Active Ingredient: Botulinum toxin type A
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intramuscular, 20 international units botulinum toxin type A, once every 3 months.
Recommended needle: Sterile 30 gauge needle.
Administration guidance: Before injection, the thumb or index finger is to be placed firmly below the orbital rim in order to prevent extravasation below the orbital rim. The needle should be oriented superiorly and medially during the injection. In addition, injections near the levator palpebrae superioris muscle must be avoided, particularly in patients with larger brow-depressor complexes (depressor supercilii). Injections in the corrugator muscle must be done in the central part of that muscle, a distance of at least 1 cm above the arch of the eyebrows (see figure).
Care should be taken to ensure that botulinum toxin type A is not injected into a blood vessel when it is injected in the glabellar lines seen at maximum frown.
Recommended dose: A volume of 0.1 ml (4 Units) is administered in each of the 5 injection sites (see Figure): 2 injections in each corrugator muscle and 1 injection in the procerus muscle for a total dose of 20 Units.
Maximum dose: In order to reduce the risk of eyelid ptosis, the maximum dose of 4 Units for each injection site as well as the number of injection sites should not be exceeded.
Additional information:
Treatment intervals should not be more frequent than every three months. In the event of treatment failure or diminished effect following repeat injections, alternative treatment methods should be employed.
In case of insufficient dose a second treatment session should be initiated by adjusting the total dose up to 40 or 50 Units, taking into account the analysis of the previous treatment failure.
The efficacy and safety of repeat injections of botulinum toxin type A for the treatment of glabellar lines beyond 12 months has not been evaluated.
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