All the Active Ingredient Drugs
Bacterial Toxin. Botilium Toxin 50, 100, 200 U. PWDR. FOR INJECT: 50, 100, 200 U/vial. Spasm. torticollis: 25-300 units accord. to
individ. req. Intervals of at least 10-12
wks. strabismus: 1.25-5 units accord. to
pt. req. Blepharospasm: 1.25-5 units.
Axillary hyperhidros: Max. 50 U to each
axilla. See lit.
Spasmod. torticollis (cervic. diston.).,
strabis. and blepharospasm
assoc. with
dyston., benign essential blepharospasm,
nerve VII disords. in pts. over 12 yrs.,
dynamic equinus foot deform. due to
spastic. in ped. cerebral palsy, focal upper
limb spasticity associat. with stroke. Temp.
improve. appearance mod. to severe
glabellar lines assoc. with corrugator and/
or procerus muscle activity in adult pts. 65
yrs. or less. Manage. prim. axillary
hyperhidros. in pts. not respond. other
medical symptomat. tmt.
Botilium Toxin 300 U/vial, 500 U/vial. VIALS (pwdr. for inject.): 1. Ped. cerebral
palsy: Initial: 20 units/kg bdy wt. (10
units/kg if only 1 calf is affected) to be inject. into calf muscle. Max. dose:
1,000 units/pt.; Spasmodic torticollis:
Initial: 500 units as a divided dose into
the 2 or 3 most active neck muscles.
Doses above 1,000 units not
recommend; Blepharospasm and
hemifacial spasm: Initial: 120 units/eye.
May be reduced on subsequent admin.
Not to be repeated more than every 8
wks. Adult arm spasm aft. stroke: 1,000
U. Axillary hyperhydros: Initial: 100 U/
axilla. Subseq. injects: 10 sites ea site
receiv. 10 units intraderm. If desired
effect not obtain: 200 U/axilla. Max.
effect aft. 2 wks. Provides protect. for
48 wks. See lit. Child: Safety and effect.
not been demonstrat. Mod-severe
glabellar lines: 50 U (0.25 ml) I.M. div.
into 5 inject. sites. See lit. May repeat
approx. every 16 wks. Interval betw.
inject: Not less than 3 mths. Child: Not
recommend. See lit.
Dynam. ft. deform. due to spasticity in
ambulant ped. C.P. 2 yrs and over,
spasmod. torticollis in adults,
blepharospasm and hemifacial spasm in
adults, adult arm spasticity post stroke.
Axillary hyperhydros., tmt. mod-severe
glabellar lines.
C/I: Pregn.
Neuromuscular Blocker Agent. Botilium Toxin (type A (150 kDa), free from complexing proteins) 50 U, 100 U. VIAL (pwdr. for sol. for inj.): 1,2,3,6 ×50, 100 Units. Dosage should be ajust. individ.
Symptomatic treatment of blepharospasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis) and of post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.
Indicated for the temporary improvement in the appearance of moder.-severe vertic. lines betwn. eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the pt.
C/I: Hypersens. Generalised disord. of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndr.). Infect. or inflamm. at the proposed inj. site.
