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Botox 100 Units

Botox 100 Units

BOTOX

Botulinum toxin (neurotoxin) injectable – prescription-only medicine
  • Authorised in the UK as a prescription Only medicine (POM) containing botulinum toxin type A (onabotulinumtoxinA), with MHRA Approved Summary of Product Characteristics and Patient Information Leaflet covering 50, 100 and 200 Unit vials.
  • Manufactured under Good Manufacturing Practice (GMP) standards in facilities inspected by competent regulatory authorities, ensuring quality, purity and batch To Batch consistency.
  • Subject to ongoing pharmacovigilance and safety monitoring by MHRA, EMA and other national regulators, with periodic updates to product information as new data become available.
  • Complies with relevant EU and UK legislation governing biological medicinal products, including requirements for cold Chain storage, labelling and controlled distribution.
  • Backed by numerous clinical trials and post Marketing studies documented in regulatory dossiers and international treatment guidelines for botulinum toxin type A.
Aesthetic neuromodulator (onabotulinumtoxinA) \u2013 2 x 100 Unit vials for anti-wrinkle treatment

Description

Botox 100 Units – Dual Vials – Anti Wrinkle Treatment is a pack of two vials of BOTOX 100 Allergan Units powder for solution for injection, a prescription-only botulinum toxin type A (onabotulinumtoxinA) used for both aesthetic and therapeutic indications. Each vial contains highly purified botulinum toxin type A that, once reconstituted with sterile sodium chloride solution, is injected into selected muscles to temporarily block the release of acetylcholine at the neuromuscular junction. This produces a reversible relaxation of overactive muscles, smoothing dynamic facial wrinkles such as crow’s feet, forehead lines and glabellar frown lines, and is also used in various licensed medical indications including focal spasticity, cervical dystonia, chronic migraine, overactive bladder, neurogenic detrusor overactivity and severe primary axillary hyperhidrosis. The AestheticsRx Pharma dual-vial presentation is aimed at qualified practitioners seeking a convenient 2 x 100 Unit pack for facial anti-wrinkle treatments and other on-label uses in appropriate clinical settings.

Bnefits

  • Premium, globally recognised BOTOX brand (onabotulinumtoxinA) with an extensive safety and efficacy record across aesthetic and therapeutic uses.
  • Dual-vial pack (2 x 100 Units) offers flexible dosing and efficient stock management for clinics performing frequent anti-wrinkle treatments.
  • Proven ability to smooth dynamic facial wrinkles, including crow’s feet, forehead lines and frown lines, while allowing natural facial expression when correctly dosed.
  • Mechanism of action based on reversible blockade of acetylcholine release at neuromuscular junctions, providing predictable, temporary muscle relaxation.
  • Clinical effects typically last around 3–4 months for upper facial lines and several months for many therapeutic indications, reducing the need for frequent retreatment.
  • Licensed for multiple neurologic, urologic and autonomic indications such as focal spasticity, cervical dystonia, chronic migraine, overactive bladder and severe primary axillary hyperhidrosis.
  • Supplied as a lyophilised powder for solution, allowing tailored reconstitution volumes and dosing according to indication-specific guidance.
  • Supported by detailed regulatory documentation (SmPC, PIL, prescribing information) and ongoing pharmacovigilance by agencies such as MHRA and EMA.
  • Distributed by a UK GPhC-registered pharmacy (Aestheticsrx Pharma Ltd), helping to ensure authentic supply and appropriate cold-chain handling.

Indications

  • Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows (glabellar lines) seen at maximum frown in adults when the severity of these lines has an important psychological impact.
  • Temporary improvement in the appearance of moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile in adults when the severity of these lines has an important psychological impact.
  • Temporary improvement in the appearance of moderate to severe horizontal forehead lines seen at maximum eyebrow elevation in adults when the severity of these lines has an important psychological impact, usually in conjunction with glabellar line treatment.
  • Temporary improvement in the appearance of vertical platysma bands in the neck (platysmal bands) in adults when the severity of these bands has an important psychological impact (where licensed).
  • Symptomatic treatment of focal spasticity of the ankle and foot in ambulant paediatric cerebral palsy patients aged 2 years and older as an adjunct to standard rehabilitative care.
  • Symptomatic treatment of focal spasticity of the upper limb in adults (e.g. elbow, wrist and finger flexors) to improve function or ease of care.
  • Symptomatic treatment of focal spasticity of the lower limb in adults (e.g. ankle and foot) following stroke or other brain injury.
  • Treatment of blepharospasm, hemifacial spasm and associated focal dystonias in adults.
  • Treatment of idiopathic cervical dystonia (spasmodic torticollis) in adults to reduce the severity of abnormal head position and neck pain.
  • Prophylaxis of headaches in adults with chronic migraine (headache on at least 15 days per month, of which at least 8 days have migraine features).
  • Management of urinary incontinence in adults with neurogenic detrusor overactivity due to spinal cord injury (at or below C5) or multiple sclerosis.
  • Management of overactive bladder with symptoms of urinary urgency, urgency urinary incontinence and frequency in adults inadequately managed by anticholinergic drugs.
  • Management of severe primary axillary hyperhidrosis that interferes with daily activities and is resistant to topical treatment.
  • Use in other facial dynamic lines (such as perioral lip lines) and bruxism may be undertaken by experienced practitioners where allowed by local regulations, generally on an off-label basis.

