DIGITEK (Page 9 of 9)

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

DIGITEK ® (digoxin tablets, USP) is available containing 125 mcg (0.125 mg) or 250 mcg (0.25 mg) of digoxin, USP.

The 125 mcg (0.125 mg) tablets are yellow, round, scored, slope-faced tablets debossed with M above the score and 145 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 42292-003-20 — Unit dose blister packages of 100 (10 cards of 10 tablets each).

The 250 mcg (0.25 mg) tablets are white, round, scored, slope-faced tablets debossed with M above the score and 147 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 42292-002-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Store in a dry place. Protect from light. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

  • Advise patients that many drugs can interact with DIGITEK ® (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 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 DIGITEK ® (digoxin tablets) may be too high.
  • Advise parents or caregivers that the symptoms of having too high DIGITEK ® (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.
  • Instruct the patient to monitor and record their heart rate and blood pressure daily.

The brands listed are trademarks of their respective owners.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-12174 R4
9/19

PRINCIPAL DISPLAY PANEL – 125 mcg (0.125 mg)

NDC 42292-003-20

DIGITEK ®
(digoxin tablets, USP)
125 mcg
(0.125 mg)

100 Tablets (10 x 10)

Each tablet contains digoxin USP,
125 mcg (0.125 mg).

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Store in a dry place. Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-12173

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Digitek (digoxin tablets, USP) 125 mc (0.125 mg) Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 250 mcg (0.25 mg)

NDC 42292-002-20

DIGITEK ®
(digoxin tablets, USP)
250 mcg
(0.25 mg)

100 Tablets (10 x 10)

Each tablet contains digoxin USP,
250 mcg (0.25 mg).

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Store in a dry place. Protect from light.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-12172

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Digitek (digoxin tablets, USP) 250 mcg (0.25 mg) Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
DIGITEK digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-003(NDC:0378-6155)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.125 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
D&C YELLOW NO. 10
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code M;145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42292-003-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42292-003-01)
1 NDC:42292-003-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (42292-003-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040282 05/06/2015
DIGITEK digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42292-002(NDC:0378-6156)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIGOXIN (DIGOXIN) DIGOXIN 0.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code M;147
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42292-002-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42292-002-01)
1 NDC:42292-002-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (42292-002-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040282 05/06/2015
Labeler — Mylan Institutional Inc. (039615992)

Revised: 04/2020 Mylan Institutional Inc.

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