Dosing & Uses
Dosage Forms & Strengths
injectable, powder for reconstitution
- 50 units/vial (Botox, Botox Cosmetic)
- 100 units/vial (Botox, Botox Cosmetic)
- 200 units/vial (Botox)
Blepharospasm and Strabismus
Indicated for the treatment of strabismus and blepharospasm associated with dystonia (eg, benign essential blepharospasm, VII nerve disorders)
Blepharospasm
- 1.25-2.5 units injected into medial and lateral pretarsal orbicularis oculi of upper lid and lateral pretarsal orbicularis oculi of lower lid; 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
Indicated for severe primary axillary hyperhidrosis that is inadequately managed with topical agents
50 units injected intradermally to each axilla evenly distributed in multiple sites approximately 1-2 cm apart
Cervical Dystonia
Indicated for adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia
Not to exceed 50 units per site
Clinical improvement generally begins within the first 2 weeks after injection with maximum clinical benefit at ~6 weeks post-injection
Spasticity
Indicated for the treatment of upper and lower limb spasticity in adults to decrease the severity of increased muscle stiffness
Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history (EMG guidance recommended)
Do not exceed a cumulative dose of 400 units in 3-month interval when treating adults for 1 or more indications
Upper limb
- In clinical trials, doses ranging from 75-400 units were divided among selected muscles to treat upper limb spasticity at a given treatment session
-
Dosage per muscle
- Biceps brachii: 60-200 units divided in 2-4 sites
- Brachioradialis: 45-75 units divided in 1-2 sites
- Brachialis: 30-50 units divided in 1-2 sites
- Pronator teres: 15-25 units in 1 site
- Pronator quadratus: 10-50 units in 1 site
- 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
- Lumbricals/interossei: 5-10 units in 1 site
- Adductor pollicis: 20 units in 1 site
- Flexor pollicis longus: 20 units in 1 site
- Flexor pollicis brevis/opponens pollicis: 5-25 units in 1 site
Lower limb
- 300-400 units divided among 5 muscles (gastrocnemius, soleus, tibialis posterior, flexor hallucis longus, and flexor digitorum longus)
-
Dosage per muscle
- 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 hallucis longus: 50 units divided in 2 sites
- Flexor digitorum longus: 50 units divided in 2 sites
Chronic Migraine
Indicated for the prophylaxis of headaches in adults with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
Recommended total dose 155 units, as 0.1 mL (5 units) IM injections per each site divided across 7 head/neck muscles q12wk
Recommended dose per muscle site (totaling 155 units)
- 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
Detrusor Overactivity
Indicated for urinary incontinence caused by detrusor overactivity in patients with neurologic conditions (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant to anticholinergic medication
200 units (divided into 30 intradetrusor injections) administered using cystoscopy
Duration of effect may last up to 10 months; may repeat procedure when effect of previous injection diminishes, but no sooner than 12 weeks from the prior bladder injection
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
Requirements for repeating procedure
- 12 weeks have elapsed since prior treatment
- Post-void residual urine volume >200 mL
- At least 2 reported urinary incontinence episodes over 3 days
Cosmetic Uses
Botox Cosmetic only
Indicated for temporary improvement in the appearance of moderate-to-severe glabellar lines (ie, frown lines) associated with corrugators and/or procerus muscle activity; lateral canthal lines (ie, crow’s feet) associated with orbicularis oculi activity; forehead lines associated with frontalis muscle activity
Dosing
- 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
- Lateral 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)
- Forehead lines: Inject 4 units (0.1 mL) into each of 5 forehead line sites (20 units); treat in conjunction with glabellar lines with 0.1 mL (4 units) into each of 5 glabellar line sites (20 units), for a recommended total of 40 units
Dosing Considerations
Botox
- Lower initial dose if no prior botulinum toxin treatment
- Adjust dose based on response
- When treating adult patients for 1 or more indications, the maximum cumulative dose should generally not exceed 400 Units in a 3 month interval
- Bladder dysfunction indications: Administer prophylactic antibiotics (except aminoglycosides) beginning 1-3 days pretreatment and continue 1-3 days post treatment to reduce risk for procedure-related UTI
