Ephedrine Sulfate - Ephedrine Sulfate injection

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

• •Ephedrine sulfate injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) is injected intravenously as a bolus. Dilute before administration. (
  2 DOSAGE AND ADMINISTRATION

  • •Ephedrine sulfate injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) is injected intravenously as a bolus. Dilute before administration.
  • •Bolus intravenous injection: 5 to 10 mg as needed, not to exceed 50 mg.

  2.1 General Dosage and Administration Instructions

  Ephedrine sulfate injection must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with normal saline or 5% dextrose in water.

  Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia

  The recommended dosages for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 to 10 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 50 mg.

  • •Adjust dosage according to the blood pressure goal (i.e., titrate to effect).

  2.3 Prepare a 5 mg/mL Solution for Bolus Intravenous Administration

  For bolus intravenous administration, prepare a solution containing a final concentration of 5 mg/mL of ephedrine sulfate injection:

  • •Withdraw 50 mg (1 mL of 50 mg/mL) of ephedrine sulfate injection 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 intravenous administration.
  )
• •Bolus intravenous injection: 5 to 10 mg as needed, not to exceed 50 mg. (
  2 DOSAGE AND ADMINISTRATION

  • •Ephedrine sulfate injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) is injected intravenously as a bolus. Dilute before administration.
  • •Bolus intravenous injection: 5 to 10 mg as needed, not to exceed 50 mg.

  2.1 General Dosage and Administration Instructions

  Ephedrine sulfate injection must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with normal saline or 5% dextrose in water.

  Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia

  The recommended dosages for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 to 10 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 50 mg.

  • •Adjust dosage according to the blood pressure goal (i.e., titrate to effect).

  2.3 Prepare a 5 mg/mL Solution for Bolus Intravenous Administration

  For bolus intravenous administration, prepare a solution containing a final concentration of 5 mg/mL of ephedrine sulfate injection:

  • •Withdraw 50 mg (1 mL of 50 mg/mL) of ephedrine sulfate injection 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 intravenous administration.
  )

Ephedrine sulfate injection, USP is available as a single-dose 1 mL vial that contains 50 mg/mL ephedrine sulfate, equivalent to 38 mg ephedrine base.

Available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are clinical considerations due to underlying conditions (

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. A decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.

Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. These reports describe umbilical artery pH of ≤7.2 at the time of delivery

Decreased fetal body weights were observed when pregnant rats were administered intravenous bolus doses of 60 mg/kg ephedrine sulfate (12 times the maximum recommended human dose (MRHD) of 50 mg based on body surface area) from Gestation Day 6-17. This dose was associated with evidence of maternal toxicity (decreased body weight of dams and abnormal head movements). No malformations or fetal deaths were noted at this dose. No effects on fetal body weight were noted at 10 mg/kg (1.9 times the MRHD of 50 mg).

No evidence of malformations or embryo-fetal toxicity were noted in pregnant rabbits administered intravenous bolus doses up to 20 mg/kg ephedrine sulfate (7.7 times the maximum recommended human dose (MRHD) of 50 mg based on body surface area) from Gestation Day 6-20. This dose was associated with expected pharmacological maternal effects (increased respiration rate, dilated pupils, piloerection).

Decreased fetal survival and body weights in the presence of maternal toxicity (increased mortality) were noted when pregnant dams were administered intravenous bolus doses of 60 mg/kg epinephrine sulfate (approximately 12 times the MRHD based on body surface area) from GD 6 through Lactation Day 20. No adverse effects were noted at 10 mg/kg (1.9 times the MRHD).

• •
  Pressor Effects with Concomitant Use with Oxytocic Drugs
  : Pressor effect of sympathomimetic pressor amines is potentiated (
  5.1 Pressor Effect with Concomitant Oxytocic Drugs

  Serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine) and an oxytocic (i.e., methylergonovine, ergonovine)

  [see Drug Interactions ]

  . Some of these patients experienced a stroke. Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic.
  )
• •
  Tachyphylaxis and Tolerance
  : Repeated administration of ephedrine may cause tachyphylaxis (
  5.2 Tolerance and Tachyphylaxis

  Data indicate that repeated administration of ephedrine can result in tachyphylaxis. Clinicians treating anesthesia-induced hypotension with ephedrine sulfate injection should be aware of the possibility of tachyphylaxis and should be prepared with an alternative pressor to mitigate unacceptable responsiveness.
  )