Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Noctiva for Frequent Urination

FDA news release; 2017 Mar 3

The FDA has approved Noctiva (desmopressin acetate) nasal spray for frequent urination at night in adults due to overproduction of urine.

Indications: Noctiva is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Dosage/administration: Prime with 5 actuations before initial use if not use for more than 3 days.

  • For patients aged <65 years who are not at increased risk for hyponatremia: Use 1 spray of 1.66 mcg in either nostril nightly approximately 30 minutes before going to bed.
  • For patients ≥65 years or younger patients at risk for hyponatremia: Use 0.83 mcg nightly, which can be increased to one spray of 1.66 mcg after at least 7 days, if needed, provided the serum sodium has remained normal.

Adverse reactions: Common adverse reactions in clinical trials (incidence >2%) included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension/blood pressure increased, back pain, epistaxis, bronchitis and dizziness.

Citation:

US Food and Drug Administration. FDA approves first treatment for frequent urination at night due to overproduction of urine. FDA Web site. March 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm. Accessed March 10, 2017.

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