Class: alpha- and beta-Adrenergic Agonists
VA Class: AU100
Chemical Name: [S-(R*,R*)]-α-[1-(Methylamino)ethyl]-benzenemethanol hydrochloride
Molecular Formula: C10H15NO•HClC10H15NO•H2SO4
CAS Number: 345-78-8
Brands: Advil Allergy & Sinus, Advil Cold & Sinus, Advil Multi-Symptom Cold, Alavert Allergy & Sinus, Allegra-D, Bromfenex, Bromfenex PD, Clarinex-D, Claritin-D, Decofed, Drixoral Cold & Allergy, Extendryl PSE, Genac, Genaphed, Genaphed Plus, Kid Kare Decongestant Drops, Kid Kare Cough/Cold Liquid, Mucinex D, Ornex, Pedia Relief, Sudafed 12 Hour Caplets, Sudafed 24 Hour, Sudafed Children’s Nasal Decongestant, Sudafed Nasal Decongestant, Suphedrin, Suphedrin Children’s
Special Alerts:
[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: and .
Introduction
Sympathomimetic agent; decongestant.
Uses for Pseudoephedrine
Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Pseudoephedrine is used for self-medication for temporary relief of nasal congestion associated with upper respiratory allergy (e.g., hay fever) or the common cold.108 109 110 112 116
Pseudoephedrine is used for self-medication for temporary relief of sinus congestion and pressure.109 110 112 116
Pseudoephedrine is used in fixed combination with other agents (e.g., acetaminophen, brompheniramine, chlorpheniramine, desloratadine, dextromethorphan, fexofenadine, guaifenesin, ibuprofen, loratadine, methscopolamine, triprolidine) for relief of nasal/sinus congestion and pressure and/or other symptoms (e.g., rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, cough, fever) associated with seasonal or perennial allergic rhinitis, nonallergic (vasomotor) rhinitis, other upper respiratory allergies, or the common cold.154 155 156 157 158 159 160 161 162 163 164 165
Single 60-mg oral doses of pseudoephedrine hydrochloride shown to be effective in relieving congestion in clinical studies.145 146 147 148 149
Pseudoephedrine may be used as an adjunct to analgesics, antihistamines, antitussives, expectorants, or antibiotics when indicated.a
Pseudoephedrine is labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis;109 110 135 however, efficacy data are lacking and/or controversial.135 136 137 In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants.135 Compliance date for preparations with annual sales <$25,000 was October 11, 2007; compliance date for all other preparations was April 11, 2007.135
Pseudoephedrine is ineffective as a bronchodilator.a
Combination of pseudoephedrine and caffeine not generally recognized as safe and effective for OTC use.105
In pediatric patients <2 years of age, OTC cough and cold preparations (i.e., containing nasal decongestants, antihistamines, cough suppressants, and expectorants) were not more effective than placebo in reducing acute cough and other symptoms of upper respiratory tract infection and reportedly are associated with adverse events and sometimes death (albeit rarely).150 (See Pediatric Use under Cautions.) Therefore, CDC states that, as an alternative to pseudoephedrine and other nasal decongestants, caregivers may consider using a rubber suction bulb to clear nasal congestion and using saline nasal drops or a cool-mist humidifier to soften secretions in infants.150
Otitic Barotrauma† and Other Otic Conditions†
Pseudoephedrine has been used for self-medication in adults to prevent symptoms of otitic barotrauma (aerotitis [barotitis] media)† (e.g., otic discomfort, otic blockage, hearing loss, otalgia) associated with air travel or underwater diving.119 120 121 Efficacy not established in children.124
Pseudoephedrine may be useful in opening obstructed eustachian ostia in patients with otic inflammation or infection.a
Misuse and Abuse
Pseudoephedrine has been used in clandestine synthesis of methamphetamine and methcathinone.100 101 102 113
The Combat Methamphetamine Epidemic Act (CMEA) of 2005 was signed into law in March 2006 to tighten control over sale and distribution of pseudoephedrine and ephedrine.130 139 140 141 CMEA created a new class of products called “scheduled listed chemical products”, which are defined in the law as products containing pseudoephedrine, ephedrine, or phenylpropanolamine or any salt, optical isomer, or salt of an optical isomer salt of these drugs that are lawful nonprescription products in the US and set additional requirements for their sale.140 142 Effective September 30, 2006 under CMEA’s provisions, pharmacies and other retail distributors must store pseudoephedrine- and ephedrine-containing preparations behind the counter or in locked cabinets; purchasers must provide approved photographic identification and sign a written or electronic logbook for each purchase; pharmacies and other retail distributors must keep information about the purchasers (e.g., name, address, signature) and purchases (e.g., name of product, quantity sold, date and time of sale) for ≥2 years; and the amount that can be purchased is limited to ≤3.6 g per day or 9 g per month.130 131 139 140 141 For additional information about legal and regulatory requirements under CMEA, visit .142 143 144
Use of pseudoephedrine in some states may be subject to additional controls.128 129 139 Where such state laws are more stringent than the provisions of CMEA, state requirements also must be followed.139 142 143 144
In response to federal and state restrictions, some manufacturers have voluntarily reformulated various existing pseudoephedrine-containing preparations, replacing the pseudoephedrine component with other decongestants such as phenylephrine.132 139
Pseudoephedrine Dosage and Administration
Administration
Oral Administration
Administer 240-mg extended-release core tablets orally once daily.110 Swallow tablets whole with fluid; do not divide, crush, chew, or dissolve.110 Matrix core of tablets does not completely dissolve and may be passed in the stool.110
Dosage
Single-entity preparation: Available as pseudoephedrine hydrochloride; dosage expressed in terms of the salt.108 109 110 112 116
Fixed-combination preparation: Available as pseudoephedrine hydrochloride or pseudoephedrine sulfate.133 a
Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.
