Indacaterol

Registered South African indications:

• Chronic obstructive pulmonary disease

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Monotherapy in the treatment of asthma

Cautions

• Pregnancy
• Breastfeeding 
• Severe hepatic impairment 
• Elderly 
• Acute asthma
• Cardiovascular disease
• Seizure disorders
• Thyrotoxicosis
• Known or suspected QT prolongation 
• Hypokalaemia
• Diabetes
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption 

Forms avail. in SA and covered in this monograph: cps

Chronic obstructive pulmonary disease

• Inhaled (cps): 150μg, dly; Max: 300μg/24hrs

Only administer using inhaler provided

Only remove capsule from packaging prior to use

DO NOT swallow capsules

Use at the same time each day

If a dose is missed, it should be taken at the usual time the next day

Not established for use in children

Pregnancy

• Caution
• There are no data from the use of indacaterol in pregnant women available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures. Like other beta2-adrenergic agonists, indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle. Indacaterol should only be used during pregnancy if the expected benefits outweigh the potential risks

Breastfeeding

• Caution
• It is not known whether indacaterol/metabolites are excreted in human milk. Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk. A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from indacaterol therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Renal impairment

• No dosage adjustment recommended

Hepatic impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no information available

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Prohibited - At all times

Central Nervous System Disorders

• Headache
• Dizziness
• Paraesthesia

Cardiovascular Disorders

• Ischaemic heart disease
• Atrial fibrillation
• Palpitations
• Tachycardia
• Chest pain
• Peripheral oedema

Respiratory Disorders

• Cough
• Oropharyngeal pain 
• Rhinorrhoea
• Paradoxical bronchospasm
• Upper respiratory tract infection
• Nasopharyngitis
• Sinusitis

Endocrine and Metabolic Disorders

• Diabetes mellitus 
• Hyperglycaemia

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash

Musculoskeletal and Connective Tissue Disorders

• Muscle spasm
• Myalgia
• Musculoskeletal pain

• Sympathomimetic agents
• Methylxanthine derivatives
• Steroids
• Diuretics
• Beta blockers
• QT prolonging agents

None routine. Specific cases may require

• Blood glucose
• Lung function test

Indacaterol is a selective long-acting beta-2 adrenoceptor agonist. It increases cyclic adenosine monophosphate, which causes relaxation of bronchial smooth muscle.

Capsules, lung admin 150μg

• Onbrez Breezhaler 150μg (Novartis) originator