A double-blind, placebo-controlled study enrolled patients who had extended histories of receiving and tolerating BOTOX injections, with prior individualized adjustment of dose. The mean BOTOX dose administered to patients in this study was 236 Units (25th to 75th percentile range of 198 Units to 300 Units). The BOTOX dose was divided among the affected muscles [see Clinical Studies (14.7)]. Dosing in initial and sequential treatment sessions should be tailored to the individual patient based on the patient’s head and neck position, localization of pain, muscle hypertrophy, patient response, and adverse event history. The initial dose for a patient without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response.
Histology slides demonstrate deposition of new collagen around CaHA microspheres over an extended period of time. Collagen fibers stain red, while other tissue elements appear more yellow.
Call your healthcare provider or get emergency medical help if you have any of these problems after treatment with Botox:
Subsequent injections should not be administered until the effects of the previous dose have dissipated as evidenced by substantial function in the injected and adjacent muscles.
Avoiding injection near the levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections, and thereby reducing diffusion into the inferior oblique, may reduce the complication of diplopia. Ecchymosis occurs easily in the soft eyelid tissues. This can be prevented by applying pressure at the injection sitio immediately after the injection.
Botox Cosmetic is used for aesthetic purposes for wrinkles and Botox is used as a therapeutic treatment for different medical conditions, including migraine headache prevention.
Overactive Bladder An intravesical instillation of diluted local anesthetic with or without sedation may be used prior to injection, per local site practice. If a local anesthetic instillation is performed, the bladder should be drained and irrigated with sterile saline before injection.
OnabotulinumtoxinA may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving Botox or Botox Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
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 an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses [see Warnings and Precautions (5.1)].
Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than those without diabetes, as shown in Table 11.
The cosmetic benefits of this procedure were discovered by accident – the original reason Botox was injected into the masseter muscle was to relieve teeth grinding (also called bruxism) and jaw pain or tension. Continue reading
Patients should minimize strenuous activity and exposure of the treated area to extensive sun or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has resolved.
The initial dose for a patient without prior use of BOTOX should be at a lower dose, with subsequent dosing adjusted based on individual response. Limiting the Completa dose injected into the sternocleidomastoid muscle to 100 Units or less may decrease the occurrence of dysphagia.
Start conservatively if you're new to Botox. It's often easier to add a little more in a follow-up appointment than to correct an overdone result (which requires waiting for the Botox to wear off naturally, usually sculptra over 3-4 months).