Inspra 25 mg/1
eplerenone · TABLET, FILM COATED · Viatris Specialty LLC
Inspra is a tablet, film coated containing eplerenone at 25 mg/1, taken oral. Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- Inspra
- Generic Name
- eplerenone
- NDC Code (Product)
58151-142- Manufacturer
- Viatris Specialty LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021437
- Drug Class
- Aldosterone Antagonist [EPC]
- Marketing Start
- 04/19/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE INSPRA is an aldosterone antagonist indicated for: • Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) • The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2 ) 1.1 Heart Failure Post-Myocardial Infarction INSPRA is indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension INSPRA is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION HFrEF Post-MI: Initiate treatment with 25 mg once daily. Titrate to maximum of 50 mg once daily within 4 weeks, as tolerated. Dose adjustments may be required based on potassium levels. ( 2.1 ) Hypertension: 50 mg once daily, alone or combined with other antihypertensive agents. For inadequate response, increase to 50 mg twice daily. Higher dosages are not recommended. ( 2.2 ) For all patients: Measure serum potassium before starting INSPRA and periodically thereafter. ( 2.3 ) 2.1 Heart Failure Post-Myocardial Infarction Initiate treatment at 25 mg once daily and titrate to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. 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 Heart Failure Post-MI Serum Potassium (mEq/L) Dose Adjustment <5.0 25 mg every other day to 25 mg once daily 25 mg once daily to 50 mg once daily 5.0-5.4 No adjustment 5.5-5.9 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 and restart at 25 mg every other day when potassium l…
Contraindications
4 CONTRAINDICATIONS For All Patients INSPRA is contraindicated in all patients with: • serum potassium >5.5 mEq/L at initiation, • creatinine clearance ≤30 mL/min, or • concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir) [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ] . For Patients Treated for Hypertension INSPRA is contraindicated for the treatment of hypertension in patients with: • type 2 diabetes with microalbuminuria, • serum creatinine >2.0 mg/dL in males or >1.8 mg/dL in females, • creatinine clearance <50 mL/min, or • concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) [see Warnings and Precautions (5.1) , Adverse Reactions (6.2) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ] . For all patients: • Serum potassium >5.5 mEq/L at initiation ( 4 ) • Creatinine clearance ≤30 mL/min ( 4 ) • Concomitant use with strong CYP3A inhibitors ( 4 , 7.1 ) For the treatment of hypertension: • Type 2 diabetes with microalbuminuria ( 4 ) • Serum creatinine >2.0 mg/dL in males, …
Drug Interactions
7 DRUG INTERACTIONS • CYP3A Inhibitors: In post-MI HFrEF patients, do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, erythromycin, saquinavir, fluconazole). In patients with hypertension, initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily. ( 2.4 , 7.1 , 12.3 ) 7.1 CYP3A Inhibitors Eplerenone metabolism is predominantly mediated via CYP3A. Do not use INSPRA with drugs that are strong inhibitors of CYP3A [see Contraindications (4) and Clinical Pharmacology (12.3) ] . In post-MI HFrEF patients taking a moderate CYP3A inhibitor, do not exceed 25 mg once daily. In patients with hypertension taking a moderate CYP3A inhibitor, initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily [see Dosage and Administration (2.3 , 2.4) and Clinical Pharmacology (12.3) ] . 7.2 ACE Inhibitors and Angiotensin II Receptor Antagonists The risk of hyperkalemia increases when eplerenone is used in combination with an ACE inhibitor and/or an ARB. A close monitoring of serum potassium and renal function is recommended, espe…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hyperkalemia [see Warnings and Precautions (5.1) ] HFrEF Post-MI: Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine. ( 6.1 ) Hypertension: In clinical studies, adverse reactions with INSPRA were uncommon. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Heart Failure Post-Myocardial Infarction In EPHESUS, safety was evaluated in 3307 patients treated with INSPRA and 3301 placebo-treated patients. The overall incidence of adverse events reported with INSPRA (78.9%) was similar to placebo (79.5%). Adverse events occurred at a similar rate regardless of age, gender, or race. Patients discontinued treatment due to an advers…
Frequently Asked Questions
What is Inspra used for?
Inspra contains eplerenone. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Inspra a controlled substance?
Inspra is not classified as a controlled substance by the DEA.
What is the generic name for Inspra?
The generic name for Inspra is eplerenone. There are 11 other brand versions of eplerenone.
What is the NDC code for Inspra 25 mg/1?
The NDC (National Drug Code) for Inspra 25 mg/1 is 58151-142, listed by Viatris Specialty LLC.