Nocdurna

Nocdurna is a prescription medication used to treat excessive nighttime urination.

Nocdurna imitates a natural hormone in your body called vasopressin. This hormone helps the kidneys produce less water at night. If you don’t have enough vasopressin, your kidneys may release too much water at night, causing frequent nighttime urination.

Nocdurna comes as a tablet that dissolves quickly under your tongue—without water. It is taken once a day 1 hour before bedtime. Keep the tablet under the tongue until it has fully dissolved.

Common side effects include dry mouth, low blood sodium, and dizziness. Do not drive or operate heavy machinery until you know how Nocdurna affects you.

Nocdurna is a prescription medicine used in adults who wake up at least 2 times during the night to urinate due to a condition called nocturnal polyuria. Nocturnal polyuria is a condition where your body makes too much urine at night.

There are other conditions that could cause you to wake up during the night to urinate. Nocdurna is only approved for the treatment of nocturnal polyuria.

Your doctor should have you measure your urine and the times that you urinate for 24 hours to determine if you have nocturnal polyuria, if you have not already done this.

It is not known if Nocdurna is safe and effective in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your gender

The recommended dose of Nocdurna is 27.7 mcg once daily 1 hour before bedtime for women and 55.3 mcg once daily 1 hour before bedtime for men.

WARNING: HYPONATREMIA

Nocdurna can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death.

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.

Ensure the serum sodium concentration is normal before starting or resuming Nocdurna. Measure serum sodium within 7 days 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.

If hyponatremia occurs, Nocdurna may need to be temporarily or permanently discontinued.

Serious side effects have been reported with Nocdurna including the following:

• 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
  • 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 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.

Do not take Nocdurna if you:

• have or have had low salt levels in your blood.
• are thirsty much of the time and drink large amounts of fluids (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

Talk to your healthcare provider before you take Nocdurna if you have any of these conditions or take any of these medicines.

Serious side effects have been reported with Nocdurna. See the “Nocdurna Precautions” section.

Common side effects of Nocdurna include the following:

• dry mouth
• low blood sodium
• dizziness

This is not a complete list of Nocdurna side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• loop or thiazide diuretics such as
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
• steroids such as prednisone (Cortan, Deltasone, Orasone, Sterapred), budesonide (Entocort), dexamethasone (Decadron), triamcinolone (Kenacort, Aristocort), flunisolide (AeroBid, Aerospan), ciclesonide (Alvesco), mometasone (Asmanex, Dulera), fluticasone (Flovent), methylprednisolone (Medrol, Solu-Medrol), fludrocortisone (Florinef), and hydrocortisone (Cortef, Cortril, Hydrocortone)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
• sulfonylureas such as chlorpropamide (Diabinese), glyburide (DiaBeta, Micronase), glimepiride (Amaryl), and glipizide (Glucotrol)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, or aspirin
• opioid pain relieving medications including tramadol (Ultram), morphine (MS Contin), hydromorphone (Dilaudid), oxymorphone (Opana), oxycodone (Oxycontin), hydrocodone (Vantrela), fentanyl (Duragesic), codeine, meperidine (Demerol)
• chlorpromazine
• carbamazepine
• lamotrigine

This is not a complete list of Nocdurna drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

Nocdurna is not recommended to treat nocturnal polyuria in pregnant women. Nocturnal polyuria during pregnancy is usually a result of normal changes in the body that do not require treatment with Nocdurna.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Nocdurna has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Nocdurna, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.