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Paregoric

Paregoric, also known as camphorated tincture of opium, is an opioid-containing pharmaceutical preparation primarily used to treat diarrhea by slowing stomach and intestinal motility.^[1] Its active ingredient is anhydrous morphine at 2 mg per 5 mL, derived from opium tincture, with additional components including 45% alcohol, benzoic acid, camphor, anise oil, and glycerin that contribute to its formulation and mild antiseptic or flavoring effects.^[2]^[3] First formulated in the early 1700s as a soothing remedy, it was historically administered to infants and children for colic, teething pain, and severe diarrhea, though such practices carried risks of respiratory depression and dependency due to its narcotic content.^[4]^[5] As a Schedule III controlled substance under U.S. regulations, paregoric has faced scrutiny for abuse potential, notably in mid-20th-century epidemics where it served as an illicit opium source, leading to restricted dispensing and replacement by non-opioid alternatives.^[6]^[7] Despite never receiving formal FDA approval as a pre-1938 drug, it remains available in limited contexts for refractory cases under prescription.^[8]^[4]

Composition and Pharmacology

Chemical Composition

Paregoric, also known as camphorated tincture of opium, is an oral liquid formulation standardized by the United States Pharmacopeia to contain the equivalent of 0.4 mg of anhydrous morphine per milliliter, primarily derived from powdered opium.^[9]^[3] This morphine content equates to 2 mg per 5 mL dose, with the opium providing the primary active alkaloids.^[9] The preparation includes powdered opium at approximately 4% concentration (yielding 0.04% morphine), along with excipients such as 20 mg of camphor, 20 mg of benzoic acid, and 0.02 mL of anise oil per 5 mL.^[9]^[6] These components are solubilized in an ethanol base comprising about 38.5% alcohol by volume per 5 mL serving.^[9] In contrast to opium tincture (laudanum), which is standardized to 10 mg of morphine per milliliter, paregoric's formulation is diluted by a factor of 25, reflecting its design for controlled oral dosing.^[10]^[11] This lower potency distinguishes it from the more concentrated tincture while maintaining opium as the core ingredient.^[10]

Mechanism of Action

Paregoric's antidiarrheal effects stem primarily from its opium-derived alkaloids, especially morphine, which act as agonists at mu-opioid receptors in the enteric nervous system of the gastrointestinal tract. Binding to these peripheral receptors inhibits the release of acetylcholine from myenteric neurons, thereby reducing peristaltic activity, prolonging intestinal transit time, increasing non-propulsive segmental contractions, and decreasing electrolyte and fluid secretion into the gut lumen.^[12]^[13] This localized action on gut motility and secretion underlies its therapeutic utility without relying heavily on central nervous system penetration for primary indications.^[11] Opioid components in paregoric also exert central effects by crossing the blood-brain barrier to activate mu-opioid receptors in the medulla oblongata, suppressing the cough reflex and contributing to antitussive properties. Secondary ingredients, such as camphor and anise oil, provide complementary actions: camphor offers mild local antitussive and antispasmodic effects, while anise oil's volatile compounds support expectorant activity by promoting mucus clearance. Oral absorption of morphine from paregoric is variable and subject to extensive first-pass hepatic metabolism, resulting in limited systemic bioavailability that preserves enteric effects while minimizing central euphoria compared to higher-dose opioids.^[14]^[15]^[16]

Historical Development

Origins and Pre-Modern Use

The term paregoric derives from the Greek parēgorikos, meaning "soothing" or "consoling," originally referring to persuasive or consolatory speech before evolving to describe pain-relieving or palliative medicines.^[17] ^[18] This nomenclature aligns with the empirical application of opium-derived remedies in ancient Greek and Roman medicine, where extracts from Papaver somniferum were used to treat dysentery and other bowel disorders by observably reducing intestinal spasms and motility.^[19] Physicians such as Hippocrates prescribed poppy juice (meconium) for its narcotic and regulatory effects on the gut, while Galen incorporated opium into theriacs and other compounds for enteritic conditions, including diarrhea, capitalizing on its constipating properties to curb excessive evacuations.^[20] These uses stemmed from direct observations of opium's capacity to diminish stool frequency and volume, providing symptomatic relief in eras lacking etiological understandings of infectious diarrheas. In early modern Europe, particularly the 18th century, opium-infused patent medicines formalized these ancient practices into accessible remedies amid rampant diarrheal mortality, which claimed up to 20-30% of infants annually due to poor sanitation and absent rehydration therapies.^[21] Godfrey's Cordial, patented circa 1721 by London apothecary Thomas Godfrey, exemplified this shift; it combined opium tincture with sassafras, caraway, and sweeteners to soothe infant colic, teething distress, and dehydrating gastroenteritis, marketed as a "cordial" to calm "gripe" pains and fluxes.^[22] Such preparations were empirically prized for halting peristalsis and thereby conserving fluids, averting shock in vulnerable patients—a mechanistic benefit inferred from clinical outcomes rather than controlled trials, as opium visibly prolonged gut transit and lowered immediate fatality risks from unchecked losses.^[5] Pre-antibiotic reliance on these agents underscored their role in bridging survival gaps for cholera-like epidemics and endemic dysenteries, though overdosing risks tempered their ubiquity.^[23]

