Noctiva

Noctiva is a prescription medication used to control frequent nighttime urination in adults who awaken at least 2 times per night to urinate. 

Noctiva belongs to a group of drugs called antidiuretic hormones. They work by replacing vasopressin, a hormone that is normally produced in the body to help balance the amount of water and salt.

Noctiva comes as a liquid that is administered as a nasal spray. It is usually used nightly about 30 minutes before bedtime.

Common side effects of Noctiva include nasal discomfort, stuffy nose, and sneezing.

Noctiva can also cause dizziness. Do not drive or operate heavy machinery until you know how Noctiva affects you.

Noctiva is a prescription medication used in adults who wake up 2 or more times during the night to urinate due to nocturnal polyuria, a condition where your body makes too much urine at night. Noctiva was not studied in patients younger than 50 years of age.

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

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

Common side effects of Noctiva include the following:

• nose discomfort
• pain or swelling (inflammation) in your nose or throat
• stuffy nose
• sneezing
• high blood pressure
• back pain
• nosebleed
• inflammation of the lining of the bronchial tubes that carry air to and from your lungs that causes a cough (bronchitis)
• dizziness

This is not a complete list of Noctiva 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:

• Drugs that may cause severe hyponatremia

  • Loop diuretics ("water pills") such as furosemide (Lasix), or torsemide (Demadex) 
  • Inhaled steroids such as beclomethasone (Beconase, QNasl, Qvar), budesonide (Pulmicort, Rhinocort, Uceris), fluticasone (Advair, Flonase, Flovent), or mometasone (Asmanex, Nasonex)
  • Oral steroids such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos)

• Drugs that may cause water retention:

  • Tricyclic antidepressants such as amitriptyline (Elavil) and imipramine (Tofranil)
  • Selective serotonin reuptake inhibitors such as citalopram (Celexa) and fluoxetine (Prozac)
  • Chlorpromazine
  • Opioid analgesics such as hydrocodone with acetaminophen (Norco)
  • NSAIDs such as ibuprofen (Motrin) and naproxen (Aleve)
  • Lamotrigine
  • Carbamazepine
• Drugs administered into the nose

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

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

• Low levels of salt (sodium) in your blood. If you develop very low salt levels in your blood, this may lead to serious or life-threatening side effects, including seizure, coma, trouble breathing, or death if not treated early. Call your doctor if you have any of the following symptoms of low salt levels in your blood:
  • headache
  • nausea or vomiting
  • feeling restless
  • fatigue
  • drowsiness
  • dizziness
  • muscle cramps
  • change in your mental condition, such as confusion, or decreased awareness or alertness
• Patients 65 years and older treated with Noctiva had a higher incidence of having low levels of sodium compared to patients less than 65 years old treated with Noctiva.
• To help decrease your risk of developing low levels of sodium in your blood:
  • Limit the amount of fluids you drink in the evening and nighttime.
  • Stop taking Noctiva and tell your doctor right away if you have a stomach or intestinal virus with vomiting or diarrhea or if you have an infection or fever.
  • Stop taking Noctiva and tell your doctor right away if you develop any nose problems, such as a blockage, stuffy nose, runny nose, or drainage.
• Fluid Retention. Noctiva can cause build-up of fluids in body tissues. Noctiva is not recommended in patients with symptoms of a heart problem called congestive heart failure. Also, Noctiva is not recommended in patients at risk for increased intracranial pressure (rise in pressure within the brain) or those with a history of urinary retention (problems with voiding urine).
• Nasal conditions. Inflammation of mucus membrane in the nose may increase absorption of Noctiva and cause low sodium levels. Tell your doctor about any nasal conditions you may have. 

• Do not take Noctiva if you:

  • are allergic to Noctiva or to any of its ingredients
  • have or have had low salt levels in your blood
  • are thirsty much of the time and drink large amounts of fluids (polydipsia)
  • wet the bed while sleeping at night
  • 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 to severe kidney problems
  • 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 lose too much salt
  • have symptoms of a heart problem called congestive heart failure
  • have high blood pressure that is not controlled

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Noctiva, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Noctiva, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Noctiva or to any of its ingredients
• have vomiting, diarrhea, fever, or infection
• have kidney or heart problems
• have diabetes mellitus
• have had a head injury
• have a heart problem called congestive heart failure
• have a history of not being able to empty your bladder all of the way (urinary retention)
• have any nose problems, such as a blockage, stuffy nose, runny nose, or drainage
• are pregnant or plan to become pregnant. 
• are breastfeeding or plan to breastfeed

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

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

There are no well-done studies that have been done in humans with Noctiva. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

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

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

Take Noctiva exactly as prescribed.

Noctiva comes as a liquid that is administered as a nasal spray. It is usually used nightly, 30 minutes before going to bed.

Administration instructions:

• Only administer Noctiva in the nose. Do not shake the bottle.
• Prime Noctiva before using for the first time by pumping 5 times into the air away from the face.
• Re-prime by pumping 2 times into the air if the product has not been used for more than 3 days.
• Two sprays of Noctiva 0.83 mcg are not interchangeable with 1 spray of Noctiva 1.66 mcg.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Noctiva at the same time.

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:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose for patients younger than 65 years of age who are not at an increased risk for having low levels of sodium is 1 spray of Noctiva 1.66 mcg in either the left or right nostril approximately 30 minutes before going to bed.

The recommended dose for patients 65 years of age or older, or younger patients at an increased risk for having low levels of sodium is 1 spray of Noctiva 0.83 mcg in either the left or right nostril approximately 30 minutes before going to bed.

Your healthcare provider will check your sodium (salt) levels:

• Prior to initiating or restarting Noctiva or increasing the dose. 
• Within 7 days and approximately 1 month after initiating therapy or increasing the dose.
• Periodically during Noctiva therapy. 
• More frequently if you are 65 years and older or at increased risk of hyponatremia.

If you take too much Noctiva, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Before opening, store Noctiva upright in a refrigerator between 36°F to 46°F (2°C to 8°C).
• After opening, store Noctiva upright at room temperature between 68°F to 77°F (20°C to 25°C).
• Throw away (discard) Noctiva 60 days after opening. Write the date the bottle is opened on the bottle label.
• Keep this and all medicines out of the reach of children.

WARNING: HYPONATREMIA

Noctiva may cause serious and possibly life-threatening hyponatremia (low level of sodium in your blood). Tell your doctor if you have or have ever had a low level of sodium in your blood, are thirsty much of the time, drink large amounts of fluids, or if you have syndrome of inappropriate antidiuretic hormone (SIADH; condition in which the body produces too much of a certain natural substance that causes the body to retain water), or kidney disease. 

Noctiva is contraindicated in patients at increased risk of severe hyponatremia. Tell your doctor if you are taking a loop diuretic ("water pills") such as furosemide (Lasix), or torsemide (Demadex); an inhaled steroid such as beclomethasone (Beconase, QNasl, Qvar), budesonide (Pulmicort, Rhinocort, Uceris), fluticasone (Advair, Flonase, Flovent), or mometasone (Asmanex, Nasonex); or an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos). 

Your doctor will order tests to monitor your sodium levels before and during your treatment to check your body's response to Noctiva. If hyponatremia occurs, Noctiva may need to be temporarily or permanently discontinued

Talk to your doctor about the risk(s) of using Noctiva.