Adult Dosing
Incontinence due to detrusor instability, associated with a neurologic condition
- 200 units administered as thirty 1mL (approximately 6.7 units/mL) injections across detrusor muscle via a flexible or rigid cytoscope
Note:
- Median time to retreatment is 42 to 48 weeks, but no sooner than 12 wks; Max 200 units per treatment
Chronic Migraine
- 155 units as 5 units (0.1mL) IM into each of 31 sites divided across 7 muscle areas in the head and neck (20 units divided in 4 sites in frontalis muscle, 10 units divided in 2 sites in corrugator muscle, 5 units in 1 site in procerus muscle, 30 units divided in 6 sites in occipitalis muscle, 40 units divided in 8 sites in temporalis muscle, 30 units divided in 6 sites in trapezius muscle, and 20 units divided in 4 sites in cervical paraspinal muscle group)
Note:
- Retreatment recommended every 12 wks
Upper limb spasticity
- Biceps Brachii: 100-200 units IM divided in 4 sites
- Flexor carpi radialis: 12.5-50 units IM in 1 site
- Flexor carpi ulnaris: 12.5-50 units IM in 1 site
- Flexor digitorum profundus: 30-50 units IM in 1 site
- Flexor digitorum sublimis: 30-50 units IM in 1 site
Notes:- Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history. Electromyographic guidance is recommended
- Use lowest recommended starting dose, and do not exceed 50 units per site
- Repeat the dose treatment when the effect of a previous injection has diminished, but generally no sooner than 12 wks after the previous injection
Cervical dystonia
- 236 units (25th to 75th percentile range of 198 Units to 300 Units) IM among affected muscles. Inject < 100 units IM injected to sternocleidomastoid muscles, to decrease the occurrence of dysphagia
Note:
- Individualize dose based on patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history
- Use lowest recommended starting dose, and do not exceed 50 units per site
- Repeat treatment after 3 months
- Clinical improvement: begins within 2 wks; maximum clinical benefit: approximately 6 wks post-injection
Primary axilary hyperhidrosis
- 50 units (2 mL) per axilla injected intradermally in 0.1-0.2 mL (10-20 unit) aliquots to each axila evenly divided in multiple sites (10-15) approximately 1-2 cm apart; repeat treatment after effect of a previous injection diminishes
Blepharospasm
- 1.25-2.5 units (0.05 mL-0.1 mL volume at each site) IM q3 months into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid
- Cumulative dose: 200 units/30 days
- Clinical improvement: begins within 3 days; peak: approximately 1-2 wks post-injection
Strabismus (Botox)
- Range 0.05-0.15 mL IM per muscle into extraocular muscles with EMG guidance
- Initial doses
- Vertical muscles & horizontal strabismus of <20 prism diopters: 1.25-2.5 units in any one muscle
- Horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any one muscle
- Persistent VI nerve palsy (duration 1mo): 1.25-2.5 units in the medial rectus muscle
- Subsequent doses: Re-examine 7-14 days post injection
- If adequate paralysis achieved: Give dose comparable to initial dose if subsequent injection required
- Incomplete paralysis achieved: Dose can be increased two fold compared to previously administered dose
- Max dose 25 units/site
Moderate-severe glabellar lines
Botox cosmetic
- 20 units IM div in 5 sites q3-4 months
Pediatric Dosing
Cervical dystonia
- >16 yrs: 236 units (25th to 75th percentile range of 198 Units to 300 Units) IM among affected muscles. Inject < 100 units IM injected to sternocleidomastoid muscles, to decrease the occurrence of dysphagia
Note:
- Individualize dose based on patient's head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history
- Use lowest recommended starting dose, and do not exceed 50 units per site
- Repeat treatment after 3 months
- Clinical improvement: begins within 2 wks; maximum clinical benefit: approximately 6 wks post-injection
Blepharospasm
- >12 yrs: 1.25-2.5 units (0.05 mL-0.1 mL volume at each site) IM q3 months into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and into the lateral pre-tarsal orbicularis oculi of the lower lid
- Cumulative dose: 200 units/30 days
- Clinical improvement: begins within 3 days; peak: approximately 1-2 wks post-injection
Strabismus
- >12 yrs: Range 0.05-0.15 mL IM per muscle into extraocular muscles with EMG guidance
- Initial doses:
- Vertical muscles & horizontal strabismus of <20 prism diopters: 1.25-2.5 units in any one muscle
