Clostridium Botulinum Toxin Type A

Registered South African indications:

• Dynamic equinus foot deformity
• Focal spasticity
• Spasmodic torticollis
• Glabellar lines
• Axillary hyperhidrosis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Elderly
• Children < 2 years
• High doses
• Defects in neuromuscular transmission
• Underlying neurological disorders
• Difficulty in swallowing or breathing
• Fixed contractures
• Prolonged bleeding time

Forms avail. in SA and covered in this monograph: inj

Focal spasticity
- Upper limb spasticity

• IM: 150-250 U/muscle, every 12-16 weeks; Max: 1000 U/patient

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Sites of injection should be guided by standard locations used for electromyography, although actual locations of injection sites are determined by palpation

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Clinical improvement can be expected within 2 weeks of administration

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Spasmodic torticollis

• IM: 500 U/patient, as divided doses into the 2-3 most active neck muscles, every 12-16 weeks; Max: 1000 U/patient

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Clinical improvement can be expected within 1 week of administration

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Glabellar lines - moderate to severe 
- Associated with corrugator and/or procerus muscle activity in patients < 65 years

• IM: 50 U/patient, as 5 divided doses into corrugator and procerus muscles, every 3 months

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Clinical effect may last up to 4 months

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Axillary hyperhidrosis

• Intradermally: 100 U/axilla, in 10 divided doses; Max: 200 U/axilla

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Area to be injected should be determined beforehand using the iodine-starch test

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Maximal clinical improvement can be expected within 2 weeks of administration

Sweat secretion should be adequately suppressed for approximately 48 weeks in most cases

Should not be administered more often than every 12 weeks

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Dosage and units are preparation specific and are not interchangeable with other preparations of botulinum type A toxin

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Should only be administered by doctors with appropriate qualifications and expertise in the treatment and the use of the required equipment

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See additional prescribing points

Paed. forms avail. in SA and covered in this monograph: inj

Dynamic equinus foot deformity in paediatric cerebral palsy patients

Younger than 2 years

• Not established for use

Older than 2 years

• IM: 10-30 U/kg, as divided doses into both calf muscles; every 8-16 weeks; Max: 1000 U/patient

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Clinical improvement can be expected within 2 weeks of administration

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Dosage and units are preparation specific and are not interchangeable with other preparations of botulinum type A toxin

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Should only be administered by doctors with appropriate qualifications and expertise in the treatment and the use of the required equipment

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution; no information available

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended 

Central Nervous System Disorders

• Neuralgic amyotrophy
• Headache
• Dizziness
• Facial paresis
• Asthenia

Respiratory Disorders

• Dysphonia
• Dyspnoea
• Aspiration
• Influenza-like illness

Gastrointestinal Disorders

• Dysphagia
• Dry mouth
• Nausea

Genitourinary Disorders

• Urinary incontinence

Musculoskeletal Disorders

• Muscular weakness
• Musculoskeletal pain
• Pain in the extremity
• Neck pain
• Myalgia
• Musculoskeletal stiffness
• Muscle atrophy
• Jaw disorder
• Gait disturbance

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Injection site reactions

Sensory Disorders

• Blurred vision
• Reduced visual acuity
• Diplopia
• Ptosis

• Agents affecting neuromuscular function
• Aminoglycosides
• Non-depolarising neuromuscular blockers
• Muscle relaxants

None routine

Administration directions

- Dynamic equinus foot deformity
- Focal spasticity
- Spasmodic torticollis

• Should be reconstituted with 1ml of 0.9% sodium chloride to yield a solution containing 500 U/ml

- Glabellar lines

• Should be reconstituted with 2.5ml of 0.9% sodium chloride to yield a solution containing 10 U/0.05ml to be delivered equally in 5 doses of 0.05ml each

- Axillary hyperhidrosis

• Should be reconstituted with 2.5ml of 0.9% sodium chloride to yield a solution containing 200 U/ml

- General

• The reconstituted product should be clear, colourless and free of particulate matter, otherwise it should not be injected
• Should be stored in a refrigerator at 2-8 degrees celsius, protected from light, and used with 24hrs

Clostridium botulinum toxin type A neurotoxin complex blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals.

Injection (per vial) 500 U

• Dysport (Litha) originator