
Caterol75 mcg
Incepta Pharmaceuticals Ltd.
Indacaterol Maleate is an inhaled, long-acting beta2-adrenergic agonist (LABA) indicated for the following use: Established / FDA-Approved Indication Chronic Obstructive Pulmonary Disease (COPD):…
Indacaterol Maleate is an inhaled, long-acting beta2-adrenergic agonist (LABA) indicated for the following use:
| Indication | Population | Recommended Dose |
|---|---|---|
| COPD maintenance bronchodilator therapy | Adults | The contents of one inhalation capsule (strength as prescribed) are inhaled orally once daily, using the dedicated inhaler device, at the same time each day. |
| COPD | Pediatric patients | Not indicated; safety and efficacy have not been established in patients under 18 years of age (see Use in Special Populations). |
Do not exceed the once-daily recommended dose of Indacaterol Maleate. More frequent dosing or additional doses do not provide added benefit and increase the risk of adverse cardiovascular effects.
The most commonly reported adverse effects with Indacaterol Maleate include:
Less common but clinically important cardiovascular effects, consistent with the beta2-agonist class, include tachycardia, palpitations, and tremor. Rarely, paradoxical bronchospasm can occur (see Precautions and Warnings).
Indacaterol Maleate is contraindicated in patients with a known hypersensitivity to indacaterol or to any excipient in the formulation, including patients with severe milk protein allergy (due to the lactose monohydrate content of the capsules), in whom serious hypersensitivity or bronchospasm may occur.
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