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INSPRA
CHF and arrhythmias
Hypertension
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Drug Name:

INSPRA Rx

Generic Name and Formulations:
Eplerenone 25mg, 50mg; tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for INSPRA:

To improve survival of stable patients with left ventricular systolic dysfunction (ejection fraction ≤40%) and clinical evidence of CHF after acute MI.

Adult:

Initially 25mg once daily; titrate within 4 weeks to 50mg once daily. Adjust based on serum K+ (see full labeling).

Children:

Not recommended.

Pharmacological Class:

Aldosterone receptor blocker (mineralocorticoid-selective).

Contraindications:

Hyperkalemia (serum K+ >5.5mEq/L) at initiation, severe renal impairment (CrCl ≤30mL/min), or concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir).

Warnings/Precautions:

Severe hepatic impairment. Renal dysfunction. Serum creatinine >2mg/dL (males) or >1.8mg/dL (females), CrCl ≤ 50mL/min, or diabetes with proteinuria. Monitor serum K+ at baseline, within 1st week, at 1 month after starting and after dose adjustment, then periodically. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

CYP3A4 inhibitors (see Contraindications and Dose). NSAIDs may antagonize antihypertensive effects. Angiotensin II receptor blockers, ACEIs increase hyperkalemia risk. Monitor lithium.

Adverse Reactions:

Hyperkalemia, dizziness, diarrhea, abdominal pain, cough, fatigue, flu-like symptoms, albuminuria; increased serum creatinine, triglycerides, cholesterol; decreased serum sodium; rare: sex hormone related effects, increased BUN, uric acid, liver enzymes.

How Supplied:

Tabs—30, 90


Indications for INSPRA:

Hypertension.

Adult:

Initially 50mg once daily; may increase after 4 weeks to max 50mg twice daily. Concomitant weak CYP3A4 inhibitors (eg, erythromycin, verapamil, saquinavir, fluconazole): initially 25mg once daily. Adjust based on serum K+ (see full labeling).

Children:

Not recommended.

Pharmacological Class:

Aldosterone receptor blocker (mineralocorticoid-selective).

Contraindications:

Hyperkalemia (serum K+ >5.5mEq/L) at initiation, severe renal impairment (CrCl ≤30mL/min), or concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir). Type 2 diabetes with microalbuminuria, CrCl<50mL/min, serum creatinine >2mg/dL (males), >1.8mg/dL (females), or concomitant K+ supplements or K+ sparing diuretics.

Warnings/Precautions:

Severe hepatic impairment. Renal dysfunction. Monitor serum K+ at baseline, within 1st week, at 1 month after starting and after dose adjustment, then periodically. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

CYP3A4 inhibitors (see Contraindications and Dose). NSAIDs may antagonize antihypertensive effects. Angiotensin II receptor blockers, ACEIs increase hyperkalemia risk. Monitor lithium.

Adverse Reactions:

Hyperkalemia, dizziness, diarrhea, abdominal pain, cough, fatigue, flu-like symptoms, albuminuria; increased serum creatinine, triglycerides, cholesterol; decreased serum sodium; rare: sex hormone related effects, increased BUN, uric acid, liver enzymes.

How Supplied:

Tabs—30, 90


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