onabotulinumtoxinA (Rx)

Brand and Other Names:Botox, Botox Cosmetic, more...botulinum toxin
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and onabotulinumtoxinA

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              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 (95)

              • 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.

              • pilocarpine ophthalmic

                pilocarpine ophthalmic 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.

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              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
                • Pediatrics
                  • Lower limb spasticity
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              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
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              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.

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              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
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              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

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Botox injection
              -
              100 unit vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              onabotulinumtoxinA injection

              BOTULINUM TOXIN - INJECTION

              (BOT-ue-LYE-num)

              WARNING: See also Uses section.This medication can spread to other parts of the body after your injection, causing serious (possibly fatal) side effects. These can occur hours or even weeks after the injection. However, the chances of such serious side effects occurring when this medication is used for migraines or skin conditions such as wrinkles, eye spasm, or excessive sweating are extremely unlikely.Children being treated for muscle stiffness/spasms have the greatest risk of these effects, as well as anyone that has certain medical conditions (see Precautions section). Discuss the risks and benefits of this medication with your doctor.Get medical help right away if any of these very serious side effects occur: chest pain, difficulty breathing, excessive muscle weakness, irregular heartbeat, severe difficulty swallowing or speaking, loss of bladder control.

              USES: There are different types of botulinum toxin products (toxin A and B) with different uses (eye problems, muscle stiffness/spasms, migraines, cosmetic, overactive bladder). Different brands of this medication deliver different amounts of medication. Your doctor will choose the correct product for you.Botulinum toxin is used to treat certain eye disorders such as crossed eyes (strabismus) and uncontrolled blinking (blepharospasm), to treat muscle stiffness/spasms or movement disorders (such as cervical dystonia, torticollis), and to reduce the cosmetic appearance of wrinkles. It is also used to prevent headaches in people with very frequent migraines. Botulinum toxin relaxes muscle by blocking the release of a chemical called acetylcholine.Botulinum toxin is also used to treat overactive bladder by patients who do not respond to or who cannot tolerate the side effects of other medications. It helps to reduce leaking of urine, feeling of needing to urinate right away, and frequent trips to the bathroom.It is also used to treat severe underarm sweating and drooling/excess saliva. Botulinum toxin works by blocking the chemicals that turn on the sweat and salivary glands.Botulinum toxin is not a cure, and your symptoms will gradually return as the medication wears off.

              HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get an injection. If you have any questions regarding the information, consult your doctor or pharmacist.This medication is given by injection by an experienced health care professional. It is injected into the affected muscles (intramuscularly) when treating eye disorders, muscle stiffness/spasms, and wrinkles. When used to prevent migraines, it is injected into the muscles of the head and neck. It is injected into the skin (intradermally) for the treatment of excessive sweating. For the treatment of drooling/excess saliva, this medication is injected into the salivary glands. When treating overactive bladder, it is injected into the bladder.Your dose, the number of injections, the site of injections, and how often you receive the medication will be determined by your condition and your response to therapy. For children, the dose is also based on weight. Most people start to see an effect within a few days to 2 weeks, and the effect usually lasts 3 to 6 months.

              SIDE EFFECTS: See also Warning section.Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating may occur.If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as cow's milk protein found in some products), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor your medical history, especially of: bleeding problems, eye surgery, certain eye problem (glaucoma), heart disease, diabetes, signs of infection near the injection site, urinary tract infection, inability to urinate, muscle/nerve disorders (such as Lou Gehrig's disease-ALS, myasthenia gravis), seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia), treatment with any botulinum toxin product (especially in the last 4 months).This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.Before having surgery, tell your doctor or dentist that you are using this medication.Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get serious infections from the medication. Consult your doctor or pharmacist for more information.Older adults using this drug for overactive bladder may be more sensitive to the side effects of this drug, especially urinary effects.Children using this drug for muscle spasms may be more sensitive to the side effects of this drug, including difficulty breathing or swallowing. See Warning section. Discuss the risks and benefits with the doctor.This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Use for the cosmetic treatment of wrinkles is not recommended during pregnancy.It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: certain antibiotics (including aminoglycosides such as gentamicin, polymyxin), anticoagulants (such as warfarin), Alzheimer's disease drugs (such as galantamine, rivastigmine, tacrine), myasthenia gravis drugs (such as ambenonium, pyridostigmine), quinidine.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. An antitoxin is available but must be used before symptoms of overdose become apparent. Symptoms of overdose may be delayed, and may include serious muscle weakness, breathing problems and paralysis.

              NOTES: It is important to understand the risks and benefits of this therapy. Discuss any questions or concerns with your health care professional.

              MISSED DOSE: Not applicable.

              STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.