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:

Andersen Pharma LLC

INN (International Name):

ephedrine sulfate

Composition:

ephedrine sulfate 50 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

unapproved drug other

Summary of Product characteristics

EPHEDRINE SULFATE- EPHEDRINE SULFATE INJECTION, SOLUTION
ANDERSEN PHARMA LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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EPHEDRINE SULFATE
INJECTION, USP
(50 MG/ML)
PRES ERVATIVE-FREE
SINGLE DOSE VIAL
PROTECT FROM LIGHT.
KEEP VIALS IN TRAY UNTIL TIME OF USE.
DESCRIPTION
Ephedrine Sulfate Injection, USP is a sterile, nonpyrogenic solution
containing ephedrine sulfate 50
mg/mL in water for injection. It is administered by subcutaneous,
intramuscular or intravenous injection
as an adrenergic agent. The solution contains no bacteriostat,
antimicrobial agent or added buffer. The
pH is 5.3 (4.5 to 7.0). The osmolar concentration of the 5% solution
is 0.35 mOsmol/mL (calc.).
Ephedrine Sulfate, USP is a sympathomimetic amine chemically
designated α-[1-(methylamino) ethyl]
benzenemethanol sulfate (2:1)(salt). It has the following structural
formula:
CLINICAL PHARMACOLOGY
Therapeutic doses of ephedrine produce mainly relaxation of smooth
muscle and, if norepinephrine
stores are intact, cardiac stimulation and increased systolic and
usually increased diastolic blood
pressure. Its vasopressor effect results largely from increased
cardiac output and to a lesser extent
from peripheral vasoconstriction. Pressor responses to parenteral
ephedrine are slower but more
prolonged than those produced by epinephrine. Ephedrine stimulates
both alpha and beta receptors and
its peripheral actions are due partly to norepinephrine release and
partly to direct effect on receptors.
Ephedrine may deplete norepinephrine stores in sympathetic nerve
endings, so that tachyphylaxis to
cardiac and pressor effects of the drug may develop. Central nervous
system effects are similar to
those of amphetamine drugs but less pronounced. The central effects of
ephedrine are overshadowed to
a large extent by its peripheral actions.
Glycogenolysis in the liver is increased by ephedrine but not as much
as by