Budesonide and Formoterol

Symbicort Inhaler

Symbicort Inhaler is an FDA-approved medication that combines Budesonide, an anti-inflammatory corticosteroid, and Formoterol, a bronchodilator. It is used for managing asthma and COPD. It has two strengths: 80/4.5 and 160/4.5 micrograms. It’s typically recommended to take two puffs twice daily. The dosage is also individualized by healthcare professionals. It is suitable for adults and children over 6 years. Symbicort side effects may include throat irritation, tremors, and headache. Rinsing your mouth after using it is advised to prevent oral fungal infections. If a dose is missed, take it promptly unless close to the next scheduled dose. Store at room temperature, away from heat, moisture, and children. Strictly adhere to your healthcare provider’s guidance to ensure effective results.

Product Overview

Symbicort Inhaler is a medication primarily approved by the FDA for managing asthma and chronic obstructive pulmonary disease (COPD). This inhaler contains two active ingredients: Budesonide and Formoterol. Budesonide is a corticosteroid that decreases inflammation in the airways. Formoterol is a long-acting beta-agonist that helps relax the muscles in the airways, making breathing easier. It is a combination therapy that provides anti-inflammatory and bronchodilator effects, offering comprehensive relief for individuals with respiratory conditions.

It is available in two strengths: one containing 80 micrograms of Budesonide and 4.5 micrograms of Formoterol per inhalation and the other with 160 micrograms of Budesonide and 4.5 micrograms of Formoterol per inhalation. The usual recommended dosage involves administering two puffs twice daily, although a healthcare provider must determine the appropriate dosage based on individual needs. Symbicort Inhaler is suitable for adults and children over 6 years who require maintenance treatment for asthma or COPD.

Symbicort side effects may include throat irritation, headache, or tremors. You should rinse your mouth with water after each use to minimize the risk of oral fungal infections. In case of a missed dose should be taken as soon as remembered unless it’s almost time for the next dose. Store the inhaler at room temperature, away from heat and light, and out of reach for children. You should adhere closely to the guidance and warnings provided by your healthcare provider for optimal management of your respiratory condition.

Uses

Targeted Treatment

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

[Important Warning: Symbicort Inhaler is not appropriate for treating sudden asthma attacks or bronchospasms.]

Benefits

• Prevent asthma symptoms such as wheezing, coughing, shortness of breath, and chest tightness in adults and children aged 6 years or older.
• Helps improve lung function.

[Note: Do not use Symbicort Inhaler without consulting your doctor. They will determine whether you need this medication based on your conditions.]

Symbicort Inhaler Dosage

Forms & Strengths

Form: Metered-dose inhaler

Strengths: 80 /4.5 mcg, 160 /4.5 mcg

Recommended Dosage

For Asthma

• Adults and Adolescents (12 Years and Older): 

• • • The initial Symbicort dosing is 2 inhalations 80/4.5 or 160/4.5 twice daily.
    • The maximum dosage is 2 inhalations of Symbicort 160/4.5 twice daily.
    • Adjustments may be needed based on individual responses.

• Pediatric Patients (6 to Less Than 12 Years): 2 inhalations of 80/4.5 twice daily.

For Chronic Obstructive Pulmonary Disease (COPD)

• The recommended dosage is 2 inhalations of Symbicort 160/4.5 twice daily.

[Note: These Symbicort dosing recommendations may vary from individual to individual. Consult your healthcare professional, and they’ll determine your dosage accordingly.]

How to Take It?

Here are the steps for using a Symbicort Inhaler:

Step 1. Remove the cap from the mouthpiece of the inhaler.

Step 2. Hold the inhaler upright with the mouthpiece facing upwards.

Step 3. Shake the inhaler well for 5 seconds to ensure the medication is mixed correctly.

Step 4. Take a deep breath out to empty your lungs.

Step 5. Place the mouthpiece between your lips and close your lips around it to form a seal.

Step 6. Start breathing in slowly and deeply through your mouth.

Step 7. Take the inhaler out of your mouth once you have inhaled the medication.

Step 8. Hold your breath for about 10 seconds or for as long as is comfortable.

Step 9. Rinse your mouth with water after using the inhaler to help prevent oral thrush.

Step 10. Put the cap back on the mouthpiece to protect it from dust and debris.

[Note: Your doctor will decide the proper Symbicort dosing for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Symbicort Inhaler Work?

