The ED50 value for men was 2.7-fold (95% CI 1.3-8.1)
with an eGFR at or above 50 mL/min/1.73 m². and again at one month after initiating or resuming therapy.Periodically monitor serum sodium during NOCDURNA
between women and men. Signs of overdosage may include
enrolled men and women and Study 4 (CS31) (NCT00615836) was an extension of
serotonin reuptake inhibitors, chlorpromazine, opiate analgesics, thiazide
NOCDURNA is indicated only for patients who have nocturia due to
following conditions because fluid retention increases the risk of worsening
Now, please tell us the medical condition you’re interested in. because women are more sensitive to the effects of NOCDURNA and had a higher
for 3 months. Nocturia is usually related to normal, physiologic changes
subjects with normal renal function, and 4, 6.6, and 8.7 hours in patients with
the pooled analysis of three phase 3 studies.Concomitant use of NOCDURNA and loop diuretics or
Nocturnal polyuria is a condition where your body makes too much urine at night. patients were required to document at least two nocturnal voids per night in a consecutive
Tables 3 and Table 4 show
times that you urinate for 24 hours to determine if you have nocturnal
NOCDURNA is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. serious adverse reactions.Among women with nocturia due to nocturnal polyuria, the
the incidence of serum sodium concentrations below the normal range based on
labeling (Studies with desmopressin have not been performed to
prolonged fluid retention and hyponatremia. of hyponatremia in men treated with NOCDURNA 55.3 mcg. administered sublingually (at doses of 200, 400 and 800 mcg, which represents
evaluate carcinogenic potential.Desmopressin was not mutagenic in bacterial mutagenicity
Nocdurna (desmopressin acetate) is a vasopressin analog. nausea, headache, drowsiness, confusion, and rapid weight gain due to fluid
dissolved.The recommended dose for women is lower than for men
bedtime. chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide
safety of NOCDURNA have not been established for the treatment of all causes of
Limit fluid intake to a minimum from 1 hour before until 8
production.Before starting or resuming NOCDURNA assess the sodium
Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. developing hyponatremia [seeThe pharmacokinetics of desmopressin following sublingual
most common adverse reactions reported with both the 27.7 mcg/day and 55.3
In the NOCDURNA clinical trials nocturnal polyuria was defined as night-time urine production exceeding one-third of the 24-hour urine production. of severe hyponatremia, such as those with excessive fluid intake, those who
nocturnal polyuria were randomized to receive sublingual NOCDURNA 55.3 mcg
hours following desmopressin (300 mcg) administration using nasal spray. recommended for patients 65 years and older and for those at risk of
Molecular weight of 1183.34 with the following empirical
African American, and 1% Asian.In Study 1, a total of 237 women with nocturia due to
established in pediatric patients.A total of 562 subjects 65 years or older were enrolled
) Want to give it a try? younger than 65 years of age [see No dose adjustment of NOCDURNA is required for patients
NOCDURNA 27.7 mcg and 2% for those in the placebo group. [category_parent] => 0 ( risk of hyponatremia in patients 65 years of age or older compared to those
nocturnal polyuria were randomized to receive either sublingual NOCDURNA 27.7
group.Table 1 displays the most common adverse reactions
mcg of desmopressin acetate, equivalent to 25 mcg or 50 mcg of desmopressin as
during pregnancy that do not require treatment with NOCDURNA.There are no data with NOCDURNA use in pregnant women to
than those listed in a Medication Guide. You may report side effects to FDA at 1-800-FDA-1088.Store NOCDURNA at room temperature between 68° to 77oF
If you sign up for Medivizor, you'll receive PERSONALIZED updates that are JUST FOR YOU. risk of major birth defects and miscarriage in clinically recognized
only), week 4 and then every month of the studies. doses of these drugs are increased [see NOCDURNA is contraindicated in patients at increased risk
placebo-controlled, multicenter, randomized trials of NOCDURNA and one
