Version January 2024
Hyperlactation, treatment (off-label use): Oral: Immediate release: 30 mg as a single dose. If milk production is not decreased after 8 to 12 hours, may administer a single dose of 60 mg. Most patients require single, as-needed doses; others may require scheduled dosing. Dosage range: 30 to 60 mg once to twice daily as needed (Ref).
Nasal congestion: General dosing guidelines: Oral: Immediate release: 60 mg every 4 to 6 hours; Extended release: 120 mg every 12 hours or 240 mg every 24 hours; maximum: 240 mg per 24 hours.
There are no dosage adjustments provided in the manufacturer's labeling. However, pseudoephedrine is substantially eliminated in the urine and patients with kidney impairment are at increased risk of accumulation. Consider using reduced doses (especially if therapy is longer-term) and monitor for adverse effects (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
Nasal congestion: Use caution in this population; initiate using immediate release formulation: 30 to 60 mg every 6 hours as needed
(For additional information see "Pseudoephedrine: Pediatric drug information")
Note: Safety and efficacy for the use of cough and cold products in infants and young children is limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children; the FDA does not recommend OTC use in infants and children <2 years of age due to the risk of serious and life-threatening adverse effects (including death) and recommends to use with caution in pediatric patients ≥2 years of age (Ref).
Nasal congestion (decongestant): Oral:
Children <4 years: Limited data available: Immediate release: 1 mg/kg/dose every 6 hours; maximum dose: 15 mg/dose (Ref).
Children 4 to <6 years: Immediate release:
Fixed dose: 15 mg every 4 to 6 hours; maximum daily dose: 60 mg/24 hours
Weight-directed dosing: 1 mg/kg/dose every 6 hours; maximum dose: 15 mg/dose (Ref).
Children 6 to <12 years: Immediate release: 30 mg every 4 to 6 hours; maximum daily dose: 120 mg/24 hours
Children ≥12 years and Adolescents:
Immediate release: 60 mg every 4 to 6 hours; maximum daily dose: 240 mg/day
Extended release: 120 mg every 12 hours or 240 mg once daily; maximum daily dose: 240 mg/24 hours
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
Cardiovascular: Cardiac arrhythmia, chest tightness, circulatory shock (with hypotension), hypertension, palpitations, tachycardia
Central nervous system: Ataxia, central nervous system stimulation (transient), chills, confusion, dizziness, drowsiness, excitability, fatigue, hallucination, headache, insomnia, nervousness, neuritis, restlessness, seizure, vertigo
Dermatologic: Diaphoresis, skin photosensitivity, skin rash, urticaria
Gastrointestinal: Anorexia, constipation, diarrhea, dry throat, ischemic colitis, nausea, vomiting, xerostomia
Genitourinary: Difficulty in micturition, dysuria, urinary retention
Hematologic & oncologic: Agranulocytosis, hemolytic anemia, thrombocytopenia
Hypersensitivity: Anaphylaxis
Neuromuscular & skeletal: Tremor, weakness
Ophthalmic: Blurred vision, diplopia
Otic: Tinnitus
Renal: Polyuria
Respiratory: Dry nose, dyspnea, nasal congestion, pharyngeal edema, thickening of bronchial secretions, wheezing
OTC labeling: When used for self-medication, do not use with or within 2 weeks of discontinuing a monoamine oxidase inhibitor.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Sodium: Some products may contain sodium.
Other warnings/precautions:
• Self-medication (OTC use): When used for self-medication (OTC), notify health care provider to use if you have diabetes, heart disease, high BP, thyroid disease, difficultly in urination due to enlargement of the prostate gland, or obstruction/narrowing of the bowel (ER products). Discontinue use and notify health care provider if symptoms do not improve within 7 days or are accompanied by fever or if nervousness, dizziness, or sleeplessness occur.
Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported (in some cases, high blood concentrations of pseudoephedrine were found). Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Liquid, Oral, as hydrochloride:
Sudafed Childrens: 15 mg/5 mL (118 mL) [alcohol free, sugar free; contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), menthol, polyethylene glycol (macrogol), saccharin sodium, sodium benzoate; grape flavor]
Tablet, Oral, as hydrochloride:
Genaphed: 30 mg [DSC]
Nasal Decongestant: 30 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
Nasal Decongestant: 30 mg [contains fd&c red #40(allura red ac)aluminum lake, polysorbate 80]
Shopko Nasal Decongestant Max: 30 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake]
Simply Stuffy: 30 mg
Sudafed: 30 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
Sudafed Congestion: 30 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
Sudafed Sinus Congestion: 30 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake, quinoline (d&c yellow #10) aluminum lake]
SudoGest: 30 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]
SudoGest: 60 mg
SudoGest: 60 mg [DSC] [scored]
SudoGest Maximum Strength: 30 mg [gluten free; contains fd&c red #40(allura red ac)aluminum lake]
Generic: 30 mg, 60 mg
Tablet Abuse-Deterrent, Oral, as hydrochloride:
Nexafed: 30 mg [DSC]
Zephrex-D: 30 mg
Tablet Extended Release 12 Hour, Oral, as hydrochloride:
Shopko Nasal Decongestant: 120 mg [DSC]
Sudafed 12 Hour: 120 mg [DSC]
Sudafed Sinus Congestion 12HR: 120 mg
SudoGest 12 Hour: 120 mg
Suphedrine 12Hour: 120 mg [gluten free]
Generic: 120 mg
Tablet Extended Release 24 Hour, Oral, as hydrochloride:
Sudafed Sinus Congestion 24HR: 240 mg
May be product dependent
Liquid (Sudafed Childrens Oral)
15 mg/5 mL (per mL): $0.05
Tablet Abuse-Deterrent (Zephrex-D Oral)
30 mg (per each): $0.23
Tablet, 12-hour (Pseudoephedrine HCl ER Oral)
120 mg (per each): $0.25 - $0.38
Tablet, 12-hour (Sudafed Sinus Congestion 12HR Oral)
120 mg (per each): $0.46
Tablet, 24-hour (Sudafed Sinus Congestion 24HR Oral)
240 mg (per each): $1.11
Tablets (Pseudoephedrine HCl Oral)
30 mg (per each): $0.10
60 mg (per each): $0.07
Tablets (Sudafed Oral)
30 mg (per each): $0.19
Tablets (Sudafed Sinus Congestion Oral)
30 mg (per each): $0.20
Tablets (SudoGest Maximum Strength Oral)
30 mg (per each): $0.05
Tablets (SudoGest Oral)
30 mg (per each): $0.03
60 mg (per each): $0.09
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Do not crush ER drug product, swallow whole. May administer with or without food. Sudafed 24 Hour tablet may not completely dissolve and appear in stool.
Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. ER tablets should be swallowed whole. Do not crush or chew. IR tablet, chewable tablet, capsule, oral solution, syrup, and suspension formulations are available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery.
Oral: Administer with water or milk to decrease GI distress; swallow timed release tablets or capsules whole, do not chew or crush; Sudafed 24 Hour tablet may not completely dissolve and appear in stool
Nasal congestion: Temporary symptomatic relief of nasal congestion due to common cold, hay fever, or upper respiratory allergies; temporary relief of sinus congestion and pressure; promotes nasal or sinus drainage; temporarily restores freer breathing through the nose
Hyperlactation, treatment
Sudafed may be confused with sotalol, Sudafed PE, Sufenta
Sudafed 12 Hour may be confused with Sudafed 12 Hour Pressure + Pain
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy
Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy
Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Benzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modification
Bromocriptine: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Carbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy
Chloroprocaine (Systemic): May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy
Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Risk X: Avoid combination
FentaNYL: Decongestants may decrease the serum concentration of FentaNYL. Risk C: Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination
Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination
Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification
Lisuride: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk X: Avoid combination
Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid combination
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy
Pergolide: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Reserpine: May diminish the therapeutic effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy
Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider therapy modification
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy
Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy
Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider therapy modification
Urinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy
Onset of effect may be delayed if pseudoephedrine is taken with food. Management: Administer without regard to food.
Pseudoephedrine has been studied for the treatment of retrograde ejaculation. Additional studies are needed to determine effectiveness and appropriate dosing. Information related to pregnancy and live birth rates following treatment is lacking (Arafa 2008; ESSM [Capogrosso 2021]; Shoshany 2017).
Use of pseudoephedrine during the first trimester may be associated with an increased risk of congenital anomalies, possibly due to vasoconstrictive effects; however, additional studies are needed (Elliott 2009; Werler 2002; Werler 2003; Werler 2006; Yau 2013).
