A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lanoxin Indications, Dosage, Storage, Stability - Digoxin
Lanoxin Indications, Dosage, Storage, Stability - Digoxin
INDICATIONS
Heart Failure: Digoxin is indicated for the treatment of
mild to moderate heart failure.
Digoxin increases left ventricular
ejection fraction and improves heart
failure symptoms as evidenced
by exercise capacity and
heart failure-related hospitalizations
and emergency care, while having no effect
on mortality. Where possible, digoxin
should be used with a diuretic and an angiotensin-converting enzyme
inhibitor, but an optimal order
for starting these 3 drugs cannot be specified.
Atrial Fibrillation: Digoxin is indicated for the control
of ventricular response
rate in patients with chronic
atrial fibrillation.
DOSAGE AND ADMINISTRATION
General
Recommended dosages of digoxin
may require considerable modification because of individual sensitivity
of the patient to the drug,
the presence of associated conditions, or the use of concurrent medications.
In selecting a dose of digoxin,
the following factors must be considered:
1. The body weight
of the patient. Doses should be calculated based upon lean
(i.e., ideal) body weight.
2. The patient's renal
function, preferably evaluated on the basis of estimated creatinine
clearance.
3. The patient's age. Infants and children require different doses
of digoxin than adults. Also,
advanced age may be indicative
of diminished renal function
even in patients with normal
serum creatinine
concentration (i.e., below 1.5 mg/dl).
4. Concomitant disease
states, concurrent medications, or other factors likely to alter the pharmacokinetic
or pharmacodynamic profile of digoxin
(see PRECAUTIONS).
Additional Information for Capsules
Due to the more complete absorption
of digoxin from soft
capsules, recommended oral doses are only 80% of those for tablets and
elixir.
Because the significance of the higher peak serum
concentrations associated with once daily capsules is not established,
divided daily dosing is presently recommended for:
1. Infants and children under 10 years of age.
2. Patients requiring a daily dose
of 300 mcg (0.3 mg) or greater.
3. Patients with a previous history of digitalis
toxicity.
4. Patients considered likely to become toxic.
5. Patients in whom compliance
is not a problem.
Where compliance is considered
a problem, single daily dosing may be appropriate.
Additional Information for Injection and Pediatric Injection
Parenteral administration
of digoxin should be used
only when the need for rapid digitalization
is urgent or when the drug cannot
be taken orally. Intramuscular injection
can lead to severe pain
at the injection site, thus
intravenous administration
is preferred. If the drug must
be administered by the intramuscular
route, it should be injected
deep into the muscle followed
by massage. No more than 500 mcg
(2 ml) [200 mcg (2 ml) for pediatric
injection] should be injected
into a single site.
Digoxin injection can be
administered undiluted or diluted with a fourfold or greater volume
of sterile water
for injection, 0.9% sodium
chloride injection, or 5% dextrose
injection. The use of less than a fourfold volume of diluent
could lead to precipitation
of the digoxin. Immediate use of the diluted product
is recommended.
If tuberculin syringes
are used to measure very small
doses, one must be aware of the problem of inadvertent overadministration
of digoxin. The syringe should not be flushed with the parenteral
solution after its contents
are expelled into an indwelling
vascular catheter.
Slow infusion of digoxin
injection is preferable
to bolus administration. Rapid
infusion of digitalis
glycosides has been shown to cause
systemic and coronary arteriolar constriction, which may be clinically
undesirable. Caution is thus advised and digoxin
injection should probably
be administered over a period
of 5 minutes or longer. Mixing of digoxin
injection with other drugs
in the same container or
simultaneous administration
in the same intravenous
line is not recommended.
Serum Digoxin Concentrations
In general, the dose of digoxin
used should be determined on clinical grounds. However, measurement of
serum digoxin
concentrations can be helpful to the clinician
in determining the adequacy of digoxin
therapy and in assigning certain probabilities to the likelihood of digoxin
intoxication. About two-thirds of adults considered adequately digitalized
(without evidence of toxicity) have serum
digoxin concentrations ranging
from 0.8 to 2.0 ng/ml. However, digoxin
may produce clinical benefits
even at serum concentrations
below this range. About two-thirds of adult
patients with clinical toxicity
have serum digoxin
concentrations greater than 2.0 ng/ml. However, since one-third of patients
with clinical toxicity have
concentrations less than 2.0 ng/ml, values below 2.0 ng/ml do not rule
out the possibility that a certain sign
or symptom is related to digoxin
therapy. Rarely, there are patients who are unable to tolerate digoxin
at serum concentrations below
0.8 ng/ml. Consequently, the serum
concentration of digoxin
should always be interpreted in the overall clinical
context, and an isolated measurement should not be used alone as the basis
for increasing or decreasing the dose
of the drug.
