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Pronunciation |
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(BOT
yoo lin num TOKS in type
aye) |
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U.S. Brand
Names |
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Botox® |
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Generic
Available |
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No |
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Pharmacological Index |
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Ophthalmic Agent, Toxin |
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Use |
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Treatment of strabismus and blepharospasm associated with dystonia (including
benign essential blepharospasm or VII nerve disorders in patients greater than
or equal to 12 years of age)
Orphan drug: Treatment of dynamic muscle contracture in pediatric
cerebral palsy patients |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Hypersensitivity to botulinum A toxin; relative contraindications to
botulinum toxin therapy include diseases of neuromuscular transmission and
coagulopathy, including anticoagulant therapy; injections into the central area
of the upper eyelid (rapid diffusion of toxin into the levator can occur
resulting in a marked ptosis). |
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Warnings/Precautions |
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Use with caution in patients taking aminoglycosides or any other antibiotic
or other drugs that interfere with neuromuscular transmission; do not exceed
recommended dose |
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Adverse
Reactions |
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>10%: Ocular: Dry eyes, lagophthalmos, ptosis, photophobia, vertical
deviation
1% to 10%:
Dermatologic: Diffuse rash
Ocular: Eyelid edema, blepharospasm
<1%: Ectropion, keratitis, diplopia, entropion |
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Overdosage/Toxicology |
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In the event of an overdosage or injection into the wrong muscle, additional
information may be obtained by contacting Allergan Pharmaceuticals at
(800)-347-5063 from 8 AM to 4 PM Pacific time, or at (714)-724-5954 at other
times |
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Drug
Interactions |
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Increased effect: Botulinum toxin may be potentiated by
aminoglycosides |
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Stability |
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Keep in undiluted vials in freezer (at or below
-5°C/23°F); administer within 4
hours after the vial is removed from the freezer and reconstituted; store
reconstituted solution in refrigerator (2°C to
8°C/36°F to
46°F) |
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Mechanism of
Action |
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Botulinum A toxin is a neurotoxin produced by Clostridium botulinum,
spore-forming anaerobic bacillus, which appears to affect only the presynaptic
membrane of the neuromuscular junction in humans, where it prevents
calcium-dependent release of acetylcholine and produces a state of denervation.
Muscle inactivation persists until new fibrils grow from the nerve and form
junction plates on new areas of the muscle-cell walls. The antagonist muscle
shortens simultaneously ("contracture"), taking up the slack created by agonist
paralysis; following several weeks of paralysis, alignment of the eye is
measurably changed, despite return of innervation to the injected
muscle. |
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Pharmacodynamics/Kinetics |
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Strabismus: Onset of action: 1-2 days after injection; Duration of paralysis:
2-6 weeks
Blepharospasm: Onset: 3 days after injection; Peak: 1-2 weeks; Duration of
paralysis: 3 months |
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Usual Dosage |
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Strabismus: 1.25-5 units (0.05-0.15 mL) injected into any one muscle
Subsequent doses for residual/recurrent strabismus: Re-examine patients 7-14
days after each injection to assess the effect of that dose. Subsequent doses
for patients experiencing incomplete paralysis of the target may be increased up
to two fold the previously administered dose. Maximum recommended dose as a
single injection for any one muscle is 25 units.
Blepharospasm: 1.25-2.5 units (0.05-0.10 mL) injected into the orbicularis
oculi muscle
Subsequent doses: Each treatment lasts approximately 3 months. At repeat
treatment sessions, the dose may be increased up to twofold if the response from
the initial treatment is considered insufficient (usually defined as an effect
that does not last >2 months). There appears to be little benefit obtainable
from injecting >5 units per site. Some tolerance may be found if treatments
are given any more frequently than every 3 months.
The cumulative dose should not exceed 200 units in a 30-day period
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Administration |
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Inject using a 27- to 30-gauge needle |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Patients with blepharospasm may have been extremely sedentary for a long
time; caution these patients to resume activity slowly and carefully following
administration |
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Nursing
Implications |
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To alleviate spatial disorientation or double vision in strabismic patients,
cover the affected eye; have epinephrine ready for hypersensitivity
reactions |
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Dosage Forms |
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Injection: 100 units Clostridium botulinum toxin type
A |
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References |
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Borodic GE and Pearce LB, "New Concepts in Botulinum Toxin Therapy," Drug
Saf, 1994, 11(3):145-52.
Cohen S and Parkman HP,
"Treatment of Achalasia - Whalebone to Botulinum Toxin," N Engl J Med,
1995, 332(12):815-6.
Ferrari AP, Jr, Siqueira ES, and Brant CQ,
"Treatment of Achalasia in Chagas' Disease With Botulinum Toxin," N Engl J
Med, 1995, 332(12):824-5.
Jankovic J and Brin MF, "Therapeutic Uses of Botulinum Toxin," N Engl J
Med, 1991, 324(17):1186-94.
Pasricha PJ, Ravich WJ, Hendrix TR, et al,
"Intrasphincteric Botulinum Toxin for the Treatment of Achalasia," N Engl J
Med, 1995, 322(12):774-8.
Pasricha PJ, Ravich WJ, Hendrix TR, et al,
"Treatment of Achalasia With Intrasphincteric Injection of Botulinum Toxin,"
Ann Intern Med, 1994, 121(8):590-1.
Repka MX, Savino PJ, and Reinecke RD,
"Treatment of Acquired Nystagmus With Botulinum Neurotoxin A," Arch
Ophthalmol, 1994, 112(10):1320-4.
Sheean GL, Murray NM, and Marsden CD,
"Pain and Remote Weakness in Limbs Injected With Botulinum Toxin A for Writer's Cramp,"
Lancet, 1995, 346(8968):154-6.
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