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Paregoric, or
camphor Camphor () is a waxy, colorless solid with a strong aroma. It is classified as a terpenoid and a cyclic ketone. It is found in the wood of the camphor laurel (''Cinnamomum camphora''), a large evergreen tree found in East Asia; and in the ka ...
ated
tincture A tincture is typically an extract of plant or animal material dissolved in ethanol (ethyl alcohol). Solvent concentrations of 25–60% are common, but may run as high as 90%.Groot Handboek Geneeskrachtige Planten by Geert Verhelst In chemistr ...
of
opium Opium (or poppy tears, scientific name: ''Lachryma papaveris'') is dried latex obtained from the seed capsules of the opium poppy '' Papaver somniferum''. Approximately 12 percent of opium is made up of the analgesic alkaloid morphine, whic ...
, also known as ''tinctura opii camphorata'', is a traditional
patent medicine A patent medicine, sometimes called a proprietary medicine, is an over-the-counter (nonprescription) medicine or medicinal preparation that is typically protected and advertised by a trademark and trade name (and sometimes a patent) and claimed ...
known for its
antidiarrheal An anti-diarrhoeal drug (or anti-diarrheal drug in American English) is any medication which provides symptomatic relief for diarrhoea. Types * Electrolyte solutions, while not true antidiarrhoeals, are used to replace lost fluids and salts in a ...
,
antitussive Cold medicines are a group of medications taken individually or in combination as a treatment for the symptoms of the common cold and similar conditions of the upper respiratory tract. The term encompasses a broad array of drugs, including a ...
, and
analgesic An analgesic drug, also called simply an analgesic (American English), analgaesic (British English), pain reliever, or painkiller, is any member of the group of drugs used to achieve relief from pain (that is, analgesia or pain management). It i ...
properties. According to Goodman and Gilman's 1965 edition, "Paregoric is a 4% opium tincture in which there is also
benzoic acid Benzoic acid is a white (or colorless) solid organic compound with the formula , whose structure consists of a benzene ring () with a carboxyl () substituent. It is the simplest aromatic carboxylic acid. The name is derived from gum benzoin, wh ...
,
camphor Camphor () is a waxy, colorless solid with a strong aroma. It is classified as a terpenoid and a cyclic ketone. It is found in the wood of the camphor laurel (''Cinnamomum camphora''), a large evergreen tree found in East Asia; and in the ka ...
, and
anise oil Anise (; '), also called aniseed or rarely anix is a flowering plant in the family Apiaceae native to Eurasia. The flavor and aroma of its seeds have similarities with some other spices and herbs, such as star anise, fennel, licorice, and ta ...
. ... Paregoric by tradition is used especially for children." The term "paregoric" has also been used for boiled sweets which contained the substance, in particular the Army & Navy brand.


Properties

In 1944, two clinicians who evaluated the expectorant action of paregoric, concluded:
The survival of paregoric through the centuries, and particularly through recent critical decades, is probably due to keen clinical observation and stubborn adherence to the clinical deduction that paregoric is useful in certain types of cough.