To allow adequate time for equilibration
of digoxin between serum
and tissue, sampling of serum
concentrations should be done just before the next scheduled dose
of the drug. If this is not possible, sampling
should be done at least 6 to 8 hours after the last dose, regardless of
the route of administration
or the formulation used. On a once-daily dosing schedule, the concentration
of digoxin will
be 10% to 25% lower when sampled at 24 versus 8 hours, depending upon
the patient's renal function.
On a twice-daily dosing schedule, there will
be only minor differences in
serum digoxin concentrations
whether sampling is done
at 8 or 12 hours after a dose.
If a discrepancy exists between the reported serum
concentration and the
observed clinical response,
the clinician should consider
the following possibilities:
1. Analytical problems in the assay procedure.
2. Inappropriate serum
sampling time.
3. Administration of a digitalis
glycoside other than digoxin.
4. Conditions (described in WARNINGS
and PRECAUTIONS) causing an alteration
in the sensitivity of the patient
to digoxin.
5. Serum digoxin concentration
may decrease acutely during periods of exercise
without any associated change in clinical
efficacy due to increased binding of digoxin
to skeletal muscle.
Heart Failure
Adults
Digitalization may be accomplished by either of two general approaches
that vary in dosage and frequency
of administration, but reach the same endpoint in terms of total amount
of digoxin accumulated in
the body.
1. If rapid digitalization
is considered medically appropriate, it may be achieved by administering
a loading dose
based upon projected peak digoxin
body stores. Maintenance dose
can be calculated as a percentage of the loading
dose.
2. More gradual digitalization
may be obtained by beginning an appropriate maintenance dose, thus allowing
digoxin body stores to accumulate
slowly. Steady-state serum digoxin
concentrations will be achieved
in approximately five half-lives of the drug
for the individual patient. Depending upon the patient's renal
function, this will take
between 1 and 3 weeks.
Rapid Digitalization with a Loading Dose
Peak digoxin body stores
of 8 to 12 mcg/kg should provide therapeutic effect with minimum
risk of toxicity in most patients
with heart failure and normal
sinus rhythm. Because of altered
digoxin distribution
and elimination, projected peak body stores for patients with renal
insufficiency should be conservative
(i.e., 6 to 10 mcg/kg). (See PRECAUTIONS.)
The loading dose
should be administered in several portions, with roughly half the total
given as the first dose. Additional fractions of this planned total dose
may be given at 6- to 8-hour intervals, with careful assessment of
clinical response
before each additional dose. If the patient's clinical response
necessitates a change from the calculated loading
dose of digoxin, then calculation of the maintenance dose
should be based upon the amount actually given.
Capsules: A single initial
dose of 400 to 600 mcg
(0.4 to 0.6 mg) of digoxin
capsules usually produces a detectable effect
in 0.5 to 2 hours that becomes maximal in 2 to 6 hours. Additional capsule
doses of 100 to 300 mcg (0.1 to
0.3 mg) may be given cautiously at 6- to 8-hour intervals until clinical
evidence of an adequate effect
is noted. The usual amount of digoxin
capsules that a 70-kg patient
requires to achieve 8 to 12 mcg/kg peak body stores is 600 to 1000 mcg
(0.6 to 1.0 mg).
Tablets: A single initial
dose of 500 to 750 mcg
(0.5 to 0.75) of digoxin tablets
usually produces a detectable effect
in 0.5 to 2 hours that becomes maximal in 2 to 6 hours. Additional tablet
doses of 125 to 375 mcg (0.125
to 0.375 mg) may be given cautiously at 6- to 8-hour intervals until clinical
evidence of an adequate effect
is noted. The usual amount of digoxin
tablets that a 70-kg patient
requires to achieve 8 to 12 mcg/kg peak body stores is 750 to 1250 mcg
(0.75 to 1.25 mg).
Injection: A single initial
intravenous dose
of 400 to 600 mcg (0.4 to 0.6
mg) of digoxin injection
usually produces a detectable effect in 5 to 30 minutes that becomes maximal
in 1 to 4 hours. Additional doses of 100 to 300 mcg
(0.1 to 0.3 mg) may be given cautiously at 6- to 8-hour intervals until
clinical evidence
of an adequate effect is noted.
