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Drug overview for BOTOX COSMETIC (onabotulinumtoxina):
Generic name: ONABOTULINUMTOXINA (BOT-ue-LYE-num)
Drug class: Neuromuscular Blockers
Therapeutic class: Locomotor System
OnabotulinumtoxinA, a type A botulinum toxin produced by Clostridium botulinum, is a neuromuscular blocking agent and inhibitor of acetylcholine release at motor nerve terminals.
Botulinum toxin has been used for a wide variety of conditions in which the principal therapeutic aim is to reduce undesired or excessive contraction of striated or smooth (involuntary) muscle. There are 7 structurally similar botulinum toxin serotypes (A, B, C, D, E, F, and G) that differ antigenically and serologically. Currently in the US, there are 3 commercially available botulinum toxin type A preparations (abobotulinumtoxinA (Dysport(R)), incobotulinumtoxinA (Xeomin(R)), and onabotulinumtoxinA (Botox(R), Botox(R) Cosmetic)) and one botulinum toxin type B preparation (rimabotulinumtoxinB (Myobloc(R))).
Units of biologic activity of onabotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin (e.g., abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB), and these preparations are not interchangeable. (See Cautions: Lack of Interchangeability Among Botulinum Toxin Preparations.) However, the 2 currently marketed formulations of onabotulinumtoxinA (Botox(R) and Botox(R) Cosmetic) are identical, and the manufacturer states that these preparations may be used interchangeably provided the appropriate dilutions and administration techniques for a given indication are used. (See Reconstitution and Dilution under Dosage and Administration: Reconstitution and Administration.)
Generic name: ONABOTULINUMTOXINA (BOT-ue-LYE-num)
Drug class: Neuromuscular Blockers
Therapeutic class: Locomotor System
OnabotulinumtoxinA, a type A botulinum toxin produced by Clostridium botulinum, is a neuromuscular blocking agent and inhibitor of acetylcholine release at motor nerve terminals.
Botulinum toxin has been used for a wide variety of conditions in which the principal therapeutic aim is to reduce undesired or excessive contraction of striated or smooth (involuntary) muscle. There are 7 structurally similar botulinum toxin serotypes (A, B, C, D, E, F, and G) that differ antigenically and serologically. Currently in the US, there are 3 commercially available botulinum toxin type A preparations (abobotulinumtoxinA (Dysport(R)), incobotulinumtoxinA (Xeomin(R)), and onabotulinumtoxinA (Botox(R), Botox(R) Cosmetic)) and one botulinum toxin type B preparation (rimabotulinumtoxinB (Myobloc(R))).
Units of biologic activity of onabotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin (e.g., abobotulinumtoxinA, incobotulinumtoxinA, rimabotulinumtoxinB), and these preparations are not interchangeable. (See Cautions: Lack of Interchangeability Among Botulinum Toxin Preparations.) However, the 2 currently marketed formulations of onabotulinumtoxinA (Botox(R) and Botox(R) Cosmetic) are identical, and the manufacturer states that these preparations may be used interchangeably provided the appropriate dilutions and administration techniques for a given indication are used. (See Reconstitution and Dilution under Dosage and Administration: Reconstitution and Administration.)
DRUG IMAGES
BOTOX 100 UNIT VIAL
The following indications for BOTOX COSMETIC (onabotulinumtoxina) have been approved by the FDA:
Indications:
Bladder hyperactivity
Blepharospasm
Cerebral palsy-associated limb spasticity
Lower limb spasticity
Migraine prevention
Primary focal hyperhidrosis of axilla
Spasmodic torticollis
Strabismus
Upper limb spasticity
Urinary incontinence due to detrusor overactivity
Professional Synonyms:
Blepharospasmus
Cervical dystonia
Detrusor overactivity
Dystonia of neck muscles
Dystonic torticollis
Hypertonic bladder
Hypertonicity of bladder
Incontinence due to detrusor instability
Low compliance of bladder
Lower limb muscle spasticity
Migraine prophylaxis
Overactive detrusor
Primary axillary hyperhidrosis
Rotatory spasm
Rotatory tic
Upper limb muscle spasticity
Indications:
Bladder hyperactivity
Blepharospasm
Cerebral palsy-associated limb spasticity
Lower limb spasticity
Migraine prevention
Primary focal hyperhidrosis of axilla
Spasmodic torticollis
Strabismus
Upper limb spasticity
Urinary incontinence due to detrusor overactivity
Professional Synonyms:
Blepharospasmus
Cervical dystonia
Detrusor overactivity
Dystonia of neck muscles
Dystonic torticollis
Hypertonic bladder
Hypertonicity of bladder
Incontinence due to detrusor instability
Low compliance of bladder
Lower limb muscle spasticity
Migraine prophylaxis
Overactive detrusor
Primary axillary hyperhidrosis
Rotatory spasm
Rotatory tic
Upper limb muscle spasticity
The following dosing information is available for BOTOX COSMETIC (onabotulinumtoxina):
Dosage of onabotulinumtoxinA should be carefully individualized according to patient response and to the particular condition being treated. When initiating treatment, the lowest recommended dose should be used. Generally, the effective dose when injecting into muscle depends on muscle mass: the larger the muscle, the higher the required dose.