History

In the very early 18th century, Jakob Le Mort (1650–1718), a professor of chemistry at
Leiden University Leiden University (abbreviated as ''LEI''; nl, Universiteit Leiden) is a public research university in Leiden, Netherlands. The university was founded as a Protestant university in 1575 by William, Prince of Orange, as a reward to the city of L ...
, prepared an elixir for
asthma Asthma is a long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wheezing, co ...
and called it "paregoric". The word "paregoric" comes from the Greek word "paregoricon" which was originally applied to oratory – to speak, but, more accurately, talk over, soothe, and finally came to have the same meaning as "
anodyne An anodyne is a drug used to lessen pain through reducing the sensitivity of the brain or nervous system. The term was common in medicine before the 20th century, but such drugs are now more often known as analgesics or painkillers. The term ''a ...
". Le Mort's elixir, consisting of "honey, licorice, flowers of Benjamin, and opium, camphor, oil of aniseed, salt of tartar and spirit of wine," was listed as "Elixir Asthmaticum" in the London
Pharmacopoeia A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by ...
of 1721. Its ingredients were assembled according to the
humoral theory Humorism, the humoral theory, or humoralism, was a system of medicine detailing a supposed makeup and workings of the human body, adopted by Ancient Greek and Roman physicians and philosophers. Humorism began to fall out of favor in the 1850s ...
of the time. Paregoric was used in various formulations for hundreds of years. Paregoric was a household remedy in the 18th and 19th centuries when it was widely used to control
diarrhea Diarrhea, also spelled diarrhoea, is the condition of having at least three loose, liquid, or watery bowel movements each day. It often lasts for a few days and can result in dehydration due to fluid loss. Signs of dehydration often begin wi ...
in adults and children, as an
expectorant Mucoactive agents are a class of chemical agents that aid in the clearance of mucus or sputum from the upper and lower airways, including the lungs, bronchi, and trachea. Mucoactive drugs include expectorants, mucolytics, mucoregulators, and mucok ...
and cough medicine, to calm fretful children, and to rub on the gums to counteract the pain from teething. A formula for paregoric from ''Dr. Chase's Recipes'' (1865): ''The Medical Companion, Or Family Physician'', a book from 1827, gave the following recipe:


Use during the twentieth century

During the twentieth century its use declined as governments regulated its ingredients (opium is a controlled substance in many countries.) Beginning in late 2011, there was a period in which paregoric was not being manufactured in the United States. , however, the manufacture of paregoric had resumed.


Regulation

The early twentieth century brought increased regulation of all manner of narcotics, including paregoric, as the addictive properties of opium became more widely understood, and "patent medicines came under fire largely because of their mysterious compositions".''In the Arms of Morpheus: The Tragic History of Laudanum, Morphine, and Patent Medicines''," by Barbara Hodgson. Buffalo, New York: Firefly Books, 2001, page 126. In the United States, the
Pure Food and Drug Act of 1906 The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration ...
required that certain specified drugs, including alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels. Cocaine, heroin, cannabis, and other such drugs continued to be legally available without prescription as long as they were labeled. It is estimated that sale of patent medicines containing opiates decreased by 33% after labeling was mandated. In 1906 in Britain and in 1908 in Canada "laws requiring disclosure of ingredients and limitation of narcotic content were instituted". The Harrison Narcotics Act of 1914 restricted the manufacture and distribution of opiates, including
laudanum Laudanum is a tincture of opium containing approximately 10% powdered opium by weight (the equivalent of 1% morphine). Laudanum is prepared by dissolving extracts from the opium poppy (''Papaver somniferum Linnaeus'') in alcohol (ethanol). Red ...
, and coca derivatives in the United States; this was followed by France's ''Loi des stupefiants'' in 1916, and Britain's Dangerous Drugs Act in 1920. In the United States, the Harrison Narcotics Act of 1914 regulated "opium or coca leaves, or any compound, manufacture, salt, derivative or preparation thereof", but not some medical products containing relatively low concentrations of these substances. Paregoric was classified as an "Exempt Narcotic", as were other medical products containing small amounts of opium or their derivatives.


Regulation and use since 1970

Until 1970, paregoric could be purchased in the United States at a pharmacy without a medical prescription, in accordance with federal law. Federal law dictated that no more than two ounces of paregoric be dispensed by any pharmacy to the same purchaser within a 48-hour period. Purchasers were also required to sign a register or logbook, and pharmacies were technically required to request identification from any purchaser not personally known to the pharmacist. Some states further limited the sale of paregoric, or banned over-the-counter sales entirely. For example, Michigan law allowed over-the-counter (non-prescription) sale of paregoric until April 1964, but still allowed OTC sales of certain exempt cough medication preparations that contain 60 mg of codeine per fluid ounce." Even where legally permissible by law, OTC sale of paregoric was subject to the discretion of individual pharmacists. In 1970, paregoric was classified as a Schedule III drug under the
Controlled Substances Act The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States ...
(DEA #9809); however, drugs that contained a mixture of kaolin, pectin, and paregoric (e.g., Donnagel-PG, Parepectolin, and their generic equivalents) were classified as Schedule V drugs. They were available
over-the-counter Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid presc ...
without a prescription in many states until the early 1990s, at which time the FDA banned the sale of anti-diarrheal drugs containing kaolin and pectin; also, Donnagel-PG contained tincture of belladonna, which became prescription-only on January 1. 1993. Paregoric is currently listed in the
United States Pharmacopeia The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization tha ...
. Manufacture of the drug was discontinued for several months beginning in late 2011; however, production and distribution resumed in 2012, so the drug is still available in the United States by prescription. Thus, it is unclear as to whether the lapse in manufacture actually resulted in a shortage of the drug at any time, since prescription drugs are often still available for many months after manufacture has been discontinued. In France, paregoric was available without prescription until 1986; nowadays, it is used to wean infants born to opiate-addicted women.


