Symbicort

What Is Symbicort

SYMBICORT is a combination product containing a corticosteroid (budesonide) and a long-acting beta2-adrenergic agonist (formoterol fumarate dihydrate).

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What are the uses of this medicine?

This medicine is indicated for:

• Treatment of asthma in patients 6 years of age and older.
• Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

Who Should Not Use this medicine ?

• SYMBICORT is NOT indicated for the relief of acute bronchospasm.

SYMBICORT cannot be used in the following conditions:

• Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.
• Hypersensitivity to any of the ingredients in SYMBICORT.

Is this medicine FDA approved

• Budesonide/formoterol was approved for medical use in the United States in 2006.
• It is on the World Health Organization's List of Essential Medicines, the safest and most effective medicines needed in a health system.
• In 2018, it was the 62nd most commonly prescribed medication in the United States, with more than 12 million prescriptions.

How should this medicine be used?

• SYMBICORT should be administered as 2 inhalations twice daily (morning and evening, approximately 12 hours apart), every day by the orally inhaled route only.
• After inhalation, the patient should rinse the mouth with water without swallowing.
• Prime SYMBICORT before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray.
• More frequent administration or a higher number of inhalations (more than 2 inhalations twice daily) of the prescribed strength of SYMBICORT is not recommended.

What are the dosage forms and brand names of this medicine?

• SYMBICORT is available as a metered-dose inhaler containing a combination of budesonide (80 or 160 mcg) and formoterol (4.5 mcg) as an inhalation aerosol in the following two strengths: 80/4.5 and 160/4.5.
• Each dosage strength contains 60 or 120 actuations per/canister.
• Each strength of SYMBICORT is supplied with a red plastic actuator with a gray dust cap.

Treatment of asthma in patients 12 years and older: 2 inhalations of SYMBICORT 80/4.5 or 160/4.5 twice daily. Starting dosage is based on asthma severity. Treatment of asthma in patients aged 6 to less than 12 years: 2 inhalations of SYMBICORT 80/4.5 twice daily. Maintenance treatment in COPD: 2 inhalations of SYMBICORT 160/4.5 twice daily.

What side effects can this medication cause?

Common possible side effects of this medicine when used for asthma include:

• nasopharyngitis
• headache
• upper respiratory tract infection
• pharyngolaryngeal pain, sinusitis
• influenza
• back pain
• nasal congestion
• stomach discomfort
• vomiting
• oral candidiasis.

Common possible side effects of this medicine when used for COPD include:

• nasopharyngitis
• oral candidiasis
• bronchitis
• sinusitis
• upper respiratory tract infections.

What special precautions should I follow?

• Do not use in acutely deteriorating asthma or COPD or to treat acute symptoms.
• Do not use in combination with additional long-acting beta2-agonist because of risk of overdose.
• Monitor patients periodically for signs of adverse effects on the oral cavity.
• Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
• Monitor patients for signs and symptoms of pneumonia and other potential lung infections.
• Use with caution in patients with existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections.
• Discontinue SYMBICORT and institute alternative therapy if paradoxical bronchospasm occurs.
• Assess bone mineral density initially and periodically while using this medication.
• Monitor growth of pediatric patients.
• Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia.

What to do in case of emergency/overdose?

SYMBICORT contains both budesonide and formoterol; therefore, the risks associated with overdosage for the individual components described below apply to SYMBICORT.

Budesonide

• The potential for acute toxic effects following overdose of budesonide is low.
• If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur

Formoterol An overdose of formoterol would likely lead to an exaggeration of effects that are typical for beta2-agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia.

• Treatment of formoterol overdosage consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive therapy.
• There is insufficient evidence to determine if dialysis is beneficial for over dosage of formoterol.
• Cardiac monitoring is recommended in cases of over dosage.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of SYMBICORT or one of its individual components, formoterol fumarate, in pregnant women.

Can this medicine be used for Pediatrics?

• Safety and effectiveness of SYMBICORT in asthma patients 12 years of age and older have been established.
• The safety and effectiveness of SYMBICORT in asthma patients less than 6 years of age have not been established.

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20°C to 25°C (68°F to 77°F) .
• Store the inhaler with the mouthpiece down.
• For best results, the canister should be at room temperature before use.
• Shake well for 5 seconds before using.
• Keep out of the reach of children. Avoid spraying in eyes.
• Do not puncture or incinerate.
• Do not store near heat or open flame.
• Exposure to temperatures over 120ºF may cause bursting.
• Never throw container into fire or incinerator.

• Dailymed label info on Symbicort
• FDA Symbicort

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