B&O Supprettes

History

B&O Supprettes (the name is derived from the generic term 'belladonna/opium suppository') is an "unapproved" drug according to the Food and Drug Administration (FDA) – that is, the drug existed before the Food, Drug and Cosmetic Act of 1938. Accordingly, the compound has never undergone specific medical trials, and its efficacy has never been required to be demonstrated. The FDA has put pressure on the manufacturers of this drug for this reason. The original manufacturer of the Supprettes, Eli Lilly and Company, has long since lost any patent to the drug. Amerifit, which manufactured generic Supprettes prior to 2008, was cautioned by the FDA due to the unapproved nature of the drug combination.{{cite web

Dosage and administration

The drug and its generic counterparts are supplied in packages of 12, and available in two strengths:

Each B&O Supprettes suppository #15 A contains 16.2 mg (1/4 grain) of belladonna and 30 mg (1/2 grain) of opium.

Each B&O Supprettes suppository #16 A contains 16.2 mg of belladonna and 60 mg (1 grain) of opium.

The usual dose is one suppository rectally once or twice daily PRN - (as needed), not to exceed four Supprettes in a 24-hour period.

In the United States, B&O Supprettes is a Schedule II drug under the Controlled Substances Act of 1970; a written prescription is mandatory, and no refills are permitted.{{cite web

References

References

1. In November 2009, manufacturers of Paregoric (Camphorated Tincture of Opium) and Laudanum (Tincture of Opium) were notified in writing that there was no FDA approval on-file for either preparation, and as-such, their manufacture and distribution may be in violation of federal (USA) laws.