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XEOMIN® 50u (English Alternative) Indications for Use

XEOMIN® (incobotulinumtoxinA) is a botulinum toxin type A product used for the treatment of various neuromuscular conditions and cosmetic concerns. It is specifically indicated for:

• Upper Limb Spasticity: Reducing muscle tightness in adult patients suffering from conditions like stroke or neurological injuries.
• Cervical Dystonia: Treatment of adults with abnormal neck positioning and pain associated with cervical dystonia.
• Blepharospasm: For adults previously treated with onabotulinumtoxinA (Botox®) who experience uncontrollable blinking or spasm of the eyelids.
• Glabellar Lines: Temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) between the eyebrows.

XEOMIN® works by inhibiting the release of acetylcholine at the neuromuscular junction, which reduces muscle activity.

XEOMIN® (incobotulinumtoxinA) Dosage Information

The dosage of XEOMIN® varies depending on the condition being treated and the muscle groups involved. It is administered through intramuscular injection, and the dose should be tailored to the individual patient based on muscle size, severity of symptoms, and prior treatment response.

• Upper Limb Spasticity:
  • Recommended total dose: Up to 400 Units.
  • Frequency: No more than once every 12 weeks.
  • Example Doses:
    • Flexor digitorum: 25-100 units per muscle.
    • Biceps: 50-200 units.
    • Flexor carpi radialis: 25-100 units.
• Cervical Dystonia:
  • Initial recommended dose: 120 Units.
  • Can be injected into the sternocleidomastoid, trapezius, or other muscles involved in head positioning.
• Blepharospasm:
  • For patients transitioning from Botox, doses should be similar to previous treatments, typically 10-50 Units per eye.
  • Maximum dose: 70 Units total, divided across both eyes.
• Glabellar Lines:
  • Recommended dose: 20 Units, divided into five injection sites (4 Units per site).

XEOMIN® (incobotulinumtoxinA) Side Effects and Precautions

While XEOMIN® is generally safe, some patients may experience adverse reactions. The side effects can range from mild to severe, depending on the treated area and patient susceptibility.

• Common side effects:
  • Upper Limb Spasticity: Dry mouth, seizure, upper respiratory tract infections, nasopharyngitis.
  • Cervical Dystonia: Dysphagia (difficulty swallowing), muscle weakness, neck pain, and injection site pain.
  • Blepharospasm: Ptosis (drooping eyelid), dry mouth, dry eye, headache, and visual impairment.
  • Glabellar Lines: Headache, facial paresis, and eyelid swelling.
• Serious side effects:
  • Spread of toxin effect: Symptoms such as muscle weakness, blurred vision, or breathing difficulties may occur due to the toxin spreading from the injection site.
  • Dysphagia and Breathing Difficulties: Particularly in patients receiving injections in neck muscles, which can lead to life-threatening complications.
  • Corneal exposure and ulceration: For patients treated for blepharospasm, insufficient blinking can lead to corneal damage.

Precautions:

• XEOMIN® should not be administered in patients with hypersensitivity to botulinum toxin or any of its excipients.
• Avoid use in patients with active infections at the injection site.
• Pregnant or breastfeeding women should avoid XEOMIN®, as its safety in these populations has not been established.

XEOMIN® (incobotulinumtoxinA) Clinical Studies and Real-World Outcomes

Clinical trials have demonstrated the efficacy of XEOMIN® in treating upper limb spasticity, cervical dystonia, blepharospasm, and glabellar lines.

• Upper Limb Spasticity:
  • In trials, XEOMIN® significantly reduced muscle tone and spasticity in patients with post-stroke or traumatic brain injury. On average, the results last 12-14 weeks.
• Cervical Dystonia:
  • In a study with doses of 120 Units and 240 Units, XEOMIN® was effective in reducing abnormal neck movements and pain, with no significant difference between the two doses.
• Blepharospasm:
  • Patients previously treated with Botox showed comparable improvement with XEOMIN®. In most cases, results lasted up to 12 weeks.
• Glabellar Lines:
  • XEOMIN® significantly reduced frown lines in cosmetic trials, with results lasting up to 120 days.

XEOMIN® (incobotulinumtoxinA) Drug Interactions

Although no formal drug interaction studies have been conducted with XEOMIN®, caution is advised when used alongside medications that affect neuromuscular transmission.

• Aminoglycosides and muscle relaxants: These can potentiate the effects of XEOMIN®, leading to increased muscle weakness.
• Other botulinum toxin products: Concurrent use can result in excessive muscle weakness or respiratory complications. It is advised to avoid administering different botulinum toxins within several months of each other.

XEOMIN® (incobotulinumtoxinA) Instructions for Use

• Reconstitution: XEOMIN® is supplied as a lyophilized powder and should be reconstituted with preservative-free 0.9% sodium chloride. Use within 24 hours of reconstitution.
• Administration: The product is intended for intramuscular injection only. Special care must be taken to avoid injection near sensitive structures like arteries and nerves.

Dilution guidelines:

• 50 Unit vial: Use 0.25 mL, 0.5 mL, or 1 mL of diluent, depending on the required concentration.

XEOMIN® (incobotulinumtoxinA) Contraindications and Warnings

XEOMIN® is contraindicated in:

• Patients with allergies to any of its components, including botulinum toxin type A.
• Patients with active infections at the injection site.

Warnings:

• XEOMIN® may spread from the injection site and cause serious side effects, including muscle weakness, swallowing difficulties, and respiratory failure.
• Patients with neuromuscular disorders (such as ALS or myasthenia gravis) are at increased risk for severe side effects.