Summary of Product Characteristics Available on Last Updated 21/12/2012

Botulinum toxin type A (Botox®) – various routes of administration.
LINKS TO RELATED MONOGRAPHS AND OTHER INJECTABLE ROUTES:
Three types of botulinum type A are available: - Botox®, Xeomin® and Dysport®. 1 unit of Botox® is equivalent to 1 unit of Xeomin® and 5 units of Dysport®.
Please ensure you are using the correct monograph for the brand you are using.
MEDICINE NAME:Botulinum toxin (Botox®)
TRADE NAME(S): Botox®
PRESENTATION OF MEDICINE:
Botox®: Powder for solution for injection.
METHOD OF ADMINISTRATION:
Detrusor overactivity – intravesical administration
Ophthalmology – injection into the medial and lateral orbicularis oculi of the upper lid and the lateral orbicularis of the lower lid
Spasticity – intramuscular injection into the affected muscle
Hyperhidrosis (non-formulary) – intradermal administration in the axillae
Migraine prophylaxis – intramuscular administration into the forehead
INSTRUCTIONS FOR RECONSTITUTION:
Botox®
BOTOX® must only be reconstituted with sterile sodium chloride 9 mg/ml (0.9%) solution for injection. The appropriate amount of diluent (see dilution table below) should be drawn up into a syringe.
100 unit vial
Resulting concentration
(Units per 0.1 ml) / Amount of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection) added in a 100 unit vial
20 Units / 0.5 ml
10 Units / 1 ml
5 Units / 2 ml
4 Units / 2.5 ml
2.5 Units / 4 ml
1.25 Units / 8 ml
The sodium chloride diluents should be directed toward the side of the vial using an appropriately sized syringe and the contents gently swirled (to prevent breakdown of fragile molecule).
INSTRUCTIONS FOR DILUTION AND SUITABLE DILUENT:
Botulinum toxin does not require further dilution
FLUSHING:
Not applicable
ADVERSE EFFECTS WHICH MAY BE CAUSED BY AN INJECTABLE ADMINISTRATION AND SUGGESTED MONITORING:
Pain / bruising at injection site. Local weakness. Advise patient in advance of possible effect.
Deep or misplaced injections may paralyse neighbouring muscle groups.
The most common adverse effects after injection into muscles around the eye, such as in the management of blepharospasm, hemifacial spasm, or strabismus, are ptosis, lacrimation, photophobia, ocular irritation, and facial swelling
Dysphagia is the most common adverse effect after injection into neck muscles
EXPIRY WHEN RECONSTITUTED IN A CLINICAL AREA:
Can be stored in the fridge for up to 24 hours following reconstitution.
COMPATIBILITY INFORMATION USEFUL IN CLINICAL PRACTICE:
Not to be mixed or given with any other intravenous medicine
SPECIAL HANDLING PRECAUTIONS:
Immediately after treatment of the patient, any residual botulinum toxin which may be present in either vial or syringe should be inactivated with dilute hypochlorite solution (0.5%). Thereafter, all items should be disposed of in accordance with standard hospital practice.
Spillage of botulinum toxin should be wiped up with an absorbent cloth soaked in dilute hypochlorite solution.
Store in a refrigerator prior to reconstitution.
SODIUM CONTENT (mmol):n/a
OSMOLARITY / OSMOLALITY:n/a
pH:n/a
OTHER COMMENTS:
PRODUCT RISK FACTORS: Risk Assessment of a common preparation (as required by NPSA Patient Safety Alert 20)
USUAL TOTAL RISK FACTORS: 3 OVERALL RISK RATING: Amber
PHARMACY NOTES:
CURRENT MANUFACTURERS / DISTRIBUTORS / LICENCE HOLDERS:
Allergan Ltd
Marlow International,
The Parkway,
Marlow,
Bucks, SL7 1YL, UK
Telephone: +44 (0)1628 494444
DELETED MANUFACTURERS / DISTRIBUTORS / LICENCE HOLDERS:
REFERENCES:

Summary of Product Characteristics available on last updated 21/12/2012.
Martindale "The Complete Drug Reference" 34th Edition accessed via on 3rd July 2012.
American Hospital Formulary Service Drug Information accessed via on 3rd July 2012.
Trissel "Handbook on injectable drugs" 15th Edition accessed via
British National Formulary no. 64, September 2012 p.317

Version
DATE PUBLISHED: / DATE PRINTED:

Written byChecked by

Breda CronnollyShangeetha Mahalingam

July 2012.