Botox Cosmetic
- Treatment for both glabellar and lateral canthal lines can be given at the same time
- Do not exceed a cumulative dose of 400 units per 3 months when treating patients for 1 or more indication
- Duration of activity is approximately 3-4 months
- More frequent dosing not recommended
Dosage Forms & Strengths
injectable, powder for reconstitution
- 50 units/vial (Botox, Botox Cosmetic)
- 100 units/vial (Botox, Botox Cosmetic)
- 200 units/vial (Botox)
Blepharospasm and Strabismus
Indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in children aged ≥12 years
Blepharospasm
- <12 years: Safety and efficacy not established
- ≥12 years:1.25-2.5 units IM; < 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
Strabismus
- <12 years: Safety and efficacy not established
- ≥12 years: 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 response to initial treatment dose
Spasticity
Indicated for spasticity in adults and pediatric patients aged ≥2 years
Upper limb
- 3-6 units/kg divided among affected muscles
- Maximum total dose per treatment session: 6 units/kg or 200 units, whichever is lower
-
Dosage range per muscle
- Biceps brachii: 1.5-3 units/kg divided in 4 injection sites
- Brachialis: 1-2 units/kg divided in 2 injection sites
- Brachioradialis: 0.5-1 units/kg divided in 2 injection sites
- Flexor carpi radialis: 1-2 units/kg divided in 2 injection sites
- Flexor carpi ulnaris: 1-2 units/kg divided in 2 injection sites
- Flexor digitorum profundus: 0.5-1 units/kg divided in 2 injection sites
- Flexor digitorum superficialis: 0.5-1 units/kg divided in 2 injection sites
Lower limb
- 4-8 units/kg divided among affected muscles
- Maximum total dose per treatment session: 8 units/kg or 300 units, whichever is lower
-
Dosage range per muscle
- Gastrocnemius medial head: 1-2 units/kg divided in 2 injection sites
- Gastrocnemius lateral head: 1-2 units/kg divided in 2 injection sites
- Soleus: 1-2 units/kg divided in 2 injection sites
- Tibialis posterior: 1-2 units/kg divided in 2 injection sites
Detrusor Overactivity Associated with a Neurologic Condition
Indicated for neurogenic detrusor overactivity (NDO) in children aged ≥5 years who have an inadequate response to or are intolerant of anticholinergic medications
≥5 years
- Administer doses as 0.5-mL injections across 20 sites into the detrusor (total volume: 10 mL) via cystoscopy
- Consider reinjection when clinical effect diminishes (median time to qualify for re-treatment was 207 days [30 weeks] for Botox 200 units), but no sooner than 12 weeks from prior bladder injection
- <34 kg: 6 units/kg per treatment session
- ≥34 kg: 200 units per treatment session
Dosing Considerations
Follow indication specific dosage and administration recommendations
Cumulative dose limits
- Use lowest recommended dose when initiating treatment
- When treating children for ≥1 indications, do not exceed a total dose of the lower of 8 units/kg body weight or 300 units, in a 3-month interval
Spasticity
- Limitation of use: Not intended to substitute for usual standard of care rehabilitation regimens
- When treating both lower limbs or upper and lower limbs in combination, the total dose should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 3-month interval
Detrusor overactivity
- Patients must not have a urinary tract infection (UTI) at time of treatment
- Administer oral prophylactic antibiotics to reduce likelihood of procedure-related UTI
- Discontinue antiplatelet therapy at least 3 days before procedure; manage patients on antiplatelet therapy appropriately
- Exercise appropriate precaution when performing cystoscopy
Muscle Contractures (Orphan)
Treatment of dynamic muscle contractures in pediatric cerebral palsy patients
Orphan indication sponsor
- Allergan, Inc; 2525 Dupont Drive, P.O. Box 19534; Irvine, CA 92713
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (23)
- abobotulinumtoxinA
onabotulinumtoxinA, abobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
- amikacin
amikacin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- amphotericin B deoxycholate
amphotericin B deoxycholate increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- capreomycin
capreomycin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- clindamycin
clindamycin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- colistin
onabotulinumtoxinA increases effects of colistin by pharmacodynamic synergism. Avoid or Use Alternate Drug. Potentiation of neuromuscular blockade; risk of respiratory arrest.
