DIGOXIN tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

State of Florida DOH Central Pharmacy

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillation. Digitalis glycosides are contraindicated in patients with ventricular fibrillation or in patients with a known hypersensitivity to digoxin. A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.

Product samenvatting:

Digoxin Tablets USP, 0.125 mg are yellow, round, scored on one side with imprint "W 40". Digoxin Tablets USP, 0.25 mg are white, round, scored on one side with imprint "WW 41". They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20-25ºC (68-77ºF) [See USP Controlled Room Temperature] in a dry place. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Lanoxicaps® is a registered trademark of GlaxoSmithKline. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DIGOXIN - DIGOXIN TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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DIGOXIN TABLETS, USP
Rx Only
DESCRIPTION:
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 two 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. lts 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.
Digoxin is supplied as 125 mcg (0.125 mg) or 250 mcg (0.25 mg) tablets
for oral administration. Each
tablet contains the labeled amount of digoxin USP and the following
inactive ingredients:
125 MCG (0.125 MG): anhydrous lactose, colloidal silicon dioxide, corn
starch, D&C yellow #10
aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate,
magnesium stearate and
pregelatinized starch.
250 MCG (0.25 MG): anhydrous lactose, colloidal silicon dioxide, corn
starch, lactose monohydrate,
magnesium stearate and pregelatinized starch.
CLINICAL PHARMACOLOGY:
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 digo