Desmopressin Nasal

IMPORTANT WARNING:

Desmopressin nasal 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. Also tell your doctor if you have an infection, a fever, or a stomach or intestinal illness with vomiting or diarrhea. Tell your doctor if you experience any of the following during your treatment: headache, nausea, vomiting, restlessness, weight gain, loss of appetite, irritability, fatigue, drowsiness, dizziness, muscle cramping, seizures, confusion, loss of consciousness, or hallucinations.

Tell your doctor if you are taking a loop diuretic ("water pills") such as bumetanide, furosemide (Lasix), or torsemide; 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 probably tell you not to use desmopressin nasal if you are using or taking one of these medications.

Keep all appointments with your doctor and the laboratory. Your doctor will order tests to monitor your sodium levels before and during your treatment to check your body's response to desmopressin nasal.

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

WHY is this medicine prescribed?

Desmopressin nasal (DDAVP^®) is used to control the symptoms of a certain type of diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine). Desmopressinnasal (DDAVP^®) is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery. Desmopressin nasal (Noctiva^®) is used to control frequent nighttime urination in adults who awaken at least 2 times per night to urinate. Desmopressin nasal (Stimate^®) is used to stop some types of bleeding in people with hemophilia (condition in which the blood does not clot normally) and von Willebrand's disease (a bleeding disorder) with certain blood levels. Desmopressin nasal is in a class of medications called antidiuretic hormones. It works by replacing vasopressin, a hormone that is normally produced in the body to help balance the amount of water and salt.

Are there OTHER USES for this medicine?

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Desmopressin nasal comes as a liquid that is administered into the nose through a rhinal tube (thin plastic tube that is placed in the nose to administer medication), and as a nasal spray. It is usually used one to three times a day. When desmopressin nasal (Stimate^®) is used to treat hemophilia and von Willebrand's disease, 1 to 2 spray(s) are given daily. If Stimate^® is used before surgery, it is usually given 2 hours before the procedure. When desmopressin nasal (Noctiva^®) is used to treat frequent nighttime urination, one spray is usually given in either the left or right nostril 30 minutes before going to bed. Use desmopressin nasal at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use nasal desmopressin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Desmopressin nasal spray (Noctiva) is available in two different strengths. These products cannot be substituted for each other. Each time you have your prescription filled, make sure that you have received the right product. If you think you received the wrong strength, talk to your doctor and pharmacist right away.

Your doctor may start you on a low dose of desmopressin nasal and adjust your dose depending on your condition. Follow these directions carefully.

If you will be using the nasal spray, you should check the manufacturer's information to find out how many sprays your bottle contains. Keep track of the number of sprays you use, not including the priming sprays. Discard the bottle after you use the stated number of sprays, even if it still contains some medication, because additional sprays might not contain a full dose of medication. Do not try to transfer the leftover medication to another bottle.

Before you use desmopressin nasal for the first time, read the written instructions that come with the medication. Be sure that you understand how to prepare the bottle before the first use and how to use the spray or rhinal tube. Ask your doctor or pharmacist if you have any questions about how to use this medication.

What SPECIAL PRECAUTIONS should I follow?

Before using desmopressin nasal,

• tell your doctor and pharmacist if you are allergic to desmopressin, any other medications, or any of the ingredients in desmopressin nasal spray. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); carbamazepine (Equetro, Tegretol, Teril); chlorpromazine; other medications used in the nose; lamotrigine (Lamictal); narcotic (opiate) medications for pain; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine, paroxetine (Paxil), and sertraline (Zoloft); thiazide diuretics ('water pills') such as hydrochlorothiazide (Microzide, many combination products), indapamide, and metolazone (Zaroxolyn); or tricyclic antidepressants ('mood elevators') such as amitriptyline, desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have had heart failure, high blood pressure, or heart disease. Your doctor will probably tell you not to use desmopressin nasal.

• tell your doctor if you have or have ever had urinary retention or cystic fibrosis (an inborn disease that causes problems with breathing, digestion, and reproduction). Also tell your doctor if you have recently had surgery of the head or face, and if you have a stuffed or runny nose, scarring or swelling of the inside of the nose, or atrophic rhinitis (condition in which the lining of the nose shrinks and the inside of the nose becomes filled with dry crusts). Call your doctor if you develop a stuffed or runny nose at any time during your treatment.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using desmopressin, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Your doctor may tell you to limit the amount of fluid you drink, especially in the evening, during your treatment with desmopressin. Follow your doctor's directions carefully to prevent serious side effects.

What should I do IF I FORGET to take a dose?

If you are using desmopressin nasal (DDAVP^®) or (Stimate^®) and miss a dose, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

If you are using desmopressin nasal (Noctiva^®) and miss a dose, skip the missed dose and take the next dose at your regular time. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Desmopressin nasal may cause side effects. Call your doctor if any of the following symptoms are severe or do not go away:

• stomach pain
• heartburn
• weakness
• difficulty falling asleep or staying asleep
• warm feeling
• nosebleed
• nostril pain, discomfort, or congestion
• itchy or light-sensitive eyes
• back pain
• sore throat, cough, chills, or other signs of infection
• flushing

Some side effects may be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• vomiting
• chest pain
• fast or pounding heartbeat
• rash
• hives
• itching
• difficulty breathing or swallowing

Desmopressin nasal may cause other side effects. Tell your doctor if you experience any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep the nasal sprays in the container it came in, tightly closed, and out of reach of children.

Store Stimate^® nasal spray upright at a room temperature not to exceed 25°C; discard the nasal spray 6 months after opening it.

Store DDAVP^® nasal spray upright at 20 to 25°C. Store DDAVP^® rhinal tube at 2 to 8°C; closed bottles are stable for 3 weeks at 20 to 25°C.

Before opening Noctiva^® nasal spray, store it upright at 2 to 8°C . After opening Noctiva^®, store the nasal spray upright at 20 to 25°C; discard it after 60 days.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• confusion
• drowsiness
• headache
• difficulty urinating
• sudden weight gain
• seizures

What OTHER INFORMATION should I know?

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.