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Indacaterol Maleate: Brands, Price & Uses in Bangladesh

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):…

About Indacaterol Maleate

Indications of Indacaterol Maleate

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 indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Important Labeling Distinctions

  • Indacaterol Maleate is NOT indicated for the treatment of asthma. Safety and efficacy of Indacaterol Maleate in asthma have not been established, and LABA monotherapy is associated with an increased risk of asthma-related death (see Precautions and Warnings).
  • Indacaterol Maleate is NOT a rescue medication and must not be used to treat acute deteriorations of COPD or acute episodes of bronchospasm.

Dosage & Administration of Indacaterol Maleate

Dosing by Indication

IndicationPopulationRecommended Dose
COPD maintenance bronchodilator therapyAdultsThe contents of one inhalation capsule (strength as prescribed) are inhaled orally once daily, using the dedicated inhaler device, at the same time each day.
COPDPediatric patientsNot indicated; safety and efficacy have not been established in patients under 18 years of age (see Use in Special Populations).

Renal and Hepatic Impairment

  • Renal impairment: No dose adjustment is generally required in mild-to-severe renal impairment; clinical experience in severe renal impairment and end-stage renal disease is limited, and Indacaterol Maleate should be used with caution in these patients.
  • Hepatic impairment: No dose adjustment is required in mild-to-moderate hepatic impairment. Indacaterol Maleate has not been studied in severe hepatic impairment and should be used with caution in this population.

Maximum Dose

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.

Side Effects of Indacaterol Maleate

The most commonly reported adverse effects with Indacaterol Maleate include:

  • Nasopharyngitis (common cold-like symptoms)
  • Cough
  • Headache
  • Nausea
  • Musculoskeletal pain (including back pain)
  • Hypertension
  • Sinusitis and upper respiratory tract infection

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).

Contraindications of Indacaterol Maleate

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.

Frequently Asked Questions about Indacaterol Maleate

What is Indacaterol Maleate used for?

Indacaterol Maleate is a long-acting inhaled bronchodilator used once daily for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). It is not used to treat asthma and is not a rescue inhaler for sudden breathing difficulty.

Can Indacaterol Maleate be used for an asthma attack or sudden shortness of breath?

No. Indacaterol Maleate is not a rescue medication and must not be used for acute symptoms or asthma attacks. A fast-acting rescue inhaler prescribed by your physician should be used for sudden symptoms, and you should seek medical attention if you need your rescue inhaler more often than usual.

Is Indacaterol Maleate safe to use during pregnancy?

Data on Indacaterol Maleate use in pregnancy are limited. It may affect uterine contractions if used near labor. Indacaterol Maleate should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus, and only under a physician's supervision.

What are the most common side effects of Indacaterol Maleate?

The most common side effects include nasopharyngitis (cold-like symptoms), cough, headache, nausea, muscle or back pain, and mild increases in blood pressure. Less commonly, it can cause a fast heartbeat, palpitations, or tremor. Contact your physician if these are severe or persistent.

Why does Indacaterol Maleate carry a warning about asthma-related death if it is used for COPD?

Indacaterol Maleate belongs to a class of medicines called long-acting beta2-agonists (LABAs), which as a class carry a boxed warning because LABA monotherapy has been associated with an increased risk of asthma-related death. Indacaterol Maleate itself is approved only for COPD, not asthma, and should never be used to treat asthma.

What should I do if I miss a dose or think I have taken too much Indacaterol Maleate?

If you miss a dose, take it as soon as you remember, but do not take a double dose to make up for a missed one, and never take more than one dose in 24 hours. If you suspect an overdose, or experience symptoms such as chest pain, rapid or irregular heartbeat, or severe tremor, seek immediate medical attention or contact a poison control center right away.

Disclaimer

The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.

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