Composition

  • Active ingredient: Botulinum toxin type A (onabotulinumtoxinA) 100 Allergan Units per vial; the dual pack contains two such vials (total 200 Units per pack).
  • Each 100 Unit vial also contains approximately 0.5 mg human albumin as a stabiliser.
  • Each 100 Unit vial contains approximately 0.9 mg sodium chloride.
  • Product is supplied as a sterile, vacuum-dried powder (lyophilised) that appears as a thin white deposit on the base of the vial prior to reconstitution.

Formulation

  • Pharmaceutical form: Powder for solution for injection.
  • Lyophilised, sterile botulinum toxin type A preparation for reconstitution with sterile, preservative-free 0.9% sodium chloride solution immediately before use.
  • After reconstitution, the solution is clear, colourless and free from visible particles, suitable for intramuscular, intradermal or intradetrusor injection depending on indication.
  • Dose is expressed in Allergan Units specific to BOTOX; these Units are not interchangeable with units of other botulinum toxin products.

Packaging

  • Dual-vial presentation containing 2 x 100 Allergan Unit clear glass vials of BOTOX powder for solution for injection, each with a rubber stopper and tamper-proof aluminium seal.
  • Each vial is individually stoppered and sealed, then packed in an outer carton with the package leaflet (PIL).
  • Authorised pack sizes in regulatory documents may include cartons of 1, 2, 3 or 6 vials; this commercial product corresponds to a dual pack focused on 2 x 100 Unit vials for professional aesthetic use.
  • Vials are intended for single use after reconstitution; any unused reconstituted solution should be discarded.

Usage

  • BOTOX must only be prescribed and administered by appropriately qualified healthcare professionals experienced in the use of botulinum toxin type A and familiar with the relevant indications and anatomy.
  • Before administration, reconstitute each 100 Unit vial with sterile, preservative-free 0.9% sodium chloride solution for injection using the volumes recommended in the official SmPC to achieve the desired concentration in Units per 0.1 ml.
  • Gently inject the diluent into the vial and rotate or tilt the vial to dissolve the powder; avoid vigorous shaking or foaming to minimise risk of denaturation.
  • Inspect the reconstituted solution and only use if it is clear, colourless and free of particulate matter, and if the vial has maintained vacuum prior to reconstitution.
  • For facial aesthetic indications (glabellar lines, crow’s feet, forehead lines), inject small intramuscular doses into the specific muscles responsible for the lines using a fine needle, following recommended injection patterns, dose limits and safe anatomical landmarks.
  • For other therapeutic indications such as spasticity, cervical dystonia, chronic migraine, bladder disorders and hyperhidrosis, follow indication-specific dosing regimens, injection techniques and maximum cumulative doses as described in the SmPC or national guidelines.
  • Do not exceed a total dose of 400 Units in any 12-week interval in adults, taking into account all indications and body areas treated; in paediatric patients, use bodyweight-based limits and maximum total doses appropriate for age and indication.
  • Advise patients that onset of effect is gradual over days and that results are temporary; schedule follow-up and potential retreatment only after the effect of the previous injection has diminished and at intervals generally not shorter than 12 weeks.
  • Use appropriate aseptic technique throughout and dispose of vials, needles and syringes as clinical sharps and biohazardous waste in accordance with local regulations.
  • This product is not for self-administration; patients should be counselled to seek immediate medical attention if they experience breathing difficulties, swallowing difficulties, drooping eyelids, severe muscle weakness, visual disturbances or other unexpected serious symptoms following treatment.