The usual amount of digoxin
injection that a 70-kg patient
requires to achieve 8- to 12-mcg/kg peak body stores is 600 to 1000 mcg
(0.6 to 1.0 mg).
Digoxin injection is frequently
used to achieve rapid digitalization, with conversion
to digoxin tablets or digoxin
capsules for maintenance therapy. If patients are switched from intravenous
to oral digoxin
formulations, allowances must be made for differences in bioavailability
when calculating maintenance dosages (see TABLE
1).
Note: Intramuscular injection
of digoxin is extremely painful
and offers no advantages unless other routes of administration are contraindicated.
Maintenance Dosing
The doses of digoxin tablets
used in controlled trials in patients with heart failure
have ranged from 125 to 500 mcg
(0.125 to 0.5 mg) once daily. In these studies, the digoxin
dose has been generally titrated
according to the patient's age, lean
body weight, and renal function.
Therapy is generally initiated at a dose
of 250 mcg (0.25 mg) once daily
in patients under age 70 with
good renal function, at a dose
of 125 mcg (0.125 mg) once daily
in patients over age 70 or with
impaired renal function, and
at a dose of 62.5 mcg
(0.0625 mg) in patients with marked renal
impairment. Doses may be increased every 2 weeks according to clinical
response.
In a subset of approximately 1800 patients enrolled in the DIG trial
(wherein dosing was based on an algorithm
similar to that in TABLE 5) the mean (±SD)
serum digoxin
concentrations at 1 month and 12 months were 1.01 ±
0.47 ng/ml and 0.97 ± 0.43 ng/ml, respectively.
The maintenance dose should
be based upon the percentage of the peak body stores lost each day through
elimination. The following formula
has had wide clinical use:
Maintenance Dose = Peak Body Stores (i.e., Loading Dose)
´ % Daily Loss/100 Where:
% Daily Loss = 14 + Ccr/5
(Ccr is creatinine clearance,
corrected to 70 kg body weight
or 1.73 m2 body surface
area).
TABLE 5 provides average
daily maintenance dose requirements
of digoxin capsules for patients with heart
failure based upon lean
body weight and renal function.
TABLE 6 provides this information for digoxin
tablets and TABLE 7 provides this information
for digoxin injection.
| TABLE 5 Usual Daily Maintenance Dose Requirements
(mcg) of Digoxin Capsules for Estimated Peak Body Stores of 10 mcg/kg |
| |
Lean Body Weight |
|
| Corrected Ccr |
kg |
50 |
60 |
70 |
80 |
90 |
100 |
|
| (ml/min per
70 kg)* |
lb |
110 |
132 |
154 |
176 |
198 |
220 |
Number of Days Before Steady State Achieved† |
| |
|
50‡ |
100 |
100 |
100 |
150 |
150 |
22 |
| 10 |
|
100 |
100 |
100 |
150 |
150 |
150 |
19 |
| 20 |
|
100 |
100 |
150 |
150 |
150 |
200 |
16 |
| 30 |
|
100 |
150 |
150 |
150 |
200 |
200 |
14 |
| 40 |
|
100 |
150 |
150 |
200 |
200 |
250 |
13 |
| 50 |
|
150 |
150 |
200 |
200 |
250 |
250 |
12 |
| 60 |
|
150 |
150 |
200 |
200 |
250 |
300 |
11 |
| 70 |
|
150 |
200 |
200 |
250 |
250 |
300 |
10 |
| 80 |
|
150 |
200 |
200 |
250 |
300 |
300 |
9 |
| 90 |
|
150 |
200 |
250 |
250 |
300 |
350 |
8 |
| 100 |
|
200 |
200 |
250 |
300 |
300 |
350 |
7 |
| * Ccr is creatinine
clearance, corrected to 70 kg body weight
or 1.73 m2 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. |
| ‡ 50 mcg= 0.05 mg. |
Example: 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 200 mcg (0.2 mg) daily of digoxin
capsules, usually taken as a divided dose
of one 100-mcg (0.1-mg) capsule
after the morning and evening meals. If no loading
dose is administered, steady-state
serum concentrations in this
patient should be anticipated
at approximately 11 days.
