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

Repackaged by Aphena Pharma Solutions — TN.
See Repackaging Information for available configurations.

Aphena Pharma Solutions -- TN

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

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count0.125mg 0.25mg
3043353-725-3043353-724-30
9043353-725-6043353-724-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20120727KRW

PRINCIPAL DISPLAY PANEL — 0.125mg

NDC 43353-725 — Digoxin (Lanoxin®) 0.125mg — Rx Only

Bottle Label 0.125mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.25mg

NDC 43353-724 — Digoxin (Lanoxin®) 0.25mg — Rx Only

Bottle Label 0.25mg
(click image for full-size original)

LANOXIN
digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-725(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:43353-725-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43353-725-60 90 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020405 09/14/1984
LANOXIN
digoxin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43353-724(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:43353-724-30 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:43353-724-60 90 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 — Aphena Pharma Solutions — Tennessee, Inc. (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, Inc. 128385585 Repack (43353-724) (43353-725)

Revised: 07/2012 Aphena Pharma Solutions — Tennessee, Inc.

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