Summary
- Main use
- Treatment of asthma, relief of symptoms of severe chronic obstructive pulmonary disease
- Who uses it
- Adults · Children
- Adult use
- This medicine is for oral inhalation only. For patients who have difficulty coordinating aerosol actuation with inhalation, an inhalation aid may be used. 1. Asthma This medicine is not for the initial treatment of asthma, and the dose should be individually adjusted according to disease severity. This should be considered both when initiating treatment and when adjusting the dose. If an individual patient requires a combination dose other than those available with this combination product, appropriate doses of a β2-agonist or corticosteroid in separate inhalers should be prescribed. This medicine is effective in treating asthma at a lower dose than beclomethasone dipropionate in other inhalers. Therefore, patients who have used another inhaler containing beclomethasone dipropionate before using this medicine should consult their physician about the appropriate dose. Patients should be assessed regularly to maintain the optimal dose of this medicine, and should not change the dose on their own without advice from a physician or pharmacist. It should also be used every day for optimal effect, even when symptoms are absent. The dose should be the lowest dose that effectively controls symptoms. Once asthma symptoms are controlled with the lowest dose of this medicine, inhaled corticosteroid monotherapy may be tried as the next step. 1. Regular maintenance therapy: 1) Patients should always carry a separate short-acting bronchodilator for treatment of worsening asthma symptoms or sudden asthma attacks. 2) Recommended dose • Adults: Inhale 1~2 puffs orally twice daily. • The maximum number of inhalations per day is 4. 2. Maintenance and reliever therapy 1) This medicine is used as maintenance therapy, with additional inhalations as needed for symptom relief. Patients should always carry this medicine for rescue treatment. 2) Maintenance and reliever therapy with this medicine should be considered particularly for the following patients: • Patients whose asthma is not adequately controlled and who require symptom-relief therapy • Patients with a history of asthma exacerbations requiring medical intervention 3) Patients who use this medicine frequently for symptom relief require monitoring for dose-related adverse reactions. 4) Recommended dose: • Adults: Inhale 1 puff orally twice daily (once in the morning and once in the evening). • Patients may take 1 additional inhalation as needed according to symptoms. If symptoms persist after several minutes, an additional inhalation is required. • The maximum number of inhalations per day is 8. • Patients who frequently need daily inhalations for symptom relief should seek medical advice, have their condition reassessed, and have their maintenance therapy reconsidered. 3. Chronic obstructive pulmonary disease • Adults: Inhale 2 puffs orally twice daily. ○ Older adults Dose adjustment is not necessary in older adults. ○ Patients with hepatic or renal impairment There are no data on the use of this medicine in patients with hepatic or renal impairment. However, formoterol fumarate dihydrate is primarily metabolized in the liver, so drug exposure may increase when administered to patients with severe cirrhosis.
- Child use
- The safety and efficacy of this medicine in children under 18 years of age have not been established.
Ingredients
- Importer
- KOLON PHARMA
Efficacy & effects
Treatment of asthma, relief of symptoms of severe chronic obstructive pulmonary disease
- Symptoms of asthma and severe chronic obstructive pulmonary disease
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This medication is used when a combination therapy of a long-acting bronchodilator and an inhaled corticosteroid is deemed necessary for the treatment of asthma. It also helps alleviate symptoms in patients with severe chronic obstructive pulmonary disease who experience repeated exacerbations despite regular treatment with long-acting bronchodilators. This medication is used to effectively improve symptoms of respiratory diseases.
How to use
Adult use
This medicine is for oral inhalation only. For patients who have difficulty coordinating aerosol actuation with inhalation, an inhalation aid may be used. 1. Asthma This medicine is not for the initial treatment of asthma, and the dose should be individually adjusted according to disease severity. This should be considered both when initiating treatment and when adjusting the dose. If an individual patient requires a combination dose other than those available with this combination product, appropriate doses of a β2-agonist or corticosteroid in separate inhalers should be prescribed. This medicine is effective in treating asthma at a lower dose than beclomethasone dipropionate in other inhalers. Therefore, patients who have used another inhaler containing beclomethasone dipropionate before using this medicine should consult their physician about the appropriate dose. Patients should be assessed regularly to maintain the optimal dose of this medicine, and should not change the dose on their own without advice from a physician or pharmacist. It should also be used every day for optimal effect, even when symptoms are absent. The dose should be the lowest dose that effectively controls symptoms. Once asthma symptoms are controlled with the lowest dose of this medicine, inhaled corticosteroid monotherapy may be tried as the next step. 1. Regular maintenance therapy: 1) Patients should always carry a separate short-acting bronchodilator for treatment of worsening asthma symptoms or sudden asthma attacks. 2) Recommended dose • Adults: Inhale 1~2 puffs orally twice daily. • The maximum number of inhalations per day is 4. 2. Maintenance and reliever therapy 1) This medicine is used as maintenance therapy, with additional inhalations as needed for symptom relief. Patients should always carry this medicine for rescue treatment. 2) Maintenance and reliever therapy with this medicine should be considered particularly for the following patients: • Patients whose asthma is not adequately controlled and who require symptom-relief therapy • Patients with a history of asthma exacerbations requiring medical intervention 3) Patients who use this medicine frequently for symptom relief require monitoring for dose-related adverse reactions. 4) Recommended dose: • Adults: Inhale 1 puff orally twice daily (once in the morning and once in the evening). • Patients may take 1 additional inhalation as needed according to symptoms. If symptoms persist after several minutes, an additional inhalation is required. • The maximum number of inhalations per day is 8. • Patients who frequently need daily inhalations for symptom relief should seek medical advice, have their condition reassessed, and have their maintenance therapy reconsidered. 3. Chronic obstructive pulmonary disease • Adults: Inhale 2 puffs orally twice daily. ○ Older adults Dose adjustment is not necessary in older adults. ○ Patients with hepatic or renal impairment There are no data on the use of this medicine in patients with hepatic or renal impairment. However, formoterol fumarate dihydrate is primarily metabolized in the liver, so drug exposure may increase when administered to patients with severe cirrhosis.