Pediatric Patients
Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral
Self-medication in children <2 years of age: Consult a pediatrician.108 112 Currently there are no FDA-approved dosage recommendations for cough and cold preparations for patients <2 years of age.150 (See Pediatric Use under Cautions.)
Self-medication in children 2–5 years of age: Pseudoephedrine hydrochloride 15 mg every 4–6 hours.112 Alternatively, some pediatricians recommend 4 mg/kg or 125 mg/m2 daily, given in 4 divided doses.a (See Pediatric Use under Cautions.)
Self-medication in children 6–11 years of age: Pseudoephedrine hydrochloride 30 mg every 4–6 hours.112
Self-medication in children ≥12 years of age: Pseudoephedrine hydrochloride 60 mg (as conventional tablets) every 4–6 hours,108 112 120 mg (as extended-release tablets) every 12 hours,109 or 240 mg (as extended-release core tablets) once daily.110
Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.108 109 110 112 116
Adults
Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral
Self-medication: Pseudoephedrine hydrochloride 60 mg (as conventional tablets) every 4–6 hours,108 112 120 mg (as extended-release tablets) every 12 hours,109 or 240 mg (as extended-release core tablets) once daily.110
Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.110 108 109 112 116
Otitic Barotrauma†
Oral
Air travelers: Pseudoephedrine hydrochloride 120 mg (as extended-release tablets) 30 minutes before flight departure.119 120
Underwater divers: Pseudoephedrine hydrochloride 60 mg 30 minutes before diving.121
Prescribing Limits
Pediatric Patients
Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral
Self-medication in children 2–5 years of age: Maximum 60 mg of pseudoephedrine hydrochloride in any 24-hour period.112
Self-medication in children 6–11 years of age: Maximum 120 mg of pseudoephedrine hydrochloride in any 24-hour period.112
Self-medication in children ≥12 years of age: Maximum 240 mg of pseudoephedrine hydrochloride in any 24-hour period (as conventional tablets,108 112 120-mg extended-release tablets,109 or 240-mg extended-release core tablets).110
Adults
Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral
Self-medication: Maximum 240 mg of pseudoephedrine hydrochloride in any 24-hour period (as conventional tablets,108 112 120-mg extended-release tablets,109 or 240-mg extended-release core tablets).110
Cautions for Pseudoephedrine
Contraindications
Severe hypertension or severe CHD.a 133
Angle-closure glaucoma or urinary retention.133
Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.108 109 110 112 116 (See Specific Drugs under Interactions.)
Known hypersensitivity to sympathomimetic drugs.a
Warnings/Precautions
Warnings
MAO Inhibitors
Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of pseudoephedrine.108 109 110 112 116
Concomitant Diseases
Patients with CHD, hypertension, hyperthyroidism, diabetes mellitus, or difficulty urinating due to prostatic hypertrophy should consult a clinician before initiating therapy with pseudoephedrine.108 109 110 112 116
Sensitivity Reactions
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Fixed dermatologic eruptions (erythematous nummular patches) reported rarely with fixed-combination preparation containing 60 mg of pseudoephedrine hydrochloride and 2.5 mg of triprolidine hydrochloride.a
General Precautions
CNS Effects
Discontinue therapy and consult a clinician if nervousness, dizziness, or insomnia develops during therapy.108 109 110 112 116
GI Effects
240-mg extended-release core tablets rarely can cause GI obstruction, particularly in patients with severe narrowing of the esophagus, stomach, or intestine.110 Patients with GI obstruction or narrowing should consult a clinician before using extended-release core tablets.110
Discontinue extended-release core tablets and consult a clinician if persistent abdominal pain or vomiting develops.110
Duration of Therapy
Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.108 109 110 112 116
Misuse and Abuse
Pseudoephedrine has been used in clandestine synthesis of methamphetamine and methcathinone.100 101 102 113
Potential for misuse and abuse.100 101 102 113 114 115 (See Misuse and Abuse under Uses.)
