Medication info
Atectra Inhalation Capsule 150/160 Micrograms

Atectra Inhalation Capsule 150/160 Micrograms

Prescription medication
Ingredient · strength
Indacaterol Acetate›0.173mg / 1 capsuleMometasone Furoate›0.16mg / 1 capsule
Manufacturer / importer
한국노바티스(주)
Appearance
An inhalation capsule containing a white to almost white powder with a colorless transparent upper and lower part (attached to the Breezhaler inhaler)
Packaging
30 capsules/pack
Approval status
Active

MFDS item code 202009235 · Approved 2020.12.24 · Insurance code 653603330

Summary

Main use
Maintenance treatment of asthma
Who uses it
Adults · Children
Adult dosage
Adults and adolescents aged 12 and older inhale 1 capsule of this medication at 150/80 micrograms, 150/160 micrograms, or 150/320 micrograms once daily. The maximum recommended dose is 150/320 micrograms once daily. Attach 1 capsule of this medication to the provided inhaler and inhale it through the mouth. Capsules should not be swallowed and only the provided Breezhaler inhaler should be used.
Children's dosage
Safety and efficacy in pediatric patients under 12 years of age have not been established. Adolescents aged 12 and older use the same dosage as adults.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Maintenance treatment of asthma

View approved original text

This medication helps adults and adolescents aged 12 and older effectively manage asthma symptoms once daily. It is appropriately used as a combination therapy with a long-acting beta2 agonist and an inhaled corticosteroid for chronic maintenance treatment of asthma. This treatment helps reduce airway inflammation and aids in bronchial dilation, promoting easier breathing. It is effective in improving patient symptoms and preventing asthma attacks. Regular use allows for more stable asthma management. Therefore, this medication is used for maintenance treatment of asthma.

Dosage and Administration

Adult dosage

Adults and adolescents aged 12 and older inhale 1 capsule of this medication at 150/80 micrograms, 150/160 micrograms, or 150/320 micrograms once daily. The maximum recommended dose is 150/320 micrograms once daily. Attach 1 capsule of this medication to the provided inhaler and inhale it through the mouth. Capsules should not be swallowed and only the provided Breezhaler inhaler should be used.

Children's dosage

Safety and efficacy in pediatric patients under 12 years of age have not been established. Adolescents aged 12 and older use the same dosage as adults.

Precautions

This medication should not be used during acute asthma symptoms or acute bronchospasm. If asthma symptoms suddenly worsen or the use of a rescue bronchodilator becomes more frequent, medical attention should be sought immediately. Discontinuing this medication may lead to a return of asthma symptoms, so it should not be stopped arbitrarily without a doctor's supervision. If asthma symptoms do not improve or worsen during treatment, contact a physician immediately. If allergic reactions, angioedema, urticaria, or skin rashes occur after using this medication, stop use immediately and switch to other treatment. This medication can rarely cause paradoxical bronchospasm, which is bronchoconstriction that occurs as a reaction; if such symptoms occur, use should be stopped immediately. Patients with allergies to this medication or its components or those with specific genetic lactose issues should not use it. Patients with certain conditions such as heart disease, seizures, thyroid issues, hypokalemia, diabetes, or chronic infections should use this medication cautiously. Common side effects that may occur with this medication include headache, infection, hypersensitivity, angioedema, hyperglycemia, oropharyngeal pain, rash, and myalgia. As this medication can affect the cardiovascular system, those with heart disease should be monitored carefully if symptoms occur. Blood potassium levels may decrease, which can affect the heart, so testing may be needed if necessary. Diabetic patients should closely monitor changes in blood glucose levels. Due to the inhaled steroid component, prolonged high-dose use may cause systemic side effects, so it should be used at the minimum effective dose possible. The effects on the fetus of using this medication during pregnancy are not fully established; it should only be used if deemed necessary by a physician. During breastfeeding, this medication may partly excrete into breast milk, so the benefits and the mother's therapeutic needs should be considered together. Overdosage of this medication may result in symptoms such as increased heart rate, tremors, headache, vomiting, drowsiness, hypokalemia, and hyperglycemia, thus immediate medical assistance should be sought. It is for inhalation use only, and capsules should not be swallowed. It must be administered using the dedicated Breezhaler inhaler with correct methods, and the instructions must be learned thoroughly. After administration, rinse the mouth with water and do not swallow the rinsed water. Store the medication away from moisture and light in a cool place at or below 25 degrees Celsius, and keep it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, paradoxical bronchospasm, worsening of asthma, severe allergic reactions (including dyspnea, swallowing difficulties, swelling of the tongue/lips/face)

Mild side effects

  • Headache
  • candidiasis
  • hyperglycemia
  • oropharyngeal pain
  • dysphonia
  • rash
  • pruritus
  • musculoskeletal pain
  • muscle cramps
  • tachycardia

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

Storage

This medication should be stored in a cool place at or below 25 degrees Celsius, being careful to avoid exposure to light and moisture. Additionally, it is important to store it in a sealed container to prevent air exposure.

Appearance and packaging

Appearance

An inhalation capsule containing a white to almost white powder with a colorless transparent upper and lower part (attached to the Breezhaler inhaler)

Package unit

30 capsules/pack

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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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.