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Onabotulinumtoxina Dosage

Applies to the following strength(s): 100 units ; 50 units ; 200 units

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Blepharospasm

OnabotulinumtoxinA (Botox(R)):
1.25 to 2.5 units IM (0.05 mL to 0.1 mL volume at each site) injected into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid

Comments:
-Reconstituted solution is injected using a sterile, 27 to 30 gauge needle without electromagnetic guidance:
-Avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis.
-Avoiding medial lower lid injections, and thereby reducing diffusion into the inferior oblique, may reduce the complication of diplopia.
-Ecchymosis occurs easily in the soft eyelid tissues. This can be prevented by applying pressure at the injection site immediately after the injection.
-The cumulative dose of this drug in a 30 day period should not exceed 200 units.
-The initial effect of the injections is usually seen within 3 days and reaches a peak at 1 to 2 weeks posttreatment. Each treatment lasts approximately 3 months, after which the procedure may be repeated. At repeat treatment sessions, the dose may be increased up to 2-fold if the response from the initial treatment is considered insufficient (usually defined as an effect that does not last longer than 2 months). However, there appears to be little benefit obtainable from injecting more than 5 units per site. Injecting more frequently than every 3 months may result in some tolerance, and is rare to have the effect be permanent.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use: Treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and older

Usual Adult Dose for Strabismus

OnabotulinumtoxinA (Botox(R)):
Use the lower listed doses for treatment of small deviations. Use the larger doses only for large deviations:
-For vertical muscles, and for horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 units IM in any one muscle
-For horizontal strabismus of 20 prism diopters to 50 prism diopters: 2.5 to 5 units IM in any one muscle
-For persistent VI nerve palsy of one month or longer duration: 1.25 to 2.5 units IM in the medial rectus muscle

Subsequent doses for residual or recurrent strabismus: It is recommended that patients be reexamined 7 to 14 days after each injection to assess the effect of that dose:
-Patients experiencing adequate paralysis of the target muscle that require subsequent injections should receive a dose comparable to the initial dose.
-Subsequent doses for patients experiencing incomplete paralysis of the target muscle may be increased up to 2-fold compared to the previously administered dose.
-Subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.
-The maximum recommended dose as a single injection for any one muscle is 25 units.

Comments:
-This drug is intended for injection into extraocular muscles utilizing the electrical activity recorded from the tip of the injection needle as a guide to placement within the target muscle. Injection without surgical exposure or electromyographic guidance should not be attempted. Physicians should be familiar with electromyographic technique.
-To prepare the eye for injection, it is recommended that several drops of a local anesthetic and an ocular decongestant be given several minutes prior to injection.
-Paralysis of injected muscles typically occurs 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time period. Overcorrections lasting more than 6 months have been rare. About one-half of patients will require subsequent doses because of inadequate paralytic response of the muscle to the initial dose, or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use: Treatment of strabismus in patients 12 years of age or older

Usual Adult Dose for Upper Limb Spasticity

OnabotulinumtoxinA (Botox(R)):
In clinical trials, doses of onabotulinumtoxinA ranging from 75 units to 400 units were divided among selected muscles at a given treatment session:
Recommended dose ranges per muscle:
Biceps Brachii: 100 to 200 units divided in 4 sites
Flexor Carpi Radialis: 12.5 to 50 units in 1 site
Flexor Carpi Ulnaris: 12.5 to 50 units in 1 site
Flexor Digitorum Profundus: 30 to 50 units in 1 site
Flexor Digitorum Sublimis: 30 to 50 units in 1 site
Adductor Pollicis: 20 units in 1 site
Flexor Pollicis Longus: 20 units in 1 site

Comments:
-Repeat treatment may be administered when the effect of a previous injection has diminished, but generally no sooner than 12 weeks after the previous injection. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose muscles to be injected.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
-This drug has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture.
-Treatment is not intended to substitute for usual standard of care rehabilitation regimens.
-Safety and effectiveness have not been established for the treatment of other upper limb muscle groups, or for the treatment of lower limb spasticity.
-Safety and effectiveness have not been established for the treatment of spasticity in pediatric patients under age 18 years.

