プソイドエフェドリン

Pharmaceuticals -> Synthetic Cannabinoids or Psychoactive Compounds

Pharmaceuticals -> Used in Switzerland

Pharmaceuticals -> Listed in ZINC15

log Kow = 0.89

0.89

1.14

Sparingly sol in water; freely sol in alc or ether

VERY SOL IN BENZENE

Breast Feeding; Lactation; Milk, Human; Adrenergic Agents; Adrenergic Alpha-Agonists; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents

Pharmaceuticals

118-118.7 °C

FINE, WHITE TO OFF-WHITE CRYSTALS OR POWDER; FAINT CHARACTERISTIC ODOR; MP: 182-185 °C; SOLN ARE NEUTRAL TO LITMUS /HCL/

119 °C

10.3 (at 0 °C)

pKa = 10.25 (conjugate acid)

Warning

H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]

P261, P264, P264+P265, P270, P271, P272, P280, P301+P317, P302+P352, P304+P340, P305+P351+P338, P317, P319, P321, P330, P332+P317, P333+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 156 reports by companies from 7 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

List I Chemical: A chemical specified by regulation that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance. (21 eCFR 1310.02)

Status: Active Update: 09-07-2013 https://echa.europa.eu/registration-dossier/-/registered-dossier/10032

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription and over-the-counter drug products, incl pseudoephedrine sulfate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Pseudoephedrine Sulfate/

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription and over-the-counter drug products, incl pseudoephedrine hydrochloride, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Pseudoephedrine Hydrochloride/

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies discontinued drug products. Pseudoephedrine polistirex is included on this list.. /Pseudoephedrine Polistirex /

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: pseudoephedrine hydrochloride and pseudoephedrine sulfate are included in bronchodilator drug products. /Pseudoephedrine Hydrochloride, Pseudoephedrine Sulfate/

The Combat Methamphetamine Epidemic Act of 2005 has been incorporated into the Patriot Act signed by President Bush on March 9, 2006. The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine. The sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine. In addition, stores are required to keep personal information about purchasers for at least two years.

Bradley JG; Postgrad Med 89 (6): 195-7 (1991). Nonprescription drugs and hypertension. Which ones affect blood pressure?

Anastasio GD, Harston PR; J Am Board Family Pract 5 (5): 527-8 (1992). Fetal tachycardia associated with maternal use of pseudoephedrine, an over the counter oral decongestant.

Hanzlick R; Toxicology 107 (2): 153-8 (1996). National Association of Medical Examiner's Pediatric Toxicology (PedTox) Registry.

Gilstrap LC, Little BB; Drugs & Pregnancy 269-75 (1992). Antihistamines, decongestants, and expectorants during pregnancy.

Pseudoephedrine hydrochloride preparation should generally be stored at 15-30 °C; freezing of the oral solution should be avoided. Pseudoephedrine hydrochloride tablets and extended release capsules should be stored in tight containers and oral solution in tight, light-resistant containers. Pseudoephedrine sulfate extended release tablets should be protected from light and stored in well-closed containers at 2-30 °C.

SRP: At the time of review, criteria for land treatment or burial (sanitary landfill) disposal practices are subject to significant revision. Prior to implementing land disposal of waste residue (including waste sludge), consult with environmental regulatory agencies for guidance on acceptable disposal practices.

Administration of pseudoephedrine prior to or shortly after anesthesia with chloroform, cyclopropane, halothane, or trichloroethylene may increase the risk of severe ventricular arrhythmias, especially in patients with pre-existing heart disease, because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetics.

Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetics; caution is recommended in patients taking pseudoephedrine.

Antihypertensive effects may be reduced when these medications /antihypertensives or diuretics used as antihypertensives/ are used concurrently with pseudoephedrine; the patient should be carefully monitored to confirm that the desired effects is being obtained.

Concurrent use /of beta-adrenergic blocking agents/ with pseudoephedrine may inhibit the therapeutic effect of these medications; beta-blockade may result in unopposed alpha-adrenergic activity of pseudoephedrine with a risk of hypertension and excessive bradycardia and possible heart block.

