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Atenolol

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Tenormin

INDICATIONS

Hypertension

TENORMIN (atenolol tablets) 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

TENORMIN (atenolol tablets) is indicated for the long-term management of patients with angina pectoris.

Acute Myocardial Infarction

TENORMIN (atenolol tablets) 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 (eg, elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.

DOSAGE AND ADMINISTRATION

Hypertension

The initial dose of TENORMIN (atenolol tablets) 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 TENORMIN (atenolol tablets) 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit.

TENORMIN (atenolol tablets) 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 TENORMIN (atenolol tablets) 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 TENORMIN (atenolol tablets) 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.

Acute Myocardial Infarction

In patients with definite or suspected acute myocardial infarction, treatment with TENORMIN (atenolol tablets) 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 TENORMIN (atenolol tablets) over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. TENORMIN (atenolol tablets) I.V. Injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of TENORMIN (atenolol tablets) I.V. Injection in Dextrose Injection USP, Sodium Chloride Injection USP, 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), TENORMIN (atenolol tablets) Tablets 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, TENORMIN (atenolol tablets) 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, TENORMIN (atenolol tablets) should be discontinued. (See full prescribing information prior to initiating therapy with TENORMIN (atenolol tablets) Tablets.)

Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given TENORMIN (atenolol tablets) Tablets 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded).

Although the demonstration of efficacy of TENORMIN (atenolol tablets) 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.

TENORMIN (atenolol tablets) is an additional treatment to standard coronary care unit therapy.

Elderly Patients or Patients with Renal Impairment

TENORMIN (atenolol tablets) is excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Evaluation of patients with hypertension or myocardial infarction should always include assessment of renal function. Atenolol excretion would be expected to decrease with advancing age.

No significant accumulation of TENORMIN (atenolol tablets) 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:

Creatinine Clearance (mL/min/1.73m2) Atenolol Elimination Half-Life (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 TENORMIN (atenolol tablets) : 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 TENORMIN (atenolol tablets) therapy is planned, it should be achieved gradually and patients should be carefully observed and advised to limit physical activity to a minimum.

HOW SUPPLIED

TENORMIN Tablets

Tablets of 25 mg atenolol, NDC 0310-0107 (round, flat, uncoated white tablets identified with "T" debossed on one side and 107 debossed on the other side) are supplied in bottles of 100 tablets.

Tablets of 50 mg atenolol, NDC 0310-0105 (round, flat, uncoated white tablets identified with "TENORMIN (atenolol tablets) " debossed on one side and 105 debossed on the other side, bisected) are supplied in bottles of 100 tablets.

Tablets of 100 mg atenolol, NDC 0310-0101 (round, flat, uncoated white tablets identified with "TENORMIN (atenolol tablets) " debossed on one side and 101 debossed on the other side) are supplied in bottles of 100 tablets.

Storage

Store at controlled room temperature, 20-25°C (68-77°F) [see USP]. Dispense in well-closed, light-resistant containers. TENORMIN (atenolol tablets) is a trademark of the Astrazeneca group of companies ©AstraZeneca 2001, 2003, 2004, 2008 Manufactured for: AstraZeneca Pharmaceuticals LP

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. By: IPR Pharmaceuticals, Inc. Carolina, PR 00984. FDA Rev date: 04/29/08

Last reviewed on RxList: 11/1/2010
This monograph has been modified to include the generic and brand name in many instances.

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