However, optimal dosages for a number of conditions in which onabotulinumtoxinA has been used have not been established. If a patient treated with onabotulinumtoxinA fails to respond, clinicians should consider the possibility of an inadequate drug dose, incorrectly reconstituted and/or improperly stored drug solution, and/or misinjection.
The manufacturer states that the maximum cumulative dose of onabotulinumtoxinA (given as Botox(R) and/or Botox(R) Cosmetic) for one or more uses in adults should not exceed 400 units in a 3-month period.
Some clinicians suggest that the interval between onabotulinumtoxinA injections should be as long as 8-12 weeks in patients receiving the drug for noncosmetic indications. In addition, some evidence suggests that the possibility of antibody formation increases with higher doses (exceeding 300 units total dose) and more frequent administration of onabotulinumtoxinA. (See Cautions: Antibody Formation.) However, in the management of hyperkinetic facial lines, some clinicians administer repeat injections of onabotulinumtoxinA 2 weeks after the initial injection if desired results have not been achieved, stating that strict adherence to the manufacturer recommended minimum injection interval of 12 weeks does not appear to be critical with the low doses of onabotulinumtoxinA used for cosmesis (usually less than 100 units total dose).
However, optimal dosages for a number of conditions in which onabotulinumtoxinA has been used have not been established. If a patient treated with onabotulinumtoxinA fails to respond, clinicians should consider the possibility of an inadequate drug dose, incorrectly reconstituted and/or improperly stored drug solution, and/or misinjection.
The manufacturer states that the maximum cumulative dose of onabotulinumtoxinA (given as Botox(R) and/or Botox(R) Cosmetic) for one or more uses in adults should not exceed 400 units in a 3-month period.
Some clinicians suggest that the interval between onabotulinumtoxinA injections should be as long as 8-12 weeks in patients receiving the drug for noncosmetic indications. In addition, some evidence suggests that the possibility of antibody formation increases with higher doses (exceeding 300 units total dose) and more frequent administration of onabotulinumtoxinA. (See Cautions: Antibody Formation.) However, in the management of hyperkinetic facial lines, some clinicians administer repeat injections of onabotulinumtoxinA 2 weeks after the initial injection if desired results have not been achieved, stating that strict adherence to the manufacturer recommended minimum injection interval of 12 weeks does not appear to be critical with the low doses of onabotulinumtoxinA used for cosmesis (usually less than 100 units total dose).
