Digoxin (Page 8 of 8)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Digoxin showed no genotoxic potential in in vitro studies (Ames test and mouse lymphoma). No data are available on the carcinogenic potential of digoxin, nor have studies been conducted to assess its potential to affect fertility.

14 CLINICAL STUDIES

14.1 Chronic Heart Failure

Two 12-week, double-blind, placebo-controlled studies enrolled 178 (RADIANCE trial) and 88 (PROVED trial) adult patients with NYHA Class II or III heart failure previously treated with oral digoxin, a diuretic, and an ACE inhibitor (RADIANCE only) and randomized them to placebo or treatment with Digoxin Tablets. Both trials demonstrated better preservation of exercise capacity in patients randomized to Digoxin Tablets. Continued treatment with Digoxin Tablets reduced the risk of developing worsening heart failure, as evidenced by heart failure-related hospitalizations and emergency care and the need for concomitant heart failure therapy.

DIG Trial of Digoxin Tablets in Patients with Heart Failure

The Digitalis Investigation Group (DIG) main trial was a 37-week, multicenter, randomized, double-blind mortality study comparing digoxin to placebo in 6800 adult patients with heart failure and left ventricular ejection fraction less than or equal to 0.45. At randomization, 67% were NYHA class I or II, 71% had heart failure of ischemic etiology, 44% had been receiving digoxin, and most were receiving a concomitant ACE inhibitor (94%) and diuretics (82%). As in the smaller trials described above, patients who had been receiving open-label digoxin were withdrawn from this treatment before randomization. Randomization to digoxin was again associated with a significant reduction in the incidence of hospitalization, whether scored as number of hospitalizations for heart failure (relative risk 75%), risk of having at least one such hospitalization during the trial (RR 72%), or number of hospitalizations for any cause (RR 94%). On the other hand, randomization to digoxin had no apparent effect on mortality (RR 99%, with confidence limits of 91-107%).

14.2 Chronic Atrial Fibrillation

Digoxin has also been studied as a means of controlling the ventricular response to chronic atrial fibrillation in adults. Digoxin reduced the resting heart rate, but not the heart rate during exercise.

In 3 different randomized, double-blind trials that included a total of 315 adult patients, digoxin was compared to placebo for the conversion of recent-onset atrial fibrillation to sinus rhythm. Conversion was equally likely, and equally rapid, in the digoxin and placebo groups. In a randomized 120-patient trial comparing digoxin, sotalol, and amiodarone, patients randomized to digoxin had the lowest incidence of conversion to sinus rhythm, and the least satisfactory rate control when conversion did not occur.

In at least one study, digoxin was studied as a means of delaying reversion to atrial fibrillation in adult patients with frequent recurrence of this arrhythmia. This was a randomized, double-blind, 43-patient crossover study. Digoxin increased the mean time between symptomatic recurrent episodes by 54%, but had no effect on the frequency of fibrillatory episodes seen during continuous electrocardiographic monitoring.

16 HOW SUPPLIED/STORAGE AND HANDLING

Digoxin Tablets, USP 0.125 mg are Yellow, Round, Scored Tablets, Debossed “W 40″ on Scored Side

Bottles of 100 tablets.
Bottles of 1000 tablets.
Bottles of 5000 tablets.

Digoxin Tablets, USP 0.25 mg are White, Round, Scored Tablets, Debossed “WW 41″ on Scored Side

Bottles of 100 tablets.
Bottles of 1000 tablets.
Bottles of 5000 tablets.

Store in a dry place at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] and protect from light. Keep out of reach of children.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

17 PATIENT COUNSELING INFORMATION

  • Advise patients that digoxin is a cardiac glycoside used to treat heart failure and heart arrhythmias.

  • Instruct patients to take this medication as directed by their physician.

  • Advise patients that many drugs can interact with Digoxin Tablets. Instruct patients to inform their doctor and pharmacist if they are taking any over the counter medications, including herbal medication, or are started on a new prescription.

  • Advise patient that blood tests will be necessary to ensure that their Digoxin Tablets dose is appropriate for them.

  • Advise patients to contact their doctor or a health care professional if they experience nausea, vomiting, persistent diarrhea, confusion, weakness, or visual disturbances (including blurred vision, green-yellow color disturbances, halo effect) as these could be signs that the dose of Digoxin Tablets may be too high.

  • Advise parents or caregivers that the symptoms of having too high Digoxin Tablets doses may be difficult to recognize in infants and pediatric patients. Symptoms such as weight loss, failure to thrive in infants, abdominal pain, and behavioral disturbances may be indications of digoxin toxicity.

  • Suggest to the patient to monitor and record their heart rate and blood pressure daily.

  • Instruct women of childbearing potential who become or are planning to become pregnant to consult a physician prior to initiation or continuing therapy with Digoxin Tablets.

Manufactured By:
West-Ward Pharmaceutical Corp.
Eatontown, NJ 07724

Revised March 2015

PRINCIPAL DISPLAY PANEL

NDC 0143-1240-01
Digoxin Tablets, USP
125 mcg (0.125 mg)
Rx Only100 Tablets

NDC 0143-1240-01 Digoxin Tablets, USP 125 mcg (0.125 mg) Rx Only 100 Tablets
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-1241-01
Digoxin Tablets, USP
250 mcg (0.25 mg)
Rx Only100 Tablets

NDC 0143-1241-01 Digoxin Tablets, USP 250 mcg (0.25 mg) Rx Only 100 Tablets
(click image for full-size original)

DIGOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-1240
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 125 ug
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color YELLOW (YELLOW) Score 2 pieces
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code W;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-1240-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0143-1240-10 1000 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:0143-1240-51 5000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077002 10/30/2007
DIGOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-1241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 250 ug
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (WHITE) Score 2 pieces
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code WW41
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-1241-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0143-1241-10 1000 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:0143-1241-51 5000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077002 10/30/2007
Labeler — West-Ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
West-ward Pharmaceutical Corp 001230762 MANUFACTURE (0143-1240), MANUFACTURE (0143-1241)

Revised: 03/2015 West-Ward Pharmaceutical Corp

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