Noctiva Approved to Treat Nighttime Urination
March 3, 2017 – The U.S. FDA approved Noctiva™ (desmopressin) nasal spray, manufactured by Serenity Pharmaceuticals. Noctiva is indicated to treat adults who have nocturnal polyuria. Also called nocturia, the condition wakes patients with the need to urinate twice or more during the night. An analog of the hormone vasopressin, Noctiva temporarily increases the amounts of water the kidneys reabsorb to decrease urine output during the night. Recommended dosing is one spray per day around a half an hour before bedtime. It will be dispensed in containers holding a 30-day supply of either 0.83mcg or 1.66mcg strength. A boxed warning on its labeling and a Medication Guide for patients caution that it may cause hyponatremia (abnormally low levels of blood sodium). Before it is prescribed, the patient should have a 24-hour urine collection test to measure nighttime urine production. Patients using it will need to have sodium levels checked before starting Noctiva, within one week, after one month and then at regular intervals. Several other brand and generic desmopressin products, including oral, injectable and nasal forms, are available in the United States, however, only Noctiva currently is approved for treating patients with nocturia.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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