Nocdurna (desmopressin acetate) is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults. NOCDURNA (desmopressin acetate) sublingual tablets are available as:
27.7 mcg of desmopressin acetate (equivalent to 25 mcg of desmopressin): White, round, sublingual tablet with "25" on one side.
NDC 55566-5050-1 Carton of 30 sublingual tablets (3 blister packs with 10 tablets each)
55.3 mcg of desmopressin acetate (equivalent to 50 mcg of desmopressin): White, round, sublingual tablet with "50" on one side.
NDC 55566-5070-1 Carton of 30 sublingual tablets (3 blister packs with 10 tablets each)
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. Keep in original package to protect from moisture and light. Use immediately upon opening individual tablet blister. These highlights do not include all the information needed to use NOCDURNA ® safely and effectively. See full prescribing information for NOCDURNA.
NOCDURNA (desmopressin acetate) sublingual tablets
Initial U.S. Approval: 1978
See full prescribing information for complete boxed warning.
NOCDURNA can cause hyponatremia, which may be life-threatening if severe (5.1)
NOCDURNA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids. (4, 5.1)
Ensure serum sodium concentration is normal before starting or resuming NOCDURNA. Measure serum sodium within 1 week and approximately 1 month after initiating therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia (2.2,5.1)
If hyponatremia occurs, NOCDURNA may need to be temporarily or permanently discontinued (5.1)
INDICATIONS AND USAGE
NOCDURNA 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. (1)
DOSAGE AND ADMINISTRATION
Dosing Information (2.1):
Women: 27.7 mcg daily, one hour before bedtime, administered sublingually without water
Men: 55.3 mcg daily, one hour before bedtime, administered sublingually without water
DOSAGE FORMS AND STRENGTHS
Sublingual Tablets: 27.7 mcg of desmopressin acetate (equivalent to 25 mcg of desmopressin) and 55.3 mcg of desmopressin acetate (equivalent to 50 mcg of desmopressin) (3)
Hyponatremia or a history of hyponatremia (4)
Concomitant use with loop diuretics or systemic or inhaled glucocorticoids (4)
Estimated glomerular filtration rate below 50 mL/min/1.73 m2 (4)
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (4)
During illnesses that can cause fluid or electrolyte imbalance (4)
Heart failure (4)
Uncontrolled hypertension (4)
WARNINGS AND PRECAUTIONS
Limit fluid intake to a minimum from 1 hour before until 8 hours after administration. Treatment without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia (5.1)
Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention. (5.2)
Common adverse reactions (> 2% incidence) included dry mouth, hyponatremia or blood sodium decreased, and dizziness. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Monitor serum sodium more frequently when NOCDURNA is concomitantly used with drugs that may increase the risk of hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, NSAIDs, lamotrigine, chlorpropamide and, carbamazepine). (7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy: Use of NOCDURNA is not recommended (8.1)
Geriatric use: Increased risk of hyponatremia if 65 years of age or older. Monitor serum sodium more frequently (8.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.