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for BOTOX COSMETIC (onabotulinumtoxina):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Misc Antibiotics/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Aminoglycosides, bacitracin, clindamycin, lincomycin, and polymyxins may enhance the pharmacologic effects of neuromuscular blocking agents. CLINICAL EFFECTS: May see an increase in the pharmacologic effects of neuromuscular blocking agents, including prolonged respiratory depression and apnea. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. DISCUSSION: Concomitant administration of aminoglycosides, bacitracin, clindamycin, lincomycin, and polymixins with neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and fatal apnea. The interaction usually occurs when the antibiotic is given prior to or concurrently with the neuromuscular blocking drug, but it may also occur when given after administration. Any antibiotic dosage or route of administration may produce respiratory depression. |
AMIKACIN SULFATE, BETHKIS, COLISTIN SULFATE, GENTAMICIN SULFATE, GENTAMICIN SULFATE IN NS, HUMATIN, KANAMYCIN SULFATE, KITABIS PAK, NEOMYCIN SULFATE, PAROMOMYCIN SULFATE, STREPTOMYCIN SULFATE, TIGECYCLINE, TOBI, TOBI PODHALER, TOBRAMYCIN, TOBRAMYCIN SULFATE, TYGACIL |
| General Anesthetics (Inhl)/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: General anesthetics enhance the pharmacologic effects of nondepolarizing muscle relaxants. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects of the nondepolarizing muscle relaxant including respiratory depression, bradycardia, hypotension, flushing, or muscle weakness. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: It may be necessary to decrease the dose of the nondepolarizing muscle relaxant. Monitor neuromuscular function and adjust the dose of the nondepolarizing muscle relaxant accordingly. DISCUSSION: Concomitant administration of general anesthetics and nondepolarizing muscle relaxants has been shown to produce synergistic neuromuscular blocking effects of nondepolarizing muscle relaxants. |
DESFLURANE, FORANE, ISOFLURANE, SEVOFLURANE, SUPRANE, TERRELL, ULTANE |
| Neuromuscular Blocking Agents/Quinine Derivatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Synergistic or additive pharmacologic activity. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid concurrent administration of neuromuscular blocking agents and quinine derivatives during the first several hours of postoperative period. If administered, respiratory support may be needed. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Administration of quinidine during the immediate postoperative period has been associated with respiratory paralysis and apnea. |
NUEDEXTA, QUALAQUIN, QUINIDINE GLUCONATE, QUINIDINE SULFATE, QUININE HCL, QUININE SULFATE |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Neuromuscular Blocking Agents/Polypeptide Antibiotics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Synergistic pharmacologic activity. Polymyxin B affects neuromuscular transmission by blocking acetylcholine receptors. Its action is thus post-synaptic and the neuromuscular block has no antagonists. Polymyxin B causes neostigmine resistance to d-tubocurarine blockade and calcium resistance to the blockade evoked by aminoglycoside antibiotics (1,2,3,4). A pre-synaptic mechanism may also be involved with decreased release of acetylcholine. CLINICAL EFFECTS: May see an increase in the neuromuscular blocking effects, including profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Concomitant administration of polypeptide antibiotics and neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and apnea. This interaction has been documented with colistimethate, polymyxin B, bacitracin, and vancomycin. |
BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC, COLISTIMETHATE, COLISTIMETHATE SODIUM, COLY-MYCIN M PARENTERAL, POLYMYXIN B SULFATE, VANCOMYCIN, VANCOMYCIN HCL, VANCOMYCIN HCL-0.9% NACL, VANCOMYCIN HCL-D5W |
| Neuromuscular Blocking Agents/Lincosamides SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Lincosamides appear to augment the neuromuscular blocking effects of nondepolarizing muscle relaxants. CLINICAL EFFECTS: The effects of nondepolarizing neuromuscular relaxants may be prolonged leading to profound sedation, respiratory depression, coma, and/or death. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Monitor respiratory function of the patient and provide the necessary support. In patients who have received nondepolarizing muscle relaxants, avoid use of lincosamides in the recovery room. If concurrent use is necessary, monitor patients for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. DISCUSSION: Lincomycin has been reported to augment the neuromuscular blocking effect of pancuronium in seven anesthetized patients. The effect was readily antagonized by neostigmine administration. In a case report, clindamycin produced prolonged neuromuscular blockade in a patient who had received pancuronium. Neostigmine was ineffective in antagonizing the blockade. |
CLEOCIN HCL, CLEOCIN PEDIATRIC, CLEOCIN PHOSPHATE, CLINDAMYCIN (PEDIATRIC), CLINDAMYCIN HCL, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE-D5W, CLINDAMYCIN-0.9% NACL, LINCOCIN, LINCOMYCIN HCL |
