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

Age

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.

HOW SUPPLIED

LANOXIN (digoxin) Tablets, Scored 125 mcg (0.125 mg): Imprinted with LANOXIN and Y3B (yellow).

Bottles of 30 NDC 54868-0790-2
Bottles of 60 NDC 54868-0790-5
Bottles of 100 NDC 54868-0790-3

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): Imprinted with LANOXIN and X3A (white).

Bottles of 30 NDC 54868-0683-2
Bottels of 60 NDC 54868-0683-4
Bottles of 100 NDC 54868-0683-1

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
GlaxoSmithKline
Research Triangle Park, NC 27709

by DSM Pharmaceuticals, Inc.
Greenville, NC 27834 or
GlaxoSmithKline
Research Triangle Park, NC 27709

©2009, GlaxoSmithKline. All rights reserved.

August 2009

LNT:1PI

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

Principal Display Panel

LANOXIN®

(digoxin)

Tablets, USP

Lanoxin Tablets label x125 mcg (0.125 mg)
(click image for full-size original)

Each scored tablet contains

125 mcg (0.125 mg)

Rx only

See prescribing information for dosage information.

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

Dispense in tight, light-resistant container as defined in the USP.

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

Principal Display Panel

LANOXIN®

(digoxin)

Tablets, USP

Lanoxin Tablets label x 250 mcg (0.25mg)
(click image for full-size original)

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.

LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0790(NDC:0173-0242)
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
STARCH, CORN
STARCH, POTATO
LACTOSE
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code LANOXIN;Y3B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0790-2 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0790-3 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0790-5 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 11/29/1994
LANOXIN digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0683(NDC:0173-0249)
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
STARCH, CORN
STARCH, POTATO
LACTOSE
MAGNESIUM STEARATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code LANOXIN;X3A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0683-1 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0683-2 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0683-4 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 11/28/1994
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.

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