B&O Supprettes
Encyclopedia
B&O Supprettes is the brand name for a prescription
medication containing powdered opium
and belladonna
alkaloids in a suppository
form. They are indicated for the treatment of moderate to severe pain
from urethral spasm
, and for extending the interval(s) between injections of opiates. The drug has various "off label" uses, including renal colic
, intestinal cramp
s, tenesmus
and diarrhea
. They are also often prescribed after urinary bladder surgery
. B&O Supprettes are unique in the United States Pharmacopeia
because they are the only drug containing opium that is for suppository use, and in-fact, one of the very few medications that contains opium in any form, along with paregoric
and opium tincture (laudanum
).
(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. Since 2008, Paddock Laboratories has manufactured a generic version of the Supprettes after working with the FDA on marketing issues related to the unapproved nature of the drug.
counterparts are supplied in packages of 12, and available in two strengths:
Each B&O Supprette #15 A contains 16.2 mg (1/4 grain) of belladonna and 30 mg (1/2 grain) of opium.
Each B&O Supprette #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 are a Schedule II drug under the Controlled Substances Act
of 1970; a written prescription is mandatory, and no refills are permitted. Refrigerated storage is preferable, but not required. Most pharmacies consider B&O Supprettes to be a "special order" item, and as such are not normally kept in inventory. Compounding pharmacies have the capability of producing a generic form of the medication, and can modify the dosage(s) of the active ingredients (for pediatric or elderly patients, and those with renal insufficiency) or the carrier (usually substituting cocoa butter
) to best meet the needs of the patient at the request of the prescriber.
Medical prescription
A prescription is a health-care program implemented by a physician or other medical practitioner in the form of instructions that govern the plan of care for an individual patient. Prescriptions may include orders to be performed by a patient, caretaker, nurse, pharmacist or other therapist....
medication containing powdered opium
Opium
Opium is the dried latex obtained from the opium poppy . Opium contains up to 12% morphine, an alkaloid, which is frequently processed chemically to produce heroin for the illegal drug trade. The latex also includes codeine and non-narcotic alkaloids such as papaverine, thebaine and noscapine...
and belladonna
Belladonna
Belladonna, from the Italian expression "bella donna" meaning "beautiful lady", may refer to:-Plants:* Atropa belladonna or belladonna or deadly nightshade, a perennial herbaceous plant...
alkaloids in a suppository
Suppository
A suppository is a drug delivery system that is inserted into the rectum , vagina or urethra , where it dissolves.They are used to deliver both systemically-acting and locally-acting medications....
form. They are indicated for the treatment of moderate to severe pain
Pain
Pain is an unpleasant sensation often caused by intense or damaging stimuli such as stubbing a toe, burning a finger, putting iodine on a cut, and bumping the "funny bone."...
from urethral spasm
Spasm
In medicine a spasm is a sudden, involuntary contraction of a muscle, a group of muscles, or a hollow organ, or a similarly sudden contraction of an orifice. It is sometimes accompanied by a sudden burst of pain, but is usually harmless and ceases after a few minutes...
, and for extending the interval(s) between injections of opiates. The drug has various "off label" uses, including renal colic
Renal colic
Renal colic is a type of abdominal pain commonly caused by kidney stones.-Presentation:The pain typically begins in the abdomen and often radiates to the hypochondrium or the groin. The pain is often colicky due to ureteric peristalsis, but may be constant...
, intestinal cramp
Cramp
Cramps are unpleasant, often painful sensations caused by muscle contraction or over shortening. Common causes of skeletal muscle cramps include muscle fatigue, low sodium, and low potassium...
s, tenesmus
Tenesmus
Rectal tenesmus is a feeling of incomplete defecation. It is experienced as an inability or difficulty to empty the bowel at defecation...
and diarrhea
Diarrhea
Diarrhea , also spelled diarrhoea, is the condition of having three or more loose or liquid bowel movements per day. It is a common cause of death in developing countries and the second most common cause of infant deaths worldwide. The loss of fluids through diarrhea can cause dehydration and...
. They are also often prescribed after urinary bladder surgery
Surgery
Surgery is an ancient medical specialty that uses operative manual and instrumental techniques on a patient to investigate and/or treat a pathological condition such as disease or injury, or to help improve bodily function or appearance.An act of performing surgery may be called a surgical...
. B&O Supprettes are unique in the United States Pharmacopeia
United States Pharmacopeia
The United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...
because they are the only drug containing opium that is for suppository use, and in-fact, one of the very few medications that contains opium in any form, along with paregoric
Paregoric
Paregoric, or camphorated tincture of opium, also known as tinctura opii camphorata, is a medication known for its antidiarrheal, antitussive, and analgesic properties.-History:...
and opium tincture (laudanum
Laudanum
Laudanum , also known as Tincture of Opium, is an alcoholic herbal preparation containing approximately 10% powdered opium by weight ....
).
History
B&O Supprettes are an "unapproved" drug according to the Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(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
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
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
Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States...
, 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. Since 2008, Paddock Laboratories has manufactured a generic version of the Supprettes after working with the FDA on marketing issues related to the unapproved nature of the drug.
Dosage and Administration
The drug and its genericGeneric drug
A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...
counterparts are supplied in packages of 12, and available in two strengths:
Each B&O Supprette #15 A contains 16.2 mg (1/4 grain) of belladonna and 30 mg (1/2 grain) of opium.
Each B&O Supprette #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
PRN
- Airports :* PRN, the IATA airport code for Pristina International Airport Adem Jashari, Pristina, Kosovo* PRN, the FAA LID code for Mac Crenshaw Memorial Airport, Butler County, Alabama, US- Medicine :...
- (as needed), not to exceed four Supprettes in a 24-hour period.
In the United States, B&O Supprettes are a Schedule II drug under the Controlled Substances Act
Controlled Substances Act
The Controlled Substances Act was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The CSA is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain...
of 1970; a written prescription is mandatory, and no refills are permitted. Refrigerated storage is preferable, but not required. Most pharmacies consider B&O Supprettes to be a "special order" item, and as such are not normally kept in inventory. Compounding pharmacies have the capability of producing a generic form of the medication, and can modify the dosage(s) of the active ingredients (for pediatric or elderly patients, and those with renal insufficiency) or the carrier (usually substituting cocoa butter
Cocoa butter
Cocoa butter, also called theobroma oil, is a pale-yellow, pure edible vegetable fat extracted from the cocoa bean. It is used to make chocolate, biscuits, and baked goods, as well as some pharmaceuticals, ointments, and toiletries...
) to best meet the needs of the patient at the request of the prescriber.