LANOXIN (Page 7 of 7)

Infants and Children

In general, divided daily dosing is recommended for infants and young children (under age 10). In the newborn period, renal clearance of digoxin is diminished and suitable dosage adjustments must be observed. This is especially pronounced in the premature infant. Beyond the immediate newborn period, children generally require proportionally larger doses than adults on the basis of body weight or body surface area. Children over 10 years of age require adult dosages in proportion to their body weight. Some researchers have suggested that infants and young children tolerate slightly higher serum concentrations than do adults.

Daily maintenance doses for each age group are given in Table 6 and should provide therapeutic effects with minimum risk of toxicity in most patients with heart failure and normal sinus rhythm. These recommendations assume the presence of normal renal function:

Table 6. Daily Maintenance Doses in Children With Normal Renal Function


Daily Maintenance Dose (mcg/kg)

2 to 5 Years

10 to 15

5 to 10 Years

7 to 10

Over 10 Years

3 to 5

In children with renal disease, digoxin must be carefully titrated based upon clinical response.

It cannot be overemphasized that both the adult and pediatric dosage guidelines provided are based upon average patient response and substantial individual variation can be expected. Accordingly, ultimate dosage selection must be based upon clinical assessment of the patient.

Atrial Fibrillation

Peak digoxin body stores larger than the 8 to 12 mcg/kg required for most patients with heart failure and normal sinus rhythm have been used for control of ventricular rate in patients with atrial fibrillation. Doses of digoxin used for the treatment of chronic atrial fibrillation should be titrated to the minimum dose that achieves the desired ventricular rate control without causing undesirable side effects. Data are not available to establish the appropriate resting or exercise target rates that should be achieved.

Dosage Adjustment When Changing Preparations

The difference in bioavailability between LANOXIN Injection or LANOXIN Tablets must be considered when changing patients from one dosage form to the other.


LANOXIN (digoxin) Tablets, Scored 125 mcg (0.125 mg): Bottles of 100 with child-resistant cap (NDC 0173-0242-55) and 1,000 (NDC 0173-0242-75); unit dose pack of 100 (NDC 0173-0242-56). Imprinted with LANOXIN and Y3B (yellow).

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature] in a dry place and protect from light.

LANOXIN (digoxin) Tablets, Scored 250 mcg (0.25 mg): Bottles of 100 with child-resistant cap (NDC 0173-0249-55), 1,000 (NDC 0173-0249-75), and 5,000 (NDC 0173-0249-80); unit dose pack of 100 (NDC 0173-0249-56). Imprinted with LANOXIN and X3A (white).

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature] in a dry place.

LANOXIN and DIGIBIND are registered trademarks of GlaxoSmithKline

DIGIFAB is a registered trademark of Prostherics Inc.

Manufactured for


Research Triangle Park, NC 27709

by DSM Pharmaceuticals, Inc.

Greenville, NC 27834 or


Research Triangle Park, NC 27709

©2011, GlaxoSmithKline. All rights reserved.

November 2011


Principal Display Panel



Tablets, USP

100 Tablets

Each scored tablet contains

250 mcg (0.25 mg)

Rx only

See prescribing information for dosage information.

Store at 25o C (77o F) in a dry place (see insert).

Dispense in tight container as defined in the USP.

Do not use if printed safety seal under cap is broken or missing.

Manufactured by

DSM Pharmaceuticals, Inc.

Greenville, NC 27834 for


Research Triangle Park, NC 27709

Made in Germany


Rev. 9/08

55289098 Label
(click image for full-size original)

PDRx Label

digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-098(NDC:0173-0249)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code LANOXIN;X3A
# Item Code Package Description Multilevel Packaging
1 NDC:55289-098-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 07/02/1984
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack

Revised: 11/2011 PD-Rx Pharmaceuticals, Inc.

All resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.