Details for: DDAVP MELT
Company: FERRING INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02284995 | DDAVP MELT | DESMOPRESSIN (DESMOPRESSIN ACETATE) | 60 MCG | TABLET (ORALLY DISINTEGRATING) | SUBLINGUAL |
| 02285002 | DDAVP MELT | DESMOPRESSIN (DESMOPRESSIN ACETATE) | 120 MCG | TABLET (ORALLY DISINTEGRATING) | SUBLINGUAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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 doctor or pharmacist if you have:
- Diarrhea
- Vomiting
- Any heart, liver or kidney problems
- Hyponatremia (low blood sodium levels)
- Bleeding problems such as Type II B or platelettype (pseudo) von Willebrand’s disease
- Constant thirst
- Eating disorders such as bulimia (over-eating followed by purging ) or anorexia nervosa (selfstarvation)
- 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
Desmopressin acetate.
What the non-medicinal ingredients are
Gelatin, mannitol, citric acid.
What dosage form 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
Warnings 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
- fever
- 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 medication
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®
- Chlorpromazine
- Carbamazepine
- Clofibrate
- Chlorpropamide
- Demeclocyclin
- Lithium
- Norepinephrine
Proper use of this medication
How to Take DDAVPMELT:
DDAVPMELT 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 DDAVPMELT out of its blister. Place the DDAVP MELT under the tongue and allow it to dissolve.
How Many DDAVPMELT 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.
Usual Dose
Overdose
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.
Missed Dose
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:
- headache
- nausea
- mild abdominal cramps
- nasal congestion
- rhinitis
- flushing
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Rare | |||
| Convulsions | ✔ | ||
| Unusually bad or prolonged headache | ✔ | ||
| Confusion | ✔ | ||
| Unexplained weight gain | ✔ | ||
| Nausea | ✔ | ||
| Vomiting | ✔ | ||
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
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 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 three ways:
- 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
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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.
More information
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.
This leaflet was prepared by Ferring Inc
Last revised: December 2015.
® DDAVP is a registered trade mark of Ferring B.V.