BOTULAX® (LETYBO®) 100u (Korean)

BOTULAX® 100u is a purified botulinum toxin type A injectable developed by Hugel Inc., indicated for the treatment of benign essential blepharospasm and widely used in aesthetic medicine. The active ingredient is produced from Clostridium botulinum (strain CBFC26) and works by blocking acetylcholine release at neuromuscular junctions, leading to localized muscle relaxation. BOTULAX® is supplied as a freeze-dried powder that requires reconstitution before intramuscular injection. It is known for its clinical equivalence to Botox®, with proven non-inferior efficacy and safety in phase III comparative trials. The product is manufactured under strict KFDA-compliant quality standards, offering reliable potency and stability.

BOTULAX® must be reconstituted with preservative-free 0.9% sodium chloride and administered intramuscularly by trained professionals.

Key Features:

• Effect visible within 3–5 days, peaking at 1–2 weeks
  
• Results last approximately 3–4 months
  

Administration Guidelines:

• Reconstitute with normal saline without preservatives
  
• Use 27–30 gauge needle
  
• Recommended dose for blepharospasm: 12.5–25U per eye (0.05–0.1 mL per injection site)
  
• Maximum cumulative dose in 30 days: 200 Units
  
• Use reconstituted solution within 24 hours, store at 2–8°C
  

Indicated for:

• Benign essential blepharospasm in patients 18 years or older
  

Contraindications:

• Hypersensitivity to any of the ingredients
  
• Neuromuscular disorders (e.g., myasthenia gravis, ALS)
  
• Pregnancy or breastfeeding
  
• Infection at the injection site
  

Reported Side Effects (Blepharospasm Patients):

• Ptosis: 6.5%
  
• Lagophthalmos: 5.6%
  
• Dry eye: 5.6%
  
• Photophobia: 4.1%
  
• Myasthenia: 1.6%
  
• Other less common effects: chills, headache, dizziness

Each vial contains:

• Clostridium botulinum toxin type A: 100 Units
  
• Human serum albumin: 0.5 mg
  
• Sodium chloride: 0.9 mg
  

It is supplied as a sterile, white freeze-dried powder.

Packaging includes:

• One single-dose vial containing 100 Units of lyophilized powder
  
• Sealed in colorless transparent glass vials
  
• Designed for intramuscular injection after reconstitution
  

Yes, both local and systemic adverse reactions may occur.

Common Adverse Reactions:

• Local pain, redness, bruising
  
• Eyelid droop (ptosis), muscle weakness
  
• Dry eye, tearing, photophobia
  

Serious Adverse Events (rare):

• Dysphagia
  
• Aspiration pneumonia
  
• Respiratory issues
  
• Allergic reactions (urticaria, anaphylaxis)
  

Storage Conditions:

• Store unopened vials at 2–8°C
  
• After reconstitution, use within 24 hours
  
• Do not freeze
  
• Keep away from direct light and moisture