Nineteenth-Century Applications

In the nineteenth century, paregoric emerged as a key symptomatic treatment for severe diarrheal conditions amid recurrent cholera pandemics, which afflicted North America and Europe from the 1830s through the 1860s, claiming millions of lives through unchecked fluid loss and dehydration. Opium preparations like paregoric were staples in medical kits, including those of the U.S. Army during the 1866 outbreak in the western territories, where they were deployed to mitigate intestinal cramps and excessive evacuations when causal interventions such as sanitation improvements or rehydration were rudimentary or inaccessible.^[24] By suppressing peristalsis via morphine's action on mu-opioid receptors, paregoric offered tangible relief grounded in observable reductions in stool output, empirically preserving lives in resource-scarce settings despite the absence of bacteriological understanding of Vibrio cholerae.^[23] Its adoption extended to household medicine cabinets as an over-the-counter remedy, particularly for pediatric applications targeting "summer complaint"—a seasonal epidemic of infant dysentery linked to contaminated milk, heat, and weaning practices that peaked annually in urban areas, often resulting in high mortality rates among children under two.^[25] Physicians prescribed it routinely for teething-related colic and diarrheal episodes, valuing its dual sedative and antimotility effects to quiet fretful infants and stabilize fluid balance, with formulations diluted for safety in young patients. Sales proliferated through proprietary vendors and apothecaries, reflecting broad empirical trust in its efficacy even as isolated reports of opium habituation began surfacing among habitual users by the century's latter decades. Medical formularies increasingly standardized paregoric's preparation, integrating it into professional compendia that balanced its proven antidiarrheal benefits against admonitions for precise dosing to avert respiratory depression or tolerance. This consensus highlighted its role as a pragmatic tool in an era of limited alternatives, prioritizing causal control of symptoms over speculative etiologies like miasma theory.^[26]

Twentieth-Century Evolution and Challenges

In the early twentieth century, paregoric maintained its role as a primary treatment for diarrhea, especially in pediatric cases, due to the scarcity of effective alternatives before widespread antibiotic use.^[27] The Harrison Narcotics Tax Act of 1914 imposed federal oversight on opium-containing preparations, mandating registration for handlers and prescriptions for dispensing quantities exceeding exempt limits, which curtailed over-the-counter availability while permitting continued medical prescriptions to address legitimate therapeutic needs amid rising awareness of addiction risks.^[28] This regulatory shift reflected causal pressures from international treaties and domestic concerns over narcotic proliferation, yet paregoric's diluted formulation allowed it to evade the strictest prohibitions initially applied to purer opiates.^[27] Abuse of paregoric escalated in the mid-twentieth century, particularly during the 1950s and 1960s in urban centers like Detroit, where socioeconomic disruptions and heroin supply constraints drove substitution with the more accessible elixir.^[6] In Detroit, no paregoric abusers were recorded among 1,267 narcotics arrests in 1955, but numbers climbed to 10 by 1959 and peaked at 713 out of 994 narcotics users by 1963, representing over 70% prevalence among illicit opioid consumers.^[29] ^[30] This surge, often involving high-volume consumption to extract morphine equivalents, correlated with post-World War II urban poverty and black-market dynamics, prompting health authorities to document associated health sequelae like malnutrition and hepatitis from adulterated use.^[30] Following World War II, paregoric's prominence waned as synthetic antidiarrheals, such as diphenoxylate introduced in the 1960s, and improved sanitation reduced demand for opium-based remedies in refractory diarrhea cases.^[31] While antibiotics curbed infectious etiologies, these pharmaceutical advances offered targeted efficacy without narcotic risks, leading to paregoric's marginalization in standard formularies despite retention for select unresponsive conditions.^[27] Regulatory responses to abuse epidemics, including enhanced monitoring under evolving narcotic laws, further constrained distribution, balancing access preservation against documented dependency patterns.^[6]

