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Lomotil® (atropine/diphenoxylate) – Revised indication and new contraindication

October 5, 2017 – The FDA approved updates to the Indications and Contraindications sections of the Lomotil (atropine/diphenoxylate) drug label, to limit use to patients ≥ 13 years of age, and to expand the contraindications for pediatric patients from 2 years old to < 6 years old secondary to the risk of respiratory and central nervous system (CNS) depression.

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