NOCDURNA- desmopressin acetate tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Available from:

Ferring Pharmaceuticals Inc.

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

NOCDURNA is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. In the NOCDURNA clinical trials nocturnal polyuria was defined as night-time urine production exceeding one-third of the 24-hour urine production. Before starting NOCDURNA: - Evaluate the patient for possible causes for the nocturia, including excessive fluid intake prior to bedtime, and address other treatable causes of nocturia. - Confirm the diagnosis of nocturnal polyuria with a 24-hour urine collection, if one has not been obtained previously. NOCDURNA is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: - Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1)] . - Polydipsia - Concomitant use with loop diuretics [see Warnings and Precautions (5.1)] - Concomitant use with systemic or inhaled glucocorticoids [see Warnings and Precautions (5.2), Drug Interactions (7.1)] - Renal impairment with estimate

Product summary:

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. 55.3 mcg of desmopressin acetate (equivalent to 50 mcg of desmopressin): White, round, sublingual tablet with "50 " on one side. 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.

Authorization status:

New Drug Application

Patient Information leaflet

Ferring Pharmaceuticals Inc.
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MEDICATION GUIDE
NOCDURNA® (knock-DUHR-nah)
(desmopressin acetate) sublingual tablets
What is the most important information I should know about NOCDURNA?
NOCDURNA may cause serious side effects, including:
•
Low levels of salt (sodium) in your blood (hyponatremia). Low levels
of salt in your blood is a
serious side effect of NOCDURNA that may be life threatening, causing
seizures, coma, trouble
breathing or death, if not treated early.
Stop taking NOCDURNA and call your healthcare provider if you have any
of the following symptoms of
low salt levels in your blood:
•
headache
•
feeling restless
•
drowsiness
•
muscle cramps
•
nausea or vomiting
•
tiredness (fatigue)
•
dizziness
•
change in your mental condition such as hallucinations, confusion,
decreased awareness or alertness
•
You should not take NOCDURNA if you are at risk for very low salt
levels in your blood, for
example, if you drink a lot of fluid, have illnesses that can cause
you to have fluid or body salt
(electrolyte) imbalances, if you take a certain type of "water-pill"
called a loop diuretic or take
glucocorticoids including inhaled steroids.
•
Tell your healthcare provider if you have a fever, infection, or
diarrhea while taking NOCDURNA as
these can cause you to have fluid or body salt (electrolyte)
imbalance. Your healthcare provider may
tell you not to take NOCDURNA while you have these symptoms.
•
Your healthcare provider should check your blood salt levels:
•
before you start or restart taking NOCDURNA.
•
within the first week after you start NOCDURNA.
•
1 month after you start NOCDURNA.
•
every so often as told to you by your healthcare provider, with
testing more often if you are
already at risk for low salt levels, for example if you are 65 years
or older or take certain
medicines that increase your risk of low salt levels.
See "What are the possible side effects of NOCDURNA?" for more
information about side effects.
What is NOCDURNA?
NOCDURNA is a prescription medici

Summary of Product characteristics

NOCDURNA- DESMOPRESSIN ACETATE TABLET
FERRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
WARNING: HYPONATREMIA
_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)
CONTRAINDICATIONS
Hyponatremia or a history of hyponatremia (4)
Polydipsia (4)
Concomitant use with loop diuretics or systemic or inhaled
glucocorticoids (4)
Estimated glomerular filtration rate below 50 mL/min/1.73 m (4)
Syndrome of i