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DESMOPRESSIN ACETATE solution


  1. Patient Information
  2. Hat Is Desmopressin Acetate Nasal Solution 0.01% (nasal Spray)?
  3. Are Allergic To Desmopressin Acetate Or Any Of The Ingredients In Desmopressin Acetate Nasal Solution 0.01% (nasal Spray). Some People Have Had Severe Allergic Reactions While Taking Desmopressin Acetate Nasal Solution 0.01% (nasal Spray). Before Using Desmopressin Acetate Nasal Solution 0.01% (nasal Spray), Tell Your Healthcare Provider About All Your Medical Conditions Including If You:
  4. How Should I Use Desmopressin Acetate Nasal Solution 0.01% (nasal Spray)?
  5. Desmopressin Acetate Nasal Solution 0.01% (nasal Spray) May Cause Serious Side Effects Including:
  6. Hat Are The Ingredients In Desmopressin Acetate Nasal Solution 0.01% (nasal Spray)?
  7. Tive Ingredient:
  8. 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 desmopressin acetate nasal solution 0.01% (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.


Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Halol-Baroda Highway,
Halol-389 350, Gujarat, India.

ISS. 01/2019
PJPI0438C

Hat Is Desmopressin Acetate Nasal Solution 0.01% (nasal Spray)? 


Desmopressin acetate nasal solution 0.01% (nasal spray) is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus.
  • desmopressin acetate nasal solution 0.01% (nasal spray) is not effective in the treatment of nephrogenic diabetes insipidus.
  • desmopressin acetate nasal solution 0.01% (nasal spray) should not be used in people with nasal problems that may keep them from using a nasal spray.
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Are Allergic To Desmopressin Acetate Or Any Of The Ingredients In Desmopressin Acetate Nasal Solution 0.01% (nasal Spray). Some People Have Had Severe Allergic Reactions While Taking Desmopressin Acetate Nasal Solution 0.01% (nasal Spray). Before Using Desmopressin Acetate Nasal Solution 0.01% (nasal Spray), Tell Your Healthcare Provider About All Your Medical Conditions Including If You: 


  • have or have had nasal sores, nasal surgery, nasal injury, or have problems such as a stuffy nose or trouble breathing through your nose.
  • have or have had any heart, blood circulation, or blood pressure problems
  • have a condition that causes fluid or water imbalance problems such as cystic fibrosis, or heart failure.
  • have or have had a condition that causes you to be very thirsty
  • are pregnant or plan to become pregnant. It is not known if desmopressin acetate nasal solution 0.01% (nasal spray) will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. It is not known if desmopressin acetate passes into your breast milk. You and your healthcare provider should decide if you will use desmopressin acetate nasal solution 0.01% (nasal spray).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How Should I Use Desmopressin Acetate Nasal Solution 0.01% (nasal Spray)? 


  • Read theInstructions for Usethat comes with your desmopressin acetate nasal solution 0.01% (nasal spray).
  • Use desmopressin acetate nasal solution 0.01% (nasal spray) exactly as your healthcare provider tells you to use it.
  • Your healthcare provider may change your dose of desmopressin acetate nasal solution 0.01% (nasal spray) if needed.
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Desmopressin Acetate Nasal Solution 0.01% (nasal Spray) May Cause Serious Side Effects Including: 


  • low levels of sodium in the blood (hyponatremia).People using desmopressin acetate nasal solution 0.01% (nasal spray) 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 desmopressin acetate nasal solution 0.01% (nasal spray).
    • 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 desmopressin acetate nasal solution 0.01% (nasal spray). They may mean that your blood sodium level is too low.
      • headache nausea, vomiting weight gain
      • restlessness tiredness sleepiness
      • disorientation loss of appetite
      • feeling irritable feeling weak muscle cramps
      • hallucinations confusion
  • nasal scarring or swelling.Some people using desmopressin acetate nasal solution 0.01% (nasal spray) for long periods of time may have nasal problems such as scarring or swelling. This may affect how well desmopressin acetate nasal solution 0.01% (nasal spray) works for you.
The most common side effects of desmopressin acetate nasal solution 0.01% (nasal spray) 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 desmopressin acetate nasal solution 0.01% (nasal spray).
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use desmopressin acetate nasal solution 0.01% (nasal spray) for a condition for which it was not prescribed. Do not give desmopressin acetate nasal solution 0.01% (nasal spray) 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 desmopressin acetate nasal solution 0.01% (nasal spray) that is written for health professionals. For more information call 1-800-818-4555.
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Hat Are The Ingredients In Desmopressin Acetate Nasal Solution 0.01% (nasal Spray)? 


Ac

Tive Ingredient: 

desmopressin acetate, USP

Inactive Ingredients: 

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

This Patient Information has been approved by the Food and Drug Administration

Instructions for Use


Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray)
10 mcg per 0.1 mL for Intranasal Use Only

Read these instructions before using desmopressin acetate nasal solution 0.01% (nasal spray), and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Children should be helped by an adult when using desmopressin acetate nasal solution 0.01% (nasal spray), to make sure the right amount of medicine is used.

The parts of your desmopressin acetate nasal solution 0.01% (nasal spray) pump
(

Store desmopressin acetate nasal solution 0.01% (nasal spray) at room temperature between 68 F to 77 F (20 C to 25 C).
Store desmopressin acetate nasal solution 0.01% (nasal spray) standing upright.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Halol-Baroda Highway,
Halol-389 350, Gujarat, India.

Rev. 01/19



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