Symbicort Inhaler combines two active ingredients: Budesonide, a corticosteroid, and Formoterol, a long-acting beta-agonist (LABA). Budesonide reduces inflammation in the airways, decreasing swelling and mucus production, which helps to prevent asthma symptoms. Formoterol relaxes the muscles around the airways to widen them, allowing for easier breathing. Together, these medications provide both anti-inflammatory and bronchodilator effects, effectively managing asthma symptoms by reducing airway inflammation and opening the airways, thereby improving lung function and preventing asthma exacerbations.

Important Safety Information

Side Effects

Common side effects of Symbicort Inhaler may include:

• Headache
• Throat irritation
• Nasal congestion
• Sinus pain
• Respiratory infections (such as the common cold)
• Nausea

Mild side effects of Symbicort Inhaler may include:

• Tremor (shakiness)
• Nervousness
• Dizziness
• Cough
• Hoarseness or voice changes
• Muscle cramps

Serious side effects of Symbicort Inhaler may include:

• Worsening asthma symptoms (increased wheezing, shortness of breath, chest tightness)
• Paradoxical bronchospasm (sudden worsening of breathing difficulties)
• Allergic reactions (rash, itching, swelling of the face, tongue, or throat, severe dizziness)
• Increased heart rate
• Increased blood pressure
• Decreased potassium levels in the blood (hypokalemia)
• Reduced bone mineral density (osteoporosis)
• Adrenal insufficiency (especially with long-term use)
• Glaucoma or cataracts (rare, but possible with long-term use)
• Immunosuppression (increased risk of infections)

[Note: This list may not cover all Symbicort side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

• Exacerbation of Asthma Symptoms: Symbicort inhalers may exacerbate asthma symptoms, including increased wheezing and chest tightness, particularly during the initiation of treatment. Patients should be monitored closely for worsening asthma symptoms after starting Symbicort Inhaler therapy.
• Paradoxical Bronchospasm: Symbicort Inhaler can cause paradoxical bronchospasm, characterized by a sudden worsening of breathing difficulties. If paradoxical bronchospasm occurs, Symbicort Inhaler should be discontinued immediately, and alternative therapy should be initiated.
• Cardiovascular Effects: Symbicort inhalers, like other medications containing beta-agonists, may cause cardiovascular effects such as increased heart rate, blood pressure, and palpitations. Caution is advised in patients with cardiovascular disorders, including arrhythmias, hypertension, and coronary artery disease.
• Immune System Effects: Corticosteroids, one of the active ingredients in Symbicort Inhaler, can suppress the immune system, increasing the risk of infections. Patients should be advised to avoid exposure to contagious diseases, and healthcare providers should closely monitor for signs of infection during treatment.
• Adrenal Suppression: Prolonged use of Symbicort Inhaler may lead to adrenal suppression, particularly in patients receiving high doses or those with underlying adrenal insufficiency. Healthcare providers should monitor adrenal function regularly in patients receiving long-term Symbicort Inhaler therapy.
• Osteoporosis and Bone Health: Corticosteroids can decrease bone mineral density over time, increasing the risk of osteoporosis and fractures. Patients at risk for osteoporosis, such as postmenopausal women or those with a family history of osteoporosis, should be monitored closely, and preventive measures should be implemented as appropriate.
• Ocular Effects: Long-term use of corticosteroids may increase the risk of ocular conditions such as cataracts and glaucoma. Patients should undergo regular eye examinations to detect changes in vision or ocular health.
• Hypersensitivity Reactions: Angioedema, rash, and urticaria have been reported with Symbicort Inhaler. Patients should be advised to discontinue Symbicort Inhaler and seek medical attention if they experience signs or symptoms of a hypersensitivity reaction.

Boxed Warning

• Asthma-Related Death: Symbicort Inhaler is not indicated for the treatment of acute asthma exacerbations of asthma-related death. A placebo-controlled study with another LABA (salmeterol) demonstrated an increase in asthma-related deaths in patients receiving salmeterol. This finding is considered a class effect of LABAs, including Formoterol. Controlled clinical trials suggest that LABAs may also increase the risk of asthma-related hospitalization in pediatric and adolescent patients. 

