Ronatox®
Generic name: Purified Clostridium botulinum toxin type A
Dosage form: 500-unit lyophilized powder, supplied with a vial of 0.9% sodium chloride diluent
Drug class: Neuromuscular blocking agent
Indications: This medicine is used for improving skin wrinkles, excessive sweating, urinary incontinence, cervical dystonia, chronic migraine, limb spasticity, and other conditions.
Ronatox® is purified Clostridium botulinum toxin type A with broad therapeutic and cosmetic applications. By temporarily blocking the release of the neurotransmitter acetylcholine at the neuromuscular junction, it inhibits neuromuscular signal transmission.
- Reduction of skin wrinkles (cosmetic use)
- Correction of gummy smile (cosmetic use)
- Primary hyperhidrosis
- Chronic migraine
- Upper- and lower-limb spasticity
- Cervical dystonia / torticollis
- Anal fissure
- Urinary incontinence
- Achalasia
- Blepharospasm (involuntary eyelid contraction)
- Strabismus (eye misalignment)
- Bruxism (teeth grinding)
- Bell’s palsy and facial asymmetry
- Sialorrhea (excessive salivation)
500 units of lyophilized powder, supplied with one vial of 0.9% sodium chloride diluent for preparation.
- The exact dose and injection site depend entirely on the physician’s diagnosis and the intended use.
- Depending on the indication and injection area, Ronatox® may be injected intramuscularly or subcutaneously.
- Signs of allergic reaction during injection and for several hours afterward
- Hypersensitivity to any type of botulinum toxin or to any ingredient used in its formulation
- Infection at the injection site
- Because sufficient controlled clinical data in pregnant women are not available, use of purified Clostridium botulinum toxin type A during pregnancy is not recommended.
- It is unknown whether botulinum toxin type A is excreted in breast milk. Considering the possibility of adverse effects in breastfed infants, a decision should be made to discontinue breastfeeding or discontinue the medicine, taking into account the importance of the medicine to the mother.
Like all medicines, alongside its desired therapeutic effects, this medicine may cause unwanted side effects. Although not all of these effects occur in every person, inform your physician if any of the following occur:
- Nausea, constipation, diarrhea, abdominal pain
- Flu-like symptoms, drowsiness, headache, weakness and fatigue, musculoskeletal pain, seizure, myasthenia, dizziness
- Pain and reaction at the injection site, bruising, skin rash, contact dermatitis, itching, hypersensitivity reactions, forehead acne
- Blurred vision, reduced visual acuity, double vision, dry-eye syndrome, eye pain, itchy eyes, eyelid edema, eyelid ptosis
- Nasopharyngitis, dysphonia, sinusitis, peripheral edema, facial paralysis, difficulty swallowing, dry mouth, heaviness of the forehead
Consult your physician or pharmacist about using Ronatox® together with other medicines or supplements.
Each package contains one 500-unit vial of lyophilized powder, along with one 5 mL vial of 0.9% sodium chloride diluent.
- Store at 2–8°C, protected from light and moisture.
- Avoid freezing after preparation.
- Keep the medicine out of the reach of children.
- Do not use expired medicine.
- The prepared medicine must be clear, colorless, and free of suspended particles.
- Drug information: UpToDate, 2024
- U.S. Food and Drug Administration. Botox® prescribing information.
