NEODOSE

INDICATIONS

• Bronchopulmonary dysplasia: Used in combination with other diuretics in the treatment of BPD (situations of increased aldosterone secretion).
• Heart Failure:
  • Aldosterone antagonist therapy is reasonable for treatment of chronic systolic HF when renal function is normal, or mildly impaired. Spironolactone is the typical agent used as an add-on to ACE inhibitor and beta-blocker therapy when such therapy has not improved ventricular function or reversed ventricular remodeling.
  • Use is not recommended in treatment of HF with preserved ejection fraction.
  • Also may be used cautiously for pulmonary hypertension as supportive care in neonates with signs of right-sided heart failure.

CONTRAINDICATIONS

Contraindicated with concomitant use of eplerenone, and in patients with hyperkalemia, or Addison disease.

PRECAUTIONS

• Endocrine and metabolic:
  • Asymptomatic hyperuricemia may occur and rarely precipitate gout.
  • Excessive diuresis may lead to symptomatic dehydration, hypotension, and worsening renal function with an increased risk in salt-depleted patients or those taking ACE inhibitors or angiotensin II receptor blockers.
  • Gynecomastia may occur and is usually reversible. Risk increases in a dose-dependent manner.
  • Hyperkalemia may occur. Increased risk in patients with impaired renal function or concomitant use of potassium supplementation, potassiumcontaining salt substitutes, or drugs that increase potassium (eg, ACE inhibitors and angiotensin receptor blockers). Dose adjustment or discontinuation may be necessary.
  • Hypomagnesemia, hyponatremia, or hypocalcemia may occur.
  • Hypochloremic alkalosis or hyperglycemia may occur.
• Renal:
  • Worsening renal function may occur with increased risk in patients taking concomitant nephrotoxic drugs (eg aminoglycosides, cisplatin, and NSAIDs).

ADVERSE EFFECTS

Rashes, vomiting, diarrhea, paresthesias, hyponatremia, hypovolemia. Dose-dependent androgenic effects in females. Gynecomastia in males. Headaches, nausea, and drowsiness. Use with caution in patients with impaired renal function. May cause false positive ELISA screening tests for congenital adrenal hyperplasia.

ADMINISTRATION

The National Institute for Occupational Safety and Health (NIOSH) recommends the use of single gloves by anyone handling intact tablets or capsules or administering from a unit-dose package. In the preparation of tablets or capsules, including cutting, crushing, or manipulating, or the handling of uncoated tablets, NIOSH recommends the use of double gloves and a protective gown. Prepare in a ventilated control device, if possible. Use respiratory protection if not prepared in a control device. During administration, wear single gloves, and wear eye/face protection if the formulation is hard to swallow or if the patient may resist, vomit, or spit up.

MONITORING

Follow serum potassium closely during long-term therapy. Also, measuring urinary potassium is a useful indicator of effectiveness.