Use:
-For the treatment of upper limb spasticity in adult patients, to decrease the severity of increased muscle tone in elbow flexors (biceps), wrist flexors (flexor carpi radialis and flexor carpi ulnaris), finger flexors (flexor digitorum profundus and flexor digitorum sublimis), and thumb flexors (adductor pollicis and flexor pollicis longus).

Usual Adult Dose for Cervical Dystonia

OnabotulinumtoxinA (Botox(R)):
-In a study of patients who had previously received and tolerated this drug, the mean dose administered was 236 units (25 th to 75 th percentile range 198 to 300 units) divided among the affected muscle groups

Comments:
-Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history.
-The initial dose for a patient without prior use of this drug should be a lower dose, with subsequent dosing adjusted based on individual response.
-Limiting the total dose injected into the sternocleidomastoid muscle to 100 units or less may decrease the occurrence of dysphagia.
-Improvement generally begins within the first 2 weeks after injection with maximum benefit at approximately 6 weeks post-injection. Most subjects were observed to have returned to pre-treatment status by 3 months post-treatment.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use: For the treatment of adults and children over 16 years of age with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia

Usual Adult Dose for Hyperhidrosis

OnabotulinumtoxinA (Botox):
50 units intradermally in 0.1 to 0.2 mL aliquots to each axilla distributed evenly in multiple sites (10 to 15) approximately 1 to 2 cm apart

Comments:
-The hyperhidrotic area to be injected should be defined using standard staining techniques, (e.g., Minor's Iodine-Starch Test).
-Patients should shave underarms and abstain from use of over-the-counter deodorants or antiperspirants for 24 hours prior to the test. Patient should be resting without exercise or hot drinks for 30 minutes prior to the test. Dry the underarm area and then immediately paint it with iodine solution. Allow the area to dry, then lightly sprinkle the area with starch powder. Gently blow off any excess. The hyperhidrotic area will develop a deep blue-black color over approximately 10 minutes.
-Each injection site has a ring of effect of up to approximately 2 cm in diameter.
-Repeat injections for hyperhidrosis should be administered when the clinical effect of a previous injection diminishes.
-Inject each dose to a depth of approximately 2 mm and at a 45 degree angle to the skin surface with the bevel side up.
-If injection sites are marked in ink do not inject directly through the ink mark to avoid a permanent tattoo mark.
-Safety and effectiveness for hyperhidrosis in other body areas have not been established.
-Weakness of hand muscles and blepharoptosis may occur in patients who receive this drug for palmar hyperhidrosis and facial hyperhidrosis, respectively. Patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease.
Safety and effectiveness of have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use:
-Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients

Usual Adult Dose for Glabellar Lines

OnabotulinumtoxinA (Botox (R) Cosmetic):
4 units IM into each of five sites, two in each corrugator muscle and one in the procerus muscle for a total of 20 units.

Comments:
-Refer to manufacturer information for injection site diagrams.
-To reduce the complication of ptosis the following steps should be taken:
-Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.
-Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
-Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
-Do not inject toxin closer than 1 cm above the central eyebrow.

Use: For the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Usual Adult Dose for Migraine Prophylaxis

OnabotulinumtoxinA (Botox(R)):
Manufacturer recommended dosing by muscle for prophylaxis of chronic migraine:
Frontalis (bilaterally): 20 Units divided in 4 sites
Corrugator (bilaterally): 10 Units divided in 2 sites
Procerus: 5 Units in 1 site
Occipitalis (bilaterally): 30 Units divided in 6 sites
Temporalis (bilaterally): 40 Units divided in 8 sites
Trapezius (bilaterally): 30 Units divided in 6 sites
Cervical Paraspinal Muscle Group (bilaterally): 20 Units divided in 4 sites

Comments:
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use: Prophylaxis of headaches in adult patients with chronic migraine (15 days or more per month with headache lasting 4 hours a day or longer).

