No information about the pharmacokinetic parameters in children
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
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Blepharospasms
Intramuscular
12 years
up to
18 years
Botox ®: initial dose of 1.25-2.5 U per injection site, medial and lateral in the upper eyelid and lateral in the lower eyelid; repeat after 3 months. If there is insufficient effect, double the initial dose to a maximum of 5 U per injection site. Max 25 U per eye; cumulative dose in 3 months: 100 U.
Subcutaneous
12 years
up to
18 years
Dysport ®: initial dose 40 E per affected eye, divided equally into 4 injection sites, medial and lateral at the level of the junction between the preseptal and orbital portions of both the upper and lower m. orbicularis oculi; repeat if necessary after at least 12 weeks, if necessary the dose can be increased to 60-120 E per eye, if necessary also 2 injections into the frontalis muscle above the brow.
Focal spasticity of ankle or foot
Intramuscular
2 years
up to
18 years
Botox®: 4-8 E/kg, distributed over affected muscles, max 300 E per treatment.
Per muscle maximum 2 E/kg, but not higher than 75 E distributed over 2 injection sites
When treating both lower limbs, the total dose should not exceed the lower of 10 units/kg body weight or 340 units, in an interval of 12 weeks.
If necessary repeat after at least 3 months
Dysport®: 3-15 E/kg divided over multiple injection sites into affected muscles in 1 limb.
Max 15 E/kg for unilateral treatment, max 1000 E
Max 30 E/kg but not more than 1000 E in case of bilateral treatment
If necessary repeat after at least 3 months
Hemifacial spasms
Intramuscular
12 years
up to
18 years
Botox ® : initial dose of 1.25-2.5 U per injection site, repeat after 12 weeks. If there is insufficient effect, double the initial dose to a maximum of 5 U per injection site. Cumulative dose in 3 months max. 100 U.
Subcutaneous
12 years
up to
18 years
Dysport®:initial dose 40 E per affected eye, divided equally into 4 injection sites, medial and lateral at the level of the junction between the preseptal and orbital portions of both the upper and lower m. orbicularis oculi; repeat if necessary after at least 12 weeks, if necessary the dose can be increased to 60-120 E per eye, if necessary also 2 injections into the frontalis muscle above the brow.
Cervical dystonia (spasmodic torticollis)
Intramuscular
12 years
up to
18 years
Botox®: First treatment session: up to 200 E. Maximum of 50 E per injection site Repeat and adjust the dose depending on effect to a maximum of 300 E per session. Repeating within 10 weeks is not recommended; the sternocleidomastoid muscle must not be injected bilaterally in order to minimize dysphagia; Maximum dose in the sternocleidomastoid muscle 100 E.
Dysport®: initial dose 500 E, distributed in the 2 or 3 most active neck muscles;
for rotational torticollis 350 E in the splenius capitis muscle ipsilateral to the direction of chin/head rotation and 150 E in the sternocleidomastoid muscle contralateral to the direction of rotation;
in laterocollis 350 E in the ipsilateral m. splenius capitis and 150 E in the contralateral m. sternocleidomastoideus; if there is a shoulder elevation, treatment of the ipsilateral trapezius or levator scapula muscles may also be necessary; if in laterocollis in 3 muscles must be injected 300 E in the m. splenius capitis, 100 E in the m. sternocleidomastoideus and 100 E in the third muscle;
for retrocollis, 250 E in each m. splenius capitis;
Repeat injections every 12-16 weeks; adjust dose if necessary to 250-1000 E, according to effect.
Hyperhidrosis of the armpits
Intracutaneous
12 years
up to
18 years
Botox®:50 units per axilla; distributed over multiple sites 1-2 cm apart in the hyperhidrosis zone.
Dysport®: initial dose 100 E per axilla, divided evenly into 10 injection sites, repeat if necessary after at least 12 weeks (usually 48 weeks); if necessary, increase dose to max 200 E per axilla next time.
CAUTION:
Route of administration not applicable
0 years
up to
18 years
Before using botulinum toxin A, check the prescribed amounts of units. The unit designation (E) is specific to each product. Interchange can have serious consequences.
Focal spasticity of the upper limbs
Intramuscular
2 years
up to
18 years
Dysport®:
Muscle
Dosis IE/kg
Number of injections sites
Brachialis
3-6
1-2
Brachioradialis
1,5-3
1
Biceps brachii
3-6
1-2
Pronator teres
1-2
1
Pronator quadratus
0,5-1
1
Flexor carpi radialis
2-4
1-2
Flexor carpi ulnaris
1,5-3
1
Flexor digitorum profundus
1-2
1
Flexor digitorum superficialis
1,5-3
1-4
Flexor pollicis brevis / opponens pollicis
0,5-1
1
Adductor pollicis
0,5-1
1
In unilaterale treatment: max 16 E/kg not exceeding 640 E In bilaterale treatment: max 21 E/kg not exceeding 840 E
Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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
Myalgia, muscle weakness, pain in extremity, urinary incontinence, flu-like symptoms, reaction at injection site (pain, erythema, bruising), gait disturbance, fatigue, asthenia, falls. (SmPC Dysport)
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
Do not use in children aged < 12 years, except for use in spastic paralysis in children.
There have been rare, spontaneous reports of death, sometimes associated with aspiration pneumonia in children with severe cerebral palsy after treatment with botulinum toxin, including after off-label use (e.g., in the neck). Extreme caution should be exercised when treating pediatric patients with significant neurologic weakness, dysphagia, or a recent history of aspiration pneumonia or pulmonary disease. (SmPC Botox)
There have been very rare reports of toxin dissemination to other sites in the body, in pediatric patients with comorbidities, especially cerebral palsy. Generally, the dose used in these cases was higher than the recommended dose (SmPC Botox).
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
