Medication info

Symbicort Rapihaler 160/4.5 Micrograms

Prescription medicationSuspension
Ingredient · strength
Budesonide Micronized›160μgFormoterol Fumarate Hydrate Micronized›4.5μg
Manufacturer / importer
한국아스트라제네카(주)
Appearance
An inhalation aerosol containing a suspension that leaves a white powder after spraying and cannot be visually confirmed with other substances.
Packaging
120 doses/container
Approval status
Active

MFDS item code 201503496 · Approved 2015.05.29 · Insurance code 650700950

Summary

Main use
Improvement of asthma and severe chronic obstructive pulmonary disease
Who uses it
Adults · Children
Adult dosage
Asthma: Adults aged 18 years and older, inhale 2 puffs, 1 or 2 times a day. During exacerbations of asthma, it may be inhaled as a temporary maximum of 4 puffs, up to 2 times a day as the maintenance dose. Chronic obstructive pulmonary disease: Inhale 2 puffs, 2 times a day, with a maximum of 4 puffs per day.
Children's dosage
For adolescents aged 12-17 years, inhale 2 puffs, 2 times a day.

Ingredients

Importer
한국아스트라제네카(주)

Efficacy & effects

Improvement of asthma and severe chronic obstructive pulmonary disease

  • Asthma
  • chronic obstructive pulmonary disease
View approved original text

Used for the treatment of asthma patients and severe chronic obstructive pulmonary disease.

Dosage and Administration

Adult dosage

Asthma: Adults aged 18 years and older, inhale 2 puffs, 1 or 2 times a day. During exacerbations of asthma, it may be inhaled as a temporary maximum of 4 puffs, up to 2 times a day as the maintenance dose. Chronic obstructive pulmonary disease: Inhale 2 puffs, 2 times a day, with a maximum of 4 puffs per day.

Children's dosage

For adolescents aged 12-17 years, inhale 2 puffs, 2 times a day.

Precautions

This medication contains two ingredients, Budesonide and Formoterol, and is used for the treatment of respiratory diseases such as asthma or chronic obstructive pulmonary disease. Patients who are allergic to this medication or have experienced side effects should not use it. Patients who have had impaired adrenal function due to systemic steroid treatment in the past should be cautious when using this medication. Common side effects when using this medication include tremors, palpitations, and headaches, which are usually mild and disappear within a few days. For patients with chronic obstructive pulmonary disease, there may be a slightly higher risk of developing skin bruising or pneumonia, so caution is necessary. Rarely, cardiac arrhythmias, hypokalemia, hypersensitivity reactions, and oral and throat candidiasis may occur. When discontinuing treatment, do not stop suddenly; instead, gradually reduce the dosage, and if symptoms worsen, seek medical attention immediately. Even if there are no symptoms, it is important to continue taking the medication as directed by your doctor, and always carry a rescue inhaler. When using this medication, it is advisable to rinse the mouth clean after administration to prevent oral candidiasis. Especially with long-term use of high doses, systemic side effects such as growth delay, decreased bone density, cataracts, and glaucoma may occur, so regular check-ups are necessary. Diabetes patients should pay attention to blood sugar control, and patients at risk of hypokalemia should monitor their blood potassium levels. Since there may be interactions with other medications, caution should be taken to avoid taking it with beta-blockers or strong CYP3A4 inhibitors. During pregnancy or breastfeeding, it should only be used at the minimum dose when necessary, considering the effects on the fetus or infant. This medication is not to be used in children under 12 years of age. In cases of overdose, symptoms may include tremors, palpitations, hypotension, and hypokalemia, and you should contact a medical institution immediately. When using the inhaler, it is important to shake well before use, rinse the mouth with water after inhalation, and keep the inhaler clean.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, anaphylaxis → severe allergic reactions
  • Bronchospasm, paradoxical bronchospasm → breathing problems
  • Angina pectoris → serious heart conditions
  • Adrenal insufficiency (adrenal suppression), growth delay, decreased bone density, cataracts, glaucoma → systemic corticosteroid effects
  • Increased blood pressure, severe edema
  • Severe arrhythmias (atrial fibrillation, supraventricular tachycardia, extrasystoles, etc.)
  • High fever with severe skin reactions (rash,

Mild side effects

  • Tremors
  • palpitations
  • tachycardia
  • nausea
  • headaches
  • dizziness
  • restlessness
  • anxiety
  • nervousness
  • sleep disturbances
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  • depression
  • behavioral problems
  • mild throat irritation
  • coughing
  • hoarseness
  • bruising
  • blood pressure fluctuations
  • blurred vision
  • oral thrush
  • pneumonia
  • hypokalemia
  • hyperglycemia
  • muscle cramps

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, avoid extremely hot or cold places, and it is safe to store it at room temperature, between 1°C and 30°C.

Appearance and packaging

Appearance

An inhalation aerosol containing a suspension that leaves a white powder after spraying and cannot be visually confirmed with other substances.

Package unit

120 doses/container

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.