- Horizontal strabismus of 20-50 prism diopters: 2.5-5 units in any one muscle
- Persistent VI nerve palsy (duration 1mo): 1.25-2.5 units in the medial rectus muscle
- Subsequent doses: Re-examine 7-14 days post injection
- If adequate paralysis achieved: Give dose comparable to initial dose if subsequent injection required
- Incomplete paralysis achieved: Dose can be increased two fold compared to previously administered dose
- Max dose 25 units/site
[Outline]
See Supplemental Patient Information
- Potency units of the formulation are specific to the preparation and utilized assay method; formulation is not interchangeable with other preparations of botulinum toxin products
- Toxin effects are observed beyond the site of local injection
- Asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties have occurred
- Life threatening swallowing and breathing difficulties has occurred; even deaths have been reported. Children treated for spasticity are at higher risk. Symptoms have also occurred in those adults having history of underlying conditions predisposing them to these symptoms [US Black Box Warning]
- In unapproved uses including spasticity in children, and in approved indications, symptoms consistent with spread of toxin effect have occurred at doses comparable to or lower than doses used to treat cervical dystonia
- On occurrence of serious and/or immediate hypersensitivity reactions discontinue therapy and institute appropriate medical treatment
- Dysphagia and breathing difficulties in treatment of cervical dystonia have occurred. Weakening of muscles in the area of injection involved in breathing or swallowing have occurred
- Persistent dysphagia for several months requires use of a feeding tube to maintain adequate nutrition and hydration. Aspiration due to severe dysphagia is a particular risk when treating patients in whom swallowing or respiratory function is already compromised
- Patients having history of respiratory disorders are prone to critical loss in breathing capacity
- Patients with smaller neck muscle mass and patients requiring bilateral injections into the sternocleidomastoid muscle are susceptible to greater risk for dysphagia
- Injecting drug into the levator scapulae is associated with an increased risk of URTI and dysphagia
- Immediately provide medical attention if problems with swallowing, speech or respiratory disorders.
- Closely monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis or neuromuscular junction disorders. Patients with neuromuscular disorders are at increased risk of clinically significant effects including severe dysphagia and respiratory compromise
- Closely monitor patients with compromised respiratory status for upper limb spasticity
- Patients with VII nerve disorders are prone to corneal exposure, persistent epithelial defect, and corneal ulceration. Employ vigorous treatment of any epithelial defect
- Retrobulbar hemorrhages sufficient to compromise retinal circulation have occurred in patients treated for strabismus
- Bronchitis and URTI have occurred in patients treated for spasticity
- Theoretical and extremely remote risk for transmission of Creutzfeldt-Jakob disease exists
Cautions: Use cautiously in:
- Inflamed skin at site of application
- Atrophy at site of application
- Dysphagia
- Small neck muscle mass (on use for cervical dystonia)
- Pulmonary impairment
- Neuromuscular disease
- Facial nerve disorder
Supplemental Patient Information
- Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking, or breathing), or if worsening of existing symptoms
- Advise patients to avoid driving a car or engaging in other potentially hazardous activities
Pregnancy Category:C
Breastfeeding: Safety Unknown; literature unavailable on the medical use of botulin A (botulinum toxin) during breastfeeding. One infant was safely breastfed during maternal botulism and no botulinum toxin was detected in the mother's milk or infant. As the doses used medically are far lower than those that cause botulism, amounts ingested by the infant, if any, are expected to be insignificant and not cause any adverse effects in breastfed infants. No special precautions required. This information is based on based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 January 2011). Manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Botox 100 UNIT SOLR [Vial] (ALLERGAN DERMATOLOGICS)
1 unit = $609.97
3 unit = $1809.86
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.