- demeclocycline
demeclocycline increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- doxycycline
doxycycline increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- gentamicin
gentamicin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- glycopyrronium tosylate topical
glycopyrronium tosylate topical, onabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of glycopyrronium tosylate topical with other anticholinergic medications may result in additive anticholinergic adverse effects.
- incobotulinumtoxinA
onabotulinumtoxinA, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
- lincomycin
lincomycin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- minocycline
minocycline increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- neomycin PO
neomycin PO increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- oxytetracycline
oxytetracycline increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- paromomycin
paromomycin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- polymyxin B
polymyxin B increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of resp. depression.
- prabotulinumtoxinA
onabotulinumtoxinA, prabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Effect of administering different botulinum toxins simultaneously or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to resolution of the effects of a previously administered botulinum toxin.
- pramlintide
pramlintide, onabotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Synergistic inhibition of GI motility.
- quinine
quinine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Contraindicated. Risk of resp. depression.
- streptomycin
streptomycin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
- tetracycline
tetracycline increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of respiratory depression.
- tobramycin
tobramycin increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Avoid or Use Alternate Drug. Risk of apnea.
Monitor Closely (94)
- aclidinium
onabotulinumtoxinA and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- amantadine
onabotulinumtoxinA, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.
- amitriptyline
onabotulinumtoxinA and amitriptyline both decrease cholinergic effects/transmission. Modify Therapy/Monitor Closely.
- amoxapine
onabotulinumtoxinA and amoxapine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- anticholinergic/sedative combos
anticholinergic/sedative combos and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor.
- aripiprazole
onabotulinumtoxinA decreases levels of aripiprazole by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of aripiprazole by pharmacodynamic antagonism. Use Caution/Monitor.
aripiprazole increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - atracurium
atracurium and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor.
- atropine
atropine and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor.
- atropine IV/IM
atropine IV/IM and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor.
- belladonna alkaloids
belladonna alkaloids and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor.
- belladonna and opium
onabotulinumtoxinA and belladonna and opium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- benperidol
onabotulinumtoxinA decreases levels of benperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of benperidol by pharmacodynamic antagonism. Use Caution/Monitor.
benperidol increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - benztropine
benztropine and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor. Additive anticholinergic adverse effects may be seen with concurrent use.
- bethanechol
bethanechol increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- carbachol
carbachol increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- cevimeline
cevimeline increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- chlorpromazine
onabotulinumtoxinA decreases levels of chlorpromazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of chlorpromazine by pharmacodynamic antagonism. Use Caution/Monitor.
chlorpromazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - cisatracurium
onabotulinumtoxinA and cisatracurium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- clomipramine
onabotulinumtoxinA and clomipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- clozapine
onabotulinumtoxinA decreases levels of clozapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of clozapine by pharmacodynamic antagonism. Use Caution/Monitor.
clozapine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - cyclizine
onabotulinumtoxinA and cyclizine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- cyclobenzaprine
onabotulinumtoxinA and cyclobenzaprine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- darifenacin
onabotulinumtoxinA and darifenacin both decrease cholinergic effects/transmission. Use Caution/Monitor.
- dicyclomine
onabotulinumtoxinA and dicyclomine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- diphenhydramine
onabotulinumtoxinA and diphenhydramine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- donepezil
donepezil increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- dosulepin
onabotulinumtoxinA and dosulepin both decrease cholinergic effects/transmission. Use Caution/Monitor.
- doxapram
doxapram decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Use Caution/Monitor.