| TABLE 6 Usual Daily Maintenance Dose
Requirements (mcg) of Digoxin Tablets for Estimated Peak Body Stores
of 10 mcg/kg |
| |
Lean Body Weight |
|
| Corrected Ccr |
kg |
50 |
60 |
70 |
80 |
90 |
100 |
|
| (ml/min per
70 kg)* |
lb |
110 |
132 |
154 |
176 |
198 |
220 |
Number of Days Before Steady State Achieved† |
| |
|
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 m2 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: Based on TABLE 6, a patient
in heart failure
with an estimated lean body weight
of 70 kg and a Ccr of 60 ml/min should be given dose
of 250 mcg (0.25 mg daily), 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.
|
TABLE 7 Usual Daily Maintenance Dose Requirements (mcg) of
Digoxin Injection for Estimated Peak Body Stores of 10 mcg/kg*
|
| |
Lean Body Weight |
|
| Corrected Ccr |
kg |
50 |
60 |
70 |
80 |
90 |
100 |
|
| (ml/min per
70 kg)† |
lb |
110 |
132 |
154 |
176 |
198 |
220 |
Number of Days Before Steady State Achieved‡ |
| |
|
75§ |
75 |
100 |
100 |
125 |
150 |
22 |
| 10 |
|
75 |
100 |
100 |
125 |
150 |
150 |
19 |
| 20 |
|
100 |
100 |
125 |
150 |
150 |
175 |
16 |
| 30 |
|
100 |
125 |
150 |
150 |
175 |
200 |
14 |
| 40 |
|
100 |
125 |
150 |
175 |
200 |
225 |
13 |
| 50 |
|
125 |
150 |
175 |
200 |
225 |
250 |
12 |
| 60 |
|
125 |
150 |
175 |
200 |
225 |
250 |
11 |
| 70 |
|
150 |
175 |
200 |
225 |
250 |
275 |
10 |
| 80 |
|
150 |
175 |
200 |
250 |
275 |
300 |
9 |
| 90 |
|
150 |
200 |
225 |
250 |
300 |
325 |
8 |
| 100 |
|
175 |
200 |
250 |
275 |
300 |
350 |
7 |
| * Daily maintenance doses have
been rounded to the nearest 25-mcg increment. |
| † Ccr is creatinine
clearance, corrected to 70 kg body weight
or 1.73 m2 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. |
| § 75 mcg
= 0.075 mg. |
Example: Based on TABLE 7, 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 175 mcg (0.175 mg) daily of
digoxin injection. 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 these
patients, where dosage adjustment
is frequent and outside the fixed dosages available, digoxin
capsules may not be the formulation of choice. 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
8 and TABLE 9 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 8 Usual Digitalizing and Maintenance Dosages for Digoxin
Capsules in Children with Normal Renal Function Based on Lean
Body Weight
|
| Age |
Digitalizing* Dose (mcg/kg) |
Daily Maintenance Dose† (mcg/kg) |
| 2-5 Years |
25-35 |
25%- 35% of |
| 5-10 Years |
15-30 |
the oral
or IV |
| Over 10 Years |
8-12 |
digitalizing dose‡ |
| * IV
digitalizing doses are the same as digitalizing doses of digoxin
capsules. |
| † Divided daily dosing is recommended
for children under 10 years of age. |
| ‡ Projected or actual
digitalizing dose providing desired clinical
response. |
|
TABLE 9 Daily Maintenance Doses of Digoxin Tablets in Children
with Normal Renal Function
|
| Age |
Daily Maintenance Dose (mcg/kg) |
| 2-5 Years |
10-15 |
| 5-10 Years |
7-10 |
| Over 10 Years |
3-5 |
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.
Additional Information for Pediatric Elixir and Pediatric Injection
Digitalization may be accomplished by either of two general approaches
that vary in dosage and frequency
of administration, but reach the same endpoint in terms of total amount
of digoxin accumulated in
the body.
1. If rapid digitalization
is considered medically appropriate, it may be achieved by administering
a loading dose
based upon projected peak digoxin
body stores. Maintenance dose
can be calculated as a percentage of the loading
dose.
2. More gradual digitalization
may be obtained by beginning an appropriate maintenance dose, thus allowing
digoxin body stores to accumulate
slowly. Steady-state serum digoxin
concentrations will be achieved
in approximately five half-lives of the drug
for the individual patient. Depending upon the patient's renal
function, this will take
between 1 and 3 weeks.
Rapid Digitalization with a Loading Dose
Digoxin injection pediatric
can be used to achieve rapid digitalization, with conversion
to an oral formulation of digoxin
for maintenance therapy. If patients are switched from intravenous
to oral digoxin
formulations, allowances must be made for differences in bioavailability
when calculating maintenance dosages (see TABLE
1 and TABLE 10).
