Oxima 75 mcg

INDICATIONS

Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

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 mcg, 150 mcg, 300 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.No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.

INTERACTION

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.

SIDE EFFECTS

The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of 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. 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.

THERAPEUTIC CLASS

Long-acting selective β-adrenoceptor stimulants

STORAGE CONDITIONS

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.