Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Growth inhibition, Cushing’s syndrome, Cushingoid symptoms, adrenergic suppression; anxiety, sleep disorders and behavioural changes including depression, hyperactivity and irritability.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

FDA label warning: elevated mortality in studies when ICS/LABA used in adults.

There is insufficient data known about the use of salmeterol/fluticasone in children aged under 4 years. A combination preparation with LABA and ICS is the medicine in step 3 of the asthma treatment and the use should therefore be prescribed as per the guidelines of the NHG (Dutch College of General Practitioners) and the SKL (Paediatric Pulmonary Disease Section). Do not use as treatment for acute asthma attacks.

Particularly in children up to 16 years of age, the use of fluticasone at a dosage of ≥ 1000 micrograms/day can be high-risk. Systemic effects may occur, especially if high doses are prescribed for longer periods. Possible systemic effects include Cushing’s syndrome, Cushingoid symptoms, adrenal cortex suppression, acute adrenal crisis and growth inhibition in children and adolescents and less often a series of psychological or behavioural effects can occur, such as psychomotor hyperactivity, sleep disorders, anxiety, depression and aggression. It is recommended in children who are given long-term treatment that the growth should be checked regularly. If there is growth retardation, the treatment should be reassessed and the dose should be lowered if possible.

Watch out for dysphonia and candidiasis.
Administration: Seretide dosing aerosol can be administered using the following holding chambers: Volumatic (> 4 years) or AeroChamber Plus.
 

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• RESPIRATORY SYSTEM
• DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

ADRENERGICS, INHALANTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Stempel DA, et al, The use of rhinitis medications in children receiving initial controller therapy for asthma, Curr Med Res Opin., 2006, Nov;22(11):, 2279-85
2. Sekhsaria S, et al, Efficacy and safety of inhaled corticosteroids in combination with a long-acting beta2-agonist in asthmatic children under age 5., J Asthma, 2004, Aug;41(5), 575-82
3. Busse WW, et al, Comparison of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler and fixed-dose fluticasone propionate/salmeterol dry powder inhaler in asthma patients, J Allergy Clin Immunol, 2008, Jun;121(6), 1407-14, 14 e1-6
4. Navaratnam P, et al, Mometasone furoate vs fluticasone propionate with salmeterol: multivariate analysis of resource use and asthma-related charges, Curr Med Res Opin, 2009, Dec;25(12), 2895-901
5. Bateman ED, et al, Stability of asthma control with regular treatment: an analysis of the Gaining Optimal Asthma controL (GOAL) study, Allergy, 2008, Jul;63(7), 932-8
6. Barnes NC, et al, Initiation of maintenance treatment with salmeterol/fluticasone propionate 50/100 microg bd versus fluticasone propionate 100 microg bd alone in patients with persistent asthma: integrated analysis of four randomised trials, Respir Med, 2007, Nov;101(11), 2358-65
7. Pearlman DS, et al, Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma, J Asthma., 2004, 41(8), 797-806
8. GlaxoSmithKline BV, SPC Seretide dosisaerosol CFK vrij (RVG 25865) en Seretide diskus (RVG 23529), www.cbg-meb.nl, Geraadpleegd 28 okt 2011, http://db.cbg-meb.nl/IB-teksten/h25865.pdf
9. NHG, Standaard Astma bij Kinderen, www.nhg.artsennet.nl, Oktober 2006, http://nhg.artsennet.nl/kenniscentrum/k_richtlijnen/k_nhgstandaarden/Samenvattingskaartje-NHGStandaard/M24_svk.htm
10. GlaxoSmithKline, SmPC atmadisc Diskus (44915.00.00/ 44915.01.00/ 44915.02.00), 03/2018
11. Mylan dura, SmPC Serkep (91143.00.00), 05/2017
12. Hexal, SmPC Airflusal® Forspiro® (89724.00.00), 01/2018
13. Hexal, SmPC Airflusal® Dosieraerosol (94827.00.00/ 94828.00.00), 11/2017
14. GlaxoSmithKline, SmPC Viani Diskus (44918.00.00/ 44918.01.00/ 44918.02.00), 03/2018
15. GlaxoSmithKline, SmPC Viani® Dosier-Aerosol Druckgasinhalation, Suspension (50681.00.00/ 50681.01.00/ 50681.02.00, 03/2018

Changes

Therapeutic Drug Monitoring

Overdose