Patient Medication Information: uses, side effects, how to take - Desmopressin Tablets
How Do PrDesmopressin Tablets (desmopressin) work?
Pr Desmopressin Tablets reduce 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.
Getting ready to use Pr Desmopressin Tablets
- 1. Reduce the number of drinks the child has after supper.
- 2. If your child was on Pr Desmopressin Spray and is now switching to Pr Desmopressin Tablets, he/she can start taking the Tablets 24 hours after the last time the Spray was used.
What the medicinal ingredient is:
Desmopressin Acetate
What the important nonmedicinal ingredients are: Lactose, Potato Starch, Povidone, Magnesium Stearate
What dosage forms it comes in:
Pr Desmopressin Tablets are supplied in bottles of 7, 30 or 100 tablets.
WARNINGS AND PRECAUTIONS
Infrequently, high doses of desmopressin have produced transient headache and nausea. Nasal congestion, rhinitis, flushing and mild abdominal cramps have been reported. These symptoms disappeared with reduction in dosage. Please contact your physician should your child experience any side effects. For PrDesmopressin Tablets to work at its best, it is very important to limit the number of drinks the child has after supper, especially 1 hour before bedtime. As most children sleep between 8 to 12 hours, further fluid restriction is not required. In the event the child wakes up during the night, liquid intake should be restricted.
INTERACTIONS WITH THIS MEDICATION
Tell your child’s doctor or pharmacist in the unlikely event your child is taking any of the following medications (they are adult medications known to cause water retention and should be avoided when taking Desmopressin Tablets: clofibrate, chlorpromazine, carbamazapine, tricyclic antidepressants (such as amitriptyline, nortriptyline), selective serotonin reuptake inhibitors (SSRIs 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®, naprosen or Naprosyn®), celecoxib or Celebrex®) and loperamide or Imodium®.
Bedwetting 
PROPER USE OF THIS MEDICATION
How many Pr Desmopressin Tablets should be used?:
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.
HOW TO STORE IT
Store between 15EC - 25EC in a dry place.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on
serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
For more information or help, call a Registered Nurse at 1-800-970-4224 or visit our Website at
www.bedwetting.ferring.ca
Rainbow Pharmaceuticals Inc.
Rainbow Pharmaceuticals Inc., Toronto, Ontario
Last revised: March 2007
PART III: CONSUMER INFORMATION
Pr Desmopressin Tablets
This leaflet is part III of a three-part “Product Monograph published when Pr Desmopressin Tablets were approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about Pr Desmopressin Tablets. Contact your doctor or pharmacist if you have any questions about the drug.
Pharmacist: Please dispense this insert with product.
ABOUT THIS MEDICATION
What is the medication used for?
What are Desmopressin Tablets?
Desmopressin Tablets are used to prevent or control the frequent urination, increased thirst, and loss of water associated with Diabetes Insipidus (water diabetes).
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 to point out that DI is not related to the type of diabetes most people have heard of, Diabetes Mellitus (sugar diabetes).
In DI, there is no problem with the sugar in the blood or urine. The problem either concerns the lack of water-retaining hormone in the blood (called vasopressin or Anti-Diuretic Hormone - ADH) or is sometimes due to an abnormality in the kidneys which prevents them from responding to this hormone. The hormone itself is normally secreted by the pituitary gland, which is located at the base of the brain, just behind the bridge of the nose.
What causes DI?
Most DI is caused by inadequate secretion of vasopressin by the pituitary gland. This can happen in varying degrees. Sometimes it occurs on its own, but in many cases it is accompanied by loss of other hormones made by the pituitary. In this event, it is most likely to be caused either by abnormalities of the pituitary gland or as a result of treatment to remove an enlarged pituitary gland.
If you experience DI following pituitary surgery, this may be temporary, in which case it will only last a week or two, but in some cases it may be permanent.
DI can occur at any age, but is mostly found in adults, as pituitary enlargement is most common between the ages of 20 and 50. It is a rare disorder, affecting only about 1 in 25,000 people.
The other form of DI occurs when the kidneys cannot respond to vasopressin secreted by the pituitary gland. It is caused by an inherited abnormality in the mechanism which recognises vasopressin in the kidney, or by a number of diseases of the kidney itself.
What does it feel like to have DI?
If you suffer from DI, you may find you feel generally unwell for no obvious reason. The main symptoms, however, are that you will feel extremely thirsty much of the time, no matter how much you drink, and you will find you need to pass urine very frequently, even during the night. You may excrete as much as 2.5-3 gallons of urine a day. 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.
How is it diagnosed?
What tests are carried out?
