DIGOXIN tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Rebel Distributors Corp

INN（国际名称）:

DIGOXIN

组成:

DIGOXIN 0.125 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. Newborn infants display considerable variability in their tolerance to digoxin. Premature and immature infants are particularly sensitive to the effec

產品總結:

Digoxin Tablets, 0.125 mg: Bottles of 30 with child-resistant cap (NDC 21695-678-30).

授权状态:

Abbreviated New Drug Application

产品特点

DIGOXIN- DIGOXIN TABLET
REBEL DISTRIBUTORS CORP
----------
DIGOZIN
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
INACTIVE INGREDIENT
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 and C yellow No 10
aluminum lake, FD and C yellow No 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
41
64
14
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 di