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
Tenormin Indications, Dosage, Storage, Stability - Atenolol
Tenormin Indications, Dosage, Storage, Stability - Atenolol
INDICATIONS
Acute Myocardial Infarction: Atenolol is indicated in the
management of hemodynamically stable
patients with definite or suspected acute myocardial
infarction to reduce
cardiovascular mortality.
Treatment can be initiated as soon as the patient's clinical
condition allows. (See DOSAGE
AND ADMINISTRATION, CONTRAINDICATIONS
,
and WARNINGS.) In
general, there is no basis for
treating patients like those who were excluded from the ISIS-1 trial (blood
pressure less than 100 mm
Hg systolic, heart
rate less than 50 bpm) or have
other reasons to avoid beta blockade.
As noted above, some subgroups
(e.g., elderly patients with systolic
blood pressure below 120 mm
Hg) seemed less likely to benefit.
Tablets
Hypertension: Atenolol is indicated in the management of
hypertension. It may be used alone or concomitantly with other antihypertensive
agents, particularly with a thiazide-type diuretic.
Angina Pectoris Due to Coronary Atherosclerosis: Atenolol
is indicated for the long-term management of patients with angina
pectoris.
DOSAGE AND ADMINISTRATION
Tablets
Hypertension: The initial
dose of atenolol
is 50 mg given as one tablet
a day either alone or added to diuretic
therapy. The full effect of this dose
will usually be seen within one
to two weeks. If an optimal response
is not achieved, the dosage
should be increased to atenolol 100 mg
given as one tablet a day.
Increasing the dosage beyond
100 mg a day is unlikely to produce
any further benefit.
Atenolol may be used alone or concomitantly with other antihypertensive
agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa.
Angina Pectoris: The initial
dose of atenolol
is 50 mg given as one tablet
a day. If an optimal response
is not achieved within one week, the dosage
should be increased to atenolol
100 mg given as one tablet a day.
Some patients may require a dosage
of 200 mg once a day for optimal
effect.
Twenty-four hour control
with once daily dosing is achieved by giving doses larger than necessary
to achieve an immediate
maximum effect. The maximum
early effect on exercise
tolerance occurs with doses
of 50 to 100 mg, but at these doses the effect
at 24 hours is attenuated, averaging about 50% to 75% of that observed
with once a day oral doses of
200 mg.
Elderly Patients or Patients with Renal Impairment: Atenolol
is excreted by the kidneys; consequently dosage
should be adjusted in cases of severe impairment
of renal function. Some reduction
in dosage may also be appropriate
for the elderly, since decreased kidney function
is a physiologic consequence of aging. Atenolol excretion
would be expected to decrease with advancing age.
No significant accumulation
of atenolol occurs until
creatinine clearance falls
below 35 ml/min/1.73m2. Accumulation of atenolol
and prolongation of its half-life
were studied in subjects with creatinine
clearance between 5 and
105 ml/min. Peak plasma levels
were significantly increased in subjects with creatinine
clearances below 30 ml/min.
The following maximum oral
dosages are recommended for elderly, renally-impaired patients and for
patients with renal impairment
due to other causes. (See TABLE 4).
| TABLE 4 Dosage and Renal Impairment |
| Atenolol |
|
Creatinine Clearance
|
Elimination Half-Life |
|
|
(ml/min/1.73m2)
|
(h) |
Maximum Dosage
|
| 15 - 35 |
16 - 27 |
50 mg daily
|
| < 15 |
> 27 |
25 mg daily
|
Some renally-impaired or elderly patients being treated for hypertension
may require a lower starting dose
of atenolol: 25 mg given as one
tablet a day. If this 25 mg dose
is used, assessment of
efficacy must be made carefully. This should include measurement of blood
pressure just prior to the
next dose ("trough"
blood pressure) to ensure that
the treatment effect is present
for a full 24 hours.
Although a similar dosage
reduction may be considered
for elderly and/or renally-impaired patients being treated for indications
other than hypertension, data are not available for these patient
populations.
Patients on hemodialysis
should be given 25 mg or 50 mg
after each dialysis; this should be done under hospital
supervision as marked falls in blood pressure can occur.
Cessation of Therapy in Patients with Angina Pectoris:
If withdrawal of atenolol
therapy is planned, it should be achieved gradually and patients should
be carefully observed and advised to limit
physical activity to a minimum.
Tablets and I.V. Injection
Acute Myocardial Infarction: In
patients with definite or suspected acute
myocardial infarction,
treatment with atenolol
I.V. injection should be initiated as soon as possible after the patient's
arrival in the hospital and
after eligibility is established. Such treatment
should be initiated in a coronary care or similar unit
immediately after the patient's hemodynamic condition
has stabilized. Treatment should begin with the intravenous administration
of 5 mg atenolol
over 5 minutes followed by another 5 mg intravenous injection
10 minutes later. Atenolol I.V. injection
should be administered under carefully controlled conditions including
monitoring of blood pressure,
heart rate, and electrocardiogram.
Dilutions of atenolol I.V. injection
in dextrose injection, sodium
chloride injection, or sodium
chloride and dextrose injection
may be used. These admixtures are stable for 48 hours if they are not
used immediately.
In patients who tolerate the full intravenous
dose (10 mg), atenolol tablets
50 mg should be initiated 10 minutes
after the last intravenous dose followed by another 50 mg
oral dose
12 hours later. Thereafter, atenolol can be given orally either 100 mg
once daily or 50 mg twice a day
for a further 6-9 days or until discharge
from the hospital. If bradycardia
or hypotension requiring treatment
or any other untoward effects occur, atenolol should be discontinued.
Data from other beta-blocker trials suggest that if there is any question
concerning the use of I.V. beta-blocker or clinical
estimate that there is a contraindication, the I.V. beta-blocker may be
eliminated and patients fulfilling the safety criteria may be given atenolol
tablets 50 mg twice daily or 100
mg once a day for at least seven
days (if the I.V. dosing is excluded).
Although the demonstration of efficacy of atenolol
is based entirely on data from the first seven postinfarction days, data
from other beta-blocker trials suggest that treatment
with beta-blockers that are effective in the postinfarction setting may
be continued for one to three years if there are no contraindications.
Atenolol is an additional treatment
to standard coronary care
unit therapy.
HOW SUPPLIED
Tablets
25 mg Tenormin:
Round, flat, uncoated white
tablets identified with “T” debossed on one side
and 107 debossed on the other side.
50 mg Tenormin:
Round, flat, uncoated white
tablets identified with with “TENORMIN” debossed on one side
and 105 debossed on the other side, bisected.
100 mg Tenormin:
Round, flat, uncoated white
tablets identified with “TENORMIN” debossed on one side
and 101 debossed on the other side.
Storage
Tablets: Store at controlled room
temperature, 20-25°C (68-77°F). Dispense in well-closed, light
resistant containers.
I.V. Injection: Protect from light. Keep ampules in outer
packaging until time of use.
Store at room temperature.
Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to
administration, whenever solution
and container permit.
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