore throat, oral thrush (yeast infection in the mouth/throat), upper respiratory tract infection (e.g., common cold, flu, sinusitis), nasal congestion, back pain, stomach discomfort, nausea, vomiting, cough, and hoarse voice.
• Serious Side Effects: Paradoxical bronchospasm (unexpected tightening of airways), increased heart rate, palpitations, tremor, high blood pressure, decreased bone mineral density, adrenal suppression, growth retardation in children, glaucoma, cataracts, and increased susceptibility to infections (e.g., pneumonia).

Precautions

• Hypersensitivity: Contraindicated in patients with known hypersensitivity to budesonide, formoterol, or lactose.
• Acute Symptoms: Not for acute relief of bronchospasm. A separate rapid-acting bronchodilator is needed for rescue.
• Cardiovascular Conditions: Use with caution in patients with heart conditions, high blood pressure, or a history of QT prolongation, as it can cause an increase in heart rate and changes in blood pressure.
• Diabetes: May increase blood sugar levels; blood glucose monitoring is recommended.
• Infections: Corticosteroids can mask signs of infection and increase susceptibility to infections. Avoid contact with sick individuals.
• Liver Impairment: Increased exposure to the active ingredients may occur in patients with severe liver cirrhosis.
• Eye Conditions: Long-term use of inhaled corticosteroids can lead to glaucoma and cataracts; monitoring is warranted.
• Osteoporosis: May decrease bone density; discuss bone health with your doctor.
• Drug Interactions: Caution with strong CYP3A4 inhibitors (e.g., itraconazole, ritonavir), beta-blockers, diuretics, and certain antidepressants (MAO inhibitors, tricyclic antidepressants).
• Discontinuation: Do not stop treatment abruptly; the dose should be tapered under medical supervision.

Storage Store at room temperature, typically between 20°C and 25°C (68°F to 77°F), away from heat and direct sunlight. Keep the container tightly closed and store with the mouthpiece down. Do not puncture the canister or expose it to fire or high heat. Keep out of sight and reach of children.

1. What is Symbicort 80/4.5 used for?

Symbicort 80/4.5 is a combination inhaler prescribed for the regular treatment and maintenance of asthma in adults and children aged 6 years and older. It is also used as a maintenance treatment for chronic obstructive pulmonary disease (COPD) in adults, including chronic bronchitis and emphysema, to help reduce the frequency and severity of exacerbations. It's important to understand that Symbicort 80/4.5 is not a rescue inhaler and should not be used for sudden breathing difficulties or acute asthma attacks.

2. How does Symbicort 80/4.5 work?

Symbicort 80/4.5 contains two active medications: Budesonide and Formoterol. Budesonide is an inhaled corticosteroid (ICS) that works by reducing inflammation, swelling, and irritation in the airways of the lungs. Formoterol is a long-acting beta2-agonist (LABA) that relaxes and widens the muscles around the airways, making breathing easier. These two components work together to provide additive effects in managing respiratory symptoms and reducing exacerbations.

3. What is the usual dosage of Symbicort 80/4.5?

For asthma, the typical dosage for adults and adolescents (12 years and older) is two puffs (inhalations) twice per day, usually taken approximately 12 hours apart. For children aged 6 to 11 years, the recommended dosage is two puffs of Symbicort 80 mcg/4.5 mcg twice daily. Your doctor will determine the appropriate strength and dosage based on your specific condition and its severity. Symbicort 80/4.5 is not considered appropriate for patients with severe asthma.

4. What are the possible side effects of Symbicort 80/4.5?

Common side effects of Symbicort 80/4.5 can include headache, sore throat, hoarse voice, upper respiratory tract infections (such as the common cold, flu, or sinusitis), nasal congestion, back pain, and stomach discomfort. Oral thrush (a fungal infection in the mouth and throat) is also a common side effect associated with inhaled corticosteroids; rinsing your mouth with water and spitting it out after each dose can help prevent this. More serious, though less common, side effects may include increased heart rate, tremors, and, in rare instances, severe allergic reactions, pneumonia, or paradoxical bronchospasm.

5. Is Symbicort 80/4.5 safe during pregnancy or breastfeeding?

During pregnancy, Symbicort should only be used if the potential benefits clearly outweigh the possible risks. The lowest effective dose of budesonide should be utilized to maintain adequate asthma control. Budesonide is excreted in breast milk, but at typical therapeutic doses, no adverse effects on a nursing infant are anticipated. It is not definitively known if formoterol passes into human breast milk. If you are breastfeeding, your doctor will weigh the expected benefits to you against any potential risks to your child before recommending Symbicort.

6. Can Symbicort 80/4.5 be taken with other medications?

Symbicort 80/4.5 can interact with certain other medications. For example, strong inhibitors of CYP3A4 enzymes (such as ketoconazole, itraconazole, ritonavir, atazanavir, clarithromycin, indinavir, nelfinavir, and telithromycin) can increase the plasma levels of budesonide, potentially leading to increased side effects. Beta-blockers, including certain eye drops, may reduce the effectiveness of formoterol and could cause severe bronchospasm in individuals with asthma. Additionally, monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants can increase the effect of formoterol on heart rate and blood pressure. Always inform your doctor about all prescription and over-the-counter medications, supplements, and herbal products you are taking.

7. What precautions should be taken when using Symbicort 80/4.5?

It is crucial to remember that Symbicort is not a rescue inhaler for acute symptoms; always have a separate short-acting rescue inhaler available. After each use, rinse your mouth thoroughly with water and spit it out to reduce the risk of oral thrush. Exercise caution if you have pre-existing conditions such as cardiovascular disorders (including heart disease, high blood pressure, irregular heartbeat, or QT prolongation), diabetes, thyroid problems, seizure disorders, osteoporosis, or eye conditions like cataracts or glaucoma. Long-term use of inhaled corticosteroids can affect eye health, bone mineral density, and adrenal gland function. Do not abruptly stop taking Symbicort, as this can worsen your breathing problems.

8. What happens if a dose of Symbicort 80/4.5 is missed?

If you miss a dose of Symbicort, you should skip the missed dose and take your next scheduled dose at the usual time. Do not take an extra dose or double up to compensate for the missed one, as this could increase the chance of experiencing side effects.

9. How should Symbicort 80/4.5 be stored?

Symbicort should be stored in a dry place at controlled room temperature, typically between 20°C and 25°C (68°F and 77°F). Keep the inhaler out of the reach of children. The canister is pressurized; do not puncture it, throw it into a fire, or store it near heat or open flame. Some Symbicort inhalers should be stored with the mouthpiece down. If your inhaler is a metered-dose inhaler, it needs to be primed before its first use, and again if it hasn't been used for more than 7 days. After the foil package is opened, some inhalers may have an expiration period, such as 3 months.