Silvergate Pharmaceuticals, Inc.

Silvergate Pharmaceuticals, Inc. Drugs

• Epaned
  

  ×

  Epaned

  

  ---

  2.1 Hypertension

  Adults: The recommended initial dose in adults is 5 mg once a day. Titrate upward to maximum of 40 mg daily as needed to help achieve blood pressure goals. The dose may be divided and administered twice daily if the antihypertensive effect diminishes at the end of the dosing interval.

  Use with diuretics: If additional blood pressure reduction is needed, EPANED may be administered with a low dose of diuretic. The recommended initial dose in patients taking diuretics is 2.5 mg daily.

  Dosage Adjustment for Renal Impairment: See table below. The dosage may be titrated upward as needed to a maximum of 40 mg daily.

  * [See Warnings and Precautions (5.2)]. † Dosage on nondialysis days should be adjusted depending on the blood pressure response.

  Renal Status

  Creatinine-Clearance mL/min

  Initial Dose mg/day

  Normal or Mild Impairment of Renal Function

            >30 mL/min          

  5 mg

  Moderate to Severe Impairment     

  ≤30 mL/min

  2.5 mg

  Dialysis Patients*

  –

       2.5 mg on dialysis days†     

  Children >1 month: The usual recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily. Dosage should be adjusted according to blood pressure response. Doses above 0.58 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].

  EPANED is not recommended in neonates and in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, as no data are available.

  2.2 Heart Failure

  Generally, the recommended initial dose is 2.5 mg twice a day titrated up to a maximum of 20 mg twice a day, as tolerated. Doses are usually given in combination with diuretics and digitalis.

  In patients with hyponatremia (serum sodium less than 130 mEq/L) or serum creatinine greater than 1.6 mg/dL, the recommended initial dose is 2.5 mg once daily.

  Diuretic dose may need to be adjusted to minimize hypovolemia and hypotension. The appearance of hypotension after the initial dose of EPANED does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

  2.3 Asymptomatic Left Ventricular Dysfunction

  The recommended initial dose is 2.5 mg twice a day titrated up to a maximum of 10 mg twice a day, as tolerated. Diuretic dose may need to be adjusted [see Dosage and Administration (2.1)].

  2.4 Preparation of EPANED (for 150 mL, 1 mg/mL enalapril solution)

  EPANED Powder for Oral Solution is a kit containing 1 bottle of enalapril powder and 1 bottle of Ora-Sweet SF diluent to be added to the enalapril powder prior to dispensing to the patient.

  Firmly tap the EPANED Powder for Oral Solution bottle on a hard surface 5 times. Add approximately one-half (75 mL) of the Ora-Sweet SF diluent to the 150 mL EPANED Powder for Oral Solution bottle. Replace the child-resistant cap. Shake well for 30 seconds. Reopen. Add the remainder of the Ora-Sweet SF diluent to the EPANED Powder for Oral Solution bottle, replace the child-resistant cap and shake well for an additional 30 seconds. Calculate 60 days from the date of reconstitution. Write this date as the discard date on the front of the label. Affix a “Do Not Use After” or a “Discard After” label with the calculated date added to the reconstituted EPANED bottle.

  Close
  More Info