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Respitide 25/250 solution

Dexa Medica

Ingredients in every dose

Salmeterol 25 mcg
Fluticasone 50 mcg

Each package contains

1 canister of 120 doses

Dosage form

solution

Dosage formPressurised inhalation; solution

Flavour

None

W.H.O. classification

R03A
R03A

A.T.C. Level 1

Anatomical Main group

R - Respiratory system
R03A

A.T.C. Level 2

Therapeutic subgroup

R03 - Drugs for Obstructive Airway Diseases
R03A

A.T.C. Level 3

Pharmacological subgroup

R03A - Adrenergics; Inhalants

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult your doctor.

Pregnancy

CAUTIONThis item may not be safe for use during pregnancy. Use with caution and after consultation with your doctor.

Lactation

CAUTIONThis item may not be safe for use during lactation. Use with caution and after consultation with your doctor.

Indication

Reversible obstructive airways disease (ROAD)
Respitide is indicated in the regular treatment of reversible obstructive airways disease (ROAD), including asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) is appropriate. This may include:
– Patients on effective maintenance doses of long-acting ß-agonist and inhaled corticosteroids
– Patients who are symptomatic on current inhaled corticosteroid therapy
– Patients on regular bronchodilator therapy who require inhaled corticosteroids
Chronic obstructive pulmonary disease (COPD)
Respitide is indicated for the regular treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Dosage

0 TO 4 YEARS OLD
There are no data available for use of salmeterol/fluticasone propionate in children aged under 4 years.

4 TO 12 YEARS OLD
— Reversible obstructive airways disease (ROAD)
Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate twice daily.

12 TO 18 YEARS OLD
Reversible obstructive airways disease (ROAD)
Two inhalations of 25 mcg salmeterol and 50 mcg fluticasone propionate twice daily
or
Two inhalations of 25 mcg salmeterol and 125 mcg fluticasone propionate twice daily
or
Two inhalations of 25 mcg salmeterol and 250 mcg fluticasone propionate twice daily.

18 TO 65 YEARS OLD
— Reversible obstructive airways disease (ROAD)
Doubling the dose of all strengths of RESPITIDE in adults for up to 14 days has comparable safety and tolerability to regular twice daily dosing and may be considered when patients require additional short-term (up to 14 days) inhaled corticosteroid therapy as outlined in asthma treatment guidelines.

— Chronic obstructive pulmonary disease (COPD)
For adult patients, the recommended dose is two inhalations 25/125 mcg to 25/250 mcg salmeterol/fluticasone propionate twice daily.

65 YEARS OLD AND ABOVE
There is no need to adjust the dose.

ADMINISTRATION
RESPITIDE inhaler is for inhalation only. Patients should be made aware that RESPITIDE Inhaler must be used regularly for optimum benefit, even when asymptomatic.

PATIENTS WITH HEPATIC IMPAIRMENT
There is no need to adjust the dose.

PATIENTS WITH RENAL IMPAIRMENT
There is no need to adjust the dose.