Botox Cosmetic (OnabotulinumtoxinA for Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 25, 2012

Botox Cosmetic

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Wrinkles facts

Skin ages all over the body but much more so where there has been sun exposure. Changes brought on by sun damage (photoaging) include "dryness" (really roughness), sagginess, skin growths like keratoses ("liver spots"), and wrinkles.
Wrinkles in turn can be divided into two categories: fine surface lines and deep furrows. Wrinkle treatments are in general much more effective for fine lines. Deeper creases may require more aggressive techniques, such as plastic surgery.
Factors that promote wrinkling include smoking, skin type (people with light-colored skin and blue eyes are more susceptible to sun damage), heredity (some families wrinkle more), hairstyle (depending on how much skin is covered by hair and protected from the sun), dress (again, by determining which skin is exposed), and occupational and recreational sun exposure over the course of many years.

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BOTOX® Cosmetic
(onabotulinumtoxinA) for Injection

Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of BOTOX® Cosmetic (onabotulinumtoxina for injection) and 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, 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 there have been reports of death. 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 occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

DRUG DESCRIPTION

BOTOX® Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.

One Unit of BOTOX® Cosmetic (onabotulinumtoxina for injection) corresponds to the calculated median intraperitoneal lethal dose (LD₅₀) in mice. The method utilized for performing the assay is specific to Allergan's product BOTOX® Cosmetic (onabotulinumtoxina for injection) . Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for the various mouse LD50 assays, Units of biological activity of BOTOX® Cosmetic (onabotulinumtoxina for injection) cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. In addition, differences in species sensitivities to different botulinum neurotoxin serotypes precludes extrapolation of animal-dose activity relationships to human dose estimates. The specific activity of BOTOX® Cosmetic (onabotulinumtoxina for injection) is approximately 20 units/nanogram of neurotoxin protein complex.

Each vial of BOTOX® Cosmetic (onabotulinumtoxina for injection) contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride or 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

What are the precautions when taking onabotulinumtoxina for injection (Botox Cosmetic)?

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, 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, signs of infection near the injection site, muscle/nerve disorders such as Lou Gehrig's disease (ALS) or myasthenia gravis, seizures, trouble swallowing (dysphagia), breathing problems (such as asthma, emphysema, aspiration-type pneumonia).

This drug may make cause muscle weakness, droopy eyelids, or blurred vision. Do not drive, use machinery, or do...

Read All Potential Precautions of Botox Cosmetic »

Last reviewed on RxList: 8/12/2009
This monograph has been modified to include the generic and brand name in many instances.