Blood flow to the uterine artery, fetal aorta, and umbilical artery were not affected by a single maternal dose of immediate-acting pseudoephedrine 60 mg administered to 12 women in their third trimester of pregnancy (26 to 40 weeks' gestation). Mother and fetus were monitored for 3 hours after the dose. There was no change in maternal BP and no change in maternal or fetal heart rate (Smith 1990). Fetal tachycardia was reported following use of ER pseudoephedrine 120 mg once daily for 7 days by a mother prior to a nonstress test at 39 weeks' gestation. The same tests completed prior to pseudoephedrine exposure were normal (Anastasio 1992).
Decongestants are not the preferred agents for the treatment of rhinitis during pregnancy due to their low or variable maternal benefit and potential fetal harm. Oral pseudoephedrine should be avoided during the first trimester. Prolonged use later in pregnancy should also be avoided (AAAAI/ACAAI [Dykewicz 2020]).
Pseudoephedrine is present in breast milk (Aljazaf 2003; Findlay 1984).
Information related pseudoephedrine breast milk concentrations is available from 8 women 8 to 76 weeks postpartum following a single oral dose of pseudoephedrine 60 mg:
• Breast milk was sampled prior to and at intervals up to 24 hours after the dose. The mean peak breast milk concentration occurred 1.7 hours after the dose; the mean half-life of pseudoephedrine in breast milk was 5.3 hours. The highest breast milk concentration observed in the study was 1,003 mcg/L.
• Using data from the patient with the highest breast milk concentration observed in the study, the authors predicted a relative infant dose (RID) of pseudoephedrine at steady state following a maternal dose of 60 mg 4 times daily. Using extrapolated data, the mean RID of pseudoephedrine was 6.7%, based on a calculated mean milk concentration of 1,227 mcg/L, providing a mean estimated daily infant dose via breast milk of 184 mcg/kg/day (Aljazaf 2003).
• In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).
Irritability and agitation have been reported in infants exposed to pseudoephedrine via breast milk (Ito 1993; Soussan 2014).
An acute decrease in milk production may occur with pseudoephedrine. Following a single oral dose of pseudoephedrine 60 mg to 8 women, an average reduction of 24% (range: 6% to 42%) over 24 hours was observed (Aljazaf 2003).
Pseudoephedrine is a recommended option for the treatment of persistent idiopathic hyperlactation in patients requiring medication therapy. Infants and mothers should be monitored for potential adverse events such as arrhythmia, insomnia, irritability, jitteriness, or tachycardia. Some patients may require single, as-needed doses; others may require scheduled dosing to achieve normal milk production. Too great a decrease of milk production should be avoided (ABM [Johnson 2020]).
Some products may contain sodium.
Hyperlactation, treatment (off-label use): Adverse events (eg, arrhythmia, insomnia, irritability, jitteriness, tachycardia) in breastfed infant and mother for 8 to 12 hours after each dose; milk production (avoid too great of decrease) (ABM [Johnson 2020]).
Directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility
Onset of action: Decongestant: Oral: 30 minutes (Chua, 1989)
Peak effect: Decongestant: Oral: ~1-2 hours (Chua, 1989)
Duration: Immediate release tablet: 3-8 hours (Chua, 1989)
Absorption: Rapid (Simons, 1996)
Distribution: Children: ~2.5 L/kg (Simons, 1996); Adults: 2.64-3.51 L/kg (Kanfer, 1993)
Metabolism: Undergoes n-demethylation to norpseudoephedrine (active) (Chua, 1989; Kanfer, 1993); Hepatic (<1%) (Kanfer, 1993)
Half-life elimination: Varies by urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine (Kanfer, 1993)
Children: ~3 hours (urine pH ~6.5) (Simons, 1996)
Adults: 9-16 hours (pH 8); 3-6 hours (pH 5) (Chua, 1989)
Time to peak:
Children (immediate release) ~2 hours (Simons, 1996)
Adults (immediate release): 1-3 hours (dose dependent) (Kanfer, 1993)
Excretion: Urine (43% to 96% as unchanged drug, 1% to 6% as active norpseudoephedrine); dependent on urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine (Kanfer, 1993)
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