Description

Botulax 100 U is a high‐purity formulation of Clostridium botulinum toxin type A, manufactured by Hugel Pharma (Korea). Clinically comparable to Allergan® Botox®, Botulax combines 100 U of neurotoxin with 0.5 mg human albumin and 0.9 mg sodium chloride per vial. Approved in Thailand and select South American markets and pending FDA and CE clearance, Botulax is available for global distribution. Each freeze‐dried vial has a 36-month shelf life and must be refrigerated (2–8 °C) before reconstitution.

Key Features

• Purity & Safety: Highly refined type A toxin with human serum albumin and NaCl for isotonic balance
• Manufacturing Standard: KFDA-approved GMP facility
• Rapid Onset: Noticeable effects within 2–3 days
• Patient Comfort: Minimal injection time (≈10 minutes) and low discomfort
• Versatility: Indicated for cosmetic and therapeutic uses

Indications

• Cosmetic correction of dynamic wrinkles (glabellar lines, brow furrows, crow’s feet, chin dimpling, neck bands)
• Facial contouring (brow lift, lip shaping)
• Treatment of hyperhidrosis (excessive sweating)
• Management of benign essential blepharospasm in adults
• Spasticity reduction in pediatric cerebral palsy (≥ 2 years)

Dosage & Administration

• Blepharospasm: 1.25–2.5 U per site (0.05–0.1 mL)
• Diplegia (spasticity): 6 U/kg total dose
• Glabellar Lines: Typically 20 U (adjust per patient)
• Maximum Single Dose: 200 U
  Reconstitute with saline per instructions. Inject using a 24–30 G needle. Retreat every 2–3 months or as muscle tone returns.

Clinical Effects

• Onset: 2–3 days (blepharospasm), up to 4 weeks for spasticity relief
• Peak: ≈ 3 weeks for blepharospasm
• Duration: 6–9 months of aesthetic effect in facial applications

Safety & Contraindications

Possible adverse effects include fatigue, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and respiratory difficulties. Use with caution in patients with neuromuscular disorders.

Specifications

• Active Ingredient: Clostridium botulinum toxin type A (100 U)
• Excipients: Human serum albumin (0.5 mg), NaCl (0.9 mg)
• Appearance: Freeze‐dried white powder (900 kDa complex)
• Package: 100 U × 1 vial
• Storage: 2–8 °C (refrigerated)
• Shelf Life: 36 months

Origin & Shipping

• Location: Korea
• Shipping: Globally (International)