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HSA Approval

FLIXOTIDE NEBULES 0.5 mg/2 ml

SIN11112P

FLIXOTIDE NEBULES 0.5 mg/2 ml

FLIXOTIDE NEBULES 0.5 mg/2 ml

September 14, 1999

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

**Dosage and Administration** Pharmaceutical form: Suspension for inhalation by nebulisation. Patients should be made aware of the prophylactic nature of therapy with inhaled _FLIXOTIDE_ and that it should be taken regularly even when they are asymptomatic. _FLIXOTIDE_ Nebules should be administered as an aerosol produced by a jet nebuliser, as directed by a physician. As drug delivery can be affected by a wide range of criteria, please refer to the directions recommended by the manufacturer of the nebuliser equipment. Use of _FLIXOTIDE_ Nebules with ultrasonic nebulisers is not generally recommended. _FLIXOTIDE_ for nebulisation should not be injected. _FLIXOTIDE_ for nebulisation is intended for oral inhalation, and use of a mouthpiece is recommended. If use of a face mask is necessary, nasal inhalation may occur. Maximal improvement in asthma may be achieved within four to seven days of starting treatment. However, _FLIXOTIDE_ has been shown to have a therapeutic effect as soon as 24 hours after starting treatment for patients who have not previously received inhaled steroids. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. To aid administration of small volumes of the suspension, or if a prolonged delivery time is desirable, _FLIXOTIDE_ suspension for nebulisation may be diluted immediately before use with sodium chloride injection. As many nebulisers operate on a continuous flow basis, it is likely that nebulised drug will be released in the local environment. _FLIXOTIDE_ Nebules should therefore be administered in a well ventilated room, particularly in hospitals when several patients may be using nebulisers at the same time. **ASTHMA** - **Adults and adolescents over 16 years** 500 to 2000 micrograms twice daily. - **Children and adolescents from 4 to 16 years of age** 1000 micrograms twice daily. Patients should be given an initial dose of nebulised _FLIXOTIDE_ which is appropriate for the severity of their disease. The dosage should then be adjusted until control is achieved or reduced to the minimum effective dose according to the individual response. A dose at the upper end of the range is recommended for the treatment of acute exacerbations of asthma for up to seven days after exacerbation. Consideration should then be given to reducing the dosage. - **Special patient groups** There is no need to adjust the dose in elderly patients or in those with hepatic or renal impairment.

RESPIRATORY (INHALATION)

Medical Information

**Indications** **ASTHMA** _FLIXOTIDE_ has a marked anti-inflammatory effect in the lungs. It reduces symptoms and exacerbations of asthma in patients previously treated with bronchodilators alone or with other prophylactic therapy. Relatively brief symptomatic episodes can generally be relieved by the use of fast-acting bronchodilators, but longer lasting exacerbations require, in addition, the use of corticosteroid therapy as soon as possible, to control the inflammation. - **Adults and adolescents over 16 years of age** Prophylactic management in severe asthma (Patients requiring high dose inhaled or oral corticosteroid therapy): On introduction of inhaled _FLIXOTIDE_ many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly or to eliminate their requirement for oral corticosteroids. - **Children and adolescents from 4 to 16 years of age** Treatment of acute exacerbations of asthma: Subsequent maintenance dosing may be more conveniently accomplished using a pressurised metered-dose inhaler or powder formulation.

**Contraindications** _FLIXOTIDE_ Nebules are contraindicated in patients with a history of hypersensitivity to any of its components.

R03BA05

fluticasone

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE AUSTRALIA PTY LTD

Active Ingredients

FLUTICASONE PROPIONATE (micronised)

0.5 mg/2 ml

Documents

Package Inserts

Flixotide Nebules PI.pdf

Approved: November 2, 2020

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