Paregoric, U.S.P. formula

The principal active ingredient in paregoric is powdered opium. In the United States the formula for Paregoric U.S.P. is a tincture of
opium Opium (or poppy tears, scientific name: ''Lachryma papaveris'') is dried latex obtained from the seed capsules of the opium poppy '' Papaver somniferum''. Approximately 12 percent of opium is made up of the analgesic alkaloid morphine, whic ...
40 ml,
anise oil Anise (; '), also called aniseed or rarely anix is a flowering plant in the family Apiaceae native to Eurasia. The flavor and aroma of its seeds have similarities with some other spices and herbs, such as star anise, fennel, licorice, and ta ...
4 ml,
benzoic acid Benzoic acid is a white (or colorless) solid organic compound with the formula , whose structure consists of a benzene ring () with a carboxyl () substituent. It is the simplest aromatic carboxylic acid. The name is derived from gum benzoin, wh ...
4 g,
camphor Camphor () is a waxy, colorless solid with a strong aroma. It is classified as a terpenoid and a cyclic ketone. It is found in the wood of the camphor laurel (''Cinnamomum camphora''), a large evergreen tree found in East Asia; and in the ka ...
4 g,
glycerin Glycerol (), also called glycerine in British English and glycerin in American English, is a simple triol compound. It is a colorless, odorless, viscous liquid that is sweet-tasting and non-toxic. The glycerol backbone is found in lipids known ...
40 ml, alcohol 450 ml, purified water 450 ml, diluted with alcohol to 1000 ml, and contains the equivalent of 0.4 mg/ml of
anhydrous A substance is anhydrous if it contains no water. Many processes in chemistry can be impeded by the presence of water; therefore, it is important that water-free reagents and techniques are used. In practice, however, it is very difficult to achie ...
morphine Morphine is a strong opiate that is found naturally in opium, a dark brown resin in poppies (''Papaver somniferum''). It is mainly used as a pain medication, and is also commonly used recreationally, or to make other illicit opioids. There ...
; one ounce of paregoric contains 129.6 mg (2 grains) of powdered opium, or the equivalent of 13 mg of anhydrous morphine.''The Extra Pharmacoepia Martindale'', Vol. 1, 24th Edition. London: The Pharmaceutical Press, 1958, p. 924. The average adult dose is 4 ml by mouth which corresponds to 16 mg of opium, or 1.6 mg of anhydrous morphine." It is unclear when the current formula for Paregoric, U.S.P. was developed in the United States, and more research is needed. For example, one formula for "Camphorated Tincture of Opium (Paregoric Elixir)" attributed to the ''United States Pharmacoepia of 1863'' is: "Macerate 1 drachm each powdered opium and benzoic acid, 1 fluid drachm of anise, 2 ounces clarified honey, and 2 scruples camphor, in 2 pints diluted alcohol for 7 days, and filter through paper." A slightly different formula is given in the 1926 pharmacoepia. The current formula for Paregoric, U.S.P. should not be assumed to be universal. For example, in the United Kingdom the formula for Paregoric, B.P. is tincture of opium 5 ml, benzoic acid 500 mg, camphor 300 mg, anise oil 0.3 ml, alcohol (60%) to 100 ml, and contains about 1/30th grain of anhydrous morphine in 60 minims, which is 25% stronger than Paregoric, U.S.P.


