LANOXIN digoxin injection solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59)

Disponible depuis:

Cardinal Health

DCI (Dénomination commune internationale):

DIGOXIN

Composition:

DIGOXIN 250 ug in 1 mL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

LANOXIN- DIGOXIN INJECTION, SOLUTION
CARDINAL HEALTH
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LANOXIN
(DIGOXIN)
INJECTION
500 MCG (0.5 MG) IN 2 ML (250 MCG [0.25 MG] PER ML)
DESCRIPTION
LANOXIN (digoxin) is one of the cardiac (or digitalis) glycosides, a
closely related group of drugs
having in common specific effects on the myocardium. These drugs are
found in a number of plants.
Digoxin is extracted from the leaves of _Digitalis lanata_ . The term
“digitalis” is used to designate the
whole group of glycosides. The glycosides are composed of 2 portions:
a sugar and a cardenolide
(hence “glycosides”).
Digoxin is described chemically as
(3β,5β,12β)-3-[(_O_-2,6-dideoxy-β-_D-ribo_-hexopyranosyl-(1→4)-_O_-
2,6-dideoxy-β-_D-ribo-_hexopyranosyl-(1→4)-2,6-dideoxy-β-_D_-_ribo_-hexopyranosyl)oxy]-12,14-
dihydroxy-card-20(22)-enolide. Its molecular formula is C
H O , its molecular weight is 780.95,
and its structural formula is:
Digoxin exists as odorless white crystals that melt with decomposition
above 230°C. The drug is
practically insoluble in water and in ether; slightly soluble in
diluted (50%) alcohol and in chloroform;
and freely soluble in pyridine.
LANOXIN Injection is a sterile solution of digoxin for intravenous or
intramuscular injection. The
vehicle contains 40% propylene glycol and 10% alcohol. The injection
is buffered to a pH of 6.8 to 7.2
with 0.17% dibasic sodium phosphate and 0.08% anhydrous citric acid.
Each 2-mL ampul contains
500 mcg (0.5 mg) digoxin (250 mcg [0.25 mg] per mL). Dilution is not
required.
CLINICAL PHARMACOLOGY
®
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64
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MECHANISM OF ACTION
Digoxin inhibits sodium-potassium ATPase, an enzyme that regulates the
quantity of sodium and
potassium inside cells. Inhibition of the enzyme leads to an increase
in the intracellular concentration of
sodium and thus (by stimulation of sodium-calcium exchange) an
increase in the intracellular
concentration of calcium. The beneficial effects of digoxin result
from direct actions on cardiac
muscle, as well as indirect actions on the cardiovascular system
media