Nocdurna (Sublingual)

Desmopressin is used to help patients who wake up 2 or more times at night to urinate due to nocturnal polyuria, a condition where your body produces too much urine at night. Your doctor may ask you to collect and measure your urine and the times you urinate for 24 hours to find out if you have nocturnal polyuria.

Desmopressin is similar to a hormone made in the body. It works on the kidneys to decrease urine production.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine together with certain diuretics (for example, furosemide, torsemide, Demadex®, Lasix®) or systemic or inhaled glucocorticoids (for example, dexamethasone, fluticasone, methylprednisolone, prednisolone, prednisone, Cortef®, Medrol®).

This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness.

Check with your doctor right away if you have an infection with fever and severe vomiting or diarrhea. Your doctor may limit the amount of fluid or water you drink. If you drink too much water during hot weather, after strenuous exercise, or after severe vomiting or diarrhea, this medicine may cause serious unwanted effects.

This medicine may cause fluid retention (body swelling). Check with your doctor right away if you have a decrease in the amount of urine, noisy, rattling breathing, swelling of the fingers, hands, feet, or lower legs, troubled breathing at rest, or weight gain.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to see how desmopressin affects children. The safety and effectiveness of this medicine for children have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of desmopressin. However, older adults are more likely to have hyponatremia (low sodium in the blood), which may require caution and a dose adjustment for those taking desmopressin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. You should weigh the potential benefits against the risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions could happen. In these cases, your doctor may change the dose, or other precautions might be needed. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Aceclofenac
• Acemetacin
• Acetohexamide
• Alfentanil
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anileridine
• Aspirin
• Bendroflumethiazide
• Benzhydrocodone
• Benzthiazide
• Bromfenac
• Bufexamac
• Buprenorphine
• Butorphanol
• Carbamazepine
• Celecoxib
• Chlorothiazide
• Chlorpromazine
• Chlorpropamide
• Chlorthalidone
• Choline Salicylate
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Codeine
• Desipramine
• Dexibuprofen
• Dexketoprofen
• Dezocine
• Diacetylmorphine
• Diazoxide
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenoxylate
• Dipyrone
• Doxepin
• Droxicam
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Ibuprofen
• Imipramine
• Indapamide
• Indomethacin
• Ketobemidone
• Ketoprofen
• Ketorolac
• Lamotrigine
• Levorphanol
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Meperidine
• Meptazinol
• Methadone
• Methyclothiazide
• Metolazone
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Nepafenac
• Nicomorphine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Opipramol
• Opium
• Opium Alkaloids
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Papaveretum
• Parecoxib
• Paregoric
• Paroxetine
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Piritramide
• Piroxicam
• Polythiazide
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Protriptyline
• Remifentanil
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sertraline
• Sodium Salicylate
• Sufentanil
• Sulindac
• Tapentadol
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Tilidine
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Tolvaptan
• Tramadol
• Trichlormethiazide
• Trimipramine
• Valdecoxib
• Vilazodone
• Vortioxetine
• Xipamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food because interactions might happen. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Gastroenteritis (inflammation of the stomach or bowels) or
• Heart failure or
• Hypertension (high blood pressure), uncontrolled or
• Hyponatremia (low sodium in the blood), or a history of or
• Infection (systemic) or
• Kidney disease, moderate to severe or
• Polydipsia (excessive thirst) or
• Salt-wasting nephropathies (kidney disease) or
• Syndrome of inappropriate antidiuretic hormone (SIADH), known or suspected—Should not be used in these cases.

• Increased pressure in the head or
• Urinary retention, history of—Use is not recommended in these situations. There may be a higher risk of fluid retention (body swelling).

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Confusion
• decreased urine output
• dizziness
• fast or irregular heartbeat
• headache
• increased thirst
• loss of consciousness
• muscle pain or cramps
• nausea
• seizures
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• vomiting

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dry mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Nocdurna

Available Dosage Forms:

• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vasopressin (class)

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Limit the amount of fluids you drink from 1 hour before using this medicine and until 8 hours after. Also avoid drinks containing caffeine or alcohol before bedtime.

Keep the tablet under your tongue until it has fully dissolved. Do not use this medicine with water.

Your doctor may instruct you to empty your bladder before bedtime.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treatment of nocturnal polyuria: Adults: Men—55.3 micrograms (mcg) under the tongue once a day, 1 hour before bedtime. Women—27.7 mcg under the tongue once a day, 1 hour before bedtime. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.