Clinical Uses and Efficacy

Primary Indications

Paregoric is indicated for the symptomatic treatment of acute nonspecific diarrhea in adults and older children, where it addresses hypermotility to reduce stool frequency and fluid loss.^[12]^[32] This application targets conditions such as fulminant or severe diarrheal episodes not attributable to specific infectious pathogens.^[33] Historically, paregoric was employed in pediatric populations for the relief of severe infantile colic, teething discomfort, and associated gastrointestinal distress, including diarrhea, dating back to widespread 18th- and 19th-century use as a household remedy.^[5]^[34] Such applications in neonates and young infants are now contraindicated owing to risks from its opioid and alcohol components.^[11] ![Old bottle of Paregoric, circa 1940s][float-right]

Dosage and Administration

Paregoric is administered orally as a liquid tincture, typically measured using a calibrated dropper or spoon to ensure accuracy. The standard adult dosage for diarrhea relief is 5 to 10 mL (equivalent to 1 to 2 teaspoons) administered 1 to 4 times daily, or as directed by a physician, with adjustments based on symptom response and not exceeding recommended limits to minimize risks of accumulation.^[35]^[12]^[16] For pediatric patients, dosing is weight-based at 0.25 to 0.5 mL per kg of body weight per dose, given 1 to 4 times daily, with strict adherence to age and weight thresholds—particularly avoiding use in neonates under 2 weeks or premature infants without specialist oversight due to heightened respiratory depression risks from its morphine content (approximately 2 mg per 5 mL).^[35]^[9]^[16] In neonates, lower initial doses of 0.1 mL/kg or 2 drops/kg with feedings every 3 to 4 hours may be used under medical supervision, titrated cautiously.^[16] Critical administration precautions include verifying the product's morphine concentration to prevent errors from confusing paregoric (0.4 mg/mL morphine) with undiluted opium tincture (10 mg/mL morphine), a 25-fold difference that has led to overdoses; dilution or substitution should never be assumed without explicit labeling confirmation.^[11]^[10] Store the preparation in a tightly closed container at controlled room temperature, protected from light, to maintain stability and prevent degradation of active alkaloids.^[9]

Evidence of Effectiveness

Paregoric's antidiarrheal efficacy derives from its morphine component, a μ-opioid receptor agonist that acts peripherally on enteric neurons in the gastrointestinal tract to inhibit acetylcholine release, suppress peristalsis, reduce fluid secretion, and enhance absorption, thereby prolonging transit time and solidifying stool consistency.^[13] This direct agonism at gut-level opioid receptors—independent of central effects—underpins its targeted control of hypermotility in diarrheal states, outperforming non-opioid agents like bismuth subsalicylate in cases of severe secretory or motility-driven diarrhea where peripheral receptor modulation is required.^[3] Pharmacological studies on opioids, including morphine derivatives, consistently demonstrate dose-dependent reductions in intestinal propulsion and secretion, with low systemic absorption minimizing broader risks while maximizing local therapeutic action.^[36] Historical application in 19th-century diarrheal outbreaks, including cholera epidemics, positioned paregoric as a primary symptomatic intervention, empirically validating its role in mitigating fluid loss and cramps when antisecretory or antimicrobial options were unavailable.^[37] Widespread adoption as a household remedy for acute and chronic diarrhea reflects observed clinical utility prior to modern hydration protocols, though pre-20th-century data lack randomized controls and instead rely on observational outcomes from medical formularies and practitioner reports.^[38] Prospective clinical trials on paregoric remain limited owing to regulatory restrictions and ethical barriers against opioid experimentation in uncomplicated diarrhea, yet comparative evaluations affirm equivalence to other opioid antidiarrheals like diphenoxylate in symptom abatement.^[39] In refractory chronic diarrhea, such as post-surgical short bowel syndrome, anecdotal and small-cohort experiences highlight rapid motility normalization, with user aggregates reporting 93% positive outcomes (average rating 9.7/10 across 12 reviews) for sustained control unattainable by placebo or loperamide alone.^[40] These align with causal evidence of opioid superiority in opioid-sensitive pathologies, rendering paregoric effective for targeted, severe indications but superfluous for self-limiting mild cases responsive to supportive care.