Intramuscular injection
of digoxin is extremely painful
and offers no advantages unless other routes of administration
are contraindicated.
Peak digoxin body stores
of 8 to 12 mcg/kg should provide therapeutic effect with minimum
risk of toxicity in most patients
with heart failure and normal
sinus rhythm. Because of altered
digoxin distribution
and elimination, projected peak body stores for patients with renal
insufficiency should be conservative
(i.e., 6 to 10 mcg/kg). (See PRECAUTIONS.)
Digitalizing and daily maintenance doses for each age
group are given in TABLE
10 and should provide therapeutic
effect with minimum
risk of toxicity in most patients
with heart failure
and normal sinus
rhythm. These recommendations assume the presence of normal
renal function.
The loading dose
should be administered in several portions, with roughly half the total
given as the first dose. Additional fractions of this planned total dose
may be given at 6- to 8-hour intervals, with careful assessment of
clinical response
before each additional dose. If the patient's clinical response
necessitates a change from the calculated loading
dose of digoxin, then calculation of the maintenance dose
should be based upon the amount actually given.
|
TABLE 10 Usual Digitalizing and Maintenance Dosages for Digoxin
Elixir Pediatric in Children with Normal Renal Function Based
on Lean Body Weight
|
| Age |
Oral Digitalizing* Dose (mcg/kg) |
IV Digitializing Dose (mcg/kg) |
Daily Maintenance Dose† (mcg/kg) |
| Premature |
20 to 30 |
15 to 25 |
20% to 30% of oral [or IV] digitalizing dose‡ |
| Full-Term |
25 to 35 |
20 to 30 |
|
| 1 to 24 Months |
35 to 60 |
30 to 50 |
|
| 2 to 5 Years |
30 to 40 |
25 to 35 |
25% to 35% of oral [or IV] digitalizing dose‡ |
| 5 to 10 Years |
20 to 35 |
15 to 30 |
|
| Over 10 Years |
10 to 15 |
8 to 12 |
|
| * IV
digitalizing doses are 80% of oral digitalizing doses. |
| † Divided daily dosing is recommended
for children under 10 years of age. |
| ‡ Projected or actual
digitalizing dose providing clinical
response. |
In children with renal disease,
digoxin dosing must be carefully
titrated based upon desired clinical
response.
Gradual Digitalization with a Maintenance Dose
More gradual digitalization
can also be accomplished by beginning an appropriate maintenance dose.
The range of percentages provided
in TABLE 9 can be used in calculating this dose
for patients with normal renal
function.
It cannot be overemphasized that these pediatric
dosage guidelines 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 absolute bioavailability
of the capsule formulation
is greater than that of the standard
tablets and very near that of the intravenous
dosage form. As a result, the doses recommended for digoxin
capsules are the same as those for digoxin
injection (see TABLE
1). Adjustments in dosage
will seldom be necessary when converting a patient
from the intravenous formulation
to digoxin capsules. The difference
in bioavailability between digoxin injection or capsules and elixir
pediatric or 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 digoxin
capsules are approximately equivalent
to 125-mcg (0.125-mg) and 250-mcg (0.25-mg) doses of digoxin
tablets and elixir pediatric,
respectively (see TABLE 1).
HOW SUPPLIED
Oral
Lanoxin Tablets, Scored 125 mcg
(0.125 mg): Imprinted with Lanoxin
and Y3B (yellow).
Lanoxin Tablets, Scored 250 mcg
(0.25 mg): Imprinted with Lanoxin and X3A (white).
Lanoxicaps 50 mcg (0.05
mg): Imprint A2C (red).
Lanoxicaps 100 mcg (0.1
mg): Imprint B2C (yellow).
Lanoxicaps 200 mcg (0.2
mg): Imprint C2C (green).
Lanoxin Elixir Pediatric: 50 mcg
(0.05 mg) per ml; bottle of 60
ml with calibrated dropper.
Storage: Store at 25°C (77°F); excursions permitted
to 15-30°C (59-86°F) in a dry place and protect from light.
Injection
Lanoxin Injection: 500 mcg
(0.5 mg) in 2 ml (250 mcg
[0.25 mg] per ml).
Lanoxin Injection Pediatric: 100 mcg
(0.1 mg) in 1 ml.
Storage: Store at 15-25°C (59-77°F) and protect
from light.
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