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CLOSTRIDIUM BOTULINUM TOXIN TYPE A

Brand Name :

(Botox) ®

Dosage form :

njection 100 IU / vial.

Indication :

Blepharospasm, strabismus, primary axillary hyperhidrosis, upper and
lower limb spasticity, chronic migraine, detrusor overactivity,
overactive bladder.

Dosage :

Children ( ≥12 Years) & Adults: Blepharospasm:
1.25-2.5 units IM; not to exceed 200 units in 30 days
May increase dose 2-fold if response to initial treatment dose does not
last longer than 2 months.
Little benefit obtained from injecting >5 units per site.
Tolerance may develop if treatment given more than every 3 months;
effect not usually permanent.

Strabismus:
1.25-5 units IM; <25 units per injection.
Vertical muscles, and horizontal strabismus of <20 prism diopters:
1.25-2.5 units in any one muscle.
Persistent VI nerve palsy of >1 month of duration: 1.25-2.5 units in
the medial rectus muscle.
Horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any one
muscle.
Incomplete paralysis of target muscle: May increase dose 2-fold if
patient experience incomplete paralysis of the target.


Primary Axillary Hyperhidrosis
Adult: 50 units injected intradermally to each axilla evenly
distributed in multiple sites approximately 1-2 cm apart.


Children: Safety and efficacy not established.
Upper and Lower Limb Spasticity: Adults: Do not exceed a cumulative dose of 400 units in 3-month interval when treating adults
for 1 or more indications.
In clinical trials, doses ranging from 75 units to 400 units were
divided among selected muscles to treat upper limb spasticity at a
given treatment session.
Biceps brachii: 100-200 units divided in 4 sites.
Flexor carpi radialis: 12.5-50 units in 1 site.
Flexor carpi ulnaris: 12.5-50 units in 1 site.
Flexor digitorum profundus: 30-50 units in 1 site.
Flexor digitorum sublimis: 30-50 units in 1 site.
Adductor pollicis: 20 units in 1 site.
Flexor pollicis longus: 20 units in 1 site.

Lower limb spasticity: Adult: Recommended dose for treating lower
limb spasticity is 300 units to 400 units divided among 5 muscles.

Gastrocnemius medial head: 75 units divided in 3 sites
Gastrocnemius lateral head: 75 units divided in 3 sites
Soleus: 75 units divided in 3 sites
Tibialis Posterior: 75 units divided in 3 sites
Flexor e-exper longus: 50 units divided in 2 sites
Flexor digitorum longus: 50 units divided in 2 sites

Chronic Migraine: Adult: Frontalis: 20 units divided in 4 sites
Corrugator: 10 units divided in 2 sites
Procerus: 5 units in 1 site
Occipitalis: 30 units divided in 6 sites
Temporalis: 40 untied divided in 8 sites
Trapezius: 30 units divided in 6 sites
Cervical paraspinal muscle group: 20 units divided in 4 sites.
<18 Years: Safety and efficacy not established


Adults: Detrusor Overactivity: 200 units (divided into 30
intradetrusor injections) administered using cystoscopy.


Adults: Overactive bladder: 100 units (divided into 20 intradetrusor
injections of 5 units each) administered using cystoscopy.

Botox Cosmetic
Glabellar lines: Inject 4 units (0.1 mL) into each of 5 sites, 2 in each
corrugator muscle and 1 in procerus muscle for a total dose of 20
units
Canthal lines: Inject 4 units (0.1 mL) into 3 sites per side (6 total
injection points) in the lateral orbicularis oculi muscle for a total of 24
units/0.6 mL (12 units per side).
Duration of activity is approximately 3-4 months.
More frequent dosing not recommended.

Warning / precaution :

Adverse reactions :

Dysphagia, ptosis of eyelid, dry eyes, urinary retention with
intradetrusor injections, influenza-like symptoms, upper respiratory
infection, headache, neck pain.

Therapeutic class :

Medication safety issues :

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