Use of Fixed Combinations
When used in fixed combination with other agents (e.g., acetaminophen, brompheniramine, chlorpheniramine, desloratadine, dextromethorphan, fexofenadine, guaifenesin, ibuprofen, loratadine, methscopolamine, triprolidine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).154 155 156 157 158 159 160 161 162 163 164 165
Specific Populations
Pregnancy
Pseudoephedrine: Category C.d
Lactation
Distributed into milk.104 106 107 Usually compatible with breast-feeding; however, use with caution.106
Pediatric Use
Safety and efficacy of extended-release preparations containing 120 or 240 mg of pseudoephedrine hydrochloride not established in children <12 years of age.109 110 116
Efficacy not established in children for treatment of otitic barotrauma (aerotitis [barotitis] media)† (e.g., otic discomfort, otic blockage, hearing loss, otalgia) associated with air travel or underwater diving.119 120 121
Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.150 151 CDC reported that cough and cold preparations containing pseudoephedrine and other drugs were found to be the underlying cause of death in 3 infants ≤6 months of age.150 151 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.150 Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.
Geriatric Use
Geriatric patients may be especially sensitive to the effects of sympathomimetic amines.a Overdosage in patients >60 years of age may cause hallucinations, CNS depression, seizures, and death.a Do not administer extended-release pseudoephedrine preparations in these patients until safety has been established with short-acting preparations.a
Common Adverse Effects
Nervous system effects (e.g., CNS stimulation, nervousness, excitability, restlessness, dizziness, weakness, insomnia, headache, drowsiness)108 109 110 112 116 and cardiovascular effects (e.g., increased irritability of heart muscle, altered rhythmic function of ventricles, tachycardia, palpitation).a
Interactions for Pseudoephedrine
Sympathomimetic Drugs
Potential pharmacologic interaction (additive effects and increased toxicity).a Use with extreme caution, if at all.a
Specific Drugs
Drug
|
Interaction
|
Comment
|
|---|
β-Adrenergic blocking agents (e.g., propranolol)
|
Increased pressor effectsa
|
|
Methyldopa
|
Decreased antihypertensive effects of methyldopaa
|
|
MAO inhibitors
|
Increased pressor effects; infrequently may result in hypertensive crisisa
|
Avoid use with or for 2 weeks after discontinuance of MAO inhibitors108 109 110 112 116
|
Reserpine
|
Decreased antihypertensive effects of reserpinea
|
|
Pseudoephedrine Pharmacokinetics
Absorption
Bioavailability
Almost completely absorbed from the GI tract following oral administration.104 Peak plasma concentrations are attained in about 1.39–2.4 or 3.8–6.1 hours following oral administration as an oral solution or extended-release preparation, respectively.103 104
Onset
Onset of nasal decongestion occurs within 30 minutes following oral administration as tablets or oral solution.a
Duration
Nasal decongestion may persist for 8 hours following oral administration of 60 mg and up to 12 hours following 120 mg of the drug in extended-release capsules.a
Food
Food delays absorption when administered as a solution, but appears not to affect absorption when the drug is administered as extended-release preparations.104
Distribution
Extent
Presumed to cross the placenta and to enter CSF.a
About 0.5% of an oral dose is distributed into milk over 24 hours.104
Metabolism
Incompletely metabolized in the liver to an inactive metabolite.a
Elimination Route
Excreted in urine; 55–96% of a dose is eliminated as unchanged drug.a
Half-life
3–6 hours at urinary pH of 5; 9–16 hours at urinary pH of 8.16 103
Stability
Storage
Oral
Tablets
Conventional tablets: 15–25°C in a dry place.108
Extended-release tablets: 15–25°C in a dry place.109 Protect from light.109
Solution
15–25°C in a dry place.108 109 Avoid freezing.a
ActionsActions
Stereoisomer of ephedrine.a
Acts directly on both α- and, to a lesser degree, β-adrenergic receptors.a Releases norepinephrine from its storage sites.a
Produces vasoconstriction, resulting in shrinkage of swollen nasal mucous membranes; reduction of tissue hyperemia, edema, and nasal congestion; an increase in nasal airway patency; and an increase in drainage of sinus secretions.a Produces little, if any, rebound congestion.a
May improve or maintain eustachian tube patency, allowing equilibration of middle ear pressure during external atmospheric pressure changes (e.g., during descent of an aircraft, underwater diving, hyperbaric oxygenation).119 120 121
Advice to Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Importance of taking only as directed; do not increase dosage or duration of therapy unless otherwise instructed by a clinician.108 109 110 112 116
Importance of informing clinicians about development of CNS adverse effects (e.g., nervousness, dizziness, insomnia).109 110 112 116
Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.109 110 112 116
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs (e.g., cough and cold preparations) and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).108 109 110 112 116
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.108 109 110 112 116
Importance of informing patients of other important precautionary information.108 109 110 112 116 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Pseudoephedrine hydrochloride is commercially available in the US alone and in fixed combination with other agents. Pseudoephedrine sulfate is commercially available only in fixed-combination preparations. Because pseudoephedrine hydrochloride and sulfate are available in combination with numerous other agents (e.g., antihistamines, analgesics, antitussives, expectorants), only some fixed-combination preparations are described below.