Contraindications

  • Known hypersensitivity to botulinum toxin type A or to any of the excipients (human albumin or sodium chloride).
  • Presence of infection at the proposed injection site(s).
  • For bladder indications: urinary tract infection at the time of treatment, acute urinary retention in patients who are not routinely catheterising, or the presence of bladder calculi.
  • For bladder indications: patients who are not willing or able to initiate clean intermittent catheterisation if required post-treatment.
  • Patients with generalised disorders of muscle activity or neuromuscular junction disorders such as myasthenia gravis, Lambert–Eaton myasthenic syndrome or amyotrophic lateral sclerosis, in whom there is a heightened risk of excessive muscle weakness.
  • Patients with pre-existing swallowing or breathing difficulties in whom further weakening of oropharyngeal or respiratory muscles may pose a serious risk, unless the potential benefit clearly outweighs the risk and careful monitoring is in place.
  • Use during pregnancy is not recommended; BOTOX should generally be avoided in pregnant women unless clearly necessary based on a specialist benefit–risk assessment.
  • Use during breastfeeding is not recommended because it is unknown whether botulinum toxin type A is excreted in human milk.
  • Caution or avoidance in patients with significant bleeding disorders or on anticoagulant therapy when the risk of injection-site bleeding or haematoma is high, particularly for certain deep muscle or bladder injections.
  • Use by untrained personnel or outside an appropriate clinical setting; BOTOX is not intended for consumer or self-injection.

Adverse Effects

  • Local injection-site reactions such as pain, tenderness, bruising, erythema, swelling, mild bleeding or localised infection.
  • Headache and flu-like symptoms including fatigue, malaise and mild fever, particularly after aesthetic facial treatment and chronic migraine protocols.
  • Eyelid ptosis, brow ptosis, facial asymmetry, dry eye, tearing abnormalities, blurred vision or diplopia when injections are performed around the eyes or upper face.
  • Localised muscle weakness in the injected or adjacent muscles, which may manifest as altered facial expression, difficulty with certain movements, neck weakness or limb weakness, depending on the treatment area.
  • Dysphagia (difficulty swallowing), dysphonia (voice changes) and dysarthria, particularly with cervical dystonia treatment, which can occasionally be severe and may require medical intervention.
  • Respiratory symptoms such as dyspnoea and, in rare cases, serious respiratory compromise or respiratory failure in vulnerable patients or with unintended spread of toxin effect.
  • Autonomic effects including dry mouth, altered sweating patterns, and gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.
  • For hyperhidrosis treatment, injection-site pain and compensatory sweating in untreated body areas.
  • For bladder indications, urinary tract infection, dysuria, haematuria, urinary retention and the need for catheterisation; in patients with spinal cord injury, episodes of autonomic dysreflexia may occur and require prompt management.
  • Hypersensitivity reactions, including rash, pruritus, urticaria, soft-tissue oedema and, very rarely, severe allergic reactions such as anaphylaxis.
  • Reports of distant spread of toxin effect leading to symptoms such as generalized muscle weakness, ptosis, diplopia, dysphagia, dysarthria, difficulty speaking or breathing and aspiration pneumonia; such events may be serious and require urgent medical attention.
  • Development of neutralising antibodies in a small proportion of patients receiving repeated injections, which may reduce the clinical effectiveness of subsequent treatments.

Storage Conditions

  • Store unopened vials in a refrigerator at 2°C–8°C or in a freezer at approximately -5°C to -20°C, in accordance with the storage conditions stated in the product’s official labelling.
  • Keep vials in the outer carton to protect from light and maintain correct temperature conditions during storage and transport (appropriate cold-chain handling).
  • Do not use vials after the expiry date printed on the carton and vial.
  • After reconstitution with sterile 0.9% sodium chloride solution, use the solution immediately where possible; if not used immediately, store at 2°C–8°C for no longer than 24 hours, and discard any remaining solution thereafter.
  • Do not freeze reconstituted solution; keep refrigerated until use if there is any delay between reconstitution and administration.
  • Keep out of the sight and reach of children and dispose of any unused product, reconstituted solution, spillage and contaminated materials in accordance with local requirements for cytotoxic or biologically active medicinal products.

Duration

In aesthetic facial indications (glabellar lines, crow\u2019s feet and horizontal forehead lines), visible effects typically last around 3\u20134 months before muscle activity gradually returns. In therapeutic indications such as chronic migraine, focal spasticity, overactive bladder, neurogenic detrusor overactivity and severe primary axillary hyperhidrosis, clinical benefit commonly persists for several months, with median response durations often in the range of 3\u20136 months or longer for some bladder indications. Retreatment is generally recommended no more frequently than every 12 weeks, guided by the return of clinical symptoms and individual patient response.

Onset

Initial clinical improvement usually appears within 3\u20135 days after injection for cosmetic facial indications, with maximum effect generally observed at around 1\u20132 weeks. For certain therapeutic indications such as spasticity, chronic migraine and bladder disorders, onset may take up to two weeks or slightly longer, with peak benefit evolving over several weeks depending on dose, injection technique and patient factors.

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