For more Interactions (Complete) data for PSEUDOEPHEDRINE (17 total), please visit the HSDB record page.

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 73(SRC), determined from a log Kow of 0.89(2) and a regression-derived equation(3), indicates that pseudoephedrine is expected to have high mobility in soil(SRC). However, the pKa of pseudoephedrine is 10.25(4), indicating that this compound will primarily exist in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Pseudoephedrine is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 8.3X10-4 mm Hg(SRC), determined from a fragment constant method(5). Biodegradation data were not available(SRC, 2007).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 73(SRC), determined from a log Kow of 0.89(2) and a regression-derived equation(3), indicates that pseudoephedrine is not expected to adsorb to suspended solids and sediment(SRC). A pKa of 10.25(4) indicates pseudoephedrine will exist almost entirely in the cation form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an important fate process(5). According to a classification scheme(6), an estimated BCF of 3(SRC), from its log Kow(2) and a regression-derived equation(7), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Biodegradation data were not available(SRC, 2007).

ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), pseudoephedrine, which has an estimated vapor pressure of 8.3X10-4 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), will exist in both the vapor and particulate phases in the ambient atmosphere. Vapor-phase pseudoephedrine is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals(SRC); the half-life for this reaction in air is estimated to be 4 hours(SRC), calculated from its rate constant of 9.9X10-11 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(3). Pseudoephedrine does not contains chromophores that absorb at wavelengths >290 nm and therefore is not expected to be susceptible to direct photolysis by sunlight(4).

EXPERIMENTAL: Drug Concentrated in Human Milk. /from Table 6/

EXPERIMENTAL: Plasma and milk concentrations of pseudoephedrine and triprolidine were determined (by radioimmunoassay) in three lactating mothers over 12-48 hr after ingestion of a combination medication containing 60 mg of pseudoephedrine hydrochloride and 2.5 mg of triprolidine hydrochloride monohydrate. Pseudoephedrine concentrations in milk were consistently higher than those in plasma. The total amount of drug in milk, as judged by areas under the respective curves (AUC), was two to three times greater than in plasma. Triprolidine concentrations in milk and plasma were more variable between subjects than those of pseudoephedrine. AUC values for milk and plasma were similar for one subject, while the plasma value exceeded that for milk in another woman. The fraction of the dose excreted in milk was estimated to be 0.4-0.7% for pseudoephedrine and 0.06-0.2% for triprolidine.

EXPERIMENTAL: Pseudoephedrine distributes into breast milk; about 0.5% of an oral dose is distributed into breast milk over 24 hours.

Pseudoephedrine acts directly on both alpha- and, to a lesser degree, beta-adrenergic receptors. Through direct action on alpha-adrenergic receptors in the mucosa of the respiratory tract, pseudoephedrine produces vasoconstriction. Pseudoephedrine relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors. Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Common adverse reactions include nervousness, restlessness, and insomnia. Rare adverse reactions include difficult/painful urination, dizziness/lightheadedness, heart palpitations, headache, increased sweating, nausea/vomiting, trembling, troubled breathing, unusual paleness, and weakness.

The Koc of pseudoephedrine is estimated as 73(SRC), using a log Kow of 0.89(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that pseudoephedrine is expected to have high mobility in soil. However, the pKa of pseudoephedrine is 10.25(4), indicating that this compound will primarily exist in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(5).

