PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 1 X 10 mL Single-Dose Vial Carton


---

DESCRIPTION SECTION

11 DESCRIPTION

Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine- releasing agent. Ephedrine Sulfate Injection, 5 mg/mL is a clear, colorless, sterile, ready-to-use solution for intravenous injection. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2 · H2SO4 and its structural formula is depicted below:


Ephedrine sulfate is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. Each mL contains ephedrine sulfate 5 mg (equivalent to 3.8 mg ephedrine base), sodium chloride 9 mg, and sodium hydroxide and/or acetic acid for pH adjustment, if necessary. The pH range is 4.5 to 7.0.

---

INDICATIONS & USAGE SECTION

Highlight: Ephedrine Sulfate Injection is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1)

1 INDICATIONS AND USAGE

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: Injection: 5 mg/mL ephedrine sulfate in a single-dose, 10 mL vial (50 mg/10 mL, equivalent to 38 mg ephedrine base) (3)

3 DOSAGE FORMS AND STRENGTHS

Ephedrine Sulfate Injection, 5 mg/mL is a clear, colorless solution available in a single-dose, 10 mL vial that contains 50 mg/10 mL ephedrine sulfate, equivalent to 38 mg ephedrine base.

---

CONTRAINDICATIONS SECTION

Highlight: None (4)

4 CONTRAINDICATIONS

None

---

ADVERSE REACTIONS SECTION

Highlight: Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

6 ADVERSE REACTIONS

The following adverse reactions associated with the use of ephedrine sulfate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Gastrointestinal disorders: Nausea, vomiting

Cardiac disorders: Tachycardia, palpitations (thumping heart), reactive hypertension, bradycardia, ventricular ectopics, R-R variability

Nervous system disorders: Dizziness

Psychiatric disorders: Restlessness

CLINICAL STUDIES SECTION

14 CLINICAL STUDIES

The evidence for the efficacy of ephedrine injection is derived from the published literature. Increases in blood pressure following administration of ephedrine were observed in 14 studies, including 9 where ephedrine was used in pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 1 study in non-obstetric surgery under neuraxial anesthesia, and 4 studies in patients undergoing surgery under general anesthesia. Ephedrine has been shown to raise systolic and mean blood pressure when administered as a bolus dose following the development of hypotension during anesthesia.

---

OVERDOSAGE SECTION

10 OVERDOSAGE

Overdose of ephedrine can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.

---