Child use
The safety and efficacy of this medicine in children under 18 years of age have not been established.
Precautions
This medication should not be used by those allergic to specific ingredients. Patients who have previously received steroid therapy and may have adrenal function problems, patients with heart disease, those with excessive thyroid function, and diabetic patients should use this medication with caution. In addition, caution should be exercised when administering to patients with hypokalemia or pulmonary tuberculosis, and it is important to regularly monitor blood glucose and potassium levels. This medication contains beclometasone and formoterol, and various side effects such as oral candidiasis, headache, palpitations, cough, wet cough, diarrhea, dry mouth, dyspepsia, dysphagia, lip burning, nausea, taste disturbances, pruritus, rash, sweating, muscle cramps, muscle pain, thrombocytopenia can occur. After inhalation, rinse or gargle the mouth thoroughly to reduce the risk of oral infection, and do not abruptly discontinue treatment; taper the dosage gradually as directed by your physician. If asthma symptoms worsen or are not controlled, consult your healthcare provider immediately, and if bronchospasm occurs during treatment, immediate emergency treatment is required. This medication should be used with caution during pregnancy, especially in late pregnancy, and while breastfeeding, it is advisable to administer after consulting with a physician. In pediatric or elderly patients, safety and effectiveness are not established or may be compromised due to declining physiological function, thus requiring extra caution. This medication may interact with other drugs, so inform your healthcare provider of any other medications you are taking, especially when using heart-related medications or beta-blockers. In case of overdose, coronary-specific abnormal symptoms or electrolyte imbalances may occur, necessitating immediate medical treatment, and the instructions for use of this medication should be followed precisely. The inhaler should be used with the correct posture and slow, deep inhalation, and the inhalation port should be kept clean after use. When storing, keep it in a cool place out of the reach of children, refrigerate it, and it is safe to use within 3 months after the start of administration.
Side effects
- pharyngitis
- oral candidiasis
- influenza
- oral fungal infection
- oropharyngeal candidiasis
- esophageal candidiasis
- vaginal candidiasis
- gastroenteritis
- sinusitis
- rhinitis
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- pneumonia
- agranulocytosis
- thrombocytopenia
- allergic dermatitis
- erythema
- lip swelling
- facial swelling
- eye swelling
- pharyngeal swelling
- adrenal insufficiency
- hypokalemia
- hyperglycemia
- headache
- restlessness
- tremors
- dizziness
- psychomotor agitation
- sleep disturbances
- anxiety
- depression
- aggressive behavior changes
- eustachitis
- glaucoma
- cataract
- blurred vision
- palpitations
- QTc interval prolongation
- ECG changes
- tachycardia
- arrhythmia
- atrial fibrillation
- congestion
- flushing
- ventricular premature contraction
- angina
- blood pressure variability
- dysphonia
- cough
- productive cough
- throat irritation
- asthma attack
- bronchospasm
- dyspnea
- asthma exacerbation
- diarrhea
- dry mouth
- dyspepsia
- dysphagia
- burning sensation of the lips
- nausea
- taste disturbance
- pruritus
- rash
- hyperhidrosis
- urticaria
- angioedema
- muscle cramps
- myalgia
- growth delay
- nephritis
- lower extremity edema
- increased C-reactive protein
- increased platelet count
- elevated free fatty acids
- increased insulin
- elevated ketones
- decreased serum cortisol
- decreased bone density
- oral pain
- sore throat
- buccal mucosa roughness
- hemorrhagic gastritis
- oral discomfort
- stomatitis
- thirst
- dysuria
- hoarseness
- conjunctival injection
- chest discomfort
- nausea
- vomiting
- metabolic acidosis
- Cushing's syndrome
- Cushing's appearance
- loss of appetite
- abdominal pain
- weight loss
- fatigue
- hypotension
- diminished consciousness
- hypoglycemia
- seizures
Not everyone experiences these, and they can vary from person to person.
Storage
This medication should be stored in a tightly sealed container to prevent exposure to air and light, and it should be kept refrigerated at temperatures between 2 and 8 degrees Celsius to maintain its effectiveness and safety.
Appearance and packaging
Appearance
A colorless and transparent liquid with a light yellow tint contained in an aluminum can fitted with a valve that dispenses a set amount of spray.
Package unit
120 doses/inhaler
Questions about this medicine
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For anything that needs medical judgment, consult a doctor or pharmacist.