DUBLIN, Jan. 22, 2016 /PRNewswire/ – Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. Botox is the first and only botulinum toxin product to be approved by the FDA to treat multiple muscle groups of the upper (elbow, wrist, fingers, and thumb) and lower limbs that may be impacted by spasticity.
Reconstitution of 200 Unit vial: Reconstitute one 200 Unit vial with 6 mL of preservative-free 0.9% sodium chloride injection (preservative-free 0.9% NaCl injection) and mix the vial gently. Draw 2 mL from the vial into each of three 10 mL syringes. Complete reconstitution by adding 8 mL of preservative-free 0.9% NaCl injection into each of the 10 mL syringes and mix gently. Each syringe will then contain 10 mL, for a total of 200 Units of reconstituted onabotulinumtoxinA.
The following adverse reactions have been identified during post-approval use of BOTOX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: abdominal pain; alopecia, including madarosis; anorexia; brachial plexopathy; denervation/muscle atrophy; diarrhea; hyperhidrosis; hypoacusis; hypoaesthesia; malaise; paresthesia; peripheral neuropathy; radiculopathy; erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption; strabismus; tinnitus; and visual disturbances.
Frown lines are caused by overactive facial muscles. Fillers correct the wrinkle by adding volume around the muscle with intradermal injections. BOTOX® Cosmetic is intramuscular blocking the chemicals that cause facial muscles to contract, thereby relaxing them. While there are many options available for fillers, BOTOX® Cosmetic is the only product of its type that affects the muscles that cause wrinkles between the brows.
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, urinary tract infection, inability to urinate, 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), treatment with any botulinum toxin product (especially in the last 4 months).
Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory Las Vegas Botox doctor disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure.