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Ephedrine Hydrochloride

Pronunciation

Class: alpha- and beta-Adrenergic Agonists
Note: This monograph also contains information on Ephedrine, Ephedrine Sulfate
VA Class: AU100
CAS Number: 299-42-3
Brands: Bronkaid, Ephed, Primatene

Introduction

Sympathomimetic agent.a

Uses for Ephedrine Hydrochloride

Bronchospasm

Used orally as a bronchodilator for symptomatic treatment of asthma.176 198 220 221 222

Used in fixed-combination with guaifenesin as self-medication for the temporary relief of mild symptoms of intermittent asthma (e.g., wheezing, chest tightness, shortness of breath).176 198 199

Use of an OTC bronchodilator may be appropriate in patients with mild symptoms of intermittent asthma; however, those with more severe asthma (i.e., persistent asthma) or worsening asthma (symptoms not relieved within 60 minutes or with maximum recommended dosages, increasing frequency of asthma attacks) should consult a clinician for other treatment options.199

While oral ephedrine was once widely used in the treatment of asthma,221 224 the drug generally has been replaced by more selective and rapid-acting agents (e.g., inhaled β2-adrenergic agonists).176 198 199 223 224 225

Hypotension During Anesthesia

Used parenterally as a pressor agent for the treatment of hypotension during neuraxial (spinal/epidural) anesthesia.178 247 249 250 251

Although ephedrine historically considered the vasopressor of choice in obstetric anesthesia, some evidence suggests that phenylephrine may provide more favorable fetal acid-base balance.247 248 249 250 251

CNS Conditions

Has been used in the treatment of narcolepsy or depressive states; however, cardiovascular effects of the drug limit usefulness in these conditions.a

Obesity

Previously used for self-medication in the management of obesity.181 184 185

Dietary supplements containing ephedrine alkaloids are no longer commercially available in the US.189 (See Risks Associated with Dietary Supplements under Cautions.)

Nasal Congestion

Has been used as a nasal decongestant, but of doubtful value when used for this condition.a

Myasthenia Gravis

Has been used in patients with myasthenia gravis; however, randomized controlled studies are needed to evaluate potential benefit.178 226

Misuse and Abuse

Has been misused and abused by athletes, bodybuilders, weight lifters, and others, including high school- and college-aged individuals engaged in sports.181

Dietary supplements containing ephedrine alkaloids are no longer commercially available in the US.189 (See Risks Associated with Dietary Supplements under Cautions.)

Ephedrine has been used in clandestine synthesis of methamphetamine and methcathinone.a Federal restrictions to reduce the potential for misuse (diversion) and abuse of ephedrine include limiting the amount that can be purchased to 3.6 g per day or 9 g per month, requiring storage behind the counter or in a locked cabinet, requiring purchasers to provide approved photographic identification, and requiring retail distributors to maintain a written or electronic logbook of purchases for at least 2 years.204 205 209 210 211 (For additional information on these and other federal restrictions, visit []).212 213 214 Additional requirements have been enacted in some states;102 104 106 109 202 203 206 follow state requirements if such requirements are more stringent than federal restrictions.209 212 213

Ephedrine Hydrochloride Dosage and Administration

Administration

Oral Administration

Administer orally as a fixed-combination preparation.176 177 198

Parenteral Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IM, sub-Q, or slow IV injection.178

Dosage

Available as ephedrine hydrochloride or ephedrine sulfate; dosage expressed in terms of the salt.176 178 198

Pediatric Patients

Bronchospasm
Oral

Ephedrine hydrochloride or sulfate self-medication in children ≥12 years of age: 12.5–25 mg every 4 hours as needed for treatment of mild symptoms of intermittent asthma; administer in fixed combination with guaifenesin.176 198

IM

Ephedrine sulfate: 0.5 mg/kg or 16.7 mg/m2 every 4–6 hours.178

Sub-Q

Ephedrine sulfate: 0.5 mg/kg or 16.7 mg/m2 every 4–6 hours.178

Hypotension During Anesthesia
IM

Ephedrine sulfate: 0.5 mg/kg or 16.7 mg/m2 every 4–6 hours.178

Sub-Q

Ephedrine sulfate: 0.5 mg/kg or 16.7 mg/m2 every 4–6 hours.178

Adults

Bronchospasm
Oral

Ephedrine hydrochloride or sulfate self-medication: 12.5–25 mg every 4 hours as needed for treatment of mild symptoms of intermittent asthma; administer in fixed combination with guaifenesin.176 198

