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Can Vigamox be used in newborns and infants?
Can Vigamox be used in infants and newborns? The leaflet for Vigamox states that the use of Vigamox is not recommended in newborns, as only very limited information is available on its use in these patients. Does this also apply to infants? On the other hand, the SmPC reports that clinical trials have shown that the use of VIGAMOX in children and adolescents, including neonates, is safe. How to interpret it? Regards, Rafał
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Aleksandra Żywiec-Pelczar Pharmacist
17 months ago
Clinical studies have shown that the use of moxifloxacin contained in Vigamox in children and adolescents, including newborns, is safe. The adverse reaction profile for children corresponds to the safety profile in adults. In the case of newborns, it is recommended to take additional precautions to limit the absorption of the drug into the bloodstream through the nasal mucosa by pressing the inner corner of the eye with squares for about 3 minutes after the administration of the drops (please remember about hand hygiene). Indeed, the Summary of Product Characteristics of Vigamox states that: "VIGAMOX should not be used for the prevention or empirical treatment of gonococcal conjunctivitis, including gonorrheic conjunctivitis of newborns, due to the presence of strains of Neisseria gonorrhoeae resistant to fluoroquinolones" and that: "The use of the medicinal product is not recommended for the treatment of Chlamydia trachomatis infections in patients less than 2 years of age, because it has not been studied in this age group" and also: "Data to determine the efficacy and safety of VIGAMOX in the treatment of conjunctivitis in newborns are very limited. Therefore, the use of this medicinal product for the treatment of conjunctivitis in newborns is not recommended." Indeed, the information cited above can be confusing. In cases of neonatal conjunctivitis, it is known that moxiflocacin applied topically is not effective and treatment requires the use of systemic antibiotic therapy. Efficacy concerns mainly concern newborns. In the case of infants and older children, the use of Vigamox in patients with suspected Chlamydia trachomatis infection raises doubts. Please note that the term 'not recommended' is not the same as 'is contraindicated'. If the doctor, on the basis of his own knowledge, experience and suspicion about the etiology of inflammation, considers that the benefits of the drug in a given case outweigh the possible risks, he has the right to prescribe the drug in the case of a newborn.