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Why is Fildena 150 not intended for use children
Why is Fildena 150 not intended for use children
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machia
116 posts
Mar 28, 2024
3:37 AM
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Fildena 150 mg, which contains sildenafil citrate as its active ingredient, is a medication used to treat erectile dysfunction (ED) in adult men. It is not intended for use in children or adolescents for several reasons:
Lack of Safety and Efficacy Data: Clinical studies evaluating the safety and efficacy of sildenafil citrate, the active ingredient in Fildena, have primarily focused on adult men with erectile dysfunction. Limited data are available on the use of sildenafil in pediatric populations, and its safety and effectiveness have not been established in children or adolescents.
Developmental Considerations: Children and adolescents undergo significant physical and hormonal changes during puberty and adolescence, which can affect their cardiovascular and reproductive systems. The safety of medications like sildenafil citrate in these populations has not been thoroughly studied, and there may be unknown risks associated with their use in children or adolescents.
Off-Label Use: Using medications like Fildena 150 Mg in pediatric populations for conditions other than those approved by regulatory agencies is considered off-label use. Off-label use of medications in children or adolescents should only be undertaken under the guidance and supervision of a healthcare provider with expertise in pediatric care.
Potential Risks: Children and adolescents may be more vulnerable to certain side effects or adverse reactions from medications like sildenafil citrate. Additionally, using medications for erectile dysfunction in pediatric populations may not address underlying causes of sexual dysfunction in this age group and could delay appropriate evaluation and treatment.
Regulatory Approval: Fildena and similar medications are approved for use in adult men with erectile dysfunction by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These regulatory agencies have not approved the use of sildenafil citrate for pediatric populations.
It's essential for healthcare providers and parents to be aware of the potential risks associated with using medications like Fildena in children or adolescents and to adhere to approved indications and dosing guidelines. If a child or adolescent experiences sexual dysfunction or other health concerns, they should be evaluated by a healthcare provider with expertise in pediatric care to determine the underlying cause and appropriate treatment approach.
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