paregoric

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Paregoric, or camphorated tincture of opium, also known as tinctura opii camphorata, is a medication known for its antidiarrheal, antitussive, and analgesic properties.

History

In the early 18th century Jakob Le Mort (1650–1718),^[1] a professor of chemistry at Leiden University, prepared an elixir for asthma and called it "paregoric".^[2] The word "paregoric" comes from the Greek word "paregoricon" which was originally applied to oratory and to a particular form of oratory in which distraction of attention was the predominant feature. It then passed through various shades of meaning from "consoling" to "soothing" and finally came to have the same significance as "anodyne".^[3] Le Mort's elixir, consisting of "honey, licorice, flowers of Benjamin, and opium, camphor, oil of aniseed, salt of tartar and spirit of wine," became official as "Elixir Asthmaticum" in the London Pharmacopoeia of 1721. Paregoric was used in various formulations for hundreds of years, and its ingredients "were assembled out of the obsolete humoral philosophy and quasiscientific reasoning of the Renaissance." 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."^[4]

Paregoric was a household remedy in the 18th and 19th centuries, when it was widely used to control diarrhea in adults and children, an expectorant and cough medicine, calm fretful children, and to rub on the gums to counteract the pain from teething. Two formulas, one for paregoric and another for a similar medication, taken from an 1870 publication, are, for Paregoric: "Best opium 1/2 dr., dissolve it in about 2 tablespoons of boiling water; then add benzoic acid 1/2 dr.; oil of anise 1/2 a fluid dr.; clarified honey 1 oz.; camphor gum 1 scruple; alcohol, 76 percent, 11 fluid ozs.; distilled water 4-1/2 fluid ozs.; macerate, (keep warm,) for two weeks. Dose--For children, 5 to 20 drops, adults, 1 to 2 teaspoons." The other, for BATEMAN'S PECTORAL DROPS, is: "Opium in powder, catechu in powder, camphor gum, red saunders, rasped, of each 1/2 oz.; oil of anise 1 dr.; dilute alcohol, (alcohol of 76 percent, and water in equal proportions,) 1 gal. Keep warm for 2 weeks. The opium strength of this is about equal to paregoric, and it is used for similar purposes, and doses."^[5] During the 20th century its use declined as governments regulated it.

As of 2010, paregoric has been discontinued in the U.S. due to FDA enforcement action; the FDA considers paregoric an "unapproved drug" because it has not undergone FDA trials to prove its efficacy^[6]

Paregoric use during the early 20th century

The early 20th 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."^[7] In the United States, the Pure Food and Drug Act of 1906 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.^[8] In 1906 in Britain and in 1908 in Canada "laws requiring disclosure of ingredients and limitation of narcotic content were instituted."^[9]

The Harrison Narcotics Act of 1914 restricted the manufacture and distribution of opiates, including laudanum, 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.^[10]

In the United States, the Harrison Narcotics Act of 1914^[11] regulated "opium or coca leaves, or any compound, manufacture, salt, derivative or prepration thereof," but not some medical products containing relatively low concentrations of these substances.^[12] Paregoric was classified as an "Exempt Narcotic," as were other medical products containing small amounts of opium or their derivatives.^[13]

In 1929-30, Parke, Davis & Co., a major United States drug manufacturer based in Detroit, Michigan, sold "Opium, U.S.P. (Laudanum)" as Tincture No. 23 for $10.80 per pint (16 fluid ounces), and "Opium Camphorated, U.S.P. (Paregoric)" as Tincture No. 20, for $2.20 per pint. Concentrated versions were available. "Opium Camphorated, for U.S.P. Tincture: Liquid No. 338" was "exactly 8 times the strength of Tincture Opium Camphorated (Paregoric) [italics in original], U.S.P.," "designed for preparing the tincture by direct dilution," and cost $7 per pint. Similarly, at a cost of $36 per pint, "Opium Concentrated, for U.S.P. Tincture: Liquid No. 336," was "four times the strength of the official tincture," and "designed for the extemporaneous preparation of the tincture."^[14] The catalog also noted: "For quarter-pint bottles add 80c. per pint to the price given for pints."

Regulation and use of Paregoric since 1970

Until 1970, the availability of Paregoric and other Exempt Narcotic preparations for purchase without a medical prescription varied according to state laws. In 27 states, Paregoric was available without a prescription, but some state or local laws or pharmacy policy limited the quantity of Paregoric that could be purchased in a given time period (e.g., 24 hours), and in some instances the purchaser was required to sign a register or logbook. The remaining 23 states in which state law required a medical prescription to buy Paregoric and some other Exempt Narcotic preparations were: Arkansas, California, Colorado, Connecticut, Iowa, Kansas, Louisiana, Maryland, Michigan, Minnesota, Montana, Nebraska, New Jersey, New York, North Dakota, Oregon, Rhode Island, South Dakota, Texas, Utah, Vermont, Washington and West Virginia."^[15] State laws regulating the sale of Exempt Narcotic preparations varied across as well as within states. Michigan law, for example, allowed over-the-counter (nonprescription) sale of Paregoric for many years, then began requiring a medical prescription to purchase Paregoric in April 1964, but did not require a prescription to purchase Elixir Terpin Hydrate and Codeine, N.F. (a cough preparation which contained 1 grain of codeine per fluid ounce).

