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Inspra (Eplerenone) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Patient Selection Considerations

Serum potassium levels should be measured before initiating INSPRA therapy, and INSPRA should not be prescribed if serum potassium is >5.5 mEq/L. [See CONTRAINDICATIONS (4) ].

Congestive Heart Failure Post-Myocardial Infarction

INSPRA is indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction ≤40%) and clinical evidence of congestive heart failure (CHF) after an acute myocardial infarction (MI).

Hypertension

INSPRA is indicated for the treatment of hypertension. INSPRA may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Congestive Heart Failure Post-Myocardial Infarction

Treatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. INSPRA may be administered with or without food.

Once treatment with INSPRA has begun, adjust the dose based on the serum potassium level as shown in Table 1.

Table 1. Dose Adjustment in Congestive Heart Failure Post-MI
Serum Potassium
(mEq/L)
Action Dose Adjustment
< 5.0 Increase 25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily
5.0—5.4 Maintain No adjustment
5.5—5.9 Decrease 50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold
≥ 6.0 Withhold Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L

Hypertension

The recommended starting dose of INSPRA is 50 mg administered once daily. The full therapeutic effect of INSPRA is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of INSPRA should be increased to 50 mg twice daily. Higher dosages of INSPRA are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. [See CLINICAL STUDIES.]

Recommended Monitoring

Serum potassium should be measured before initiating INSPRA therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. [See WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS.] In the EPHESUS study [See CLINICAL STUDIES], the majority of hyperkalemia was observed within the first three months after randomization.

In all patients taking INSPRA who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3—7 days.

Dose Modifications for Specific Populations

For hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of INSPRA should be reduced to 25 mg once daily. [See DRUG INTERACTIONS.]

No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. [See CLINICAL PHARMACOLOGY.]

DOSAGE FORMS AND STRENGTHS

  • 25 mg tablets: yellow diamond biconvex film-coated tablets debossed with Pfizer on one side and NSR over 25 on the other
  • 50 mg tablets: yellow diamond biconvex film-coated tablets debossed with Pfizer on one side and NSR over 50 on the other

HOW SUPPLIED/STORAGE AND HANDLING

INSPRA Tablets, 25 mg, are yellow diamond biconvex film-coated tablets. They are debossed with Pfizer on one side and NSR over 25 on the other. They are supplied as follows:

NDC Number Size
0025-1710-01 Bottle of 30 tablets
0025-1710-02 Bottle of 90 tablets
0025-1710-03 Hospital Unit Dose

INSPRA Tablets, 50 mg, are yellow diamond biconvex film-coated tablets. They are debossed with Pfizer on one side and NSR over 50 on the other. They are supplied as follows:

NDC Number Size
0025-1720-03 Bottle of 30 tablets
0025-1720-01 Bottle of 90 tablets

Store at 25C (77F); excursions permitted to 15—30C (59—86F) [See USP Controlled Room Temperature].

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