| Hydantoins/Select Neuromuscular Blocking Agents SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: It has been suggested that phenytoin increases end-plate anticholinesterase activity, resulting in higher acetylcholine concentration at the neuromuscular junction.(1) CLINICAL EFFECTS: A higher plasma concentration of the neuromuscular blocking agent was required to effect a given level of neuromuscular blockade in patients receiving phenytoin.(2,3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving hydantoin anticonvulsants should be monitored for a decreased response to the neuromuscular blocking agent. The dose of the neuromuscular blocking agent may need to be increased and/or given more frequently.(9) DISCUSSION: In a study, patients receiving phenytoin were administered metocurine, attained 83% of maximum neuromuscular blockade compared with 98% in the control group.(1) In another study, patients maintained on phenytoin for more than one week had a significantly higher pancuronium requirement than those patients not receiving phenytoin.(1) In two separate case reports, patients maintained on phenytoin demonstrated a resistance to pancuronium and a decreased duration of neuromuscular blockade.(3,4) In a study, patients maintained on phenytoin and receiving vecuronium had a significantly shorter total duration and effect of neuromuscular blockade compared to those patients not receiving phenytoin.(5) In contrast, neither the effect nor duration of atracurium's neuromuscular blockade was affected by phenytoin.(5) Two in vitro studies showed that the neuromuscular blockade of curare and tubocurarine was potentiated by the use of phenytoin.(6,7) Ten children received a bolus dose of vecuronium 0.15mg/Kg while on phenytoin and showed a significantly increased clearance of vecuronium compared to the control group, 15.1 and 9.0 ml/Kg/min, respectively.(8) In a case report, a 58 year-old male previously stabilized on phenytoin (400 mg daily) was given an injection of vecuronium (8 mg) to induce muscle blockade during bowel surgery. While monitoring the effectiveness of vecuronium only 75% twitch height blockade was noted after seven minutes. The medication, due to its short duration and impaired effectiveness, had to be given more frequently throughout the surgery in order to maintain adequate muscle block.(9) A separate case report records a decreased response to pancuronium in a 15 year-old male, previously stabilized on phenytoin (350 mg daily), while undergoing surgery to remove a parietal tumor. Pancuronium (0.7 mg/kg) was given as a relaxant during the surgery and monitored using the train-of-four method. Intermittent doses of pancuronium (0.17 mg/kg) were given for the first hour of surgery without successful blockade apparent by the return of all four twitches within ten minutes of each dose. A second attempt at muscular blockade was made with continuous infusion atracurium (0.26-0.55 mg/kg/hour) for the duration of the surgery. Only 16 minutes after stopping the infusion, all four twitches were visible.(10) |
CEREBYX, DILANTIN, DILANTIN-125, FOSPHENYTOIN SODIUM, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED |
The following contraindication information is available for BOTOX COSMETIC (onabotulinumtoxina):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 14 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Amyotrophic lateral sclerosis |
| Aspiration pneumonia |
| Blepharoptosis |
| Blurred vision |
| Botulism |
| Diplopia |
| Dysarthria |
| Dysphagia |
| Dyspnea |
| Eaton-lambert syndrome |
| Myasthenia gravis |
| Peripheral motor neuropathy |
| Respiratory depression |
| Urinary incontinence |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Atherosclerotic cardiovascular disease |
| Hoarseness |
| Polyopia |
The following adverse reaction information is available for BOTOX COSMETIC (onabotulinumtoxina):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 31 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dysphagia Lagophthalmos Muscle weakness Voice change |
Diplopia Fever Infection |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Acute respiratory distress syndrome Anaphylaxis Aspiration pneumonia Atrioventricular block Botulism Brachial plexus disorder Cardiac arrhythmia Corneal ulcer Dysarthria Dyspnea Entropion Erythema Erythema multiforme Hearing loss Hematoma Hypersensitivity drug reaction Keratitis Muscle atrophy Pneumonia Respiratory depression Seizure disorder Serum sickness Urinary incontinence |
There are 64 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Back pain Blepharoptosis Bronchitis Cough Dysuria Ecchymosis Eyelid edema Fatigue Headache disorder Influenza Injection site infection Injection site sequelae Nausea Neck pain Ocular irritation Pharyngitis Rhinitis Upper respiratory infection Urinary retention Urinary tract infection Xerostomia |
Pruritus of skin Skin rash Visual changes |
| Rare/Very Rare |
|---|
|
Acute abdominal pain Alopecia Anorexia Arthralgia Blurred vision Chest pain Diarrhea Dizziness Dry eye Edema Excessive granulation tissue Eyes vertical deviation Facial palsy Flu-like symptoms Gait abnormality General weakness Heavy feeling Hematuria Hyperhidrosis Hypertonia Hypoesthesia Madarosis of eyelid Malaise Muscle fasciculation Musculoskeletal pain Myalgia Paresthesia Peripheral neuropathy Photophobia Psoriasiform eruption Retrobulbar hemorrhage Sinusitis Stinging of skin Strabismus Symptoms of anxiety Syncope Tinnitus Urticaria Vertigo Vomiting |
The following precautions are available for BOTOX COSMETIC (onabotulinumtoxina):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and well-controlled studies of onabotulinumtoxinA in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; most clinicians state that the drug should not be used for cosmetic purposes during pregnancy. Abortion, decreased fetal body weight, and fetal malformations (e.g., skeletal ossification) have been observed in animals (e.g., mice, rats, rabbits) given onabotulinumtoxinA during gestation.
