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Tenormin I.V. (Atenolol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Acute Myocardial Infarction

TENORMIN 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

Acute Myocardial Infarction

In patients with definite or suspected acute myocardial infarction, treatment with TENORMIN 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 over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. TENORMIN I.V. Injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of TENORMIN 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 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 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 should be discontinued. (See full prescribing information prior to initiating therapy with TENORMIN 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 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 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 is an additional treatment to standard coronary care unit therapy.

Elderly Patients or Patients with Renal Impairment

Since TENORMIN is excreted via the kidneys, dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of TENORMIN occurs until creatinine clearance falls below 35 mL/min/1.73m2 (normal range is 100-150 mL/min/1.73m2); therefore, the following maximum oral dosages are recommended for patients with renal impairment.

Creatinine Clearance

(mL/min/1.73m2)

Atenolol

Elimination Half-life

(h)

Maximum Dosage

15-35

16-27

50 mg daily

<15

>27

50 mg every other day

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.

Patients on hemodialysis should be given 50 mg after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Cessation of Therapy

If withdrawal of TENORMIN therapy is planned, it should be achieved gradually over a period of about two weeks. Patients should be carefully observed and advised to limit physical activity to a minimum.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

TENORMIN I.V. Injection

TENORMIN I.V. Injection, NDC 0310-0108, is supplied as 5 mg atenolol in 10 mL ampules of isotonic citrate-buffered aqueous solution.

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