SYMBICORT RAPIHALER SUSPENSION FOR INHALATION 80/4.5 MCG/ACTUATION

ASTRAZENECA DUNKERQUE PRODUCTION (AZDP) (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Feb 24, 2016
Approval ID: bce3046d92abdf1b
Company: ASTRAZENECA DUNKERQUE PRODUCTION (AZDP) (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: bce3046d92abdf1b
Drug Name: SYMBICORT RAPIHALER SUSPENSION FOR INHALATION 80/4.5 MCG/ACTUATION
Product Name: SYMBICORT RAPIHALER SUSPENSION FOR INHALATION 80/4.5 MCG/ACTUATION
Approval Number: SIN14962P
Approval Date: 2016-02-24
Registrant: ASTRAZENECA SINGAPORE PTE LTD
Licence Holder: ASTRAZENECA SINGAPORE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: AEROSOL, METERED
Dosage: 4.2 Posology and method of Administration Asthma The dosage of the components of Symbicort Rapihaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2-agonists and/or corticosteroids by individual inhalers should be prescribed. Symbicort can be used according to different treatment approaches: <ol type="A"> <li>Symbicort anti-inflammatory reliever therapy.</li> <li>Symbicort anti-inflammatory reliever plus maintenance therapy.</li> </ol> As an alternative, Symbicort can be used in a fixed dose therapy: <ol type="A"> <li value="3">Symbicort maintenance therapy.</li> </ol> <ol type="A"> <li>Symbicort anti-inflammatory reliever therapy (patients with mild disease): Symbicort is taken as needed for the relief of asthma symptoms when they occur, and to prevent allergen- or exercise- induced bronchoconstriction (or to prevent symptoms in those circumstances recognised by the patient to precipitate an asthma attack). The formoterol component in Symbicort pMDI provides fast onset of effect (within 1–3 minutes) with long-acting (at least 12 hours after a single dose) bronchodilation in reversible airways obstruction. Patients should be advised to always have Symbicort available for relief of symptoms. Clinical studies have demonstrated that Symbicort anti-inflammatory reliever therapy provides significant reductions in severe exacerbations and was statistically superior on daily asthma symptom control compared to a short-acting β2 agonist therapy alone, and comparable to budesonide maintenance therapy given with as-needed short-acting β2 agonist in reducing severe exacerbations (see Section 5.1 Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Asthma symptom control was inferior for Symbicort as needed compared to a maintenance dose of corticosteroid given with as needed short-acting β2 agonist. Recommended doses: Physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency. <img src="/TGIF/SymbicortRapihaler-Table1_230922.png" alt="Symbicort Rapihaler Dosage Table 1" /> </li> <li>Symbicort anti-inflammatory reliever plus maintenance therapy: When maintenance treatment with a combination of inhaled corticosteroid and long-acting β2 agonist is required, Symbicort Rapihaler is taken both as an anti-inflammatory reliever and as regular maintenance treatment. The as needed inhalations provide both rapid relief of symptoms and improved asthma control. Patients should be advised to have Symbicort Rapihaler available for relief of symptoms at all times. A separate reliever inhaler is not necessary. Clinical studies have demonstrated that Symbicort anti-inflammatory reliever plus maintenance therapy provides clinically meaningful reductions in severe exacerbations while maintaining symptom control, compared to Symbicort maintenance therapy with a separate short-acting bronchodilator (see Section 5.1 Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Recommended doses: Physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the strength and dose frequency. When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. <img src="/TGIF/SymbicortRapihaler-Table2_230922.png" alt="Symbicort Rapihaler Dosage Table 2" /> </li> <li>Symbicort maintenance therapy (fixed dose): When maintenance treatment with a combination of inhaled corticosteroid and long-acting β2 agonist is required, Symbicort is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator as reliever. Patients should be advised to have their separate short-acting bronchodilator available for relief of symptoms at all times. Recommended doses: When control has been achieved, the dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. <img src="/TGIF/SymbicortRapihaler-Table3_230922.png" alt="Symbicort Rapihaler Dosage Table 3" /> </li> </ol> COPD <img src="/TGIF/SymbicortRapihaler-Table4_230922.png" alt="Symbicort Rapihaler Dosage Table 4" /> General information If patients take Symbicort as a maintenance therapy, they should be instructed that Symbicort Rapihaler must be used even when asymptomatic for optimal benefit. There are no special dosing requirements for elderly patients. There are no data available for use of Symbicort in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver diseases. Instructions for correct use of Symbicort Rapihaler On actuation of Symbicort Rapihaler, a volume of the suspension is expelled from the canister at high velocity. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways. Note: It is important to instruct the patient to: <ul> <li>Carefully read the instructions for use/handling in the leaflet which is packed together with each inhaler.</li> <li>Shake the inhaler gently prior to each use to mix its contents properly.</li> <li>Prime the 40/2.25 mcg/actuation inhaler by actuating it three times into the air when the inhaler is new, and two times if it has not been used for more than one week or if it has been dropped.</li> <li>Prime the 80/2.25, 160/4.5 and 80/4.5 mcg/actuation inhaler by actuating it two times into the air when the inhaler is new, if it has not been used for more than one week or if it has been dropped.</li> <li>Place the mouthpiece in the mouth. While breathing in slowly and deeply, press the device firmly to release the medication. Continue to breathe in and hold the breath for approximately 10 seconds or as long as is comfortable.</li> <li>Shake the inhaler again and repeat.</li> <li>Rinse the mouth with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.</li> <li>Clean the mouthpiece of the inhaler regularly, at least once a week with a clean dry cloth.</li> <li>Do not put the inhaler into water.</li> </ul> To enable patients with difficulty in coordinating inhalation with actuation to use Symbicort Rapihaler (such as young children or the elderly), a spacer device can be used. See Section 6.6 Instructions for use, handling and disposal for instructions for the correct use of Symbicort Rapihaler with a spacer device – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Route Of Administration: RESPIRATORY (INHALATION)
Indication Info: 4.1 Therapeutic indications Asthma Symbicort Rapihaler is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations. Symbicort Rapihaler is indicated for treatment of asthma, where the use of inhaled corticosteroids is appropriate. Chronic Obstructive Pulmonary Disease (COPD) Symbicort Rapihaler is indicated in the regular treatment of patients with severe COPD (FEV1 <50% predicted normal), with frequent symptoms and a history of exacerbations despite regular bronchodilator therapy.
Contraindications: 4.3 Contraindications Hypersensitivity (allergy) to budesonide, formoterol or any of the excipients.
Atc Code: R03AK07
Atc Item Name: formoterol and budesonide
Pharma Manufacturer Name: ASTRAZENECA SINGAPORE PTE LTD
Company Detail Path: /organization/astrazeneca-singapore-pte-ltd

Active Ingredients

Formoterol 3.7 mcg eqv Formoterol fumarate dihydrate micronised

4.5 mcg/actuation

Budesonide micronised

80 mcg/actuation

Budesonide micronised

80 mcg/actuation

Formoterol 3.7 mcg eqv Formoterol fumarate dihydrate micronised

4.5 mcg/actuation

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 24, 2016

Approval ID

bce3046d92abdf1b

Type

Therapeutic

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