Product Information
Botox 100 Units contains botulinum toxin type A, a neurotoxin produced by Clostridium botulinum. Upon reconstitution, it is administered via intramuscular or intradermal injection, depending on the indication. The toxin functions by inhibiting acetylcholine release at neuromuscular junctions, leading to temporary muscle paralysis. This mechanism is beneficial in treating conditions characterized by excessive muscle contractions or glandular activity and in cosmetic applications to smooth dynamic facial lines.
Indications
Botox 100 Units is indicated for:
- Neurological Disorders:
- Management of focal spasticity in adult post-stroke patients affecting the wrist, hand, ankle, and foot.
- Treatment of blepharospasm, hemifacial spasm, and associated focal dystonias.
- Management of cervical dystonia (spasmodic torticollis).
- Prophylaxis of chronic migraine in adults experiencing headaches on ≥15 days per month, with at least 8 days having migrainous features, who have responded inadequately or are intolerant to prophylactic migraine medications.
- Bladder Disorders:
- Treatment of urinary incontinence due to neurogenic detrusor overactivity (e.g., spinal cord injury or multiple sclerosis) in adults who are not adequately managed with anticholinergic therapy.
- Management of idiopathic overactive bladder with symptoms of urinary incontinence, urgency, and frequency in adults who have an inadequate response to or are intolerant of anticholinergic medication.
- Hyperhidrosis:
- Treatment of severe primary hyperhidrosis of the axillae (underarms) that interferes with daily activities and is resistant to topical treatments.
- Cosmetic Indications:
- Temporary improvement in the appearance of moderate to severe glabellar lines (frown lines between the eyebrows) and lateral canthal lines (crow’s feet) in adults.
Composition
Each vial contains:
- Active Ingredient: 100 units of botulinum toxin type A (as a haemagglutinin complex).
- Excipients: 0.5 mg human albumin and 0.9 mg sodium chloride.
Note: The product appears as a thin white deposit that may be difficult to see on the base of the vial.
Dosage and Administration
- Reconstitution:
- Reconstitute the 100-unit vial with 2.5 mL of sterile, preservative-free 0.9% sodium chloride solution for injection to yield a solution containing 4 units/0.1 mL.
- Gently mix to dissolve; do not shake vigorously.
- Administration:
- Use a sterile needle and syringe for reconstitution and administration.
- Inject the reconstituted solution intramuscularly or intradermally, depending on the indication.
- Dosage varies based on the condition being treated, muscle mass, and patient response.
Note: Units of botulinum toxin are not interchangeable between different products.
Precautions
- Contraindications:
- Hypersensitivity to botulinum toxin type A or any excipients.
- Presence of infection at the proposed injection site(s).
- Warnings:
- Administer only by trained healthcare professionals familiar with the product’s use and potential complications.
- Monitor for signs of systemic botulinum toxin effects, such as muscle weakness, dysphagia, or respiratory difficulties.
- Use with caution in patients with neuromuscular disorders or those receiving aminoglycosides or other agents interfering with neuromuscular transmission.
- Pregnancy and Lactation:
- Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Caution is advised when administering to nursing mothers.
Storage
- Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 36 months.
- After reconstitution, store in a refrigerator and use within 24 hours.
- Do not freeze reconstituted solution.
Note
- Adverse Reactions: Common side effects include localized pain, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising at the injection site. Systemic effects are rare but can include muscle weakness and flu-like symptoms.
- Patient Counseling: Inform patients about the expected effects, potential side effects, and the importance of adhering to follow-up appointments.