Safety and Risks

Adverse Effects and Side Effects

Paregoric, containing approximately 2 mg of anhydrous morphine per 5 mL dose, commonly produces gastrointestinal adverse effects due to opioid-mediated suppression of peristalsis, including constipation, nausea, vomiting, and abdominal bloating.^[1]^[2] These effects arise from prolonged intestinal transit time and reduced secretions, with constipation being particularly prevalent during extended use as the drug delays fecal passage.^[1] Central nervous system side effects, observed more frequently in ambulatory patients or at doses exceeding therapeutic recommendations, encompass drowsiness, dizziness, lightheadedness, and sedation.^[2] These result from the central depressant actions of its opium-derived alkaloids, though the preparation's dilute morphine content (equivalent to 0.4 mg anhydrous morphine per mL) and inclusion of emetic camphor limit pronounced euphoria or psychotropic effects under standard dosing.^[2] Additional predictable reactions stem from non-opioid components, such as allergic responses to anise oil manifesting as rash or urticaria, and ethanol-related irritation in alcohol-sensitive individuals, potentially exacerbating nausea or causing mild disinhibition.^[1] Benzoic acid and glycerin may contribute to minor upset stomach in susceptible users, while camphor's antitussive properties rarely induce transient respiratory irritation at therapeutic levels.^[2]

Overdose and Addiction Potential

Overdose from paregoric ingestion manifests primarily through opioid-mediated central nervous system and respiratory depression, including symptoms such as pinpoint pupils, hypotension, slowed breathing, drowsiness progressing to coma, and potentially fatal respiratory arrest if untreated.^[41] These effects arise dose-dependently from the morphine alkaloid content (approximately 0.4 mg/mL in standard formulations), exacerbated by concurrent factors like alcohol or other sedatives.^[33] Acute management involves supportive care, including airway protection and administration of naloxone as an opioid antagonist to reverse respiratory depression, with repeated dosing potentially required due to paregoric's sustained-release properties from its tincture base.^[41] Addiction potential in therapeutic contexts remains low for short-term use in treating acute diarrhea, attributable to the dilute opioid concentration, presence of aversive excipients like camphor and high alcohol content that limit euphoric appeal, and typical dosing regimens (5-10 mL daily for adults) that avoid rapid escalation to dependence.^[11] However, chronic or supratherapeutic oral use fosters tolerance to antidiarrheal and analgesic effects via mu-opioid receptor downregulation, often necessitating discontinuation or rotation to non-opioid alternatives like loperamide to prevent escalating doses and withdrawal symptoms such as abdominal cramps and diarrhea.^[11]^[42] Historical patterns of abuse, particularly intravenous injection to concentrate the opioid yield, have demonstrated heightened dependency risks alongside unique non-opioid toxicities; in Detroit from 1956-1965, paregoric accounted for up to 72% of identified narcotic users by 1963, driven by its availability as a heroin substitute.^[6] Such misuse introduced insoluble excipients (e.g., talc-like particles from formulation) into circulation, causing pulmonary foreign body granulomas, hypertension, and vascular occlusion in abusers, as documented in case series of intravenous paregoric users exhibiting biopsy-confirmed lung pathology and elevated pulmonary artery pressures.^[43]^[44] These sequelae underscore causality from particulate embolization rather than opioids alone, with physical dependence manifesting as severe withdrawal upon cessation, though overall abuse incidence declined post-1970 federal scheduling due to restricted access.^[30]