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 products containing pseudoephedrine hydrochloride or sulfate have been or are being reformulated to contain other decongestants (e.g., phenylephrine) or discontinued.
In response to concerns regarding the safety and efficacy of cough and cold preparations in young children, many nonprescription cough and cold preparations specifically formulated for infants have been voluntarily withdrawn from the US market.152 Because of these measures, 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.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Pseudoephedrine Hydrochloride
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Bulk
|
Powder*
|
|
|
|
Oral
|
Solution
|
15 mg/5 mL
|
Sudafed Children’s Nasal Decongestant (with povidone)
|
McNeil
|
|
|
30 mg/5 mL*
|
Decofed
|
Alpharma
|
|
|
|
Suphedrin Children’s
|
Bergen Brunswig
|
|
|
7.5 mg/0.8 mL
|
Kid Kare Decongestant Drops (with propylene glycol)
|
Rugby
|
|
|
|
Pedia Relief
|
Bergen Brunswig
|
|
Tablets
|
30 mg*
|
Genaphed
|
Teva
|
|
|
|
Sudafed Nasal Decongestant (with povidone)
|
McNeil
|
|
|
|
Suphedrin
|
Bergin Brunswig
|
|
|
60 mg*
|
|
|
|
Tablets, extended release
|
120 mg*
|
Pseudoephedrine Hydrochloride 12 Hour Tablets
|
Cardinal Health
|
|
|
240 mg
|
Sudafed 24 Hour (with povidone)
|
McNeil
|
|
Tablets, extended-release, film-coated
|
120 mg*
|
Sudafed 12 Hour Caplets (with povidone)
|
McNeil
|
Pseudoephedrine Hydrochloride Combinations
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Capsules, extended-release
|
60 mg with Brompheniramine Maleate 6 mg
|
Bromfenex PD (with propylene glycol)
|
Ethex
|
|
|
120 mg with Brompheniramine Maleate 12 mg
|
Bromfenex (with propylene glycol)
|
Ethex
|
|
Capsules, liquid-filled
|
30 mg with Ibuprofen 200 mg
|
Advil Cold & Sinus Liqui-Gels
|
Wyeth
|
|
Solution
|
15 mg/5 mL with Chlorpheniramine Maleate 1 mg/5 mL and Dextromethorphan Hydrobromide 5 mg/5mL
|
Kid Kare Cough/Cold Liquid (with propylene glycol)
|
Rugby
|
|
Tablets
|
30 mg with Acetaminophen 325 mg
|
Ornex Caplets (with povidone)
|
B.F. Ascher
|
|
|
30 mg with Chlorpheniramine Maleate 2 mg and Ibuprofen 200 mg
|
Advil Allergy & Sinus (with propylene glycol)
|
Wyeth
|
|
|
|
Advil Multi-Symptom Cold (with propylene glycol)
|
Wyeth
|
|
|
30 mg with Ibuprofen 200 mg
|
Advil Cold & Sinus (with povidone and parabens)
|
Wyeth
|
|
|
60 mg with Chlorpheniramine Maleate 4 mg
|
Genaphed Plus
|
Teva
|
|
|
60 mg with Triprolidine Hydrochloride 2.5 mg
|
Genac
|
Teva
|
|
Tablets, extended-release
|
60 mg with Guaifenesin 600 mg
|
Mucinex D
|
Adams
|
|
|
120 mg with Fexofenadine Hydrochloride 60 mg
|
Allegra-D 12 Hour (film-coated)
|
Sanofi-Aventis
|
|
|
120 mg with Methscopolamine Nitrate 2.5 mg
|
Extendryl PSE (scored)
|
Auriga
|
|
|
120 mg with Methscopolamine Nitrate 2.5 mg
|
|
|
|
|
240 mg with Fexofenadine Hydrochloride 180 mg
|
Allegra-D 24 Hour (film-coated; with povidone)
|
Sanofi-Aventis
|
Pseudoephedrine Sulfate Combinations
