Onabotulinumtoxina (injection route, intradermal route, intramuscular route)

Botox, Botox Cosmetic

OnabotulinumtoxinA is used to treat certain eye conditions, such as blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) or strabismus (a condition where the eyes do not line up properly). OnabotulinumtoxinA is also used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck) and some types of axillary hyperhidrosis (severe sweating of the armpits). OnabotulinumtoxinA is used to treat increased muscle stiffness in the elbow, wrist, and finger muscles or ankle and toe muscles in adults with upper or lower limb spasticity or in children 2 to 17 years of age with upper and lower limb spasticity. OnabotulinumtoxinA is also used to prevent headaches in patients with chronic migraine (severe headaches for 15 or more days a month lasting 4 or more hours a day). OnabotulinumtoxinA is used cosmetically to temporarily improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines), forehead lines, and crow's feet lines around the eyes (lateral canthal lines). OnabotulinumtoxinA is also used to treat urinary incontinence (loss of bladder control) in patients with an overactive bladder caused by nervous system disorders (eg, multiple sclerosis, spinal cord injury). It is also used to treat an overactive bladder caused by a nervous system disorder or overactive bladder with symptoms, such as loss of bladder control, increased urge to urinate, and frequent need to urinate in patients who have failed treatment with other medicines (eg, anticholinergics). OnabotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles. OnabotulinumtoxinA is injected into the affected muscles. Depending on your condition, more than one treatment may be required. This medicine is available only with your doctor's prescription and will be administered by your doctor. This product is available in the following dosage forms:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onabotulinumtoxinA in children. However, safety and effectiveness have not been established in children younger than 2 years of age forupper limb spasticity and lower limb spasticity (except spasms caused by cerebral palsy), in children younger than 5 years of age foroveractive bladder caused by a nervous system disorder, in children younger than 12 years of age forblepharospasm or strabismus, in children younger than 16 years of age forcervical dystonia, or in children younger than 18 years of age forchronic migraine, hyperhidrosis, or overactive bladder with symptoms. Use of onabotulinumtoxinA to treat glabellar lines, forehead lines, and lateral canthal lines is not recommended in children. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of onabotulinumtoxinA in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving onabotulinumtoxinA. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: