Ephedrine

Ephedrine Sulfate Injection, USP is indicated in the treatment of allergic disorders, such as bronchial asthma. The drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotension frequently occurs. In Stokes-Adams syndrome with complete heart block, ephedrine has a value similar to that of epinephrine. It is indicated as a central nervous system stimulant in narcolepsy and depressive states. It is also used in myasthenia gravis.

Ephedrine is available in the following forms:

• Injectable Solution
• Nasal Solution
• Oral Capsule
• Oral Solution
• Oral Suspension
• Oral Tablet
• Prefilled Syringe

With large doses of ephedrine sulfate most patients will experience nervousness, insomnia, vertigo, headache, tachycardia, palpitation and sweating. Some patients have nausea, vomiting and anorexia. Vesical sphincter spasm may occur and result in difficult and painful urination. Urinary retention may develop in males with prostatism.

Precordial pain and cardiac arrhythmias may occur following administration of Ephedrine Sulfate Injection, USP.

Drug Abuse And Dependence

Prolonged abuse of Ephedrine Sulfate Injection, USP can lead to symptoms of paranoid schizophrenia. When this occurs, patients exhibit such physical signs as tachycardia, poor nutrition and hygiene, fever, cold sweat and dilated pupils.

Some measure of tolerance may develop with prolonged or excessive use but addiction does not occur. Temporary cessation of medication and subsequent readministration restores its effectiveness.

Read the entire FDA prescribing information for Ephedrine (Ephedrine)

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 IV injection.178 200 Also has been administered by sub-Q† or IM† injection.178

Administer ephedrine sulfate (Akovaz) by direct IV (“bolus”) injection.200 252 Must dilute commercially available injection prior to IV administration.200 May prepare a 5-mg/mL solution by diluting 1 mL of the 50-mg/mL injection concentrate with 9 mL of 0.9% sodium chloride injection or 5% dextrose injection.200

Vials are for single-use only; discard unused portions.200

Dosage

Available as ephedrine hydrochloride or ephedrine sulfate; dosage expressed in terms of the salt.176 178 198 200

Pediatric Patients

Ephedrine sulfate: Usual dose of 0.5 mg/kg or 16.7 mg/m2 every 4–6 hours has been administered.178 However, ephedrine sulfate injection not FDA-labeled for use in pediatric patients.200 252

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

Ephedrine sulfate: Usual dose of 0.5 mg/kg or 16.7 mg/m2 every 4–6 hours has been administered.178 However, ephedrine sulfate injection not FDA-labeled for use in pediatric patients.200 252

Adults

Ephedrine sulfate: Initially, 5–10 mg by IV bolus injection; administer additional bolus doses as needed (up to a total dose of 50 mg) to achieve desired BP response.200

Other IV dosage regimens have been recommended.178 250

Ephedrine sulfate: Usual dose of 25–50 mg has been administered.178

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

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

Prescribing Limits

Pediatric Patients

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

Adults

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

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

• Stimulates both α- and β-adrenergic receptors.172 178 200

• Relaxes bronchial smooth muscle, stimulates cardiac muscle (producing positive inotropic effects),a constricts arterioles, increases BP, and stimulates the cerebral cortex and subcortical centers.178 198 200

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

• ephedrine may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to ephedrine. Using ephedrine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take this medication.
• Do not take diet or appetite control medicines while you are taking ephedrine.
• Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains ephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Diabetes patients - ephedrine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use this medication with caution in the elderly because they may be more sensitive to its effects.
• Use ephedrine with extreme caution in children. Safety and effectiveness have not been confirmed.
• Pregnancy and breast-feeding: It is unknown if this medication can cause harm to the fetus. If you become pregnant while taking ephedrine, discuss with your doctor the benefits and risks of using ephedrine during pregnancy. Ephedrine is excreted in breast milk. If you are or will be breast-feeding while you are using ephedrine, check with your doctor or pharmacist to discuss the risks to your baby.

Applies to ephedrine: intravenous solution

Along with its needed effects, ephedrine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ephedrine:

• Blurred vision
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Some side effects of ephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Nausea or vomiting
• restlessness

Data not available

Data not available

Storage requirements:
-Store vials in carton until time of use; protect from light.
-Oral Tablets: Protect from light and moisture; dispense in tight, light resistant container.

Reconstitution/preparation techniques:
-Akovaz(TM): Withdraw 50 mg (1 mL of 50 mg/mL) of Akovaz(TM) and dilute with 9 mL of 5% dextrose injection or 0.9% sodium chloride injection. Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus IV administration.

Monitoring:
-Metabolic: Monitor newborns for signs/symptoms of metabolic acidosis, including monitoring of acid-base status
-Renal: Monitor renal function in patients with renal impairment and elderly patients; monitor patients with renal impairment carefully for adverse events following initial bolus dose

Patient advice:
-Contact your healthcare provider if after taking the oral formulation, symptoms are not relieved within 1 hour or worsen.
-This drug may cause nervousness, tremor, insomnia, nausea, and loss of appetite; consult your physician if symptoms persist or worsen.