Botox cosmetic

What is Botox cosmetic?

• Botox cosmetic (onabotulinumtoxinA injection) is an acetylcholine release inhibitor and a neuromuscular blocking agent.

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Botulinum toxin 3BTA

What are the uses of this medicine?

Botox cosmetic (onabotulinumtoxinA injection) is a prescription medicine for adults that is injected into muscles and used for a short period of time (temporary) to improve the look of:

• moderate to severe frown lines between the eyebrows (glabellar lines)
• moderate to severe crow’s feet lines
• moderate to severe forehead lines

How does this medicine work?

• BOTOX Cosmetic blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine.
• This inhibition occurs as the neurotoxin cleaves SNAP-25, a pre-synaptic protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings.
• When injected intramuscularly at therapeutic doses, BOTOX Cosmetic produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
• In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop.
• There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX Cosmetic.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known Hypersensitivity to Botulinum Toxin
• Infection at the Injection Site

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following:

• certain antibiotics such as amikacin, clindamycin (Cleocin), colistimethate (Coly-Mycin), gentamicin, kanamycin, lincomycin (Lincocin), neomycin, polymyxin, streptomycin, and tobramycin
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antihistamines
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• heparin
• medications for allergies, colds, or sleep
• muscle relaxants
• platelet inhibitors such as clopidogrel (Plavix), dipyridamole (Persantine, in Aggrenox), prasugrel (Effient), and ticlopidine (Ticlid)

• Also tell your doctor if you have received injections of any botulinum toxin product including abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or rimabotulinumtoxinB (Myobloc) within the past four months.

Is this medicine FDA approved?

• Initial U.S. Approval: 1989

How should this medicine be used?

Recommended dosage:

• For Glabellar Lines Administration: 0.1 mL (4 Units) into each of 5 sites, for a total dose of 20 Units.
• For Lateral Canthal Lines Administration: 0.1 mL (4 Units) into each of 3 sites per side (6 total injection points), for a total of 24 Units.
• For Forehead Lines Administration: 0.1 mL (4 Units) into each of 5 forehead line sites (20 Units) with 0.1 mL (4 Units) into each of 5 glabellar line sites (20 Units), for a recommended total of 40 Units.
• Follow dosage and administration recommendations. In treating adults for more than one approved indications with BOTOX and BOTOX Cosmetic, do not exceed a total dose of 400 Units administered in a 3 month interval.

Administration:

• BOTOX Cosmetic is an injection that your doctor will give you.
• BOTOX Cosmetic is injected into your affected muscles.
• Your doctor may change your dose of BOTOX Cosmetic, until you and your doctor find the best dose for you.
• Your doctor will tell you how often you will receive your dose of BOTOX Cosmetic injections.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 Units or 100 Units vacuum-dried powder in a single-dose vial for reconstitution

This medicine is available in fallowing brand namesː

• BOTOX Cosmetic

What side effects can this medication cause?

The most common side effects of this medicine include:

• dry mouth
• discomfort or pain at the injection site
• tiredness
• headache
• neck pain
• eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes
• drooping eyebrows
• allergic reactions
• upper respiratory tract infection

BOTOX Cosmetic may cause serious side effects that can be life threatening, including:

• Problems swallowing, speaking, or breathing
• Spread of toxin effects

What special precautions should I follow?

• Potency Units of BOTOX Cosmetic are not interchangeable with other preparations of botulinum toxin products.
• Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur.
• Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. The safety and effectiveness of BOTOX for unapproved uses have not been established.
• Serious and/or immediate hypersensitivity reactions have been reported. If such a reaction occurs, further injection of BOTOX Cosmetic should be discontinued and appropriate medical therapy immediately instituted.
• There have been reports following administration of BOTOX/BOTOX Cosmetic of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes.
• Patients with 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 onabotulinumtoxinA.
• Treatment with BOTOX and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders.
• Caution should be used when BOTOX Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s), ptosis, or when excessive weakness or atrophy is present in the targeted muscle(s).
• There have been reports of dry eye associated with BOTOX Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (e.g., eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
• This product contains albumin, a derivative of human blood. There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote.
• Patients should be counseled that if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.
• There are no data on the presence of BOTOX Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Excessive doses of BOTOX (onabotulinumtoxinA) for injection may be expected to produce neuromuscular weakness with a variety of symptoms.
• If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia.

Management of overdosage:

• If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.
• In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA.
• In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100.

Can this medicine be used in pregnancy?

• There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX Cosmetic in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in patients below the age of 18 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: onabotulinumtoxinA
• Inactive ingredients: human albumin and sodium chloride

Who manufactures and distributes this medicine?

Manufactured by: Allergan Pharmaceuticals Ireland a subsidiary of: Allergan, Inc.

Distributed by: Allergan USA, Inc. Madison, NJ

What should I know about storage and disposal of this medication?

• Unopened vials of BOTOX Cosmetic should be stored in a refrigerator 2° to 8°C (36º to 46ºF).
• Do not use after the expiration date on the vial.
• Reconstituted BOTOX Cosmetic should be stored in a refrigerator 2° to 8°C (36º to 46ºF) and administered within 24 hours.

• Dailymed label info on Botox cosmetic
• FDA Botox cosmetic

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