Salmeterol

Registered South African indications:

• Asthma
• Chronic obstructive pulmonary disease

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Hepatic impairment 
• Acute asthma
• Cardiovascular disease
• Thyrotoxicosis
• Diabetes mellitus
• Hypokalaemia
• Lactose intolerance
• Concomitant use of systemic ketoconazole
• Patients with cognitive impairment (poor inhaler technique)

Forms avail. in SA and covered in this monograph: acc, inh

Chronic asthma (Additional agent required)
Chronic obstructive pulmonary disease

• Inhaled (acc, inh): 50-100μg, 12hrly; Max: 200μg/24hrs

Not to be used as monotherapy in asthma (see additional prescribing points)

Paed. forms avail. in SA and covered in this monograph: acc, inh

Chronic asthma (Additional agent required)

Younger than 4 years

• Not established for use 

Older than 4 years

• Inhaled (acc, inh): 50μg, 12hrly; Max: 100μg/24hrs

Not to be used as monotherapy in asthma (see additional prescribing points)

Pregnancy

• Caution
• A moderate amount of clinical data on pregnant women (between 300 to 1000 pregnancy outcomes) indicate no malformative or foetal/ neonatal toxicity of salmeterol. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity with the exception of evidence of some harmful effects on the foetus at very high dose levels. As a precautionary measure, it is preferable to avoid the use of salmeterol during pregnancy

Breastfeeding

• Caution
• Available pharmacodynamic/toxicological data in animals have shown excretion of salmeterol in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from salmeterol therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Nervousness
• Insomnia
• Headache 
• Tremor 
• Dizziness

Cardiovascular Disorders

• Palpitations 
• Tachycardia
• Arrhythmias
• Chest pain

Respiratory Disorders

• Oropharyngeal irritation
• Paradoxical bronchospasm

Gastrointestinal Disorders

• Nausea

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hyperglycaemia

Musculoskeletal Disorders

• Muscle cramps
• Arthralgia

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylactic reactions
• Anaphylactic shock

• Beta blockers
• Xanthine derivatives
• Steroids
• Diuretics
• CYP3A4 inhibitors
• CYP3A4 inhibitors

None routine. Specific cases may require

• Serum potassium
• Blood glucose
• Vital signs

• Patients with asthma should never be on a long-acting beta agonist (such as Salmeterol or Formoterol) without an inhaled corticosteroid
• Salmeterol Accuhaler should be used regularly. The full benefits of treatment will be apparent after several doses of the drug

Salmeterol is a selective long-acting beta-2 adrenoceptor agonist with a long side chain which binds to the exo-site of the receptors in the lungs and on bronchiolar smooth muscle. This causes relaxation of bronchial smooth muscle, bronchodilation and increased bronchial airflow.

Inhaler 25μg 

• Serevent Inhaler CFC-Free (Aspen) originator

Accuhaler 50μg 

• Serevent Accuhaler (GSK) originator

COMBINATION PREPARATIONS

Salmeterol/ Fluticasone propionate

Inhaler 25μg/50μg

• Sereflo 25/50 Hfa (Cipla)
• Foxair inhaler (Aspen) originator
• Seretide CFC inhaler (GSK)

Inhaler 25μg/125μg

• Sereflo 25/125 Hfa (Cipla)
• Foxair inhaler (Aspen) originator
• Seretide CFC inhaler (GSK)

Inhaler 25μg/250μg

• Sereflo 25/250 Hfa (Cipla)
• Foxair inhaler (Aspen) originator
• Seretide CFC inhaler (GSK)

Accuhaler 50μg/100μg

• Foxair Accuhaler (Aspen)
• Seretide Accuhaler (GSK)

Accuhaler 50μg/250μg

• Foxair Accuhaler (Aspen)
• Seretide Accuhaler (GSK)

Accuhaler 50μg/500μg

• Foxair Accuhaler (Aspen)
• Seretide Accuhaler (GSK)