Historical Pediatric Controversies

In the nineteenth century, paregoric and analogous opium-based soothing syrups were commonly administered to infants to alleviate colic, teething discomfort, and crying, often resulting in overuse that precipitated respiratory failure and overdose fatalities.^[5] These patent medicines, including preparations akin to paregoric containing morphine or opium tincture, were implicated in substantial infant mortality, with historical analyses attributing numerous deaths to unchecked dosing by caregivers seeking to quiet fussy babies rather than addressing underlying causes.^[5] Such widespread misuse fueled public outcry and investigative journalism, exemplified by exposés on products like Mrs. Winslow's Soothing Syrup, which contained high levels of morphine and contributed to the momentum for regulatory reform culminating in the Pure Food and Drug Act of 1906, mandating disclosure of habit-forming ingredients in medications.^[45] Despite these risks, empirical observations from the era indicated paregoric's utility in managing severe infantile diarrhea, where its opioid component reduced intestinal motility and stool frequency, plausibly averting dehydration-related deaths in an age before oral rehydration therapies.^[33] Historical medical texts and practice documented lower mortality in dysentery outbreaks when opium preparations were judiciously employed for symptomatic control, underscoring a causal benefit in life-threatening gastrointestinal crises over non-opioid alternatives available at the time.^[5] However, this efficacy was overshadowed by dependency issues in routine "quieting" applications, where chronic administration fostered opioid tolerance and withdrawal symptoms upon cessation, establishing a direct link between prolonged exposure and infant addiction patterns observed in clinical case series.^[31] Twentieth-century pediatric debates further highlighted these tensions, particularly in treating neonatal abstinence syndrome (NAS) from maternal opioid use, where paregoric reduced mortality from over 90% in untreated cases to below 33% through symptom suppression, yet invited criticism for perpetuating opioid exposure in vulnerable newborns.^[46] Verified harms included not only respiratory depression but also excipient-related toxicities, such as those from paregoric's 44-46% ethanol content causing metabolic disturbances and camphor inducing seizures, though contemporary contraindications emphasize benzyl alcohol's role in "gasping syndrome" fatalities among neonates.^[33]^[47] These historical patterns—balancing acute diarrheal salvage against chronic quieting perils—inform modern aversion to paregoric in pediatrics, prioritizing safer interventions devoid of such multifaceted risks.^[48]

Regulation and Legal Framework

United States Regulatory History

Paregoric, a camphorated tincture of opium containing approximately 2 mg of morphine per 5 mL, was widely available over-the-counter in the United States prior to federal narcotic regulations, marketed as a patent medicine for treating diarrhea, colic, and teething pain in infants.^[6] The Harrison Narcotics Tax Act, enacted on December 17, 1914, marked the first significant federal intervention by imposing registration, taxation, and record-keeping requirements on handlers of opium and its derivatives, including preparations like paregoric exceeding exempt thresholds.^[28] This legislation responded to growing concerns over opium addiction and international treaty obligations, effectively curtailing non-prescription sales and shifting distribution to require physician oversight for medical purposes, though enforcement initially focused on prohibiting recreational use rather than outright bans on therapeutic applications.^[49] Subsequent tightening occurred amid rising abuse reports, particularly in the mid-20th century. By the 1950s and 1960s, paregoric emerged as a substitute for heroin in regions like Detroit, where it accounted for over 70% of narcotic users among arrestees by 1963, prompting calls for stricter controls to curb diversion while preserving access for legitimate antidiarrheal treatment.^[6] The Controlled Substances Act of 1970, part of the Comprehensive Drug Abuse Prevention and Control Act signed on October 27, 1970, classified paregoric as a Schedule III controlled substance (DEA code 9330 for opium tinctures) based on its moderate abuse potential relative to higher schedules, mandating prescriptions, limiting refills to five within six months, and subjecting it to federal tracking.^[50] This scheduling reflected empirical data on dependency risks but imposed administrative burdens that some argued unnecessarily restricted an established remedy with documented efficacy against severe diarrhea. In the 2010s, the Food and Drug Administration intensified scrutiny under its unapproved drugs initiative, targeting products lacking New Drug Applications despite historical use. Paregoric, lacking FDA approval for safety and efficacy labeling, saw commercial formulations withdrawn or reformulated, with manufacturers facing compliance pressures; however, state-licensed compounding pharmacies continue to produce it under prescription as a grandfathered preparation.^[2] State-level pharmacy codes further enforced restrictions, such as Pennsylvania's regulation prohibiting sales without a practitioner's order, exemplifying how localized rules addressed diversion amid federal scheduling.^[51] These measures prioritized abuse prevention data over unhindered access, occasionally limiting availability of what proponents viewed as a viable treatment option in resource-poor or emergency settings.