Usual Adult Dose for Urinary Incontinence

OnabotulinumtoxinA (Botox(R)):
GENERAL COMMENTS:
-Patients should not have an acute urinary tract infection prior to treatment. Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on the treatment day, and 1 to 3 days posttreatment.
-Patients should discontinue antiplatelet therapy at least 3 days before the injection procedure. Patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.
-Appropriate caution should be exercised when performing a cystoscopy.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

OVERACTIVE BLADDER (OAB):
100 units per treatment

OAB COMMENTS:
-An intravesical instillation of diluted local anesthetic with or without sedation may be used prior to injection, per local site practice. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
-Reconstituted drug is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but over-distension should be avoided.
-The injection needle should be filled (primed) with approximately 1 mL of reconstituted drug prior to the start of injections (depending on the needle length) to remove any air.
-After the injections are given, patients should demonstrate their ability to void prior to leaving the clinic. The patient should be observed for at least 30 minutes post-injection and until a spontaneous void has occurred.
-Patients should be considered for reinjection when the clinical effect of the previous injection has diminished (median time until patients qualified for the second treatment about 24 weeks, but no sooner than 12 weeks from the prior bladder injection.

DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION:
200 units per treatment

DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION COMMENTS:
-An intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia may be used prior to injection. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.

Uses:
-OVERACTIVE BLADDER (OAB): Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
-DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION: Treatment of urinary incontinence due to detrusor over activity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Usual Adult Dose for Urinary Frequency

OnabotulinumtoxinA (Botox(R)):
GENERAL COMMENTS:
-Patients should not have an acute urinary tract infection prior to treatment. Prophylactic antibiotics (except aminoglycosides) should be administered 1 to 3 days pretreatment, on the treatment day, and 1 to 3 days posttreatment.
-Patients should discontinue antiplatelet therapy at least 3 days before the injection procedure. Patients on anticoagulant therapy should be managed appropriately to decrease the risk of bleeding.
-Appropriate caution should be exercised when performing a cystoscopy.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

OVERACTIVE BLADDER (OAB):
100 units per treatment

OAB COMMENTS:
-An intravesical instillation of diluted local anesthetic with or without sedation may be used prior to injection, per local site practice. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
-Reconstituted drug is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but over-distension should be avoided.
-The injection needle should be filled (primed) with approximately 1 mL of reconstituted drug prior to the start of injections (depending on the needle length) to remove any air.
-After the injections are given, patients should demonstrate their ability to void prior to leaving the clinic. The patient should be observed for at least 30 minutes post-injection and until a spontaneous void has occurred.
-Patients should be considered for reinjection when the clinical effect of the previous injection has diminished (median time until patients qualified for the second treatment about 24 weeks, but no sooner than 12 weeks from the prior bladder injection.

DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION:
200 units per treatment

DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION COMMENTS:
-An intravesical instillation of diluted local anesthetic with or without sedation, or general anesthesia may be used prior to injection. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.

Uses:
-OVERACTIVE BLADDER (OAB): Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
-DETRUSOR OVER ACTIVITY ASSOCIATED WITH A NEUROLOGIC CONDITION: Treatment of urinary incontinence due to detrusor over activity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

Usual Adult Dose for Orbicularis Oculi

OnabotulinumtoxinA (Botox (R) Cosmetic):
4 units IM into 3 sites per side (6 total injection points) in the lateral orbicularis oculi muscle for a total of 24 Units (12 units per side)

Comments:
-Refer to manufacturer information for injection site diagrams.

Use: For the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients

Usual Pediatric Dose for Strabismus

OnabotulinumtoxinA (Botox(R)):
Use the lower listed doses for treatment of small deviations. Use the larger doses only for large deviations:
-For vertical muscles, and for horizontal strabismus of less than 20 prism diopters: 1.25 to 2.5 units IM in any one muscle
-For horizontal strabismus of 20 prism diopters to 50 prism diopters: 2.5 to 5 units IM in any one muscle
-For persistent VI nerve palsy of one month or longer duration: 1.25 to 2.5 units IM in the medial rectus muscle

Subsequent doses for residual or recurrent strabismus: It is recommended that patients be reexamined 7 to 14 days after each injection to assess the effect of that dose:
-Patients experiencing adequate paralysis of the target muscle that require subsequent injections should receive a dose comparable to the initial dose.
-Subsequent doses for patients experiencing incomplete paralysis of the target muscle may be increased up to 2-fold compared to the previously administered dose.
-Subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.
-The maximum recommended dose as a single injection for any one muscle is 25 units.