- doxepin
onabotulinumtoxinA and doxepin both decrease cholinergic effects/transmission. Use Caution/Monitor.
- droperidol
onabotulinumtoxinA decreases levels of droperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of droperidol by pharmacodynamic antagonism. Use Caution/Monitor.
droperidol increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - echothiophate iodide
echothiophate iodide increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- fesoterodine
onabotulinumtoxinA and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- flavoxate
onabotulinumtoxinA and flavoxate both decrease cholinergic effects/transmission. Use Caution/Monitor.
- fluphenazine
onabotulinumtoxinA decreases levels of fluphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of fluphenazine by pharmacodynamic antagonism. Use Caution/Monitor.
fluphenazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - galantamine
galantamine increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- glycopyrrolate
onabotulinumtoxinA and glycopyrrolate both decrease cholinergic effects/transmission. Use Caution/Monitor.
- glycopyrrolate inhaled
onabotulinumtoxinA and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.
- haloperidol
onabotulinumtoxinA decreases levels of haloperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of haloperidol by pharmacodynamic antagonism. Use Caution/Monitor.
haloperidol increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - henbane
onabotulinumtoxinA and henbane both decrease cholinergic effects/transmission. Use Caution/Monitor.
- homatropine
onabotulinumtoxinA and homatropine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- huperzine A
huperzine A increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- hyoscyamine
onabotulinumtoxinA and hyoscyamine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- hyoscyamine spray
onabotulinumtoxinA and hyoscyamine spray both decrease cholinergic effects/transmission. Use Caution/Monitor.
- iloperidone
onabotulinumtoxinA decreases levels of iloperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of iloperidone by pharmacodynamic antagonism. Use Caution/Monitor.
iloperidone increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - imipramine
onabotulinumtoxinA and imipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- ipratropium
onabotulinumtoxinA and ipratropium both decrease cholinergic effects/transmission. Use Caution/Monitor. Due to the poor systemic absorption of ipratropium, interaction unlikely at regularly recommended dosages.
- levodopa
onabotulinumtoxinA, levodopa. Other (see comment). Use Caution/Monitor. Comment: Anticholinergic agents may enhance the therapeutic effects of levodopa; however, anticholinergic agents can exacerbate tardive dyskinesia. In high dosage, anticholinergics may decrease the effects of levodopa by delaying its GI absorption. .
- lofepramine
onabotulinumtoxinA and lofepramine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- loxapine
onabotulinumtoxinA decreases levels of loxapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of loxapine by pharmacodynamic antagonism. Use Caution/Monitor.
loxapine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - loxapine inhaled
loxapine inhaled increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.
onabotulinumtoxinA decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor. - magnesium sulfate
magnesium sulfate increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Interaction occurs with parenteral magnesium.
- maprotiline
onabotulinumtoxinA and maprotiline both decrease cholinergic effects/transmission. Use Caution/Monitor.
- meclizine
onabotulinumtoxinA and meclizine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- methscopolamine
onabotulinumtoxinA and methscopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- neostigmine
neostigmine increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- nortriptyline
onabotulinumtoxinA and nortriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.
- olanzapine
onabotulinumtoxinA decreases levels of olanzapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of olanzapine by pharmacodynamic antagonism. Use Caution/Monitor.
olanzapine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - orphenadrine
onabotulinumtoxinA and orphenadrine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- oxybutynin
onabotulinumtoxinA and oxybutynin both decrease cholinergic effects/transmission. Use Caution/Monitor.
- oxybutynin topical
onabotulinumtoxinA and oxybutynin topical both decrease cholinergic effects/transmission. Use Caution/Monitor.
- oxybutynin transdermal
onabotulinumtoxinA and oxybutynin transdermal both decrease cholinergic effects/transmission. Use Caution/Monitor.