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Tablets, extended-release core (pseudoephedrine sulfate only)
|
120 mg with Desloratadine 2.5 mg
|
Clarinex-D 12 Hour (with povidone)
|
Schering-Plough
|
|
|
120 mg with Dexbrompheniramine Maleate 6 mg
|
Drixoral Cold & Allergy (with butylparaben and povidone)
|
Schering-Plough
|
|
|
120 mg with Loratadine 5 mg
|
Alavert Allergy & Sinus D-12 Hour (with povidone)
|
Wyeth
|
|
|
|
Claritin-D 12 Hour (with povidone)
|
Schering-Plough
|
|
|
240 mg with Desloratadine 5 mg
|
Clarinex-D 24-Hour (film-coated; with povidone)
|
Schering-Plough
|
|
|
240 mg with Loratadine 10 mg
|
Claritin-D 24 Hour (with povidone)
|
Schering-Plough
|
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Allegra-D 12 Hour 60-120MG 12-hr Tablets (SANOFI-AVENTIS U.S.): 30/$81.57 or 60/$150.18
Allegra-D 24 Hour 180-240MG 24-hr Tablets (SANOFI-AVENTIS U.S.): 30/$147.98 or 90/$414.97
Cheratussin DAC 30-10-100MG/5ML Solution (QUALITEST): 480/$35.99 or 960/$60.97
Clarinex-D 12 Hour 2.5-120MG 12-hr Tablets (SCHERING): 100/$312.99 or 300/$870.95
Clarinex-D 24 Hour 5-240MG 24-hr Tablets (SCHERING): 30/$145.99 or 90/$426.95
Fexofenadine-Pseudoephedrine 60-120MG 12-hr Tablets (TEVA PHARMACEUTICALS USA): 30/$62.99 or 90/$175.96
Mytussin DAC 30-10-100MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 473/$39.66 or 1419/$118.98
Pseudoephedrine HCl 60MG Tablets (SANDOZ): 100/$18.99 or 300/$36.97
Sudal 12 4-30MG Chewable Tablets (ATLEY PHARMACEUTICALS): 100/$109.99 or 300/$310.98
SudoGest 60MG Tablets (MAJOR PHARMACEUTICALS): 100/$13.99 or 200/$16.98
SudoGest Sinus/Allergy 4-60MG Tablets (MAJOR PHARMACEUTICALS): 24/$11.99 or 48/$12.98
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 01, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
16. Kuntzman RG, Tsai I, Brand L et al. The influence of urinary pH on the plasma half-life of pseudoephedrine in man and dog and a sensitive assay for its determination in human plasma. Clin Pharmacol Ther. 1971; 12:62-7. [IDIS 15659] [PubMed 5541135]
100. Public Law 104-237, 104th Cong., (3 October 1996), Comprehensive Methamphetamine Control Act of 1996.
101. Maltz GA. Methamphetamine law will control bulk sales of “precursor chemicals”: earlier DEA ruling nullified. Pharmacy Today. 1996; 2:1,17.
102. Drug Enforcement Administration. Implementation of the Comprehensive Methamphetamine Control Act of 1996; regulation of pseudoephedrine, phenylpropanolamine, and combination ephedrine drug products and reports of certain transactions to nonregulated persons. 21 CFR Parts 1300, 1309, 1310. Proposed rule. [DEA No. 163P] Fed Regist. 1997; 62:52294-304.
103. Simons FER, Gu X, Watson WTA et al. Pharmacokinetics of the orally administered decongestants pseudoephedrine and phenylpropanolamine in children. J Pediatr. 1996; 129:729-34. [IDIS 374882] [PubMed 8917241]
104. Kanfer I, Dowse R, Vuma V. Pharmacokinetics of oral decongestants. Pharmacotherapy. 1993; 13(6 Part 2):116S-28S. [IDIS 323174] [PubMed 7507589]
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126. Reviewers’ comments.
