Finished product reference
Ephedrine Hydrochloride
Injection · Parenteral · 30 mg/1mL · 1 mL
- List code
- 53223
What it is and how it works
Mechanism of Action Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and β-adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Indirect adrenergic stimulation is caused by norepinephrine release from sympathetic nerves.
Indications
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. 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.
Dosage and administration (summary)
Should be administered by trained healthcare providers Ephedrine sulfate injection, 50 mg/mL, must be diluted before administration as an intravenous bolus dose. Bolus intravenous injection: 5 to 10 mg as needed, not to exceed 50 mg. General Dosage and Administration Instructions Ephedrine sulfate injection, 50 mg/mL 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.
Contraindications
None None
Warnings and precautions
Pressor Effects with Concomitant Use with Oxytocic Drugs : Pressor effect of sympathomimetic pressor amines is potentiated Tachyphylaxis and Tolerance : Repeated administration of ephedrine may cause tachyphylaxis 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.
Pregnancy
Pregnancy Risk Summary 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.
Storage and supply
Ephedrine sulfate injection USP, 50 mg/mL, is supplied as follows: NDC Strength How Supplied 43598-725-2550 mg/mL of ephedrine sulfateequivalent to 38 mg/mL of ephedrine base 50 mg/mL of ephedrine sulfate equivalent to 38 mg/mL of ephedrine base 1 mL fill in a 2 mL clear glass vial with purple flip-off cap.
Source: Ephedrine Sulfate (Ephedrine Sulfate) — US FDA prescribing information, 2023-08-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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