- paliperidone
onabotulinumtoxinA decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.
paliperidone increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - pancuronium
onabotulinumtoxinA and pancuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- perphenazine
onabotulinumtoxinA decreases levels of perphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of perphenazine by pharmacodynamic antagonism. Use Caution/Monitor.
perphenazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - physostigmine
physostigmine increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- pilocarpine
pilocarpine increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- pimozide
onabotulinumtoxinA decreases levels of pimozide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of pimozide by pharmacodynamic antagonism. Use Caution/Monitor.
pimozide increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - pralidoxime
onabotulinumtoxinA and pralidoxime both decrease cholinergic effects/transmission. Use Caution/Monitor.
- prochlorperazine
onabotulinumtoxinA decreases levels of prochlorperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of prochlorperazine by pharmacodynamic antagonism. Use Caution/Monitor.
prochlorperazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - promethazine
onabotulinumtoxinA decreases levels of promethazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of promethazine by pharmacodynamic antagonism. Use Caution/Monitor.
promethazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - propantheline
onabotulinumtoxinA and propantheline both decrease cholinergic effects/transmission. Use Caution/Monitor.
- protriptyline
onabotulinumtoxinA and protriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.
- pyridostigmine
pyridostigmine increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- quetiapine
onabotulinumtoxinA decreases levels of quetiapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of quetiapine by pharmacodynamic antagonism. Use Caution/Monitor.
quetiapine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - rapacuronium
onabotulinumtoxinA and rapacuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- risperidone
onabotulinumtoxinA decreases levels of risperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of risperidone by pharmacodynamic antagonism. Use Caution/Monitor.
risperidone increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - rocuronium
onabotulinumtoxinA and rocuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- scopolamine
onabotulinumtoxinA and scopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride increases effects of onabotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate increases effects of onabotulinumtoxinA by Other (see comment). Use Caution/Monitor. Comment: Magnesium may potentiate the effects of the neuromuscular blocking agents.
- solifenacin
onabotulinumtoxinA and solifenacin both decrease cholinergic effects/transmission. Use Caution/Monitor.
- succinylcholine
succinylcholine increases and onabotulinumtoxinA decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- thioridazine
onabotulinumtoxinA decreases levels of thioridazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of thioridazine by pharmacodynamic antagonism. Use Caution/Monitor.
thioridazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - thiothixene
onabotulinumtoxinA decreases levels of thiothixene by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of thiothixene by pharmacodynamic antagonism. Use Caution/Monitor.
thiothixene increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - tiotropium
onabotulinumtoxinA and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- tobramycin inhaled
tobramycin inhaled increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Aminoglycosides may aggravate muscle weakness because of a curare-like effect.
- tolterodine
onabotulinumtoxinA and tolterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- trifluoperazine
onabotulinumtoxinA decreases levels of trifluoperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of trifluoperazine by pharmacodynamic antagonism. Use Caution/Monitor.
trifluoperazine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - trihexyphenidyl
onabotulinumtoxinA and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor. Potential for additive anticholinergic effects.
- trimipramine
onabotulinumtoxinA and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.
- trospium chloride
onabotulinumtoxinA and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.
- vecuronium
onabotulinumtoxinA and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.
- ziprasidone
onabotulinumtoxinA decreases levels of ziprasidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of ziprasidone by pharmacodynamic antagonism. Use Caution/Monitor.
ziprasidone increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia. - zotepine
onabotulinumtoxinA decreases levels of zotepine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
onabotulinumtoxinA decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor.
Minor (40)
- acetazolamide
acetazolamide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- amlodipine
amlodipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- carbamazepine
carbamazepine decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- clevidipine
clevidipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- clonazepam
clonazepam decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- desipramine
onabotulinumtoxinA and desipramine both decrease cholinergic effects/transmission. Minor/Significance Unknown.
- diazepam
diazepam decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- dimenhydrinate
dimenhydrinate increases toxicity of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Additive anticholinergic effects.