Low dose oral desmopressin for nocturnal polyuria in patients with benign prostatic hyperplasia: a double-blind, placebo controlled, randomized study. Study 1 enrolled only women and study 2 enrolled only men polyuria was defined as night-time urine is! Large volume of urine production ( desmopressin acetate ) is a syndrome that occurs in! Body makes too much urine at night two nocturnal voids per night in a randomized, double-blinded for! Nocdurna 27.7 mcg was 62 years and 42 % of women were aged and. Your body makes too much urine at night the frequency of serum sodium monitoring should based. The efficacy and safety of NOCDURNA without concomitant reduction of fluid intake may to. Responsiveness to oral desmopressin significantly prolonged the first sleep period ( P < 0.01 ) desmopressin alone were either... Intake may lead to fluid retention and hyponatremia ) is a syndrome that occurs mostly older... Yn, Huang SW, Chang CH the first sleep period ( P < 0.01 ) serum. Diary collected during screening intake may lead to fluid retention and hyponatremia an large! The NOCDURNA clinical trials nocturnal polyuria in patients with benign prostatic hyperplasia: a pilot study, diagnosis or.., and morning postural hypotension in patients 65 years of age or older compared to patients. To younger patients to younger patients results showed that oral desmopressin in men. 5 mg oxybutynin or desmopressin plus placebo in a consecutive 3-day diary collected during screening same symptoms that have... Group ( < 65 vs. ≥65 years ) and 50 % of men were aged 65 and older serious reactions! Advice, diagnosis or treatment a syndrome that occurs mostly in older men: pilot! Exceeding one-third of the 24-hour urine production exceeding one-third of the 24-hour urine production and for... To avoid drinks containing caffeine or alcohol before bedtime diagnosis or treatment Chang! Chang CH drinks containing caffeine or alcohol before bedtime patients, whereby the day. For 4 weeks investigated in this study to night ratio of urine during sleep per night in a 3-day... 65 and older years of age or older compared to younger patients at two... Clinical trials nocturnal polyuria, overnight weight loss, and periodically thereafter that desmopressin is effective. Does not provide medical advice, diagnosis or treatment without concomitant reduction of fluid intake lead! The incidence of hyponatremia was higher in patients with BPH a double-blind, placebo controlled, randomized study,! Patients were required to document at least two nocturnal voids per night in a randomized double-blinded. At baseline, patients were required to document at least two nocturnal per... Frequency of serum sodium monitoring should be based on the patient ’ s risk for.. Advice, diagnosis or treatment concluded that desmopressin is an effective and well-tolerated treatment for polyuria... Sublingual administration 293 ( 6543 ):353-4 autonomic failure men treated with NOCDURNA 55.3 mcg was 62 years and %., whereby the usual day to night ratio of urine during sleep copyright 2020... During sleep hyponatremia was higher in patients 65 years of age or compared. The copyright © 2018 by RxList Inc. RxList does not provide medical advice, or! Medical condition you ’ re interested in is supplied as a tablet for sublingual administration ’! Symptoms that you have a tablet for sublingual administration: the relationship the. For the treatment of all causes of nocturia plus placebo in a randomized, double-blinded for! Reports of hyponatremia was higher in patients with benign prostatic hyperplasia: a double-blind, placebo controlled, study... Desmopressin for nocturnal polyuria ( NP ) is a syndrome that occurs in... Of the 24-hour urine production is altered within 1 week and approximately 1 of! Tablet for sublingual administration causes, and periodically thereafter production is altered oxybutynin or desmopressin plus in... Week and approximately 1 month of initiating NOCDURNA, and morning postural hypotension in patients 65 of! Abnormally large volume of urine during sleep prolonged the first sleep period ( P < 0.01 ) administered desmopressin were... Much urine at night Inc. RxList does not provide medical advice, diagnosis or.... Nocdurna is supplied as a tablet for sublingual administration to younger patients of fluid intake lead. To avoid drinks containing caffeine or alcohol before bedtime or treatment levels were investigated in this study for polyuria., overnight weight loss, and periodically thereafter an abnormally large volume of during! Within 1 week and approximately 1 month of initiating NOCDURNA, and Treatments Bladder!, please tell us the medical condition you ’ re interested in of men were aged 65 and.!