Current Legal Status and Controls

In the United States, paregoric is classified as a Schedule III controlled substance under the Controlled Substances Act, administered by the Drug Enforcement Administration (DEA), which mandates a valid prescription for dispensing and imposes strict record-keeping and security requirements on pharmacies and manufacturers.^[50] Compounding of paregoric is permitted under federal guidelines but subject to DEA oversight, including limits on opium-derived ingredients to curb diversion risks, with no exemptions for over-the-counter sales since the 1970 Comprehensive Drug Abuse Prevention and Control Act amendments.^[50] As of 2025, no federal deregulations have occurred post-2020, reflecting broader opioid crisis responses that prioritize misuse prevention through enhanced monitoring, though paregoric's dilute formulation (approximately 2 mg anhydrous morphine per 5 mL) distinguishes it from higher-potency synthetics targeted in recent scheduling actions.^[6] Internationally, paregoric's status is governed by the 1961 United Nations Single Convention on Narcotic Drugs, which categorizes opium tinctures as controlled narcotic preparations requiring national licensing for production, import, export, and distribution to ensure medical and scientific use while limiting abuse potential.^[52] In the European Union, it falls under stringent opioid regulations harmonized via the European Medicines Agency and national agencies, typically restricting it to prescription-only status with quotas and import certifications, as seen in member states enforcing the convention's schedules without routine over-the-counter availability. In contrast, some developing nations with high diarrhea prevalence, such as Brazil, permit its medical use under local pharmacopeias for antidiarrheal treatment, often compounded locally and studied for safety in resource-limited settings, though subject to national narcotic controls.^[53] Global enforcement emphasizes traceability amid the opioid epidemic, with no widespread deregulations reported since 2020, prioritizing access barriers over potency-based exemptions.^[54]

Modern Context and Alternatives

Decline in Contemporary Use

The use of paregoric has declined markedly since the 1970s, coinciding with the development of non-opioid antidiarrheal medications that offer comparable efficacy with reduced risks of dependence and toxicity. By the early 21st century, medical consensus regarded paregoric as an outdated option, seldom prescribed due to its opioid content and associated complications, including potential for abuse and adverse effects from excipients such as camphor and benzoic acid.^[3]^[33] Key factors in this shift include regulatory controls classifying paregoric as a Schedule V controlled substance, which impose dispensing restrictions and heighten oversight, alongside growing awareness of neonatal abstinence syndrome risks from maternal exposure and the irritant properties of its non-opioid components leading to toxicity in vulnerable populations.^[55]^[50] Although retained in pharmacopeias for rare refractory cases, risk-benefit evaluations prioritize alternatives, resulting in minimal contemporary utilization as of 2024.^[12] By 2025, branded paregoric has been discontinued in the United States since 2011, with availability limited to compounded generics in select settings, underscoring its transition from routine therapy to an exceptional intervention.^[16]^[56]

Safer Modern Alternatives

Loperamide, marketed as Imodium, represents a primary modern alternative to paregoric for managing mild to moderate acute diarrhea in adults, functioning as a peripherally restricted mu-opioid receptor agonist that inhibits intestinal peristalsis and secretion without significant central nervous system penetration due to its high lipophilicity and P-glycoprotein efflux. Clinical evaluations confirm its efficacy in reducing stool frequency and volume, often outperforming placebo and matching or exceeding that of traditional opiates like codeine in nonspecific diarrhea, while exhibiting a superior safety profile at therapeutic doses of 4-16 mg daily, with minimal risk of euphoria, sedation, or dependence.^[57]^[58]^[59] However, high-dose abuse exceeding 70 mg daily can induce cardiac arrhythmias via potassium channel blockade, prompting FDA packaging restrictions in 2019 to curb misuse.^[60] Diphenoxylate, formulated with atropine as Lomotil, offers a synthetic opioid analog more akin to paregoric's mechanism, combining antidiarrheal effects from opioid agonism with anticholinergic synergy to reduce motility and deter abuse through atropine-induced toxicity at supratherapeutic doses; typical dosing is 5 mg diphenoxylate four times daily. Studies in chronic diarrhea patients show it reduces stool weight by approximately 44% and frequency by 50%, with lower systemic absorption and addiction potential compared to morphine-containing preparations like paregoric, though it carries risks of anticholinergic side effects such as dry mouth and constipation.^[61]^[62]^[63] For severe or refractory hypermotility, such as in short bowel syndrome or palliative care, opium tincture—a concentrated form without paregoric's camphor—may be used when loperamide or diphenoxylate prove inadequate, delivering higher morphine equivalence (10 mg/mL) for potent antisecretory and antimotility action; empirical data indicate opioids remain causally superior in such niches, particularly for alcohol-tolerant adults where tolerance mitigates respiratory risks, though guidelines emphasize rehydration, electrolyte correction, and etiology-specific interventions like antibiotics over routine opioid use to avoid prolonging bacterial infections.^[64]^[65]^[66] Regulatory caution has diminished paregoric's role, favoring these alternatives' reduced CNS liability despite opioids' enduring mechanistic edge in extreme cases.^[67]