- donepezil
donepezil decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- eslicarbazepine acetate
eslicarbazepine acetate decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- ethosuximide
ethosuximide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- felbamate
felbamate decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- felodipine
felodipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- fosphenytoin
fosphenytoin decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- gabapentin
gabapentin decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- gabapentin enacarbil
gabapentin enacarbil decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- galantamine
galantamine decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- isradipine
isradipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- lacosamide
lacosamide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- lamotrigine
lamotrigine decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- levetiracetam
levetiracetam decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- lithium
lithium increases effects of onabotulinumtoxinA by unknown mechanism. Minor/Significance Unknown.
- lorazepam
lorazepam decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- methsuximide
methsuximide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- nicardipine
nicardipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- nifedipine
nifedipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- nisoldipine
nisoldipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- oxcarbazepine
oxcarbazepine decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- phenobarbital
phenobarbital decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- phenytoin
phenytoin decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- primidone
primidone decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- quinidine
quinidine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown.
- rufinamide
rufinamide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- thiamine
thiamine increases effects of onabotulinumtoxinA by unspecified interaction mechanism. Minor/Significance Unknown.
- tiagabine
tiagabine decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- topiramate
topiramate decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- trazodone
onabotulinumtoxinA and trazodone both decrease cholinergic effects/transmission. Minor/Significance Unknown.
- valproic acid
valproic acid decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
- verapamil
verapamil increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.
- zonisamide
zonisamide decreases effects of onabotulinumtoxinA by pharmacodynamic antagonism. Minor/Significance Unknown.
Adverse Effects
>10% (Botox)
Urinary tract infection (26-31%)
Residual urine volume (3-17%)
Urinary retention (17-18%)
Somnolence and sedation (16%)
Urinary retention (6-15%)
Dizziness (4-12%)
1-10% (Botox Cosmetic)
Headache (9%)
Eyelid ptosis (2-3%)
Brow ptosis (2%)
Skin tightness (2%)
Facial paresis (1%)
Muscular weakness (1%)
Eyelid edema (1%)
1-10% (Botox)
Bacteriuria (9%)
Dysuria (5-9%)
Neck pain (8-9%)
Headache (5%)
Migraine (4%)
Eyelid ptosis (4%)
Hematuria (4%)
Musculoskeletal stiffness (4%)
Muscular weakness (4%)
Myalgia (3%)
Bronchitis (3%)
Musculoskeletal pain (3%)
Muscle spasms (2%)
Hypertension (2%)
Postmarketing Reports
Botox Cosmetic
- Ear and labyrinth disorders: Hypoacusis; tinnitus; vertigo
- Eye disorders: Diplopia; dry eye; lagophthalmos; strabismus; visual disturbances; vision blurred
- Gastrointestinal disorders Abdominal pain; diarrhea; dry mouth; nausea; vomiting
- General disorders and administration site conditions: Denervation; malaise; pyrexia
- Metabolism and nutrition disorders: Anorexia
- Musculoskeletal and connective tissue disorders: Localized muscle twitching/involuntary muscle contractions; muscle atrophy; myalgia
- Nervous system disorders: Brachial plexopathy; dysarthria; facial palsy; hypoaesthesia; localized numbness; myasthenia gravis; paresthesia; peripheral neuropathy; radiculopathy; syncope
- Respiratory, thoracic and mediastinal disorders: Aspiration pneumonia; dyspnea; respiratory depression and/or respiratory failure
- Skin and subcutaneous tissue disorders: Alopecia, including madarosis; hyperhidrosis; pruritus; skin rash (eg, erythema multiforme, dermatitis psoriasiform, psoriasiform eruption)
Botox
- Abdominal pain; alopecia, including madarosis; anorexia; brachial plexopathy; denervation/muscle atrophy; diarrhea; dry eye; hyperhidrosis; hypoacusis; hypoaesthesia; localized muscle twitching; malaise; paresthesia; peripheral neuropathy; radiculopathy; erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption; strabismus; tinnitus; visual disturbance, diplopia, strabismus, vision blurred, involuntary muscle contractions, myalgia, eyelid edema
