Therapeutic Class: Long-acting selective β-adrenoceptor stimulants
Indications:
Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Indications:
Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Presentation:
Indacaterol Maleate 150 Convicap: Each capsule contains Indacaterol Maleate INN equivalent to 150 µg Indacaterol.
Description:
Indacaterol is a long-acting β2-adrenergic agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pharmacology:
Indacaterol is a long-acting β2-adrenergic agonist. It relaxes the bronchial smooth muscle by selective action on β2-receptor which acts locally in the lungs and with little effect on heart rate.
When inhaled, Indacaterol acts locally in the lung as a bronchodilator. The pharmacological effects of β2-adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic monophosphate. Increased cyclic AMP levels cause relaxation of bronchial smooth muscle.
Dosage & Administration:
Description:
Indacaterol is a long-acting β2-adrenergic agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Pharmacology:
Indacaterol is a long-acting β2-adrenergic agonist. It relaxes the bronchial smooth muscle by selective action on β2-receptor which acts locally in the lungs and with little effect on heart rate.
When inhaled, Indacaterol acts locally in the lung as a bronchodilator. The pharmacological effects of β2-adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic monophosphate. Increased cyclic AMP levels cause relaxation of bronchial smooth muscle.
Dosage & Administration:
- Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.
- The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75/150 mcg Indacaterol capsule using the device.
- Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.
Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.
Contraindications:
All LABA are contraindicated in patients with asthma without the use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.
Side Effects:
The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis, and dizziness.
Pregnancy & Lactation:
Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. The indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.
Precautions & Warnings:
Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta-agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.
Use in Special Populations:
The expected signs and symptoms associated with overdosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis, and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Indacaterol powder.
Storage:
Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.
Contraindications:
All LABA are contraindicated in patients with asthma without the use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.
Side Effects:
The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis, and dizziness.
Pregnancy & Lactation:
Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. The indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.
Precautions & Warnings:
Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta-agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.
Use in Special Populations:
- Geriatric patients: No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renal impaired patients.
- Hepatic impairment: No data are available for subjects with severe hepatic impairment.
- Hepatic use: Not indicated for use in the hepatic impairment. Safety and efficacy have not been established.
The expected signs and symptoms associated with overdosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis, and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an overdose of Indacaterol powder.
Storage:
Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.
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