Alvesco 80 Inhaler

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ciclesonide

Available from:

ASTRAZENECA SINGAPORE PTE LTD

ATC code:

R03BA08

Dosage:

80 mcg/ actuation

Pharmaceutical form:

AEROSOL, METERED

Composition:

Ciclesonide 80 mcg/ actuation

Administration route:

OROPHARYNGEAL

Prescription type:

Prescription Only

Manufactured by:

3M Health Care Limited

Authorization status:

ACTIVE

Authorization date:

2007-02-07

Summary of Product characteristics

ALVESCO
®
PACKAGE INSERT
ALVESCO
® 80 AND 160 INHALER
1. NAME OF THE MEDICINAL PRODUCT
ALVESCO® 80 micrograms pressurised inhalation, solution;
ALVESCO® 160 micrograms pressurised inhalation, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ALVESCO
®
80 inhaler: 1 actuation (delivered dose from the mouthpiece) contains
80 micrograms
of ciclesonide.
ALVESCO
®
160 inhaler: 1 actuation (delivered dose from the mouthpiece) contains
160
micrograms of ciclesonide.
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pressurised inhalation, solution
Clear and colourless
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ALVESCO
®
is Indicated as prophylactic treatment of asthma in adults,
adolescents and in children
6 years of age and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose range for adult patients is 80 to 320 mcg per
day.
The recommended starting dose for adult patients previously maintained
on bronchodilator
therapy alone is 80 mcg once daily.
Patients previously maintained on another inhaled corticosteroid may
require a higher dose
depending on their current maintenance dose.
The dose should be adjusted to the lowest dose at which effective
control of asthma is
maintained.
For once daily dosing, ALVESCO
®
should preferably be administered in the evening although
morning dosing of ALVESCO
®
has also been shown to be effective. The final decision on morning
or evening dosing should be left to the discretion of the physician.
Symptoms start to improve with ALVESCO
®
within 24 hours of treatment. Once control is
achieved, the dose of ALVESCO
®
should be individualized and titrated to the minimum dose
needed to maintain good asthma control.
ALVESCO
®
is for oral inhalation use only.
Symptoms start to improve with ALVESCO
®
within 24 hours of treatment. However, due to its
prophylactic nature, ALVESCO
®
should be taken regularly even when patients are asymptomatic.
DOSING RECOMMENDATION FOR ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND
OLDER:
The recommended dose range is 8