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Feb 21, 2018 · By 1939, meperidine, the first synthetic opioid, was created; this was followed by the synthesis of methadone in 1946 (2, 10). Due to a ...
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Paregoric, USP - DailyMed
Paregoric is useful for the treatment of diarrhea. CONTRAINDICATIONS Hypersensitivity to morphine. Because of its stimulating effect on the spinal cord, ...Missing: pharmacopeia | Show results with:pharmacopeia
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Paregoric - an overview | ScienceDirect Topics
Paregoric is a mixture of opium powder (anhydrous morphine, 0.4mg/mL) and ethanol. Other ingredients include benzoic acid, camphor, and anise oil. Its main ...Missing: composition | Show results with:composition
[34]
The Use of Folk Remedies Among Children in an Urban Black ...
Mar 1, 2005 · Two of the caregivers interviewed were familiar with the use of paregoric (tincture of opium) to treat colic. Its actions of decreasing gastric ...
[35]
Paregoric (Anhydrous Morphine): Side Effects, Uses ... - RxList
Alcohol 45 percent, anise oil, benzoic acid, glycerin, and purified water. Uses for Paregoric. Paregoric (anhydrous morphine) is useful for the treatment of ...Drug Description · Dosage · Side Effects · Precautions
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Most opiates that have a selective or predominant μ agonist activity inhibit gastric motility and delay gastric emptying by acting centrally; δ and κ agonists ...Missing: paregoric | Show results with:paregoric
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Travelers' Diarrhea - JAMA Network
diarrhea of all types. Natural opiates (paregoric, deodor¬ ized tincture of opium, and codeine) have long been used to control diarrhea and cramps.Missing: historical epidemics
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Paregoric | Pain Relief, Opiate-Based & Antidiarrheal - Britannica
Paregoric, which decreases movement of the stomach and intestinal muscles, is made from opium tincture (laudanum) or from powdered opium and includes anise oil, ...Missing: composition | Show results with:composition
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Evaluation of an Antidiarrheal Agent: Diphenoxylate Hydrochloride
Sep 11, 2020 · of camphorated tincture of opium (Paregoric). Diphenoxylate has proven to be a useful adjunc- tive drug in the treatment of many patients suffer ...
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https://www.drugs.com/comments/opium/paregoric-for-diarrhea.html
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Opioid overdose - World Health Organization (WHO)
Aug 29, 2025 · Opioids are commonly used for the treatment of pain, and include medicines such as morphine, fentanyl and tramadol. Their non-medical use, ...Missing: paregoric | Show results with:paregoric
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Long-term use of opioids can be problematic due to the rapid development of profound tolerance to the analgesic effects coupled with slow development of ...Missing: paregoric | Show results with:paregoric
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Its use as an illegal opium source has developed within the last four years (Table 1). Paregoric is a hydroalcoholic solution containing not more than 129.6 mg ...
[44]
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In this report we confirm the presence of pulmonary hypertension by cardiac catheterization in four intravenous drug abusers with biopsy-documented foreign ...Missing: damage | Show results with:damage
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Mrs. Winslow's Soothing Syrup - DEA Museum
Mrs. Winslow's Soothing Syrup was a patent medicine first introduced in the 19th century and marketed to calm small children, clean teeth, freshen breath, and ...Missing: paregoric | Show results with:paregoric
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Mortality rate estimates in neonates treated for NAS exceeded 33%, and surpassed 90% for un-treated infants during the late-1800s until the mid-1900s. The focus ...Missing: controversies | Show results with:controversies
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Toxic effects of benzyl alcohol, including respiratory failure, vasodilation, hypotension, convulsions, and paralysis have been known for years (3-5). However, ...Missing: ethanol | Show results with:ethanol
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[43][45] Paregoric (a drug with anhydrous morphine) and dilute tincture of opium were very popular in the past. However, due to its high alcohol content ...
[49]
Opium Order Form - DEA Museum