Comments:
-This drug is intended for injection into extraocular muscles utilizing the electrical activity recorded from the tip of the injection needle as a guide to placement within the target muscle. Injection without surgical exposure or electromyographic guidance should not be attempted. Physicians should be familiar with electromyographic technique.
-To prepare the eye for injection, it is recommended that several drops of a local anesthetic and an ocular decongestant be given several minutes prior to injection.
-Paralysis of injected muscles typically occurs 1 to 2 days after the initial injection, lasts 2 to 6 weeks, and resolves over a similar time period. Overcorrections lasting more than 6 months have been rare. About one-half of patients will require subsequent doses because of inadequate paralytic response of the muscle to the initial dose, or because of mechanical factors such as large deviations or restrictions, or because of the lack of binocular motor fusion to stabilize the alignment.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use: Treatment of strabismus in patients 12 years of age or older

Usual Pediatric Dose for Blepharospasm

OnabotulinumtoxinA (Botox):

The safety and efficacy of onabotulinumtoxinA for the treatment of blepharospasm in children less than 12 years have not been established.

1.25 to 2.5 units (0.05 to 0.1 mL) intramuscularly each into the medial and lateral pretarsal orbicularis oculi of the upper lid and into the lateral pretarsal orbicularis oculi of the lower lid. The cumulative dose of onabotulinumtoxinA in a 30 day period should not exceed 200 units.

Approved indication: Treatment of blepharospasm associated with dystonia in patients 12 years of age or older.

Usual Pediatric Dose for Cervical Dystonia

OnabotulinumtoxinA (Botox(R)):
-In a study of patients who had previously received and tolerated this drug, the mean dose administered was 236 units (25 th to 75 th percentile range 198 to 300 units) divided among the affected muscle groups

Comments:
-Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history.
-The initial dose for a patient without prior use of this drug should be a lower dose, with subsequent dosing adjusted based on individual response.
-Limiting the total dose injected into the sternocleidomastoid muscle to 100 units or less may decrease the occurrence of dysphagia.
-Improvement generally begins within the first 2 weeks after injection with maximum benefit at approximately 6 weeks post-injection. Most subjects were observed to have returned to pre-treatment status by 3 months post-treatment.
-When initiating treatment, the lowest recommended dose should be used. In treating adult patients for one or more indications, the maximum cumulative dose should not exceed 400 units in a 3 month interval.
-Caution should be exercised when treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Use: For the treatment of children over 16 years of age with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

US BLACK BOX WARNING:
Distant Spread of Toxin Effect:
-The effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, 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 potentially fatal. 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 with an underlying condition that would predispose them to these symptoms. Spread of effects have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.

Safety and efficacy have not been established in patients under 18 years of age for the prophylaxis of headaches in chronic migraine, treatment of OAB, detrusor overactivity associated with a neurologic condition, upper limb spasticity, and axillary hyperhidrosis; in patients under 16 years of age for treatment of cervical dystonia; and in patients under 12 years of age for treatment of blepharospasm and strabismus.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Potency determinations expressed in "Units" or "U" are different among the botulinum toxin products. Doses expressed in units are not comparable from one botulinum product to the next.
-There is a potential for systemic effects following administration of botulinum toxins such as: dysphagia, dysphonia, weakness, dyspnea or respiratory distress.
These effects have been reported as early as one day and as late as several weeks after treatment.

Storage requirements:
-Refer to the manufacturer product information.

Reconstitution/preparation techniques:
-Refer to the manufacturer product information for detailed reconstitution advice.
-Refer to the manufacturer product information for information on injection technique and detailed diagrams of injection sites.

Patient advice:
-Patients and caregivers should be provided with the information they need to be able to identify the signs and symptoms of systemic effects after receiving an injection of a botulinum toxin.
-Patients should receive immediate medical attention if they have worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness.

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