Clostridium Botulinum Toxin Type A Neurotoxin
Indications
Clostridium Botulinum Toxin Type A Neurotoxin is used for:
Muscle spasm, Strabismus, Blepharospasm, Achalasia, Cervical dystonia, Limb spasticity, Overactive bladder, Chronic migraine, Severe Primary Axillary Hyperhidrosis, Glabellar and lateral Canthal lines (cosmetic purpose)
Adult Dose
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.
Blepharospasm
1.25-2.5 units IM; not to exceed 200 units in 30 days.
Strabismus
1.25-5 units IM; <25 units per injection .
Chronic Migraine
Recommended total dose 155 units, as 0.1 mL (5 units) IM injections per each site divided across 7 head/neck muscles q12wk.
Overactive Bladder
Indicated for adults with overactive bladder symptoms (urge incontinence, urgency, frequency) who cannot use or do not adequately respond to anticholinergic medication.
100 units (divided into 20 intradetrusor injections of 5 units each) administered using cystoscopy.
Persistent VII th nerve palsy of >1 mth 1.25-2.5 U in the medial rectus muscle. Max: 25 U as single inj for any 1 muscle.
Spasmodic torticollis (cervical dystonia) 25-200 U depending on the muscle groups. Max total dose: 6 U/kg every 2 mth.
Hyperhidrosis of the axilla 50 U intradermally to each axilla, evenly distributed in multiple sites 1-2 cm apart.
Child Dose
Renal Dose
Administration
Contra Indications
As with other immunoglobulin preparations, it should not be used in individuals with a prior history of severe reaction to other human immunoglobulin preparations.
Individuals with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to the subsequent administration of blood products that contain immunoglobulin A.
Precautions
Patient Monitoring for Administration
Patients should be well hydrated prior to the initiation.
Assess renal function, including the measurement of blood urea nitrogen (BUN) or serum creatinine prior to the initial infusion. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential risk for developing acute renal failure. Increases in serum creatinine and BUN have been observed as soon as one to two days following treatment with other IGIV products.
During administration, monitor the patient's vital signs continuously and observe the patient carefully for any associated symptoms.
DO NOT EXCEED THE RECOMMENDED INFUSION RATE of 1 mL/kg/hour (50 mg/kg/h), and follow the infusion schedule closely . If a patient develops an infusion reaction, slow the rate of infusion immediately or temporarily interrupt the infusion.
Pregnancy-Lactation
Interactions
Adverse Effects
Side effects of Clostridium Botulinum Toxin Type A Neurotoxin :
Serious adverse reactions were not observed in clinical trials.
The most common adverse reaction was skin rash.
Other reactions such as chills, muscle cramps, back pain, fever, nausea, vomiting, and wheezing were the most frequent adverse reactions observed during the clinical trials of similarly-prepared human IGIV products.
Mechanism of Action
Neurotoxin from Clostridium botulinum; prevents ACh release from presynaptic membrane, causing temporary calming of muscle contractions by blocking the transmission of nerve impulses.