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DESCRIPTION |
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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"). |
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Digoxin is described chemically as (3b,
5b, 12b)-3-[(O-2,6-dideoxy-b-D-ribo-hexopyranosyl-(1“4)-O-2,6-dideoxy-b-D-ribo-hexopyranosyl-(1“4)-2,6-dideoxy-b-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide.
Its molecular formula is C41H64O14,
and its molecular weight is 780.95. |
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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. |
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Tablets: Lanoxin 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 and the following inactive ingredients: corn and
potato starches, lactose, and magnesium stearate. In addition, the dyes used
in the 125-mcg (0.125-mg) tablets are D&C yellow no. 10 and FD&C yellow no.
6. |
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Capsules: Lanoxicaps is a stable solution of digoxin
enclosed within a soft gelatin capsule for oral use. Each capsule contains
the labeled amount of digoxin dissolved in a solvent comprised of
polyethylene glycol 400, 8% ethyl alcohol, propylene glycol, and purified
water. Inactive ingredients in the Lanoxin capsule shell include FD&C red
no. 40 (0.05-mg capsule), D&C yellow no. 10 (0.1-mg and 0.2-mg capsules),
FD&C blue no. 1 (0.2 mg capsule), gelatin, glycerin, methylparaben and
propylparaben (added as preservatives), purified water and sorbitol.
Capsules are printed with edible ink. |
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Pediatric Elixir: Lanoxin elixir pediatric is a stable
solution of digoxin specially formulated for oral use in infants and
children. Each ml contains 50 mg
(0.05 mg) digoxin. The lime-flavored elixir contains the inactive
ingredients alcohol 10%, methylparaben 0.1% (added as a preservative),
citric acid, D&C green no. 5 and yellow no. 10, flavor, propylene glycol,
sodium phosphate, and sucrose. Each package is supplied with a specially
calibrated dropper to facilitate the administration of accurate dosage even
in premature infants. Starting at 0.2 ml, this 1-ml dropper is marked in
divisions of 0.1 ml, each corresponding to 5 mg
(0.005 mg) digoxin. |
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Lanoxin Injection (Including Pediatric): Lanoxin
injection is a sterile solution of digoxin for intravenous 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% sodium phosphate and 0.08%
anhydrous citric acid. For Adult Injection:
Each 2-ml ampul contains 500 mg
(0.5 mg) digoxin (250 mg
[0.25 mg] per ml). For Pediatric Injection:
Each 1-ml ampul contains 100 mg
(0.1 mg) digoxin. Dilution is not required. |