At least one woman who received onabotulinumtoxinA during pregnancy reportedly gave birth prematurely, although a causal relationship to the drug was considered unlikely. Reductions in fetal body weight and/or delayed ossification were observed in pregnant mice and rats receiving IM onabotulinumtoxinA in doses of 4, 8, or 16 units/kg 2 times during the period of organogenesis (gestation days 5 and 13). The reproductive developmental no-observed-effect level (NOEL) following IM injection of 4, 8, or 16 units/kg of onabotulinumtoxinA was 4 units/kg in pregnant mice or rats.
These no-effect doses for developmental toxicity are approximately equal to the human dose of 400 units or 4 times the average high human dose (64 units) for glabellar, lateral canthal lines, and forehead lines on a body weight (units/kg) basis. Reduced fetal weights and decreased fetal skeletal ossification were observed with IM onabotulinumtoxinA doses of 4 or 8 units/kg in pregnant rats or 0.5 units/kg in rabbits during the period of organogenesis.
These doses were associated with substantial maternal toxicity, including abortions, early deliveries, and maternal death. In these studies, the developmental NOEL of 1 unit/kg in rats is approximately equal to the human dose of 64 units based on units/kg, and the developmental NOEL of 0.25 units/kg in rabbits is less than the human dose of 400 units based on units/kg.
At least one woman who received onabotulinumtoxinA during pregnancy reportedly gave birth prematurely, although a causal relationship to the drug was considered unlikely. Reductions in fetal body weight and/or delayed ossification were observed in pregnant mice and rats receiving IM onabotulinumtoxinA in doses of 4, 8, or 16 units/kg 2 times during the period of organogenesis (gestation days 5 and 13). The reproductive developmental no-observed-effect level (NOEL) following IM injection of 4, 8, or 16 units/kg of onabotulinumtoxinA was 4 units/kg in pregnant mice or rats.
These no-effect doses for developmental toxicity are approximately equal to the human dose of 400 units or 4 times the average high human dose (64 units) for glabellar, lateral canthal lines, and forehead lines on a body weight (units/kg) basis. Reduced fetal weights and decreased fetal skeletal ossification were observed with IM onabotulinumtoxinA doses of 4 or 8 units/kg in pregnant rats or 0.5 units/kg in rabbits during the period of organogenesis.
These doses were associated with substantial maternal toxicity, including abortions, early deliveries, and maternal death. In these studies, the developmental NOEL of 1 unit/kg in rats is approximately equal to the human dose of 64 units based on units/kg, and the developmental NOEL of 0.25 units/kg in rabbits is less than the human dose of 400 units based on units/kg.
Data on the presence of onabotulinumtoxinA in human milk, the effects on the breastfed infant, or the effects of the drug on milk production are lacking. The benefits of breastfeeding should be considered along with the mother's clinical need for onabotulinumtoxinA and any potential adverse effects on the breastfed infant from onabotulinumtoxinA or from the underlying maternal condition.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for BOTOX COSMETIC (onabotulinumtoxina):
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.
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.
