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BOTOX® (onabotulinumtoxinA) Indications for Use

BOTOX® (onabotulinumtoxinA) is indicated for the temporary improvement of moderate to severe glabellar lines, crow’s feet, and forehead lines in adults. It works by blocking the release of acetylcholine, a neurotransmitter responsible for muscle contraction, resulting in temporary muscle paralysis.

• Target areas: Glabellar lines (frown lines), lateral canthal lines (crow’s feet), and forehead lines.
• Mechanism of action: Inhibits acetylcholine release, reducing muscle contractions, which softens wrinkles caused by repeated facial expressions.

BOTOX® (onabotulinumtoxinA) Dosage Information

BOTOX is administered by intramuscular injection at specific points depending on the target area. The total dose for a treatment session depends on the number of areas treated and the severity of the wrinkles.

• Recommended doses:
  • Glabellar lines: 20 Units, injected as 0.1 mL (4 Units) into each of the five injection sites.
  • Lateral canthal lines: 24 Units, injected as 4 Units into each of three sites per side.
  • Forehead lines: 20 Units for forehead lines and 20 Units for glabellar lines, resulting in a total dose of 40 Units.
• Administration:
  • The product should be reconstituted with sterile, preservative-free saline before injection.
  • Maximum cumulative dose: 400 Units in a 3-month period.
  • BOTOX should be used within 24 hours after reconstitution and stored between 2-8°C.

BOTOX® (onabotulinumtoxinA) Side Effects and Precautions

BOTOX is generally well-tolerated, but it carries potential risks, particularly if the toxin spreads beyond the injection site.

• Common side effects:
  • Headache (up to 9%).
  • Eyelid ptosis (3% for glabellar lines).
  • Eyelid edema (1% for lateral canthal lines).
  • Localized pain or swelling at the injection site.
• Serious side effects:
  • Spread of toxin effects, leading to symptoms such as muscle weakness, difficulty swallowing, and breathing problems. In rare cases, this can be fatal.
  • Cardiovascular issues like arrhythmias and myocardial infarction have been reported, particularly in patients with pre-existing conditions.
  • Hypersensitivity reactions (e.g., anaphylaxis, urticaria, and dyspnea).

Precautions:

• Avoid treatment if there is a hypersensitivity to botulinum toxin or an infection at the injection site.
• Patients with neuromuscular disorders or dysphagia are at higher risk for severe side effects.
• Special caution is needed for individuals with cardiovascular disease or respiratory compromise.

BOTOX® (onabotulinumtoxinA) Clinical Studies or Real-World Outcomes

Several clinical studies confirm BOTOX’s effectiveness for cosmetic indications. Results are typically seen within a week, with the full effect developing after 14 days and lasting 3 to 4 months.

• Study findings:
  • In a study of 405 subjects treated for glabellar lines, 80% showed significant improvement by day 30.
  • Lateral canthal lines: In two studies with over 830 participants, 26.1% of those treated with BOTOX saw a 2-grade improvement in wrinkle severity compared to 1.3% of placebo subjects.
  • For forehead lines, response rates were higher in younger patients. The improvement rate was 61% at day 30.

BOTOX® (onabotulinumtoxinA) Drug Interactions

Certain medications can amplify the effects of BOTOX or increase the risk of side effects. It’s important to inform your healthcare provider about all medications being taken.

• Potential interactions:
  • Aminoglycoside antibiotics (e.g., gentamicin).
  • Muscle relaxants.
  • Anticholinergic drugs.
  • Concurrent use of other botulinum toxin products can lead to excessive muscle weakness.

Special Considerations

• Pregnancy and breastfeeding: There is limited data on BOTOX use during pregnancy or breastfeeding. Animal studies suggest potential risks to fetal development, so BOTOX should only be used if absolutely necessary during pregnancy.
• Geriatric use: Clinical studies suggest that the effectiveness of BOTOX may be lower in patients over the age of 65.