Difenoxin - Legal Status

Legal Status

Difenoxin is a Schedule I drug by itself (Lyspafen) in the USA. It has been approved for use in the late 1990s in the form of Motofen (difenoxin HCl and atropine tablets and elixir) which like Lomotil is a less-restrictive category Schedule IV on account of the adulterant; one difference is that the diphenoxylate and atropine formulation is Schedule V. Atropine is present in each doseage unit in the amount of 25 µg, or 1/40 of the therapeutic dose. Many other countries have been using this combination product for many years as a second-line centrally-acting and/or opioid-agonist anti-diarrhoeal, betwixt loperamide and paregoric.

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