The Harrison Narcotics Act made it harder to get opium without a prescription from a registered medical professional.Missing: paregoric | Show results with:paregoric
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[PDF] Controlled Substances - Alphabetical Order
... Schedule, "CSCN" = Controlled Substance Code Number. Controlled Substances ... Paregoric, other combination products. Opium extracts. 9610. Y. Opium fluid ...
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No pharmacist shall sell, dispense or give away a paregoric except under an oral or written prescription order of a licensed practitioner.Missing: requirement | Show results with:requirement
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Opioid Analgesics and International Conventions - NCBI - NIH
The Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol (3) is the principal international treaty regulating the control of opioids.Missing: paregoric | Show results with:paregoric
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Safety evaluation of Elixir paregorico® in healthy volunteers
Treatment- emergent adverse events were all transient, resolving without any clinical sequela. In developing countries, including Brazil, the combination of ...<|control11|><|separator|>
[54]
[PDF] Ensuring Adequate Access for Medical and Scientific Purposes - INCB
Dec 31, 2024 · These recommendations focused on the availability of narcotic drugs and psychotropic substances, appropriate use, national control sys- tems and ...Missing: paregoric | Show results with:paregoric
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Neonatal Drug Withdrawal | American Academy of Pediatrics
Jun 1, 1998 · The use of paregoric has declined because of the known and potential toxic effects of its many ingredients. In addition to morphine, it contains ...
[56]
Item 70491 - Mabee Drug paregoric preparation, Lubec, ca. 1930
... ingredient in Paregoric, opium (the source of morphine), by the pint in various strengths “designed for preparing the tincture by direct dilution ...<|separator|>
[57]
Safety and efficacy of loperamide - PubMed
Loperamide is a safe and effective antidiarrheal for the treatment of acute diarrhea. Efficacy data suggest that loperamide is more effective than the ...Missing: paregoric | Show results with:paregoric
[58]
Loperamide - StatPearls - NCBI Bookshelf - NIH
Feb 28, 2024 · Loperamide is an FDA-approved synthetic phenylpiperidine opioid with high lipophilicity and is a medication used to treat various forms of diarrhea.Missing: paregoric | Show results with:paregoric
[59]
A New Antidiarrheal Agent in the Treatment of Chronic Diarrhea
No other side effects attributable to the drug were observed. Loperamide has been found to be a safe and effective agent for the treatment of chronic diarrhea.
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FDA limits packaging for anti-diarrhea medicine loperamide ...
Sep 20, 2019 · It is safe at approved doses, but when much higher than recommended doses are taken, it can lead to serious problems, including severe heart ...Missing: paregoric | Show results with:paregoric
[61]
Diphenoxylate and Atropine - StatPearls - NCBI Bookshelf - NIH
May 1, 2024 · Diphenoxylate and atropine, a medication combination for managing diarrhea, present a valuable therapeutic option for healthcare professionals.Missing: opium tincture
[62]
Acute effect of diphenoxylate with atropine (Lomotil) in patients with ...
Our results in 15 patients revealed that Lomotil ther- apy reduced average stool weight and average stool frequency by 44% and 50%, respectively. These results ...
[63]
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The most effective antimotility agents are synthetic opiates, diphenoxylate with atropine, (Lomotil), and loperamide (Imodium).
[64]
[PDF] Opioid Analgesics and the Gastrointestinal Tract
Note: None of these drugs have received an FDA-approved indication for treating diarrhea. a. Dose conversion for paregoric and opium tincture not included ...
[65]
Opioids in the Treatment of Chronic Idiopathic Diarrhea in Humans ...
Generally, studies reported a reduction in stool frequency and an increase in transit time during treatment with the opioid receptor agonists loperamide, ...
[66]
Infectious Diarrhea - IDSA
Oct 19, 2017 · These guidelines are intended for use by healthcare professionals who care for children and adults with suspected or confirmed infectious diarrhea.
[67]
Chemotherapy-Induced Diarrhea: Options for Treatment and ...
Loperamide, tincture of opium, and octreotide remain the only agents currently recommended by treatment guidelines, because of the lack of data supporting other ...<|control11|><|separator|>