Symbitrol

Indications

Asthma

Symbitrol is indicated in is indicated in adults, adolescents, and children aged 6 years and older for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β 2 adrenoceptor agonist) is appropriate:

• Patients not adequately controlled with inhaled corticosteroids and “ as needed”

inhaled short-acting β 2 adrenoceptor agonists. or

• Patients already adequately controlled on both inhaled corticosteroids and

long-acting β 2 adrenoceptor agonists.

Chronic Obstructive Pulmonary Disease (COPD)

Symbitrol is indicated in adults, aged 18 years and older, for the symptomatic

treatment of patients with COPD with forced expiratory volume in 1 second

(FEV1) <70% predicted normal (post bronchodilator) and an exacerbation

history despite regular bronchodilator therapy

Dosage & Administration:

Asthma: For Symbitrol there are two treatment approaches:

• Maintenance therapy: Symbitrol is taken as regular maintenance treatment

with a separate rapid-acting bronchodilator as rescue.

• Maintenance and reliever therapy: Symbitrol is taken as regular maintenance

treatment and as needed in response to symptoms.

• Reliever therapy: Taken as needed in response to symptoms

1. Maintenance Therapy: Symbitrol 6/200 1-2 inhalations twice daily; some patients may require up to a maximum of 4 inhalations twice daily.

Symbitrol 12/400: 1 inhalation twice daily; some patients may require up to a

maximum of 2 inhalations twice daily. some patients may require up to a

maximum of 8 actuations twice daily.

Adolescents (12-17 years): Symbitrol 6/200 1-2 inhalations twice daily.

Symbitrol 12/400 1 inhalation twice daily. Children (6 years and older):

.

1. Maintenance and reliever therapy (MART): Symbitrol 6/100 & 6/200, can

be taken as a regular maintenance and as needed, as a reliever, in response to

asthma symptoms for adults and adolescents (12 years and older) only.

Symbitrol 6/200: 2 inhalations per day, either as 1 inhalation in the

morning and evening or as 2 inhalations once daily, either morning or evening.

Take 1 additional inhalation as needed in response to symptoms. If symptoms

persist after a few minutes, 1 additional inhalation should be taken. Not more

than 6 inhalations should be taken on any single occasion. Patients using more

than 8 inhalations daily should be reassessed. The maximum daily dose is 12

inhalations for a limited period.

1. Reliever therapy: Adults and adolescents (12 years and older):

Symbitrol 6/200 Patients should take 1 inhalation as needed in response to

symptoms. If symptoms persist after a few minutes, an additional inhalation

should be taken. Not more than 6 inhalations should be taken on any single

occasion.

COPD: Symbitrol 12/400: The usual dose is 1 inhalation twice daily. Only to be used by adults (aged 18 years and above).

How supplied:

Symbitrol 6/200 Sykonahaler: One Sykonahaler device contains a foil strip

with 60 doses. It is packaged in a moisture-protective foil pouch and a polyester

fabric bag is provided for convenient handling.

Symbitrol 12/400 Sykonahaler: One Sykonahaler device contains a foil strip

with 60 doses. It is packaged in a moisture-protective foil pouch and a polyester