Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral:
Bronkaid: Ephedrine sulfate 25 mg and guaifenesin 400 mg
Primatene Asthma: Ephedrine sulfate 12.5 mg and guaifenesin 200 mg [scored]
Pharmacology
Mechanism of Action
Ephedrine: Releases tissue stores of norepinephrine and thereby produces an alpha- and beta-adrenergic stimulation; longer-acting and less potent than epinephrine
Guaifenesin: Thought to act as an expectorant by irritating the gastric mucosa and stimulating respiratory tract secretions, thereby increasing respiratory fluid volumes and decreasing mucous viscosity
Contraindications
OTC labeling: When used for self-medication, do not use if asthma is not confirmed by a health care provider; coadministration with a monoamine oxidase inhibitor (MAOI) or 2 weeks after discontinuing an MAOI; hypersensitivity to ephedrine, guaifenesin, or any component of the formulation.
Dosage and Administration
Administration
Administer without regard to food.
Storage
Store at 20° to 25°C (68° to 77°F).
Drug Interactions
Alkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy
Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Atropine (Systemic): May enhance the therapeutic effect of EPHEDrine (Systemic). 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. Consider therapy modification
Bretylium: May enhance the therapeutic effect of Alpha-/Beta-Agonists (Direct-Acting). Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
Carbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy
Cardiac Glycosides: EPHEDrine (Systemic) may enhance the arrhythmogenic effect of Cardiac Glycosides. Monitor therapy
Chloroprocaine: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Monitor therapy
CloNIDine: May enhance the therapeutic effect of EPHEDrine (Systemic). Monitor therapy
CloZAPine: May diminish the therapeutic effect of Alpha-/Beta-Agonists. 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. Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Droxidopa: EPHEDrine (Systemic) may enhance the hypertensive effect of Droxidopa. Monitor therapy
Ergot Derivatives: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination
FentaNYL: Alpha-/Beta-Agonists (Indirect-Acting) may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Hyaluronidase: May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Management: Avoid the use of hyaluronidase to enhance dispersion or absorption of alpha-/beta-agonists. Use of hyaluronidase for other purposes in patients receiving alpha-/beta-agonists may be considered as clinically indicated. Consider therapy modification
Inhalational Anesthetics: EPHEDrine (Systemic) may enhance the arrhythmogenic effect of Inhalational Anesthetics. Avoid combination
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. Avoid combination
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
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. Exceptions: Linezolid. Avoid combination
Oxytocin: May enhance the hypertensive effect of EPHEDrine (Systemic). Monitor therapy
Propofol: May enhance the therapeutic effect of EPHEDrine (Systemic). Monitor therapy
QuiNIDine: EPHEDrine (Systemic) may diminish the therapeutic effect of QuiNIDine. QuiNIDine may diminish the therapeutic effect of EPHEDrine (Systemic). Monitor therapy
Rocuronium: EPHEDrine (Systemic) may enhance the therapeutic effect of Rocuronium. 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. Consider therapy modification
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Monitor therapy
Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. 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. Consider therapy modification
Urinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy
Adverse Reactions
Frequency not defined.
Cardiovascular: Hypertension, tachycardia
Central nervous system: Emotional disturbance, headache, insomnia, nervousness, seizure
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Tremor
Respiratory: Cough, exacerbation of asthma, productive cough
Warnings/Precautions
Concerns related to adverse effects:
- Cardiovascular effect: May cause hypertension or tachycardia, increasing the risk of myocardial infarction (MI) and/or stroke. Serious cardiovascular events (eg, MI, stroke, arrhythmias), including deaths, have been previously reported with use of dietary supplements containing ephedra alkaloids (Haller, 2000).
Disease-related concerns:
- Asthma: Only use with a diagnosis of asthma; notify health care provider if asthma becomes worse during use. Inhaled bronchodilators provide more rapid symptomatic relief of asthma than ephedrine/guaifenesin.
- Cardiovascular disease: Use with caution in patients with heart disease and/or hypertension.
- Diabetes: Use with caution in patients with diabetes mellitus.
- Glaucoma: Use with caution in patients with narrow angle glaucoma.
- Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.
- Psychiatric conditions: Use with caution in patients with psychiatric or emotional conditions.
- Seizures: Use with caution in patients with a history of seizure disorder.
- Thyroid disease: Use with caution in patients with thyroid disease.
Special populations:
- Pediatric: Not for OTC use in children <12 years.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience trouble sleeping or tremors. Have patient report immediately to prescriber severe headache, severe dizziness, passing out, vision changes, chest pain, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), fast heartbeat, seizures, or severe anxiety (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