Botox (pediatrics)
- Lower limb spasticity
Warnings
Black Box Warnings
Effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects
These symptoms may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties
These symptoms have been reported hours to weeks after injection
Swallowing and breathing difficulties can be life threatening, and death have been reported
The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms
In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses
Contraindications
Hypersensitivity
Neuromuscular disease
Infection at the proposed injection site
Intradetrusor injection: Urinary tract infection or urinary retention (post-void residual >200 mL, who are not routinely performing clean intermittent self-catheterizationwho are not routinely performing clean intermittent self-catheterization)
Cautions
Avoid injections near the levator palpebrae superioris minimize the risk of ptosis, especially in individuals with larger brow-depressor complexes
Risk of respiratory compromise & death esp in children treated for cerebral palsy-associated spasticity
Effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism - watch for dyspnea, dysphagia or speech impairment
The different botulinum toxin products are not interchangeable
Patients with pre-existing neuromuscular disorders should be monitored when given botulinum toxin; patients with known or unrecognized neuromuscular disorders or neuromuscular junction disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from therapeutic doses
Only consider for treatment of urinary incontinence for patients willing and able to initiate catheterization post-treatment, if required (due to risk of urinary retention); patients with diabetes mellitus more likely to develop urinary retention than non-diabetics
Increased risk for UTI; do not use for treatment of urinary incontinence with present UTI, routine catheterization, or if patient is unable to empty bladder without assistance
Use with caution in patients with compromised respiratory function
Corneal exposure and ulceration due to reduced blinking may occur when treating blepharospasm
Retrobulbar hemorrhages and compromised retinal circulation may occur when treating strabismus
Bronchitis and upper respiratory tract infections in patients treated for upper limb spasticity reported
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, reported in patients who received injections for unapproved uses
Tailor dosing in initial and sequential treatment sessions to the individual based on the size, number and location of muscles involved, severity of spasticity, presence of local muscle weakness, patient’s response to previous treatment, or adverse event history with this therapy
Product contains albumin, a derivative of human blood; based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD); risk for transmission of CJD is theoretical; no cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products
Patients with known or unrecognized neuromuscular disorders or neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia and respiratory compromise from therapy
Adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes reported; risk factors including pre- existing cardiovascular disease may increase risk; use caution when administering to patients with pre-existing cardiovascular disease
Autonomic dysreflexia associated with intradetrusor injections could occur in patients treated for detrusor overactivity associated with a neurologic condition; may require prompt medical therapy
Use for the treatment of overactive bladder in patients taking antibiotics chronically due to recurrent UTIs and in patients with multiple recurrent UTIs during treatment should only be considered when the benefit is likely to outweigh potential risk
Drug interactions overview
- Coadministration of abobotulinumtoxin A and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated
- Anticholinergic drugs: Use of anticholinergic drugs after abobotulinumtoxin A administration may potentiate systemic anticholinergic effects
- Administration of different botulinum neurotoxin products concomitantly or within several months of each other is unknown; excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin
- Muscle Relaxants: Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of abobotulinumtoxin A
Pregnancy & Lactation
Pregnancy
There are no adequate data from postmarketing surveillance on the developmental risk associated with use in pregnant women
In animal studies, administrations during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity
Lactation
Not known if excreted in breast milk; effect on nursing infant not known