/HUMAN EXPOSURE STUDIES/ Pseudoephedrine is contained in decongestants such as the Sudafed line of products. ... Two analyses of health maintenance organization pharmacy data identified 9 malformed infants among 902 first-trimester pseudoephedrine exposures, suggesting no association with birth defects overall; however, studies of such data sets often lack sufficient power to identify risks for specific birth defects. The related compounds, epinephrine, ephedrine, and phenylephrine, have been associated with hemorrhages and cardiovascular and limb malformations in animal models. Risk of ventricular septal defects was associated with decongestant use in pregnant women in 1 recent study. The vasoconstrictive effects of these drugs raise the hypothesis that their use in early pregnancy might increase the risk of vascular disruption defects. Case-control studies, which often do have power to identify risks related to specific birth defects, have explored this hypothesis. Decongestant use in the first trimester has been associated with small increases in risks of 3 defects thought to arise, at least in some instances, from vascular disruption-gastroschisis, small intestinal atresia, and hemifacial microsomia. These findings are somewhat consistent in terms of magnitude of effect and suggest that risks are even greater among women also exposed to the vasoconstrictive effects of cigarette smoking. There are, however, limitations to these studies, including the possibilities of inaccurate recall of exposures and confounding by indication. In addition, the majority of decongestant use is in oral form and the question of whether intranasal formulations carry risk has not been adequately addressed.

/SIGNS AND SYMPTOMS/ Symptoms of overdose: Convulsions; fast breathing; hallucinations; increase in blood pressure; irregular heartbeat, continuing;shortness of breath or troubled breathing, severe or continuing; slow or fast heartbeat, severe or continuing; unusual nervousness, restlessness, or excitement.

/CASE REPORTS/ ... /The authors/ report a case of intracerebral hemorrhage occurring in a middle-aged man who suffered from chronic sinusitis and had been ingesting pseudoephedrine daily for one year. This patient was previously well with no known cardiovascular risk factors. Clinical examination revealed no evidence of vasculitis nor coagulopathy and initial neuroimaging (i.e., computed tomography, angiography, magnetic resonance imaging) demonstrated no features consistent with aneurysm, arteriovenous malformation, cavernoma, nor cerebral metastases. A follow-up cerebral angiogram demonstrated a small arteriovenous malformation arising off a branch of the pericallosal artery and a small arteriovenous fistula arising off the costal marginal branch. The arteriovenous malformation was embolized without incident, however, the arteriovenous fistula was not accessible. ... There is a paucity of literature etiologically inculpating other ephedra alkaloids in the causation of intracerebral hemorrhage. This is a case of pseudoephedrine-induced intracerebral hemorrhage in a patient with an underlying vascular malformation.

/CASE REPORTS/ We present a case of a 7 year old girl who developed an episode of myoclonic movements and tremors after being medicated with a not well quantified amount of a pseudoephedrine/antihistamine combination. We want to highlight the potential toxicity of pseudoephedrine, usually administered as part of cold-syrup preparations which are used for symptomatic treatment of upper respiratory tract cough and congestion associated with the common cold and allergic rhinitis. Although these products are generally considered to be safe either by physicians and parents, we can't underestimate the potential adverse events and toxic effects that can occur when administering these medications.

For more Human Toxicity Excerpts (Complete) data for PSEUDOEPHEDRINE (20 total), please visit the HSDB record page.

Drug-Induced Liver Injury Severity and Toxicity (DILIst)

pseudoephedrine

DILI Negative

Oral

DOI:10.1016/j.drudis.2019.09.022

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription and over-the-counter drug products, incl pseudoephedrine sulfate, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Pseudoephedrine Sulfate/

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription and over-the-counter drug products, incl pseudoephedrine hydrochloride, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act. /Pseudoephedrine Hydrochloride/

The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies discontinued drug products. Pseudoephedrine polistirex is included on this list.. /Pseudoephedrine Polistirex /

Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses. A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses: pseudoephedrine hydrochloride and pseudoephedrine sulfate are included in bronchodilator drug products. /Pseudoephedrine Hydrochloride, Pseudoephedrine Sulfate/

The Combat Methamphetamine Epidemic Act of 2005 has been incorporated into the Patriot Act signed by President Bush on March 9, 2006. The act bans over-the-counter sales of cold medicines that contain the ingredient pseudoephedrine, which is commonly used to make methamphetamine. The sale of cold medicine containing pseudoephedrine is limited to behind the counter. The amount of pseudoephedrine that an individual can purchase each month is limited and individuals are required to present photo identification to purchase products containing pseudoephedrine. In addition, stores are required to keep personal information about purchasers for at least two years.

