IMPORTANT SAFETY INFORMATION including BOXED WARNING
What is the most important information you should know about NOCDURNA?
- NOCDURNA may cause serious side effects, including low levels of salt (sodium) in your blood (hyponatremia) which may be life threatening, causing seizures, coma, trouble breathing or death if not treated early.
- Stop taking NOCDURNA and call your doctor if you have symptoms of low salt levels in your blood: headache, nausea or vomiting, feeling restless, tiredness (fatigue), drowsiness, dizziness, muscle cramps, change in your mental condition such as hallucinations, confusion, decreased awareness or alertness.
- You should not take NOCDURNA if you are at risk for low salt levels in your blood, such as if you drink a lot of fluid or have illness that can cause you to have fluid or body salt (electrolyte) imbalance or, if you take certain type of "water pill" called a loop diuretic or glucocorticoids including inhaled steroids.
- Tell your doctor if you have a fever, infection, or diarrhea while taking NOCDURNA as these can cause you to have fluid or electrolyte imbalance.
- Your doctor should check your blood salt levels before you start or restart, within the first week and 1 month after you start taking NOCDURNA, and every so often as told by your doctor, with testing more often if you are at risk for low salt levels, such as those 65 years or older or take certain medicines that increase your risk.
What is NOCDURNA?
NOCDURNA is a prescription medicine only approved for adults who wake up at least 2 times during the night to urinate due to nocturnal polyuria (condition where your body makes too much urine at night). Other conditions could cause you to wake up during the night to urinate. Your doctor should have you measure your urine and the times that you urinate for 24 hours to determine if you have nocturnal polyuria. It is not known if NOCDURNA is safe and effective in children.
Do not take NOCDURNA if you:
- have or had low salt levels in your blood
- are thirsty much of the time and drink large amounts of fluid (polydipsia)
- are taking a type of water pill called a loop-diuretic
- are taking a glucocorticoid (steroid) medicine, including an inhaled glucocorticoid (steroid) medicine
- have moderate or severe kidney disease
- have or may have a condition called syndrome of inappropriate antidiuretic hormone (SIADH) secretion
- have an illness that can cause you to have low levels of fluid or electrolytes in your blood such as vomiting, diarrhea, an infection, or a kidney problem that causes you to have low levels of salt
- have a heart condition called heart failure
- have high blood pressure that is not controlled
- are allergic to any ingredient in NOCDURNA tablets
Before taking NOCDURNA, tell your doctor about all of your medical conditions, including if you:
- are at risk for low salt levels in your blood
- currently have vomiting, diarrhea, fever or an infection
- have any heart or kidney problems
- have high blood pressure
- have increased pressure in your brain (increased intracranial pressure)
- have a history of not being able to empty your bladder all the way (urinary retention)
- are pregnant or planning to become pregnant. It is not known if NOCDURNA can harm your unborn baby. NOCDURNA is not recommended to treat normal symptoms of pregnancy that cause pregnant women to urinate often at night
- are breastfeeding, plan to breastfeed or the best way to feed your baby. Desmopressin, an ingredient in NOCDURNA, passes into breastmilk
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using NOCDURNA with certain medicines may cause serious side effects. Do not start taking any new medicines until you talk to your doctor.
Especially tell your doctor if you take a:
- Water pill (diuretic)
- glucocorticoid (steroid) including an inhaled glucocorticoid (steroid). Your doctor should stop your treatment with NOCDURNA for a period of time while you are taking and after you stop taking an oral or inhaled glucocorticoid (steroid) medicine
- medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI)
- medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine
- medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine
- non-steroidal anti-inflammatory medicine (NSAID)
Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Your doctor may tell you not to take NOCDURNA if you have fever, infection, or diarrhea while taking NOCDURNA as these can cause you to have fluid or electrolyte imbalance. Tell your doctor if you have any of these symptoms.
How should you take NOCDURNA?
- Place 1 tablet under your tongue 1 time each day, 1 hour before bedtime without water. Leave the tablet under your tongue until it dissolves. While taking NOCDURNA, empty your bladder just before bedtime and limit the amount of liquids you drink 1 hour before taking NOCDURNA until 8 hours after. You may have serious side effects if you drink too much liquid.
- Avoid drinks with caffeine and alcohol before bedtime as this can cause your body to make more urine.
- Do not take more NOCDURNA than prescribed for you. If you take too much NOCDURNA, call your doctor right away or get emergency treatment.
What are the possible side effects of NOCDURNA?
- NOCDURNA may cause serious side effects. See “What is the most important information you should know about NOCDURNA?”
- The most common side effects are dry mouth, low levels of salt in blood (hyponatremia), and dizziness
These are not all of the possible side effects of NOCDURNA. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