In 1970, Paregoric was reclassified as a Schedule III drug under the Controlled Substances Act (DEA #9809);^[16] before then, Paregoric was a Schedule V drug, and available over-the-counter without a prescription in some states, as previously discussed. Paregoric is currently listed in the United States Pharmacopeia and is available only by medical prescription, although as of 2011, paregoric has been discontinued in the U.S. resulting from regulatory action by the FDA (see above). In France, Paregoric was available without prescription until 1986; nowadays, it is used to wean infants born from 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 tincture of opium 40 cc, anise oil 4 cc, benzoic acid 4 gm, camphor 4 gm, glycerin 40 cc, alcohol 450 cc, purified water 450 cc, diluted alcohol^[17] to 1000 cc, and contains the equivalent of 0.4 mg/cc of anhydrous morphine; one ounce of paregoric contains 129.6 mg (2 grains) of powdered opium, or the equivalent of 13 mg of anhydrous morphine.^[18][19] The average adult dose is 4 cc by mouth which corresponds to 16 mg of opium, or 1.6 mg of anhydrous morphine."^[20]

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."^[21] A slightly different formula is given in the 1926 pharmacoepia.^[22]

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 cc, benzoic acid 500 mg, camphor 300 mg, anise oil 0.3 cc, alcohol (60%) to 100 cc, and contains about 1/30th grain of anhydrous morphine in 60 minims,^[23] which is 25% stronger than Paregoric, U.S.P.

Dosage

Paregoric is sometimes confused with Laudanum, 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 deaths in several patients. Thus the term "Paregoric" should be used instead of "Camphorated Opium Tincture," since the latter may be confused with Laudanum.^[24]

Bottle of Paregoric

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 in this article 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 fuidrachm 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."^[25] 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."^[26] 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).^[27]

Indications

The main effects of Paregoric are to increase the muscular tone of the intestine, to inhibit normal peristalsis, and as an expectorant. Its main medicinal use is to control fulminant diarrhea, and as an antitussive (cough suppressant). Problems with its use include opiate dependency and analgesia which can mask symptoms of diseases that need treatment.

Although Paregoric was characterized in 1966 as "a needlessly complex pharmacopeial mixture... of a former day" without any apparent scientific or medical basis,^[28] a peer-reviewed clinical study in 1944 reported "that all of [its] ingredients 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."^[29]

In popular culture

Paregoric is mentioned in the following works:

• William Cowper Brann's "Brann the Iconoclast" (1898)
• Many works by William S. Burroughs, including The Yage Letters, Junkie, Queer and Naked Lunch
• William S. Burroughs, Jr.'s Speed
• Robin Cook's Harmful Intent (1990)
• Sir Arthur Conan Doyle's The Adventure of the Three Gables
• Richard Fariña's Been Down So Long It Looks Like Up to Me
• James T. Farrell's Studs Lonigan
• William Golding's Rites of Passage (laudanum is also mentioned in the book)
• Herman Melville's "Moby Dick" (1851)
• Paul Metcalf's "Araminta and the Coyotes" (1991)
• Rick Moody's novel The Ice Storm
• John Steinbeck's East of Eden
• Thomas Pynchon's Against the Day
• Kōbō Abe's The Box Man
• The "anonymous" work Go Ask Alice
• Ken Kesey's Sometimes a Great Notion
• Anton Myrer's Once an Eagle
• William Faulkner's "Pylon"
• Katherine Paterson's Jacob Have I Loved
• Caleb Carr's The Angel of Darkness
• George Orwell's Down and Out in Paris and London and A Clergyman's Daughter
• Joseph Conrad's novella The Nigger of the Narcissus
• John Fowles' "The Magus"
• Mark Twain's Letters From the Earth
• Mark Twain's A Tramp Abroad
• Alexandra Ripley's "Scarlett"
• Woody Guthrie's "Bound For Glory"
• Homer H. Hickam, Jr.'s "Rocket Boys"
• Catherine Cookson's "Fanny McBride"
• Abraham Verghese's Cutting for Stone
• Tennessee Williams's one-act play 27 Wagons Full of Cotton (1946) (as the medicine Flora drinks to relax herself.)
• Night Nurse
• The Ice Storm
• Little House on the Prairie, in the episodes "A Matter of Faith" and "To Live with Fear"
• M*A*S*H, in the episodes "The Yalu Brick Road" and briefly in "Sticky Wicket"
• Paregoric by Black River Circus: the music video for this song shows vintage photos of smoke pollution in Pittsburgh, Pennsylvania, and describes the antitussive effects of the medication ("Paregoric let my lungs breathe deep")
• Street Scene an opera by Kurt Weill: In Act One, Scene One, the characters talk about giving it to a teething baby.
• You Look Nice Today Podcast: In the episode "That's Babies (Keep it Paregoric)"

References