Dosage

Paregoric is sometimes confused with
Laudanum Laudanum is a tincture of opium containing approximately 10% powdered opium by weight (the equivalent of 1% morphine). Laudanum is prepared by dissolving extracts from the opium poppy (''Papaver somniferum Linnaeus'') in alcohol (ethanol). Red ...
, because their chemical names are similar: Camphorated Tincture of Opium (Paregoric) vs. Tincture of Opium (Laudanum). However, Laudanum contains 10 milligrams of morphine per milliliter, 25 times more than Paregoric. Confusion between the two drugs has led to overdose and death in patients. Thus the term "Paregoric" should be used instead of "Camphorated Opium Tincture", since the latter may be confused with Laudanum. The differences between Tincture of Opium (Laudanum) and Camphorated Tincture of Opium (Paregoric) are important and should be kept in mind when administering either of these drugs. Care and caution should always be taken in administering doses of Tincture of Opium, such as the use of a dosage syringe or other suitable measurement device, and by pharmacists in preparing Paregoric from Laudanum, and to note that the dosages noted here refer to Apothecaries weight and fluid measure. In particular, "the difference between a minim and a drop should be borne in mind when figuring doses. A minim is always a sixtieth part of a fluid drachm regardless of the character of the substance, while a drop varies from a forty-fifth to a two-hundred-and-fiftieth part, according to the surface tension of the fluid." Tincture of Opium (Laudanum) and Camphorated Tincture of Opium (Paregoric) each have 50.9 drops per gram; 50.0 drops per cc; 185.0 drops per fluid drachm; and 3.10 drops per minim." The importance of these distinctions is evident in view of the dangers of erroneously relying upon more general descriptions of Apothecaries' fluid measures, which typically list 60 minims per fluid dram, and 8 fluid drams per fluid ounce (480 minims).


Indications

The main effects of paregoric are to increase the muscular tone of the intestine, to inhibit normal
peristalsis Peristalsis ( , ) is a radially symmetrical contraction and relaxation of muscles that propagate in a wave down a tube, in an anterograde direction. Peristalsis is progression of coordinated contraction of involuntary circular muscles, which ...
, and as an expectorant; a peer-reviewed clinical study in 1944 reported "that all of tsingredients have been found to contribute toward the expectorant action of paregoric, and, further, that an advantage is contained in the combination over the sum of the effects of the individual constituents," that Paregoric "is expectorant by virtue of a reflex from the stomach," and "preparations of paregoric which have aged for two or three years are superior as an expectorant to preparations aged for less time.". The authors note: "Because of its marked expectorant action paregoric is superior to morphine, which has probably no expectorant action, and to tincture of opium which has very little expectorant action. Its main medical use is to control
fulminant Fulminant () is a medical descriptor for any event or process that occurs suddenly and escalates quickly, and is intense and severe to the point of lethality, i.e., it has an explosive character. The word comes from Latin ''fulmināre'', to strike ...
diarrhea Diarrhea, also spelled diarrhoea, is the condition of having at least three loose, liquid, or watery bowel movements each day. It often lasts for a few days and can result in dehydration due to fluid loss. Signs of dehydration often begin wi ...
, and as an antitussive (cough suppressant). Problems with its use include opiate dependency and analgesia which can mask symptoms of diseases that need treatment. However, Paregoric was characterized as "a needlessly complex pharmacopeial mixture... of a former day" by a 1966 study. In the 21st century its two main uses have been largely supplanted by minimally psychoactive cough-suppressant drugs (such as
dextromethorphan Dextromethorphan (DXM) is a medication most often used as a cough suppressant in over-the-counter cold and cough medicines. It is sold in syrup, tablet, spray, and lozenge forms. In 2022, the FDA approved a formulation of it combined with b ...
) and non-psychoactive antidiarrheal drugs (such as
loperamide Loperamide, sold under the brand name Imodium, among others,Drugs.co Page accessed September 4, 2015 is a medication used to decrease the frequency of diarrhea. It is often used for this purpose in inflammatory bowel disease and short bowel synd ...
).


References

{{Opioidergics Antidiarrhoeals Opiates Antitussives