Lanoxin

[Digoxin]

Table 5: Usual Daily Maintenance Dose Requirements (mcg) of LANOXIN for Estimated Peak Body Stores of 10 mcg/kg
Lean Body Weight
Corrected C crkg50 60 70 80 90100 Number of Days Before

(mL/min per 70 kg)* lb 110 132 154 176 198 220 Steady State Achieved †
0 62.5 ‡ 125 125 125 187.5 187.5 22 10 125 125 125 187.5 187.5 187.5 19
20 125 125 187.5 187.5 187.5 250 16 30 125 187.5 187.5 187.5 250 250 14
40 125 187.5 187.5 250 250 250 13 50 187.5 187.5 250 250 250 250 12
60 187.5 187.5 250 250 250 375 11 70 187.5 250 250 250 250 375 10
80 187.5 250 250 250 375 375 9 90 187.5 250 250 250 375 500 8
100 250 250 250 375 375 500 7 *Ccr is creatinine clearance, corrected to 70 kg body weight or 1.73 m 2 body surface area. For adults, if only serum creatinine concentrations (Scr) are available, a Ccr (corrected to 70 kg body weight) may be estimated in men as (140 -Age)/Scr. For women, this result should be multiplied by 0.85. Note: This equation cannot be used for estimating creatinine clearance in infants or children.
† If no loading dose administered. ‡
62.5 mcg = 0.0625 mg

Example:

Text Continues Below

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Based on Table 5, a patient in heart failure with an estimated lean body weight of 70 kg and a Ccr of 60 mL/min should be given a dose of 250 mcg (0.25 mg) daily of LANOXIN Tablets, usually taken after the morning meal. If no loading dose is administered, steady-state serum concentrations in this patient should be anticipated at approximately 11 days.

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 LANOXICAPS and LANOXIN Elixir Pediatric or LANOXIN Tablets must be considered when changing patients from one dosage form to another. Doses of 100 mcg (0.1 mg) and 200 mcg (0.2 mg) of LANOXICAPS are approximately equivalent to 125-mcg (0.125-mg) and 250-mcg (0.25-mg) doses of LANOXIN Tablets and Elixir Pediatric, respectively (see Table 1 in CLINICAL PHARMACOLOGY: Pharmacokinetics).

HOW SUPPLIED

LANOXIN (digoxin) Tablets, Scored 125 mcg (0.125 mg): Bottles of 100 with child-resistant cap (NDC 0173-0242-55) and 1000 (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), 1000 (NDC 0173-0249-75), and 5000 (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 (digoxin) Tablets, USP

GlaxoSmithKline Research Triangle Park, NC 27709
©2001, GlaxoSmithKline All rights reserved.
August 2001 RL-972

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