The method of diagnosis is simply to deprive you of fluid for 6-8 hours and see if there is a reduction in the volume of urine. You can expect to feel quite thirsty during this part of the test. The next stage is to give you a small quantity of vasopressin, usually as an injection. You will then make less urine. Once you are allowed to drink again, you will feel better. If you need other hormone treatments, you will need to continue taking them during the test. This can be
performed in an outpatient clinic, but it does require attendance for a whole day.
How is DI treated?
If your DI is diagnosed as being caused by a lack of vasopressin production from the pituitary gland, it needs to be treated with a substance like vasopressin, which acts specifically on the kidneys. This substance is called desmopressin, but you will normally hear it referred to as Desmopressin Tablets.
You will gradually feel better once you are taking desmopressin. Overall, the treatment of DI is very straightforward and you need not worry about handling this aspect of your illness.
It is possible that your condition will require long term monitoring. If you do not take enough desmopressin, your original symptoms of thirst and passing a lot of urine will return. If you take more desmopressin than you need, your body may become overloaded with fluid, which could result in headaches, dizziness and abnormal weight gain. In turn this may result in low amounts of sodium in your blood, which is called hyponatremia. It is important that you contact your doctor if you experience any of these symptoms. Your doctor will help you to find the right dose of desmopressin and will advise you on the amount of fluid you should take.
How Do Pr Desmopressin Tablets work?:
Pr Desmopressin 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.
Who Should Not Take Desmopressin Tablets?
There are people who should not take Desmopressin Tablets. Tell your doctor or pharmacist if you have:
- Hyponatremia (low blood sodium levels)
- Diarrhea
- Any heart, liver or kidney problems
- Bleeding problems
- Bulimia or anorexia nervosa
Type II B or platelet-type (pseudo) von
Willebrand’s disease.
- Adrenal problems (e.g. Addison’s disease)
An allergy to desmopressin acetate or to any of
the ingredients listed.
What do Desmopressin Tablets contain?
What the medicinal ingredient is:
This medicine contains an active drug called desmopressin acetate. If you have a known allergy or sensitivity to desmopressin acetate, call your doctor before using this medicine.
What the important nonmedicinal ingredients are:
lactose, potato starch, povidone, magnesium stearate
What dosage forms it comes in:
Pr Desmopressin Tablets are supplied in bottles of 7, 30 or 100 tablets.
WARNINGS AND PRECAUTIONS
BEFORE you use Desmopressin Tablets, talk to your doctor or pharmacist if you are:
Breast-feeding
- Pregnant or think you might be pregnant
And/or if you have:
- heart problems
- liver disease
- kidney problems
- bleeding problems
- fever
- any allergies to desmopressin acetate or any of the ingredients listed in “What the important nonmedicinal ingredients are.”
Infrequently, high doses of desmopressin have produced temporary headache and nausea, and mild abdominal cramps have been reported. Symptoms disappeared with reduction in dosage. Please contact your doctor if you experience any side effects.
If you are taking any of the drugs that are known to cause water retention listed in “Interactions with This medication”, it may be necessary to monitor the amount of sodium in your blood. Use of both drugs together could increase the chances of getting low amounts of sodium in your blood. Contact your doctor if you experience worsening of the symptoms such as headache, nausea and vomiting. This may indicate possible changes in the amount of sodium in your blood and your doctor may need to do a blood test.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Desmopressin Tablets include: clofibrate, chlorpromazine, carbamazapine, tricyclic antidepressants (such as amitriptyline, nortriptyline), selective serotonin reuptake inhibitors (SSRIs 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®, naprosen or Naprosyn®), celecoxib or Celebrex®) and loperamide or Imodium®.
If you are taking any of these drugs, please talk to your doctor or pharmacist before taking Desmopressin Tablets.
PROPER USE OF THIS MEDICATION
How Many Desmopressin Tablets Should I Take?
Take the medication only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.
When using Desmopressin Tablets, it is important that you get the right amount of medicine for your condition. The dose of desmopressin will be different for different patients. You doctor will determine the right amount of Desmopressin Tablets for you.
Usual dose:
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.
What if I forget to take Desmopressin Tablets?
If you miss a dose of Desmopressin Tablets, take the missed dose as soon as possible. Then go back to your regular dosing schedule. 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
What are the possible side effects of Desmopressin
Tablets?
As with all medicines, side effects may be experienced. With Desmopressin Tablets, these may include headache, dizziness, rash, and 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.
HOW TO STORE IT
Where should I keep Desmopressin Tablets?
Store between 15ºC - 25ºC in a dry place.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789 By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
For more information or help, call 1-800-263-4057.
Rainbow Pharmaceuticals Inc., Toronto, Ontario
Last revised: 13 April 2007
Rainbow Pharmaceuticals Inc.