DDAVP Melt for Primary Nocturnal Enuresis - Consumer Medicine Information
|Condition:||Primary Nocturnal Enuresis|
|Ingredients:||desmopressin, gelatin , mannitol, citric acid|
Desmopressin oral disintegrating tablets
About This Medication
What the Medication is Used For
DDAVP MELT is a drug that is prescribed for children 5 years of age and older who wet their bed at night. This condition is called Primary Nocturnal Enuresis (PNE).
What it Does
DDAVP MELT reduces the amount of urine (pee) that your child makes at night. The result is your child’s bladder will not fill up as much and your child will be less likely to wet the bed at night.
When it Should not be Used:
There are people who should not take DDAVP MELT. Tell your child’s doctor or pharmacist if your child has:
- Any heart, liver or kidney problems
- Hyponatremia (low blood sodium levels)
- Bleeding problems such as Type II B or platelet-type (pseudo) von Willebrand’s disease
- Constant thirst
- Eating disorders such as bulimia (over-eating followed by purging ) or anorexia nervosa (self-starvation)
- Adrenal problems (e.g. Addison’s disease)
- An allergy to desmopressin acetate or to any of the ingredients listed under “What the nonmedicinal ingredients are”
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Gelatin, mannitol, citric acid.
What Dosage Forms it Comes In
DDAVP MELT, 60 μg, is a white, round tablet marked with a drop shaped figure on one side.
DDAVP MELT,120 μg, is a white, round tablet marked with two drop shaped figures on one side.
DDAVP MELT, 240 μg, is a white, round tablet marked with three drop shaped figures on one side.
DDAVP MELT is supplied in a blister pack. Each blister pack contains 10 tablets in boxes of 10 and 30.
Warning and Precautions
BEFORE your child uses DDAVP MELT, talk to your child’s doctor or pharmacist if your child has:
- hyponatremia (low blood sodium level)
- heart problems
- liver disease
- kidney problems
- bleeding problems
- cystic fibrosis
- any allergies to desmopressin acetate or any of the ingredients listed in “What the nonmedicinal ingredients are”
It is important to limit the number of drinks of any kind that your child has after supper, especially one hour before bedtime, until the next morning (at least 8 hours) in order to decrease the potential occurrence of water intoxication and hyponatremia.This can become a serious problem and may lead to convulsions.
DDAVP MELT should not be given to dehydrated patients until water balance is adequately restored.
Interactions with this Medicatio
Tell your child’s doctor or pharmacist if your child is taking any of the following medications:
- Nonsteroidal anti-inflammatory drugs (NSAIDs such as etodolac or Ultradol, ibuprofen or Advil or Motrin, naproxen or Naprosyn ; celecoxib or Celebrex)
- Tricyclic antidepressants (amitriptyline, nortriptyline)
- Serotonin reuptake inhibitors (for example, fluoxetine or Prozac, paroxetine or Paxil, sertraline or Zoloft, fluvoxamine or Luvox, citalopram or Celexa)
- Diuretics (water pills)
- Loperamide or Imodium
Proper Use of this Medication
How to Take DDAVP MELT
DDAVP MELT should be placed under the tongue one hour before bedtime. The tablet quickly disintegrates in the mouth without the need for water.
It is important to limit the number of drinks of any kind that your child has after supper, especially one hour before bedtime, until the next morning (at least 8 hours) after taking the medication.
- Completely remove the end tab of a blister strip by tearing along the perforations, starting from the corner with the hand symbol.
- Remove one blister from the strip by tearing along the perforations.
- Remove the foil on each blister, starting at the corner with the printed arrow, by peeling off the foil in the direction of the arrow.
- Carefully take a DDAVP MELT out of its blister. Place the DDAVP MELT under the tongue and allow it to dissolve.
How Many DDAVP MELT Should My Child Take
Take the medication according to the dosing schedule as directed by your child’s doctor. The usual recommended initial dose is 120 μg 1 hour before bedtime. If this does not keep your child dry, your doctor may adjust the dose up to either 240 mg or 360 μg.
What Should I do if the Child is Still Wetting the Bed
- Make sure the child is taking the correct number of DDAVP MELT tablets each night
- Limit the number of drinks the child has after supper
- If it is still not working, call your doctor
How Long Should the Child Take DDAVP MELT
As children eventually outgrow bedwetting, they should be checked every 3 months to see if they still need the medication.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Symptoms of overdose may include headache, nausea, vomiting, abdominal cramps, facial flushing, and weight gain due to water retention and, in severe cases, convulsions.
You should restrict your child’s fluid intake until your child is assessed by his/her doctor.
Your child should not to take any extra DDAVP MELT. Take the same number of DDAVP MELT as before the child forgot. For example, Mary took 120 μg of DDAVP MELT on Monday but she forgot to take it on Tuesday. On Wednesday, Mary should take 120 μg of DDAVP MELT.
Side Effects and What to do About Them
As with all medicines, side effects may be experienced.
With DDAVP MELT, side effects may include:
- mild abdominal cramps
- nasal congestion
These have occurred usually when the medication is being adjusted. Once your child is taking the right amount of medicine for his/her condition, these side effects will usually go away.
Tell your child’s doctor about any side effects your child experiences.
Serious Side Effects, How Often they Happen and What to do About Them
|Symptoms / effect||Talk with your|
drug and call
This is not a complete list of side effects. For any unexpected effects while taking DDAVP MELT, contact your doctor or pharmacist.
How to Store It
DDAVP MELT should be stored in the original package in a dry place at a temperature between 15ºC to 25ºC.
Keep out of reach of children
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Ferring Inc., at 1-866-384-1314.