The following icd codes are available for BOTOX COSMETIC (onabotulinumtoxina)'s list of indications:
| Bladder hyperactivity | |
| N32.81 | Overactive bladder |
| Blepharospasm | |
| G24.5 | Blepharospasm |
| Cerebral palsy-associated limb spasticity | |
| G80 | Cerebral palsy |
| G80.0 | Spastic quadriplegic cerebral palsy |
| G80.1 | Spastic diplegic cerebral palsy |
| G80.2 | Spastic hemiplegic cerebral palsy |
| G80.3 | Athetoid cerebral palsy |
| G80.4 | Ataxic cerebral palsy |
| Lower limb spasticity | |
| G04.1 | Tropical spastic paraplegia |
| G11.4 | Hereditary spastic paraplegia |
| G80.0 | Spastic quadriplegic cerebral palsy |
| G80.1 | Spastic diplegic cerebral palsy |
| G80.2 | Spastic hemiplegic cerebral palsy |
| G81.1 | Spastic hemiplegia |
| G81.10 | Spastic hemiplegia affecting unspecified side |
| G81.11 | Spastic hemiplegia affecting right dominant side |
| G81.12 | Spastic hemiplegia affecting left dominant side |
| G81.13 | Spastic hemiplegia affecting right nondominant side |
| G81.14 | Spastic hemiplegia affecting left nondominant side |
| M62.838 | Other muscle spasm |
| Migraine prevention | |
| G43 | Migraine |
| G43.0 | Migraine without aura |
| G43.00 | Migraine without aura, not intractable |
| G43.001 | Migraine without aura, not intractable, with status migrainosus |
| G43.009 | Migraine without aura, not intractable, without status migrainosus |
| G43.01 | Migraine without aura, intractable |
| G43.011 | Migraine without aura, intractable, with status migrainosus |
| G43.019 | Migraine without aura, intractable, without status migrainosus |
| G43.1 | Migraine with aura |
| G43.10 | Migraine with aura, not intractable |
| G43.101 | Migraine with aura, not intractable, with status migrainosus |
| G43.109 | Migraine with aura, not intractable, without status migrainosus |
| G43.11 | Migraine with aura, intractable |
| G43.111 | Migraine with aura, intractable, with status migrainosus |
| G43.119 | Migraine with aura, intractable, without status migrainosus |
| G43.4 | Hemiplegic migraine |
| G43.40 | Hemiplegic migraine, not intractable |
| G43.401 | Hemiplegic migraine, not intractable, with status migrainosus |
| G43.409 | Hemiplegic migraine, not intractable, without status migrainosus |
| G43.41 | Hemiplegic migraine, intractable |
| G43.411 | Hemiplegic migraine, intractable, with status migrainosus |
| G43.419 | Hemiplegic migraine, intractable, without status migrainosus |
| G43.5 | Persistent migraine aura without cerebral infarction |
| G43.50 | Persistent migraine aura without cerebral infarction, not intractable |
| G43.501 | Persistent migraine aura without cerebral infarction, not intractable, with status migrainosus |
| G43.509 | Persistent migraine aura without cerebral infarction, not intractable, without status migrainosus |
| G43.51 | Persistent migraine aura without cerebral infarction, intractable |
| G43.511 | Persistent migraine aura without cerebral infarction, intractable, with status migrainosus |
| G43.519 | Persistent migraine aura without cerebral infarction, intractable, without status migrainosus |
| G43.6 | Persistent migraine aura with cerebral infarction |
| G43.60 | Persistent migraine aura with cerebral infarction, not intractable |
| G43.601 | Persistent migraine aura with cerebral infarction, not intractable, with status migrainosus |
| G43.609 | Persistent migraine aura with cerebral infarction, not intractable, without status migrainosus |
| G43.61 | Persistent migraine aura with cerebral infarction, intractable |
| G43.611 | Persistent migraine aura with cerebral infarction, intractable, with status migrainosus |
| G43.619 | Persistent migraine aura with cerebral infarction, intractable, without status migrainosus |
| G43.7 | Chronic migraine without aura |
| G43.70 | Chronic migraine without aura, not intractable |
| G43.701 | Chronic migraine without aura, not intractable, with status migrainosus |
| G43.709 | Chronic migraine without aura, not intractable, without status migrainosus |