R01BA02

R - Respiratory system

QR - Respiratory system

Pseudoephedrine causes vasoconstriction which leads to a decongestant effect. It has a short duration of action unless formulated as an extended release product. Patients should be counselled regarding the risk of central nervous system stimulation.

Pseudoephedrine acts mainly as an agonist of alpha adrenergic receptors and less strongly as an agonist of beta adrenergic receptors. This agonism of adrenergic receptors produces vasoconstriction which is used as a decongestant and as a treatment of priapism. Pseudoephedrine is also an inhibitor of norepinephrine, dopamine, and serotonin transporters. The sympathomimetic effects of pseudoephedrine include an increase in mean arterial pressure, heart rate, and chronotropic response of the right atria. Pseudoephedrine is also a partial agonist of the anococcygeal muscle. Pseudoephedrine also inhibits NF-kappa-B, NFAT, and AP-1.

THESE AGENTS /BRONCHODILATORS/ ACT ON BETA-2 RECEPTORS TO RELAX BRONCHIAL SMOOTH MUSCLE & PERIPHERAL VASCULATURE, APPARENTLY BY STIMULATING PRODN OF CYCLIC ADENOSINE-3.5-MONOPHOSPHATE (CAMP)...

Pseudoephedrine acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. The medication shrinks swollen nasal mucous membranes; reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. Also, drainage of sinus secretions may be increased and obstructed eustachian ostia may be opened.

The pharmacological properties of the ephedrine derivative pseudoephedrine were investigated at the nuclear level. Following intraperitoneal injection of Sprague Dawley rats with pseudoephedrine, Fos induction was measured in various brain areas by Western blots and immunocytochemistry. Pseudoephedrine induced Fos-like immunoreactivity in the nucleus accumbens and striatum in a time and concentration-dependent manner with maximal effect at 60 mg/kg 2 hr after injection. Immunocytochemical studies confirmed that the majority of the signal was detectable in the nucleus accumbens and striatum. Pre-injection with the D1 dopamine receptor antagonist SCH23390 partially and completely blocked pseudoephedrine-induced Fos-like immunoreactivity in the striatum and nucleus accumbens, respectively, suggesting that the action of pseudoephedrine is mediated via dopamine release and results in the activation of D1 dopamine receptors. With the exception of the higher doses required, the actions of pseudoephedrine were similar to those previously described for the psychostimulant amphetamine.

The mean elimination half life of pseudoephedrine is 6.0h.

In two sequential double-blind, parallel-group, single-dose studies, 21 children received either pseudoephedrine, 30 or 60 mg, or placebo, and 20 children received either phenylpropanolamine, 20 or 37.5 mg, or placebo. Before dosing and at intervals up to 7 hours after dosing, serum pseudoephedrine or phenylpropanolamine concentrations were measured, and pulse and blood pressure were recorded. In two children receiving each drug, these tests were also performed at 12 and 24 hours, and urine was collected from 0 to 12 and from 12 to 24 hours. In children, the mean (+/-SEM) terminal elimination half-life values for pseudoephedrine, 3.1 +/- 0.5 hours, and for phenylpropanolamine, 2.6 +/- 0.6 hours, were significantly shorter than those found by other investigators in adults. Pharmacokinetics were not dose dependent in the dose ranges studied.

Urinary pH can affect the elimination half-life of pseudoephedrine, prolonging it when alkaline (pH 8) and reducing it when acidic (pH 5). The elimination half-life of pseudoephedrine ranges from 3-6 or 9-16 hours when urinary pH is 5 or 8, respectively, while when urinary pH is 5.8, the elimination half-life of the drug ranges from 5-8 hours. In one study in children 6-12 years of age, the elimination half-life of pseudoephedrine averaged about 3 hours when urinary pH was 6.5.

Pseudoephedrine is <1% N-demethylated to an inactive metabolite. The majority of pseudoephedrine is eliminated unmetabolized in the urine.

Pseudoephedrine is incompletely metabolized (less than 1%) in the liver by N-demethylation to an inactive metabolite. The drug and its metabolite are excreted in urine; 55-96% of a dose is excreted unchanged.