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
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
Pharmacokinetics
Metabolism: unknown
Excretion: unknown
Minimal levels in circulation after IM injection
Onset of action
- Blepharospasm: 3-4 days
- Strabismus: 1-2 days
- Cervical Dystonia: 2 weeks
- Detrusor overactivity: 2 weeks
Duration
- Blepharospasm: 3-4 months
- Strabismus: 1-2 days
- Cervical Dystonia: 3-4 months
- Detrusor overactivity: 42-48 weeks
Administration
IM Preparation (Botox)
Chronic migraine or spasticity: Reconstitute 2 mL (100 unit/2 mL vial) or 4 mL (200 unit/4 mL) of 0.9% NaCl, preservative free, with a final concentration of 5 Units per 0.1 mL
Preparation for detrusor administration
- Reconstitute vials to result in a final concentration of 20 units/mL
- 200-unit vials: Add 10 mL of preservative-free 0.9% NaCl
- 100-unit vials: Add 5 mL of preservative-free 0.9% NaCl to one 100-unit vial (BW <34kg) or each of two 100-unit vials (BW ≥34 kg)
- Gently mix vial(s)
-
Further dilution
- BW <34 kg: Refer to prescribing information dilution instructions
- BW ≥34 kg: Draw 10 mL from vial(s) into one 10-mL syringe
- Use immediately; dispose of any unused saline
IM Preparation (Botox Cosmetic)
Reconstitute 1.25 mL (50 unit/vial) or 2.5 mL (100 unit/vial) of 0.9% NaCl, preservative free (concentration: 4 units/0.1 mL)
Slowly inject diluent into the vial; discard vial if vacuum does not pull the diluent into the vial
Gently mix; administered within 24 hr after reconstitution
Discard any remaining solution
IM Administration (Botox)
Blepharospasm: Use sterile, 27- or 30-gauge needle without EMG guidance to inject into the medial & lateral pretarsal orbicularis oculi of upper lid and into the lateral pretarsal orbicularis oculi of lower lid
Axillary Hyperhidrosis: standard staining techniques (eg, Minor's iodine starch test) are used to identify the hyperhidrotic area to be injected; pts should shave their underarms & refrain from using OTC deodorants/antiperspirants for 24 hr prior to such staining tests
Strabismus: Inject into extraocular muscles
Detrusor administration via injection
-
UTI prophylaxis
- Oral antibiotics, except aminoglycosides: Administer 1-3 days pretreatment, on treatment day, and 1-3 days posttreatment
- Alternative for patients receiving general anesthesia (or conscious sedation): On treatment day, administer 1 dose of IV prophylactic antibiotics, except aminoglycosides, before treatment
-
Local anesthesia
- Age 5 to <12 years: Consider general anesthesia (or conscious sedation) before injection, per local site practice
- Age ≥12 years: Consider an intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia before injection, per local site practice
- All age groups: At a minimum, consider a diluted instillation of local anesthetic; if a local anesthetic instillation is performed, drain and irrigate bladder with sterile saline before injection
-
Administration
- Prime injection needle with ~1 mL of diluted solution before start of injections (depending on needle length) to remove any air
- Insert needle ~2 mm into detrusor and 20 injections of 0.5 mL each (total volume: 10 mL) should be spaced ~1 cm apart
- For final injection, inject ~1 mL of sterile normal saline so that any remaining drug in the needle is delivered to bladder
- After injections are given, saline used for bladder wall visualization should be drained
- Observe for at least 30 minutes post-injection
IM Administration (Botox Cosmetic)
Draw up the appropriate volume from reconstituted vial with a sterile syringe, preferably a tuberculin syringe, and expel any air bubbles
Remove needle and attach a 30–33-gauge needle; confirm patency of needle
Glabellar lines: At least 0.5 mL
Lateral canthal lines: 0.6 mL
Forehead lines treated in conjunction with glabellar lines: 1 mL
Refer to prescribing information for specific instructions for administration
Do not use Botox Cosmetic and contact Allergan (1-800-890-4345) if
- Carton labeling does not contain an intact seal with a translucent silver Allergan logo (on both ends of the carton) or the seal has a black circle with a diagonal line through it (ie, prohibition sign) Vial label does not contain a holographic film containing the name “Allergan” within rainbow-colored horizontal lines, OR
- U.S. License number 1145 is not present on the vial label and carton labeling
- Carefully examine package to detect fraudulent products
Storage
Unopened vials: Refrigerate at 2- 8°C (36-46ºF)
Reconstituted vials: Use single-dose vials within 24 hr after reconstitution; discard any remaining solution
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Botox injection - | 100 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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