DIGOXIN- digoxin tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Medzinárodný Name):

DIGOXIN

Zloženie:

DIGOXIN 250 ug

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Digoxin Tablets are indicated for the treatment of mild to moderate heart failure. Digoxin Tablets increase left ventricular ejection fraction and improve 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 Tablets should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Digoxin Tablets are 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.

Prehľad produktov:

Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed "W 40" on Scored Side. Digoxin Tablets, USP 0.25 mg are White, Round, Scored Tablets, Debossed "WW 41" on Scored Side and are available in: 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. Digibind®   is a registered trademark of GlaxoSmithKline. DigiFab     is a registered trademark of Prostherics Inc. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised December 2011

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DIGOXIN- DIGOXIN TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
DIGOXIN TABLETS, USP
Revised 12/11
Rx Only
DESCRIPTION:
Digoxin Tablets, USP are 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 Tablets, USP are 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 starch
1500.
250 MCG (0.25 MG): anhydrous lactose, colloidal silicon dioxide, corn
starch, lactose monohydrate,
magnesium stearate and starch 1500.
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
41
64
14
concentration of calci