Parenteral

Ephedrine sulfate: Parenteral doses of 12.5–25 mg have been given.a

Hypotension During Anesthesia
IV

Ephedrine sulfate: 5–25 mg; repeat in 5–10 minutes if necessary.178 250

IM or Sub-Q

Ephedrine sulfate: 25–50 mg.178

Prescribing Limits

Pediatric Patients

Bronchospasm
Oral

Ephedrine hydrochloride or sulfate self-medication in children ≥12 years of age: Maximum 150 mg in any 24-hour period.176 198

Adults

Bronchospasm
Oral

Ephedrine hydrochloride or sulfate self-medication: Maximum 150 mg in any 24-hour period.176 198

Cautions for Ephedrine Hydrochloride

Contraindications

  • For self-medication in asthma: Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor, pediatric patients <12 years of age, known hypersensitivity to the specific product or any of its ingredients.176 198

  • Known hypersensitivity to ephedrine or sympathomimetic drugs.178

Warnings/Precautions

Warnings

Cardiovascular Effects

May cause hypertension and tachycardia; risk of serious adverse effects (e.g., MI, stroke, intracranial hemorrhage, exacerbation of CHF, death).178 189 (See Risks Associated with Dietary Supplements under Cautions.)

Risk of anginal pain in patients with coronary insufficiency or ischemic heart disease.a Risk of potentially fatal arrhythmias in patients with organic heart disease or in those receiving drugs that sensitize the myocardium (e.g., cyclopropane, halothane).a

Caution in patients with cardiovascular disease (e.g., angina) and in those receiving digoxin.178

Concomitant Diseases

Use with caution in patients with cardiovascular disease, hypertension, angina, hyperthyroidism, diabetes mellitus, or prostatic hyperplasia.178 Patients with cardiovascular disease, hypertension, diabetes mellitus, thyroid disease, seizures, angle-closure (narrow-angle) glaucoma, psychiatric or emotional conditions should consult a clinician before initiating self-medication with ephedrine.176 198

Use for self-medication for bronchospasm only if previously diagnosed with asthma; do not use if previously hospitalized for asthma unless directed by a clinician.176 198

Risks Associated with Dietary Supplements

Dietary supplements containing ephedrine alkaloids have been associated with serious adverse cardiac effects (e.g., hypertension, possibly resulting in MI, stroke, or death),189 CNS effects, and death.113 114 115 117 118 120 131 134 144 160 172 181 183

In February 2004, FDA declared dietary supplements containing ephedrine alkaloids adulterated by virtue of their unreasonable health risks to consumers.189 Manufacturing, sale, and distribution of all dietary supplements containing ephedrine alkaloids (e.g., Ephedra spp. [“ma huang”], Sida cordifolia, Pinellia spp.) were prohibited after April 12, 2004.189 190 This regulation does not apply to traditional Chinese herbal remedies or products regulated as conventional foods (e.g., herbal teas).190 Ephedra is not generally recognized as safe for foods and not approved for use as a food additive.190 After litigation, FDA’s rule was upheld, and FDA reiterated its position that no dosage of dietary supplements containing ephedrine alkaloids is safe, and the sale of these products in the US is illegal and subject to FDA enforcement action.195 196 197 201 207 208

General Precautions

When used in fixed combination with guaifenesin, observe the usual cautions, precautions, and contraindications associated with guaifenesin.176 177 198

Prolonged Use

Prolonged parenteral use may produce a syndrome resembling an anxiety state.178 Tolerance may develop; effectiveness may return after the drug is withheld temporarily.178

Duration of Therapy

Self-medication in asthma: Consult a clinician if symptoms are not improved within 1 hour or worsen, more than the recommended dosage of ephedrine is required, or asthma attacks become more frequent (i.e., >2 asthma attacks in a week).176 198

Misuse and Abuse

Potential for misuse and abuse.a

Specific Populations

Pregnancy

Category C.178

Lactation

Distributed into milk.178 Use not recommended.178

Pediatric Use

Should not be used for self-medication in children <12 years of age unless otherwise directed by a clinician.177 198

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.215 216 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.215 Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children 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 agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 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.

