EPHEDRINE SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. None 8.1 Pregnancy Risk Summary Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. However, there are clinical considerations [see Clinical Considerations]. Animal reproduction studies have not been conducted with ephedrine sulfate. The estimated background risk of major birth defects and miscarriage for the indicated population is 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 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions 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 [see Clinical Pharmacology 12-12.3]. Monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. Monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible. 8.2 Lactation Risk Summary Limited published literature reports that ephedrine is present in human milk. However, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Ephedrine and its metabolite are excreted in urine. In patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. Monitor patients with renal impairment carefully after the initial bolus dose for adverse events.

Product summary:

EPHEDRINE SULFATE INJECTIONS, USP is supplied in the following dosage forms. NDC 51662-1325-1 EPHEDRINE SULFATE INJECTIONS, USP 50 mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ephedrine Sulfate Injection, USP, 50 mg/mL, is supplied as follows: Vial stoppers are not manufactured with natural rubber latex. Store ephedrine sulfate injection, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. For single use only. Discard unused portion.

Authorization status:

New Drug Application

Summary of Product characteristics

EPHEDRINE SULFATE- EPHEDRINE SULFATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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EPHEDRINE SULFATE INJECTIONS, USP 50 MG/ML 1ML VIAL
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
EPHEDRINE SULFATE
INJECTION safely and effectively. See full prescribing information for
EPHEDRINE
SULFATE INJECTION.
EPHEDRINE SULFATE injection, USP, for intravenous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
Ephedrine Sulfate Injection, USP is an alpha- and beta- adrenergic
agonist and a
norepinephrine-releasing agent indicated for the treatment of
clinically important
hypotension occurring in the setting of anesthesia. ( 1)
DOSAGE AND ADMINISTRATION
Treatment of hypotension developing during anesthesia: Bolus
intravenous injection: 5
to 10 mg as needed, not to exceed 50 mg. Dilute before use. See Full
Prescribing
Information for instructions on administration and preparation for
injection. ( 2)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mg/mL ephedrine sulfate in single-dose vial ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
• Pressor Effect with Concomitant Oxytocic Drugs: Pressor effect of
sympathomimetic
pressor amines is potentiated ( 5-5.1)
• Tachyphylaxis and Tolerance: Repeated administration of ephedrine
may cause
tachyphylaxis ( 5-5.2)
ADVERSE REACTIONS
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 or www.fda.gov/medwatch.
DRUG INTERACTIONS
• Interactions that Augment the Pressor Effect: clonidine, oxytocin
and oxytocic drugs,
propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor
blood pressure.
( 7)
• Interactions that Antagonize the Pressor Effect: Antagonistic
effects with α-adrenergic
antagonists, β-adrenergic antagonists, reserpine, quinidine,
mephentermine. Monitor
blood pressure. ( 7)
• Guanethidine: Ephedrine may inhibit the neuron blocka