Precautions

• Use as Directed: Use Symbicort Inhaler precisely as your healthcare provider prescribes. Only alter the dose or frequency of use after consulting your doctor.
• Not for Acute Symptoms: Symbicort Inhaler is not intended to relieve acute asthma symptoms or exacerbations. It should not be used as a rescue medication for sudden breathing difficulties.
• Regular Monitoring: You should regularly monitor your asthma symptoms and lung function using Symbicort Inhaler. Contact your doctor if your symptoms worsen or require more frequent use of rescue inhalers.
• Avoid Triggering Substances: Minimize exposure to asthma triggers such as allergens, pollutants, smoke, and respiratory infections while using Symbicort Inhaler to help prevent asthma exacerbations.
• Do Not Abruptly Discontinue: Do not abruptly stop using Symbicort Inhaler without consulting your healthcare provider, as this may lead to worsening asthma symptoms or withdrawal effects.
• Adrenal Function Monitoring: Your doctor may periodically monitor your adrenal function, especially if you are on long-term or high-dose therapy.
• Bone Health Monitoring: Your doctor may recommend bone density testing and preventive measures if you are at risk for osteoporosis.
• Eye Examinations: Regular eye examinations may be necessary during the long-term use of Symbicort Inhaler to monitor for potential ocular side effects such as cataracts or glaucoma.
• Hypersensitivity Reactions: Be aware of signs of hypersensitivity reactions such as rash, itching, swelling of the face or throat, or difficulty breathing. Discontinue Symbicort Inhaler and seek medical attention if these symptoms occur.
• Medical Alert: Inform healthcare providers about your use of Symbicort Inhaler before undergoing any surgical procedures or starting new medications, as it may interact with certain drugs or procedures.

Contraindications

• Hypersensitivity to any of the ingredients in Symbicort.
• Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures.

Missed Dose

• If you forget to take a dose of Symbicort Inhaler, take it as soon as you recall.
• If your next dose is approaching, skip the missed one.
• Avoid taking extra doses to compensate for the missed one.
• Continue with your usual dosing schedule the following day.

[Note: If you need a Symbicort dosing and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

Symptoms of overdose may include:

• Chest pain
• Fast or irregular heartbeat
• Tremors
• Seizures
• Fainting

[Note: If you consumed more than the recommended Symbicort dosing, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Store the Symbicort Inhaler at room temperature, away from moisture and heat.
• Avoid direct sunlight and keep children out of reach.
• Keep the Symbicort inhaler sealed until ready for use.
• Do not freeze the Symbicort inhaler.
• Check the expiration date and discard it if it has expired.

[Note: Discuss with your healthcare professional about the proper disposal of any unused Symbicort Inhaler and any questions you may have regarding its storage.]

Symbicort Inhaler Interactions

• Strong CYP3A4 inhibitors:
  • Ketoconazole
  • Ritonavir
  • Atazanavir
  • Clarithromycin
  • Indinavir
  • Itraconazole
  • Nefazodone
  • Nelfinavir
  • Saquinavir
  • Telithromycin
• Diuretics
• Theophylline
• Testosterone
• Steroids (Prednisone or other corticosteroids)
• Monoamine oxidase inhibitors (MAOIs)
• Tricyclic antidepressants (amitriptyline and nortriptyline)
• QTc prolonging drugs

[Note: This isn’t a complete list, and there could be other drugs that interact with Symbicort Inhaler. Tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

Symbicort Inhaler Alternatives

• Trelegy (fluticasone/umeclidinium/vilanterol)
• Advair Diskus (fluticasone/salmeterol)
• Breztri (fluticasone/umeclidinium/vilanterol)
• Breo Ellipta (fluticasone/vilanterol)
• Dulera (mometasone/formoterol)

[Note: Your doctor will choose the best Symbicort Inhaler alternative. Only use these alternative medications after consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

1. Is it safe to use Symbicort Inhaler during Pregnancy?

Symbicort inhalers are generally safe to use during pregnancy. There is no increased risk of adverse pregnancy outcomes or congenital disabilities associated with its use. However, always consult your healthcare provider to determine the best treatment plan for managing asthma during pregnancy.

2. Can I use Symbicort Inhaler as a rescue inhaler?

Symbicort Inhaler is not typically used as a rescue inhaler. It is a maintenance medication designed for the long-term management of asthma and COPD. For immediate relief during an asthma attack, rely on a short-acting bronchodilator like Albuterol. Always consult your healthcare provider for personalized advice.

3. How often should I use Symbicort Inhaler?

Symbicort Inhaler is used twice daily, with each dose containing a combination of Budesonide (a corticosteroid) and Formoterol (a long-acting beta-agonist). Always follow your doctor’s instructions for the correct dosage and frequency.

4. How long does it take to see results from Symbicort Inhaler?

The onset of action for Symbicort Inhaler can vary, but most individuals start experiencing improvements within 15 minutes after using it. However, the full benefits may take a few weeks of consistent use. Remember to follow your healthcare provider’s guidance for optimal results.

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