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.

RADIESSE® is also used for correcting volume loss in the back of the hands. RADIESSE® (+) is also used for improving moderate to severe loss of jawline contour in adults over 21 years old.

In 1997, the original formulation was changed to reduce the protein load per dose, and since then treatment failure rates have dropped; however, experts estimate that 0.3 to seis% of people are still at risk of antibody development. The risk is greatest when dosages of more than 200 units per session are used, and reinjection occurs within one month. Experts are unsure if neutralizing antibodies resolve over time or if injections of botulinum toxin type B products are useful in patients with neutralizing antibodies to type A.

Medicines that interact with Botox may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Botox. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does.

OnabotulinumtoxinA injections should be given only by a trained medical professional, even when used for cosmetic purposes.

After the injections are given, patients should demonstrate their ability to void prior to leaving the clinic. The patient should be observed for at least 30 minutes post-injection and until a spontaneous void has occurred.

However, there appears to be little benefit obtainable from injecting more than 5 Units per site. Some tolerance may be found when BOTOX is used in treating blepharospasm if treatments are given any more frequently than every three months, and is rare to have the effect be permanent.

An appropriately sized needle (e.g., 25-30 gauge) may be used for superficial muscles, and a longer 22 gauge needle may be used for deeper musculature. Localization of the involved muscles with techniques such as needle electromyographic guidance, nerve stimulation, or ultrasound is recommended. Repeat BOTOX treatment may be administered when the effect of a previous injection has diminished, but generally pelo sooner than 12 weeks after the previous injection. The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of BOTOX and muscles to be injected.

If injection sites are marked in ink, do not inject BOTOX directly through the ink mark to avoid a permanent tattoo effect.

You should not use RADIESSE® or RADIESSE® (+) if you have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder, or if you are pregnant sculptra or breastfeeding. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.

Reconstituted BOTOX (100 Units/10 mL) is injected into the detrusor muscle via a flexible or rigid cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve adequate visualization for the injections, but over-distension should be avoided.

Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX with the diluent by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX should be administered within 24 hours after reconstitution. During this time period, unused reconstituted BOTOX should be stored in a refrigerator (2° to 8°C) for up to 24 hours until time of use. BOTOX vials are for single-dose only. Discard any unused portion.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, tell your new provider how long it has been since your last botulinum toxin injection.

Clinical improvement generally begins within the first two weeks after injection with maximum clinical benefit at approximately six weeks post-injection. In the double-blind, placebo-controlled study most subjects were observed to have returned to pre-treatment status by 3 months post-treatment.