Digitek

[digoxin]

Table 5: Usual Daily Maintenance Dose Requirements (mcg) of Digoxin for Estimated Peak Body Stores of 10 mcg/ kg *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 clear-ance in infants or children. * If no loading dose administered. * 62.5 mcg = 0.0625 mg
Example:

Based on the above table, 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 digoxin tablets, usually taken after the morning meal. If no loading dose is administered, steady-state serum concentrations in this patient should be antici-pated at approximately 11 days.

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Infants and Children:

In general, divided daily dosing is recommended for infants and young children (under age 10). In the newborn peri-od, 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
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. Ac-cordingly, 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 undesir-able 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 Digoxin injection or Digoxin Solution in Capsules and Digoxin Pediatric Elixir or digoxin tablets must be con-sidered when changing patients from one dosage form to another.
Doses of 100 mcg (0.1 mg) and 200 mcg (0.2 mg) of Digoxin Solution in Capsules are approximately equivalent to 125-mcg (0.125-mg) and 250-mcg (0.25-mg) doses of digoxin tablets and Pediatric Elixir, respectively. (see table in CLINICAL PHARMACOLOGY: Pharmacokinetics).

HOW SUPPLIED

DIGITEK ® (digoxin tablets, USP) 125 mcg (0.125 mg) are yellow, round tablets, and imprinted with B 145 on the scored side of the tablet. They are available as follows:
NDC 62794-145-01 bottles of 100 tablets
NDC 62794-145-10 bottles of 1000 tablets
NDC 62794-145-56 bottles of 5000 tablets

DIGITEKª (digoxin tablets, USP) 250 mcg (0.25 mg) are white, round tablets, and imprinted with B 146 on the scored side of the tablet. They are available as follows: NDC 62794-146-01 bottles of 100 tablets
NDC 62794-146-10 bottles of 1000 tablets
NDC 62794-146-56 bottles of 5000 tablets

Store at 15° to 25° C (59° to 77° F) in a dry place and protect from light. Dispense in a tight, light-resistant container as defined in the USP.
REVISED NOVEMBER 2000 BKDGTK: R4
8070-02
Distributed by: BERTEK PHARMACEUTICALS INC. Sugar Land, TX 77478 USA
Manufactured by: AMIDE PHARMACEUTICAL, INC. 101 East Main Street, Little Falls, NJ 07424 USA
Daily Maintenance Dose Age (mcg/ kg)
2 to 5 years 10 to 15 5 to 10 years 7 to 10 Over 10 years 3 to 5
Lean Body Weight Number of Corrected Ccr kg 50 60 70 80 90 100 Days Before (mL/ min Steady-State per 70 kg)* lb 110 132 154 176 198 220 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
Digoxin Patients Placebo Patients
Adverse Experience (n= 123) (n= 125)

Cardiac Palpitation 1 4
Ventricular extrasystole 1 1
Tachycardia 2 1
Heart arrest 1 1
Gastrointestinal Anorexia 1 4
Nausea 4 2
Vomiting 2 1
Diarrhea 4 1
Abdominal pain 0 6
CNS Headache 4 4
Dizziness 6 5
Mental disturbances 5 1
Other Rash 2 1
Death 4 3 2

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