D-PSEUDOEPHEDRINE YIELDS D-NORPSEUDOEPHEDRINE & L-PSEUDOEPHEDRINE YIELDS L-NORPSEUDOEPHEDRINE IN RABBIT: DANN, RE ET AL, EUR J PHARMAC, 16, 233 (1971). /FROM TABLE/

Ephedrine (EPH), pseudoephedrine (PEPH), phenylpropanolamine (PPA), methylephedrine (MEPH) and cathine are sympathomimetic amines. ... Excretion studies of the ephedrine-related drugs have been performed to better understand the metabolic yields of ephedrines in urine. After consuming a single clinical dose of each of these drugs, urine samples from volunteers (n=3 for each drug) were subjected to tert-butyl-methyl-ether (TBME) extraction and trifluoroacetic acid (TFAA) derivatization before gas chromatography-mass spectrometry (GC-MS) analysis. Most ephedrines were excreted unchanged in urine, including EPH (40.9%), PEPH (72.2%), and PPA (59.3%). However, only a relatively small amount of MEPH (15.5%) was excreted unchanged in urine. In addition, a trace amount of PPA (1.6%) and cathine (0.7%) was found to be the metabolites of EPH and PEPH, respectively. Urinary EPH, PEPH, and PPA reached peaks at 2-6 hr and disappeared in urine at approximately 24-48 hr post-administration. ...

Hepatic. Half Life: 9-16 hours

7CUC9DDI9F

PSEUDOEPHEDRINE

Mechanisms of Action [MoA] - Adrenergic alpha-Agonists

Established Pharmacologic Class [EPC] - alpha-Adrenergic Agonist

Pseudoephedrine is an alpha-Adrenergic Agonist. The mechanism of action of pseudoephedrine is as an Adrenergic alpha-Agonist.

Agents that cause an increase in the expansion of a bronchus or bronchial tubes.

Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993)

A 240mg oral dose of pseudoephedrine reaches a Cmax of 246.3±10.5ng/mL fed and 272.5±13.4ng/mL fasted, with a Tmax of 6.60±1.38h fed and 11.87±0.72h fasted, with an AUC of 6862.0±334.1ng\*h/mL fed and 7535.1±333.0ng\*h/mL fasted.

55-75% of an oral dose is detected in the urine as unchanged pseudoephedrine.

The apparent volume of distribution of pseudoephedrin is 2.6-3.3L/kg.

A 60mg oral dose of pseudoephedrine has a clearance of 5.9±1.7mL/min/kg.

Elimination: Renal. About 55 to 75% of a dose is excreted unchange. The rate of excretion is accelerated in acidic urine.

Oral capsules containing 100 mg pseudoephedrine hydrochloride and different grades of sodium alginate were prepared and studied to determine drug dissolution, the penetration of dissolution medium into the capsules, and the bioavailability of the formulations in 16 healthy subjects (ages 19-24 yr) using a randomized crossover design. At pH 1.2, there was no difference in dissolution between the formulations. At pH 7.2, release rates correlated with the viscosity grade of sodium alginate. Bioavailability tests confirmed that capsules containing high viscosity grades of alginate led to slow release, with a time to reach peak concn of 6.5 hr, and no loss of amount of drug absorbed. It was concluded that controlled release pseudoephedrine capsules can be prepared with high viscosity grades of sodium alginate. /Pseudoephedrine hydrochloride/

Optically pure amines used as resolving agents include alkaloids such as ...pseudoephedrine.

Because pseudoephedrine has been used in the clandestine synthesis of methamphetamine and methcathinone, both CNS stimulants with great potential for habituation and physical and/or psychic dependence, the US enacted the Comprehensive Methamphetamine Control Act of 1996 (US Public Law 104-237) and later the Methamphetamine Anti-Proliferation Act (MAPA (US Public Law 106-310), title XXXVI of the Children's Health Act of 2000) to reduce the potential for misuse (diversion) of pseudoephedrine.

