Source: Health Products and Food Branch (CA) Revision Year: 2014
NOCDURNA is indicated for treatment of nocturia in adults with four or less nocturnal voids. An insufficient number of adults with more than four nocturnal voids were studied to allow a conclusion on the efficacy of NOCDURNA in these subjects.1,2,3,4,5,17,24,26,27,28,29,30,31,32,44
Clinical studies of desmopressin in the elderly at higher doses and with different dosage forms have shown an increased risk of hyponatremia with age and declining creatinine clearance. Desmopressin acetate is known to be excreted by the kidney, and the risk of adverse reactions to desmopressin may be greater in patients with impaired renal function. Desmopressin is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).8 [See Clinical Pharmacology and Contraindications]
Use of NOCDURNA requires careful fluid restriction to prevent possible prolonged fluid retention and subsequent hyponatremia. Fluid restriction should be discussed with the patient.35 [See Warnings and Precautions)]
Although the efficacy and safety of desmopressin acetate for use in pediatric Primary Nocturnal Enuresis (PNE) have been established with other formulations of desmopressin acetate, NOCDURNA doses of 25 µg and 50 µg have not been studied in this population.
Patients should be instructed to limit fluid intake to a minimum from 1 hour before until 8 hours after administration. Overall fluid restriction should be observed. Treatment without concomitant reduction of fluid intake may lead to fluid retention and/or hyponatremia with or without accompanying warning signs and symptoms.
All patients should receive a baseline serum sodium test to confirm serum sodium is in normal range before treatment initiation. Remind patients over age 65 of the importance of adhering to the recommended sodium monitoring schedule. NOCDURNA should be discontinued if serum sodium is below normal range.3,4,5
Patients should be informed about the following signs and symptoms associated with hyponatremia: headache, nausea/vomiting, weight gain, restlessness, fatigue, tiredness, disorientation, muscle weakness, muscle spasms or cramps, and confusion. Desmopressin acetate treatment should be discontinued if serum sodium levels falls below 125mmol/L.
Patients should be informed that treatment should be stopped during acute intercurrent illnesses that can lead to fluid and/or electrolyte imbalance such as systemic infections (flu), fever, or chronic diarrhea. Caution patients about concomitant medications that can lead to hyponatremia.
| Women | 25 µg daily at bedtime administered sublingually |
| Men <65 | 50µg daily at bedtime administered sublingually |
| Men >65 | 50µg daily at bedtime administered sublingually with additional serum sodium monitoring o within 4-8 days after initiation and at one month of treatment |
If the patient misses a dose, the patient should be advised not to take the missed dose.
NOCDURNA is an orally disintegrating tablet taken sublingually.
Restricted fluid intake is recommended a few hours before administration, especially one hour before, and until the next morning (at least 8 hours) after administration.
Recommended doses of NOCDURNA should not be exceeded. Overdose leads to a prolonged duration of action with an increased risk of prolonged fluid retention and hyponatremia. Signs of overdose may include nausea, headache, drowsiness, confusion, and rapid weight gain due to fluid retention. [See Warnings and Precautions]
In case of overdose, therapy should be discontinued. There is no known specific antidote for desmopressin. Symptomatic patients should be observed and cases of hyponatremia should be treated appropriately.
Store at 25°C; excursions permitted to 15–30°C. Keep in original package to protect from moisture and light. Use immediately upon opening individual tablet blister.
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