Table 2 |
||||
|
Description of ICSRs for children in the ATC code R03DC. All ICSRs concerned the substance montelukast. |
||||
|
Age (years) |
Dose (mg/day) |
Treatment duration (when known) |
ADR |
SPC (Yes/No) |
|
|
||||
|
4 |
4 |
- |
Night mares |
Yes |
|
3 |
4 |
- |
Sleep disorders |
Yes |
|
3 |
4 |
- |
Cranial nerve lesion |
No |
|
4 |
4 |
2 years |
Haemorrhage |
Yes |
|
Pruritus |
Yes |
|||
|
Abdominal pain |
Yes |
|||
|
Rectal pain |
No |
|||
|
2 |
4 |
- |
Fever |
No |
|
Fatigue |
Yes |
|||
|
Rash |
No |
|||
|
1 |
4 |
4 days |
Anxiety |
No |
|
3 |
4 |
- |
Night mares |
Yes |
|
Aggressiveness |
Yes |
|||
|
2 |
4 |
4 days |
Aggressiveness |
Yes |
|
3 |
4 |
continuing |
Night mares |
Yes |
|
3 |
4 |
2 doses |
Asthma aggravated |
No |
|
2 |
4 |
11 days |
Rash |
No |
|
Pruritus |
Yes |
|||
|
Sleep disorder |
Yes |
|||
|
Night mares |
Yes |
|||
|
1 |
4 |
2 weeks |
Anxiety |
No |
|
Sleep disorder |
Yes |
|||
|
6 |
5 |
8 weeks |
Xerophthalmia |
No |
|
5 |
4 |
3 weeks |
Appetite increased |
No |
|
8 |
5 (on demand) |
5 weeks |
Leucopenia |
No |
|
Red blood cell disorder |
No |
|||
|
14 |
10 |
2 years |
Arthralgia |
Yes |
|
Myalgia |
Yes |
|||
|
|
||||
|
ADR, adverse drug reaction; ICSR, individual case safety report; SPC, summary of product characteristics |
||||
|
Brunlöf et al. BMC Clinical Pharmacology 2008 8:1 doi:10.1186/1472-6904-8-1 |
||||
