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DDAVP- desmopressin acetate spray


  1. Patient Information
  2. What Is Ddavp?
  3. Do Not Use Ddavp If You:
  4. Ddavp May Cause Serious Side Effects Including:
  5. Active Ingredient:
  6. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)

Administration

  • Inform caregivers for pediatric patients that administration should be supervised to ensure the patient receives the prescribed dose.
  • Inform patients that the pump must be primed prior to first use and again if not used for greater than one week. Inform patients that the DDAVP Nasal Spray bottle delivers 50 sprays of 10 mcg each following the initial 4 priming pumps.
  • Inform patients to discard any solution remaining after 50 sprays since the amount delivered thereafter may be substantially less than 10 mcg of drug.

Monitoring

  • Educate patients about the signs and symptoms of hyponatremia and advise them to contact a healthcare provider if such symptoms occur.
  • Discuss downward adjustment of fluid intake and monitoring of urine output with patients.

U.S. Pat. Nos. 5,500,413, 5,596,078, and 5,674,850

Manufactured for:
Ferring Pharmaceuticals Inc.
Parsippany, NJ 07054 USA
Origin Sweden

XXXXXXXXXX

This Patient Information has been approved by the Food and Drug Administration09/18
Patient Information
DDAVP (phonetic spelling)
Nasal Spray, 10 mcg per 0.1 mL

for Intranasal Use Only

What Is Ddavp? 

DDAVP is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus.
  • DDAVP is not effective in the treatment of nephrogenic diabetes insipidus.
  • DDAVP should not be used in people with nasal problems that may keep them from using a nasal spray.

Do Not Use Ddavp If You: 

  • are allergic to DDAVP or any of the ingredients in DDAVP. Some people have had severe allergic reactions while taking DDAVP.
    • Read theInstructions for Usethat comes with your DDAVP.
    • Use DDAVP exactly as your healthcare provider tells you to use it.
    • Your healthcare provider may change your dose of DDAVP if needed.

Ddavp May Cause Serious Side Effects Including: 

  • low levels of sodium in the blood (hyponatremia).People using DDAVP are at risk for low sodium levels in the blood, water intoxication, and fluid overload. Follow your healthcare provider's instructions on limiting the amount of fluid you can drink when using DDAVP.
    • Do notdrink more than you need to satisfy your thirst. You can have serious side effects such as seizures, coma, and death from drinking too much fluid.
    • Children and the elderly are at higher risk for these problems and should follow their healthcare provider's limits on drinking fluids.
    • Call your healthcare provider right away if you have any of the following symptoms while using DDAVP. They may mean that your blood sodium level is too low.
  • headache
  • restlessness
  • disorientation
  • feeling irritable
  • hallucinations
  • nausea, vomiting
  • tiredness
  • loss of appetite
  • feeling weak
  • confusion
  • weight gain
  • sleepiness
  • muscle cramps
  • nasal scarring or swelling.Some people using DDAVP for long periods of time may have nasal problems such as scarring or swelling. This may affect how well DDAVP works for you.
The most common side effects of DDAVP include: headache, stuffy nose, runny nose, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and stomach cramps.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.General information about the safe and effective use of DDAVP.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DDAVP for a condition for which it was not prescribed. Do not give DDAVP to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about DDAVP that is written for health professionals. For more information call1-888-FERRING (1-888-337-7464).

Active Ingredient: 

desmopressin acetate

Inactive Ingredients: 

benzalkonium chloride solution (50%), sodium chloride, citric acid monohydrate, disodium phosphate dihydrate, purified water



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