THERAP CAT: Decongestant (nasal)

MEDICATION

Use (kg; approx.) in Germany (2009): >2500

For the treatment of nasal congestion, sinus congestion, Eustachian tube congestion, and vasomotor rhinitis, and as an adjunct to other agents in the optimum treatment of allergic rhinitis, croup, sinusitis, otitis media, and tracheobronchitis. Also used as first-line therapy of priapism.

Although pseudoephedrine occurs naturally as an alkaloid in certain plant species (for example, as a constituent of extracts from the ephedra species, also known as Ma Huang, in which it occurs together with other isomers of ephedrine), the majority of pseudoephedrine produced for commercial use is derived from yeast fermentation of dextrose in the presence of benzaldehyde. In this process, specialized strains of yeast (typically a variety of Candida utilis or Saccharomyces cerevisiae) are added to large vats containing water, dextrose and the enzyme pyruvate decarboxylase (such as found in beets and other plants, inter alia). After the yeast has begun fermenting the dextrose, the benzaldehyde is added to the vats, and in this environment the yeast convert the precursor ingredients to L-phenylacetylcarbinol. /L-phenylacetylcarbinol/ is then chemically converted to pseudoephedrine via reductive amination.

Oral: Solution: 15 mg/5 mL Simply Stuffy, (McNeil), Sudafed Children's Nasal Decongestant (with povidone), (Pfizer), Triaminic AM Decongestant Syrup, (Novartis); 30 mg/5 mL Decofed, Alpharma Suphedrin Children's, (Bergen Brunswig); 7.5 mg/0.8 mL Dimetapp Decongestant Infant Drops (with propylene glycol), (Wyeth), Kidkare Decongestant Drops, (Rugby), PediaCare Infants' Oral Decongestant Drops (with propylene glycol), (Pfizer), Pedia Relief, (Bergen Brunswig), Triaminic Infant Oral Decongestant Drops, (Novartis). Tablets30 mg Genaphed, (Teva), Sudafed Nasal Decongestant (with povidone and propylene glycol), (Pfizer), Suphedrin, (Bergin Brunswig), Su-Phedrin, (Eckerd), 60 mg (available by nonproprietary name). Tablets, extended release: 120 mg Pseudoephedrine Hydrochloride 12 Hour Tablets, (Cardinal Health), Su-Phedrin, (Eckerd). Tablets, chewable: 15 mg Sudafed Children's Nasal Decongestant (with aspartame), (Pfizer) Tablets, extended-release core: 240 mg (core 180 mg with 60 mg immediate release) Efidac 24 Pseudoephedrine (with povidone), (Hogil), Sudafed 24 Hour (with povidone), (Pfizer). Tablets, extended-release, film-coated: 120 mg Drixoral Nasal Decongestant, (Schering-Plough), Sudafed 12 Hour Caplets (with povidone), (Pfizer). NOTE: In response to state and federal efforts to restrict sales of pseudoephedrine to prevent diversion of the drug for use in illicit synthesis of methamphetamine, some nonprescription preparations containing pseudoephedrine hydrochloride or sulfate have been or are being reformulated to contain other decongestants (e.g., phenylephrine). Therefore, some of the preparations described below may no longer be commercially available in the US or may have been reformulated to no longer contain pseudoephedrine. /Pseudoephendrine hydrochloride/

Trade Names: Afrinol (Schering Corp.), Besan (Tutag), Eltor (Dow Chemical), First Sign (Williams), Novafed 120 (Dow Chemical), Sinufed (Hauck), Sudaped (Wellcome), Symptom 2 (Parke Davis), Tussaphed (Knoll) /Pseudoephedrine Hydrochloride/

Pseudoephedrine, its salts, optical isomers, and salts of optical isomers

A chemical specified by regulation that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance. (21 eCFR 1310.02)

Benzenemethanol, .alpha.-[(1S)-1-(methylamino)ethyl]-, (.alpha.S)-: ACTIVE

...L-PSEUDOEPHEDRINE...& D-PSEUDOEPHEDRINE.../ARE/ NATURALLY OCCURRING ISOMERS /OF EPHEDRINE/.