What DDAVP Melt for Central Diabetes Insipidus is used for and how to use it
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DDAVP Melt for Central Diabetes Insipidus - Consumer Medicine Information

Manufacture: Ferring Pharmaceuticals
Country: Canada
Condition: Primary Nocturnal Enuresis
Class: Antidiuretic hormones
Form: Tablets
Ingredients: desmopressin, gelatin , mannitol, citric acid

Desmopressin oral disintegrating tablets

About This Medication

What the Medication is Used For

DDAVP MELT is used to prevent or control the frequent urination, extreme thirst, and loss of water associated with Diabetes Insipidus (water diabetes), following head trauma and surgery in the pituitary gland.

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.

It is important that you do not try to prevent this by ignoring your thirst and drinking less, or you will disturb the balance of water in your body.

What it Does

DDAVP MELT contains desmopressin, an antidiuretic hormone. DDAVP MELT reduces 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 as often.

When it Should not be Used

There are people who should not take DDAVPÒ 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 platelet-type (pseudo) von Willebrand’s disease
  • 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 any of the other ingredients in DDAVP Melt (see What the nonmedicinal ingredients are)

What the Medicinal Ingredient Is

This medicine contains an active drug called desmopressin acetate.

What the Nonmedicinal Ingredients Are

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 you use DDAVP MELT 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 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 MELT should not be given to dehydrated patients until water balance is adequately restored.

Talk to your doctor before stopping or interrupting treatment with DDAVP MELT.

Interactions with his Medication

Drugs that may interact with DDAVP MELT 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)
  • 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 MELT.

Proper Use of this Medication

How to Take DDAVP MELT

DDAVP MELT should be placed under the tongue (sublingually). The tablet disintegrates instantaneously in the mouth without the need for water.

  1. Completely remove the end tab of a blister strip by tearing along the perforations, starting from the corner with the hand symbol.
  2. Remove one blister from the strip by tearing along the perforations.
  3. 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.
  4. 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 I Take

Usual dose

Follow your doctor’s direction on how much medicine you should take. The recommended treatment range for diabetes insipidus is 120-720 μg per day divided equally into 2 or 3 doses a day.

Overdose

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, weight gain due to water retention and, in severe cases, convulsions.

Missed dose

If you miss a dose of DDAVP MELT, 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.

Proper Use of this Medication

How to Take DDAVP MELT

DDAVP MELT should be placed under the tongue (sublingually). The tablet disintegrates instantaneously in the mouth without the need for water.

  1. Completely remove the end tab of a blister strip by tearing along the perforations, starting from the corner with the hand symbol.
  2. Remove one blister from the strip by tearing along the perforations.
  3. 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.
  4. Carefully take a DDAVP MELT out of its blister. Place the DDAVP MELT under the tongue and allow it to dissolve.

 

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 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.

Serious Side Effects, How Often they Happen and What to do About Them

Symptoms / effectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor
or pharmacist
Only if
severe
In all
cases
Rare Convulsions     T
  Unusually bad
or prolonged
headache
    T
  Confusion     T
  Unexplained
weight gain
    T
  Nausea     T
  Vomiting     T

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
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 0701D
    Ottawa, Ontario
    K1A 0K9

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.

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.