Common Adverse Effects

Parenteral ephedrine: Nervousness, insomnia, vertigo, headache, tachycardia, palpitation, sweating, nausea, vomiting, anorexia, vesical sphincter spasm (resulting in difficult and painful urination), urinary retention (particularly in males with prostatism).178

Interactions for Ephedrine Hydrochloride

Specific Drugs

Drug

Interaction

Comment

α-Adrenergic blocking agents

Vasopressor response to ephedrine decreaseda

β-Adrenergic blocking agents

Antagonism of cardiac and bronchodilating effects of ephedrinea

Anesthetics, general (e.g., halogenated hydrocarbons [e.g., halothane], cyclopropane)

Increased cardiosensitivity to ephedrine178

Cardiac glycosides

Increased cardiosensitivity to ephedrine178

Use with caution178

Diuretics

Decreased arterial responsiveness to pressor drugsa

MAO inhibitors

Pressor effects of ephedrine increased; may result in hypertensive crisis or subarachnoid hemorrhage rarelya

Avoid use with or for 2 weeks after discontinuance of MAO inhibitors176

Oxytocics

Severe hypotension possible178

Sympathomimetic drugs

Additive effects and increased toxicity178

Avoid concomitant use178

Ephedrine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Peak serum concentrations attained within 2.6–3 hours following oral administration.120

Onset

Oral administration: Bronchodilation occurs within 15–60 minutes.a

Duration

Oral administration: Bronchodilation persists for 2–4 hours; pressor and cardiac responses persist for up to 4 hours.a

Parenteral administration: Pressor and cardiac responses persist for 1 hour.a

Distribution

Extent

Distributed into milk.178

Elimination

Metabolism

Slowly metabolized in the liver.a

Elimination Route

Ephedrine and its metabolites are excreted in urine; most of the drug is excreted as unchanged ephedrine.a The rate of urinary excretion of ephedrine and its metabolites is dependent upon urinary pH.a

Half-life

About 3 hours when the urine is acidified to pH 5; about 6 hours when urinary pH is about 6.3.a

Stability

Storage

Oral

Fixed-dose Combination with Guaifenesin

Primatene tablets: 20–25°C.176

Bronkaid caplets: Room temperature; avoid exposure to >40°C.198

Parenteral

Injection

20–25°C.178 Protect from light.178

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible

Dextrose–Ringer’s injection combinations

Dextrose–Ringer’s injection, lactated, combinations

Dextrose–saline combinations

Dextrose 2½, 5, or 10% in water

Ionosol products

Ringer’s injection

Ringer’s injection, lactated

Sodium chloride 0.45 or 0.9%

Sodium lactate (1/6) M

Drug Compatibility
Admixture CompatibilityHID

Compatible

Chloramphenicol sodium succinate

Lidocaine HCl

Nafcillin sodium

Penicillin G potassium

Incompatible

Pentobarbital sodium

Phenobarbital sodium

Y-site CompatibilityHID

Compatible

Bivalirudin

Dexmedetomidine HCl

Etomidate

Fenoldopam mesylate

Hetastarch in lactated electrolyte injection (Hextend)

Propofol

Actions

  • Sympathomimetic agent; occurs naturally in plants of the genus Ephedra.172 179

  • Stimulates both α- and β-adrenergic receptors.172 178

  • Relaxes bronchial smooth muscle, stimulates cardiac muscle (producing positive inotropic effects),a constricts arterioles, increases BP, and stimulates the cerebral cortex and subcortical centers.178 198

  • Relaxes GI smooth muscle.178 Contracts urinary bladder trigone and sphincter and relaxes the detrusor muscle.178

Advice to Patients

  • For self-medication in asthma, importance of not exceeding recommended dosages or frequency of administration unless otherwise instructed by a clinician.176 198

  • For self-medication in asthma, importance of discontinuing therapy and contacting a clinician if symptoms are not improved within 1 hour or they become worse.176 198

  • For asthma, advise that ephedrine should be used for self-medication only if asthma was previously diagnosed by a clinician.176 198 Before considering self-medication, inform clinician of any history of hospitalization for asthma.176 198

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses (e.g., cardiovascular disease).176 178 Importance of avoiding MAO inhibitors and allowing 2 weeks to elapse after discontinuing these antidepressants.176 178 198 199

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.176 178

  • Importance of informing patients of other important precautionary information.176 178 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ephedrine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ephedrine Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection

50 mg/mL*

Ephedrine Sulfate Injection

Ephedrine Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

12.5 mg with Guaifenesin 200 mg

Ephed Plus

DMD

Primatene

Pfizer

25 mg with Guaifenesin 200 mg

Ephed Plus

DMD

Ephedrine Sulfate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

25 mg with Guaifenesin 400 mg

Bronkaid Caplets

Bayer

AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.

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