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Postmarketing Experience The following reactions have been identified during postmarketing use of LATISSE in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.The reactions, which have been chosen for inclusion due to either their seriousness.
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Postmarketing reports indicate that the effects of BOTOX Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated.
Human Albumin and Transmission of Viral Diseases This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases.
If such reactions occur, further injection of BOTOX Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
The most frequently reported adverse event following injection of BOTOX Cosmetic for lateral canthal lines was eyelid edema (1). DRUG INTERACTIONS Co-administration of BOTOX Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the.
CONTRAINDICATIONS BOTOX Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
Use of anticholinergic drugs after administration of BOTOX Cosmetic may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown.
LATISSE contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
Patients using prostaglandin analogs including. LUMIGAN for IOP reduction should only use. LATISSE after consulting with their physician and should be monitored for changes to their intraocular pressure. Increased iris pigmentation has occurred when bimatoprost solution was administered.
Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX Cosmetic.
LATISSE solution comes in repeated contact with skin surfaces. Apply. LATISSE only to the skin of the upper eyelid margin at the base of the eyelashes. LATISSE solution should be used with caution in patients with active intraocular inflammation (eg, uveitis) because the inflammation may.