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The following adverse reactions are discussed in greater detail in other sections of the labeling:
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.
Congestive 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 adverse event at similar rates in either treatment group (4.4% INSPRA vs. 4.3% placebo), with the most common reasons for discontinuation being hyperkalemia, MI, and abnormal renal function.
Adverse reactions that occurred more frequently in patients treated with INSPRA than placebo were hyperkalemia (3.4% vs. 2.0%) and increased creatinine (2.4% vs. 1.5%). Discontinuations due to hyperkalemia or abnormal renal function were less than 1.0% in both groups.
INSPRA has been evaluated for safety in 3091 patients treated for hypertension. A total of 690 patients were treated for over 6 months and 106 patients were treated for over 1 year.
In placebo-controlled studies, the overall rates of adverse events were 47% with INSPRA and 45% with placebo. Adverse events occurred at a similar rate regardless of age, gender, or race. Therapy was discontinued due to an adverse event in 3% of patients treated with INSPRA and 3% of patients given placebo. The most common reasons for discontinuation of INSPRA were headache, dizziness, angina pectoris/MI, and increased GGT.
Gynecomastia and abnormal vaginal bleeding were reported with INSPRA but not with placebo. The rates increased with increasing duration of therapy.
The following adverse reactions have been identified during postapproval use of INSPRA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin: angioneurotic edema, rash
Clinical Laboratory Test Findings
Congestive Heart Failure Post-Myocardial Infarction
Creatinine: Increases of more than 0.5 mg/dL were reported for 6.5% of patients administered INSPRA and for 4.9% of placebo-treated patients.
Potassium: In EPHESUS [see Clinical Studies], the frequencies of patients with changes in potassium ( < 3.5 mEq/L or > 5.5 mEq/L or ≥ 6.0 mEq/L) receiving INSPRA compared with placebo are displayed in Table 2.
Table 2:Hypokalemia ( < 3.5 mEq/L) or Hyperkalemia
( > 5.5 or ≥ 6.0 mEq/L) in EPHESUS
|< 3.5||273 (8.4)||424 (13.1)|
|> 5.5||508 (15.6)||363 (11.2)|
|≥ 6.0||180 (5.5)||126 (3.9)|
Rates of hyperkalemia increased with decreasing renal function.
Table 3: Rates of Hyperkalemia ( > 5.5 mEq/L) in
EPHESUS by Baseline Creatinine Clearance*
|Baseline Creatinine Clearance||INSPRA
|< 30 mL/min||160 (32)||82 (23)|
|31-50 mL/min||122 (24)||46 (13)|
|51-70 mL/min||86 (17)||48 (13)|
|> 70 mL/min||56 (11)||32 (9)|
|* Estimated using the Cockroft-Gault formula.|
Potassium: In placebo-controlled fixed-dose studies, the mean increases in serum potassium were dose-related and are shown in Table 4 along with the frequencies of values > 5.5 mEq/L.
Table 4: Increases in Serum Potassium in the
Placebo-Controlled, Fixed-Dose Hypertension Studies of INSPRA
|Daily Dosage||n||Mean Increase mEq/L||% > 5.5 mEq/L|
Read the Inspra (eplerenone) Side Effects Center for a complete guide to possible side effects
In post-MI CHF 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 and CLINICAL PHARMACOLOGY].
ACE Inhibitors And Angiotensin II Receptor Antagonists
The risk of hyperkalaemia increase 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, especially in patients at risk for impaired renal function, e.g., the elderly [see WARNINGS AND PRECAUTIONS].
A drug interaction study of eplerenone with lithium has not been conducted. Lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics and ACE inhibitors. Serum lithium levels should be monitored frequently if INSPRA is administered concomitantly with lithium.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
A drug interaction study of eplerenone with an NSAID has not been conducted. The administration of other potassium-sparing antihypertensives with NSAIDs has been shown to reduce the antihypertensive effect in some patients and result in severe hyperkalemia in patients with impaired renal function. Therefore, when INSPRA and NSAIDs are used concomitantly, monitor blood pressure and serum potassium levels.
Read the Inspra Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/16/2016
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Report Problems to the Food and Drug Administration
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