Source: Medicines Authority (MT) Revision Year: 2022 Publisher: Glenmark Pharmaceuticals Nordic AB, Propellergatan 2, SE-211 15 Malmö, Sweden
Salmex is indicated for use in patients with severe asthma 12 years of age and older only.
Salmex is indicated in the regular treatment of patients with severe asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate:
Salmex is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.
Salmex is indicated in adults and adolescents 12 years of age and older only. Salmex is not indicated for use in children younger than 12 years of age.
Route of administration: Inhalation use.
Patients should be made aware that Salmex must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Salmex they are receiving remains optimal and is changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Note: Salmex is only available in one strength i.e. Salmeterol/Fluticasone 50 mcg/500 mcg. It is not available in the two lower strengths (i.e. salmeterol/fluticasone 50/250 and 50/100 mcg).
These strengths are available for other similar fixed-dose combination DPI products containing these two actives and currently available on the market.
Therefore, when it is appropriate to titrate down to a lower strength not available for Salmex a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.
Salmex should not be used for patients with mild or moderate asthma, in whom a low dose of the inhaled corticosteroid, either alone or with a long-acting β2 agonist, may be required.
Patients should be given the strength of the combination product containing the appropriate fluticasone propionate dosage for the severity of their disease. Salmex is appropriate for use in treatment of patients with severe asthma. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Once control of asthma is attained, treatment should be reviewed, and consideration given as to whether patients should be stepped down to a lower dose inhaled corticosteroid/LABA combination or ICS alone.
A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. In general, inhaled corticosteroids remain the first line treatment for most patients. Salmex is not intended for the initial management of mild or moderate asthma.
Salmex is for the treatment of patients with severe asthma only. It should not be used for the treatment of patients with mild or moderate asthma or for the initiation of treatment for patients with severe asthma unless the requirement for such a high dose of the corticosteroid together with a long-acting β2 agonist has been established previously.
Salmex is not intended as the treatment of asthma when a fixed-dose combination of salmeterol and fluticasone propionate is required for the first time. Patients should commence treatment with a fixed-dose combination containing a lower dose of the corticosteroid component and will then be titrated up in respect of the corticosteroid dose until control of asthma is achieved. Once control of asthma is achieved patients should be reviewed regularly and the dose of inhaled corticosteroid titrated downwards as appropriate to maintain disease control.
Children: Limited data are available. No recommendation on a posology can be made for children under 12 years of age.
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Salmex in patients with hepatic impairment.
The device is opened and primed by sliding the lever. The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled and the device closed.
There are no data available from clinical trials on overdose with Salmex inhaler, however data on overdose with both drugs are given below:
The signs and symptoms of salmeterol overdose are dizziness, increases in systolic blood pressure, tremor, headache and tachycardia. If Salmex therapy has to be withdrawn due to overdose of the β agonist component of the drug, provision of appropriate replacement steroid therapy should be considered. Additionally, hypokalaemia can occur and therefore serum potassium levels should be monitored. Potassium replacement should be considered.
Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not need emergency action as adrenal function is recovered in a few days, as verified by plasma cortisol measurements.
Chronic overdose of inhaled fluticasone propionate: Adrenal reserve should be monitored and treatment with a systemic corticosteroid may be necessary. When stabilised, treatment should be continued with an inhaled corticosteroid at the recommended dose. Refer to section 4.4: risk of adrenal suppression.
In cases of both acute and chronic fluticasone propionate overdose, Salmex therapy should be continued at a suitable dosage for symptom control.
2 years.
Store below 30°C, in the original package in order to protect from moisture.
Blisters made from polyamide (OPA)/Aluminium/polyvinyl chloride (PVC)/Aluminium/polyethylene terephthalate (PET)/paper contained in a molded plastic inhaler equipped with a mouthpiece and dose counter. The inhaler is packed in a cardboard box.
One inhaler contains 60 inhalations.
The plastic devices are available in cardboard containers, which hold 1 × 60 dose, 2 × 60 dose, 3x 60 dose, 10 × 60 dose Salmex
Not all pack sizes may be marketed.
The Salmex inhaler releases a powder which is inhaled into the lungs. A dose indicator on the device indicates the number of doses left. For detailed instructions for use see the Patient Information Leaflet.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
