Consumer Information for: DDAVP TABLETS 0.1MG

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

DDAVP Tablets are used to prevent or control the frequent urination, increased thirst, and loss of water associated with Diabetes Insipidus (water diabetes).

DDAVP Tablets 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 Tablets 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.

What is Diabetes Insipidus (DI)?

Diabetes Insipidus is a medical condition in which your kidneys are unable to retain water. This results in the production of large volumes of urine which in turn makes you feel dry and very thirsty.

DDAVP Tablets reduce the amount of urine that you make. The result is that your bladder (where urine is stored) does not fill as quickly, so a person taking this medicine does not need to pass urine so often.

When it should not be used

There are people who should not take DDAVP Tablets. Tell your child’s doctor or pharmacist if your child has:

  • 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
  • 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 any of the other ingredients in DDAVP Tablet (see What the nonmedicinal ingredients are)
  • Lactose intolerance
What the medicinal ingredient is

Desmopressin acetate

What the non-medicinal ingredients are

Lactose monohydrate, magnesium stearate potato starch, povidone,

What dosage form it comes in

DDAVP Tablets are available as white uncoated tablets containing 0.1 mg or 0.2 mg of desmopressin acetate. DDAVP Tablets are supplied in bottles of 30 or 100 tablets.

Warnings and precautions

BEFORE you use DDAVP Tablets, talk to your doctor or pharmacist if you are:

  • Breast-feeding
  • Pregnant or think you might be pregnant

And/or if you have:

  • 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 important nonmedicinal ingredients are.”

Before you commence treatment with this medicine, you should receive appropriate advice concerning fluid intake from your doctor. Excessive fluid intake may lead to a build-up of water in the body resulting in water intoxication and hyponatremia.

DDAVP tablets should not be given to dehydrated patients until water balance is adequately restored.

Talk to your doctor before stopping or interrupting treatment with DDAVP

Interactions with this medication

Drugs that may interact with DDAVP Tablets include:

  • 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® )
  • Nonsteroidal anti-inflammatory drugs (NSAIDs such as etodolac or Ultradol® , ibuprofen or Advil® or Motrin® , naproxen or Naprosyn® ; celecoxib or Celebrex® )
  • Diuretics (water pills)
  • Loperamide or Imodium®
  • Chlorpromazine
  • Carbamazepine
  • Clofibrate
  • Chlorpropamide
  • Demeclocyclin
  • Lithium
  • Norepinephrine

If you are taking any of these drugs, please talk to your doctor or pharmacist before taking DDAVP Tablets.

Proper use of this medication

Take the medication at the dose prescribed by your physician 1 hour before bedtime. Use the following dosage plan or one that has been recommended by your physician.

Step 1 For the first 3 nights

Take 1 tablet (1 X 0.2 mg) 1 hour before bedtime.

If the child is dry for 3 nights taking 1 tablet each night, continue this way. Do NOT increase the dose.

If the child is NOT dry for these 3 nights, move to Step 2.

Step 2 Nights 4, 5 & 6.

Take 2 tablets (2 X 0.2 mg) 1 hour before bedtime. If the child is dry for 3 nights taking 2 tablets each night, continue this way. Do NOT increase the dose.

If the child is NOT dry for these 3 nights, move to Step 3.

Step 3 Nights 7, 8 & 9.

Take 3 tablets (3 X 0.2 mg) 1 hour before bedtime. If the child is dry for 3 nights taking 3 tablets each night, continue this way. Do NOT increase the dose.

If your child is not dry every night after taking 3 tablets each night for 3 nights, see the “What should I do if...?” section below or visit your doctor to find out why the medicine has not worked.

What should I do if the child is still wetting the bed?

  • Make sure the child is taking the correct number of tablets each night.
  • Limit the number of drinks the child has after supper.
  • If it’s still not working, call your doctor.

Dose habituelle

Follow your doctor’s direction on how much medicine you should take. The recommended treatment range for diabetes insipidus is 0.2 mg to 1.2 mg per day divided equally into 2 or 3 doses a day

Surdose

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.

Dose oubliée

If you miss a dose of DDAVP Tablets, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose.

Side effects and what to do about them

As with all medicines, side effects may be experienced. With DDAVP Tablets, these may include:

  • headache,
  • nausea
  • nasal congestion
  • rhinitis
  • flushing
  • mild abdominal cramps.

These have occurred usually when the medication is being adjusted. Once you are taking the right amount of medicine for your condition, these side effects will usually go away. Tell your doctor about any side effects you experience.

Effets secondaires graves : fréquence et procédures à suivre
Symptôme / effet Consultez votre médecin ou votre pharmacien seulement pour les effets secondaires graves Consultez votre médecin ou votre pharmacien dans tous les cas Cessez de prendre le médicament et téléphonez à votre médecin ou à votre pharmacien
Rare
Convulsions     ✔
Unusually bad or prolonged headach     ✔
Confusion     ✔
Unexplained weight gain     ✔
Nausea     ✔
Vomiting     ✔

This is not a complete list of side effects. For any unexpected effects while taking DDAVP Tablets, contact your doctor or pharmacist.

How to store

DDAVP Tablets should be stored in the original package between 15°C -25°C in a dry place.

Keep out of reach of children

Reporting side effects

Vous pouvez déclarer les effets indésirables soupçonnés associés à l’utilisation des produits de santé au Programme Canada Vigilance de l’une des 3 façons suivantes :

  • En ligne à www.santecanada.gc.ca/medeffet
  • Par téléphone sans frais au 1-866-234-2345
  • En remplissant un formulaire de déclaration de Canada Vigilance puis en l'envoyant :
    • par télécopieur sans frais au 1-866-678-6789, ou
    • par la poste au :
      Programme Canada Vigilance
      Santé Canada
      Indice postal 0701E
      Ottawa ON K1A 0K9

Les étiquettes de port payé, les formulaires de déclaration de Canada Vigilance et le mode d'emploi sur la déclaration d'effets indésirables sont disponibles sur le site Web de MedEffetMC Canada à l’adresse www.santecanada.gc.ca/medeffet.

REMARQUE : Pour obtenir des renseignements relatifs à la gestion des effets secondaires, veuillez communiquer avec votre professionnel de la santé. Le Programme Canada Vigilance ne fournit pas de conseils médicaux.

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 17, 2015

® DDAVP is a Registered Trademark of Ferring B.V.

Ferring Inc., Toronto, Ontario

Date modified: