LANOXIN- digoxin tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Cardinal Health

INN (Jina la Kimataifa):

DIGOXIN

Tungo:

DIGOXIN 0.25 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, LANOXIN should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. Digoxin increases myocardial contractility in pediatric patients with heart failure. LANOXIN is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. LANOXIN is contraindicated in patients with: LANOXIN should be given to a pregnant woman only if clearly needed. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Animal reproduction studies have not been conducted with digoxin. There are not enough data from clinical trials to determine

Bidhaa muhtasari:

LANOXIN Tablets have “LANOXIN” on one side and are supplied as follows: Mcg Scored Color Imprint NDC 24987-xxx-xx Bottle/100 Bottle/1000 Unit dose/100 62.5 No Peach U3A 240-55 240-75 Not applicable 125 Yes Yellow Y3B 242-55 242-57 242-75 242-76 242-56 187.5 No Blue F3F 245-55 245-75 Not applicable 250 Yes White X3A 249-55 249-57 249-75 249-76 249-56 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) in a dry place and protect from light. Keep out of reach of children.

Idhini hali ya:

New Drug Application

Tabia za bidhaa

LANOXIN- DIGOXIN TABLET
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANOXIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LANOXIN.
LANOXIN (DIGOXIN) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1954
INDICATIONS AND USAGE
LANOXIN is a cardiac glycoside indicated for:
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DOSAGE AND ADMINISTRATION
LANOXIN dose is based on patient-specific factors (age, lean body
weight, renal function, etc.). See full prescribing
information. Monitor for toxicity and therapeutic effect. (2)
DOSAGE FORMS AND STRENGTHS
Unscored Tablets: 62.5 and 187.5 mcg. Scored Tablets 125 and 250 mcg
(3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The overall incidence of adverse reactions with digoxin has been
reported as 5-20%, with 15-20% of adverse events
considered serious. Cardiac toxicity accounts for about one-half,
gastrointestinal disturbances for about one-fourth, and
CNS and other toxicity for about one-fourth of these adverse events.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT COVIS PHARMACEUTICALS,
INC AT 1-866-488-4423 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2018
®
Treatment of mild to moderate heart failure in adults. (1.1)
Increasing myocardial contractility in pediatric patients with heart
failure. (1.2)
Control of resting ventricular rate in patients with chronic atrial
fibrillation in adults. (1.3)
Ventricular fibrillation. (4)
Known hypersensitivity to digoxin or other forms of digitalis. (4)
Risk of rapid ventricular response leading to ventricular fibrillation
in patients with AV accessory pathway. (5.1)
Risk of advanced or complete heart block in patients with sinus node
disease and AV block. (5.2)
Digoxin toxicity: Indicated by nausea, vomiting, visual disturbances,
and cardiac arrhythmias. Advanced age, low body
weight, impa