| G43.71 | Chronic migraine without aura, intractable |
| G43.711 | Chronic migraine without aura, intractable, with status migrainosus |
| G43.719 | Chronic migraine without aura, intractable, without status migrainosus |
| G43.8 | Other migraine |
| G43.80 | Other migraine, not intractable |
| G43.801 | Other migraine, not intractable, with status migrainosus |
| G43.809 | Other migraine, not intractable, without status migrainosus |
| G43.81 | Other migraine, intractable |
| G43.811 | Other migraine, intractable, with status migrainosus |
| G43.819 | Other migraine, intractable, without status migrainosus |
| G43.82 | Menstrual migraine, not intractable |
| G43.821 | Menstrual migraine, not intractable, with status migrainosus |
| G43.829 | Menstrual migraine, not intractable, without status migrainosus |
| G43.83 | Menstrual migraine, intractable |
| G43.831 | Menstrual migraine, intractable, with status migrainosus |
| G43.839 | Menstrual migraine, intractable, without status migrainosus |
| G43.9 | Migraine, unspecified |
| G43.90 | Migraine, unspecified, not intractable |
| G43.901 | Migraine, unspecified, not intractable, with status migrainosus |
| G43.909 | Migraine, unspecified, not intractable, without status migrainosus |
| G43.91 | Migraine, unspecified, intractable |
| G43.911 | Migraine, unspecified, intractable, with status migrainosus |
| G43.919 | Migraine, unspecified, intractable, without status migrainosus |
| G43.B | Ophthalmoplegic migraine |
| G43.B0 | Ophthalmoplegic migraine, not intractable |
| G43.B1 | Ophthalmoplegic migraine, intractable |
| G43.C | Periodic headache syndromes in child or adult |
| G43.C0 | Periodic headache syndromes in child or adult, not intractable |
| G43.C1 | Periodic headache syndromes in child or adult, intractable |
| G43.D | Abdominal migraine |
| G43.D0 | Abdominal migraine, not intractable |
| G43.D1 | Abdominal migraine, intractable |
| G43.E | Chronic migraine with aura |
| G43.E0 | Chronic migraine with aura, not intractable |
| G43.E01 | Chronic migraine with aura, not intractable, with status migrainosus |
| G43.E09 | Chronic migraine with aura, not intractable, without status migrainosus |
| G43.E1 | Chronic migraine with aura, intractable |
| G43.E11 | Chronic migraine with aura, intractable, with status migrainosus |
| G43.E19 | Chronic migraine with aura, intractable, without status migrainosus |
| Primary focal hyperhidrosis of axilla | |
| L74.510 | Primary focal hyperhidrosis, axilla |
| Spasmodic torticollis | |
| G24.3 | Spasmodic torticollis |
| Strabismus | |
| H49.2 | Sixth [abducent] nerve palsy |
| H49.20 | Sixth [abducent] nerve palsy, unspecified eye |
| H49.21 | Sixth [abducent] nerve palsy, right eye |
| H49.22 | Sixth [abducent] nerve palsy, left eye |
| H49.23 | Sixth [abducent] nerve palsy, bilateral |
| H50.00 | Unspecified esotropia |
| H50.01 | Monocular esotropia |
| H50.011 | Monocular esotropia, right eye |
| H50.012 | Monocular esotropia, left eye |
| H50.10 | Unspecified exotropia |
| H50.11 | Monocular exotropia |
| H50.111 | Monocular exotropia, right eye |
| H50.112 | Monocular exotropia, left eye |
| H50.2 | Vertical strabismus |
| H50.21 | Vertical strabismus, right eye |
| H50.22 | Vertical strabismus, left eye |
| H50.9 | Unspecified strabismus |
| Upper limb spasticity | |
| G04.1 | Tropical spastic paraplegia |
| G11.4 | Hereditary spastic paraplegia |
| G80.0 | Spastic quadriplegic cerebral palsy |
| G80.1 | Spastic diplegic cerebral palsy |
| G80.2 | Spastic hemiplegic cerebral palsy |
| G81.1 | Spastic hemiplegia |
| G81.10 | Spastic hemiplegia affecting unspecified side |
| G81.11 | Spastic hemiplegia affecting right dominant side |
| G81.12 | Spastic hemiplegia affecting left dominant side |
| G81.13 | Spastic hemiplegia affecting right nondominant side |
| G81.14 | Spastic hemiplegia affecting left nondominant side |
| M62.838 | Other muscle spasm |
| Urinary incontinence due to detrusor overactivity | |
| N32.81 | Overactive bladder |
Formulary Reference Tool