DDAVP

Generic Name: desmopressin (Nasal route, Oral route, Injection route)

des-moe-PRES-in

Commonly used brand name(s):

In the U.S.

• DDAVP
• DDAVP Rhinal Tube
• Minirin
• Stimate

Available Dosage Forms:

• Solution
• Spray
• Tablet

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vasopressin (class)

Uses For DDAVP

Desmopressin is a hormone taken through the nose, by mouth, or given by injection to prevent or control the frequent urination, increased thirst, and loss of water associated with diabetes insipidus (water diabetes). It is used also to control bed-wetting and frequent urination and increased thirst associated with certain types of brain injuries or brain surgery. Desmopressin works by acting on the kidneys to reduce the flow of urine.

Desmopressin is also given by injection to treat some patients with certain bleeding problems such as hemophilia or von Willebrand's disease.

Desmopressin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, desmopressin is used in certain patients to determine the cause of Cushing's syndrome.

Before Using DDAVP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of nasal desmopressin in children and infants. However, infants may be more sensitive to the effects of nasal desmopressin, which may require caution in patients receiving this medicine .

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oral desmopressin in infants and children with diabetes insipidus. However, safety and efficacy have not been established in children below 6 years of age with bed-wetting problems .

Appropriate studies have not been performed on the relationship of age to the effects of desmopressin injection in infants below 3 months of age for the treatment of hemophilia A or Von Willebrand's disease, and in children below 12 years of age with diabetes insipidus. Safety and efficacy have not been established in these age groups .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of desmopressin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving desmopressin .

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots—Use with caution. Desmopressin injection may worsen this condition .

• Cystic fibrosis or
• Dehydration or
• Fluid or electrolyte imbalance or
• Heart failure—Loss of sodium from the blood and serious side effects may be more likely to occur in patients with these conditions .

• Headache, severe, or migraine or
• Heart or blood vessel disease or
• High blood pressure—Large doses of desmopressin can cause an increase or decrease in blood pressure.

• Hyponatremia, or history of or
• Kidney problems—Desmopressin should NOT be used in patients with these conditions .

• Stuffy nose caused by cold or allergy—May prevent nasal desmopressin from being absorbed through the lining of the nose into the blood stream.

Proper Use of desmopressin

This section provides information on the proper use of a number of products that contain desmopressin. It may not be specific to DDAVP. Please read with care.

Use this medicine only as directed. 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.

Your doctor may want you to decrease the amount of fluids that you drink while you are using this medicine .

For patients using the nasal solution form of this medicine:

• This medicine comes with patient instructions. Read and follow these instructions carefully.
• Before using the medicine, gently blow your nose to clear the nostrils.
• If you are using the nasal spray for the first time, you will need to prime the spray. To do this, press the pump down four times or until some of the medicine sprays out. If you have not used the medicine for one week or longer, re-prime the pump by pressing once.
• Do not use the nasal spray more times than the number indicated on the label. If you do, you may not receive the correct amount of medicine.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
• The Rhinal Tube is a soft plastic tube with numbers (doses) marked on the side. Draw the drops into the tube until the liquid reaches the number of your dose. Put one end of the tube into your nose and the other end into your mouth. Blow gently until all the medicine has sprayed into your nose. Do not let any medicine run down through the tube into your mouth.
• After using the rhinal tube, wash it with water and shake thoroughly until no more water is left. Put the seal back on the dropper tip and close the bottle with the plastic cap .

For patients using the tablet form of this medicine:

• Do not drink water or any other liquids from 1 hour before to 8 hours after taking the tablets .

For patients using the injection form of this medicine:

• A nurse or other trained health professional will give you this medicine. Sometimes you, a family member, or a friend can also be taught to give your medicine .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (nasal solution):
  • For preventing or controlling diabetes insipidus (water diabetes):
    • Adults and teenagers—0.1 to 0.4 milliliters (ml) or 10 to 40 micrograms (mcg) given as a single dose or divided into two or three doses a day .
    • Children 3 months to 12 years of age— 0.05 to 0.3 milliliters (ml) or 5 to 30 micrograms (mcg) given as a single dose or divided into two doses a day .
    • Children up to 3 months of age—Use and dose must be determined by your doctor .
• For oral dosage form (tablets):
  • For preventing or controlling diabetes insipidus (water diabetes):
    • Adults, teenagers, and children—At first, 0.05 milligram (mg) two times a day. Then, your doctor may change the dose to 0.1 to 0.8 mg. The dose may be divided into several doses a day.
  • For controlling bed-wetting:
    • Adults, teenagers, and children 6 years of age or older—At first, 0.2 mg once a day at bedtime. Then, your doctor may increase the dose to as much as 0.6 mg a day.
    • Children up to 6 years of age—Use and dose must be determined by your doctor .
• For parenteral dosage form (injection):
  • For preventing or controlling frequent urination:
    • Adults and teenagers—2 to 4 mcg injected into a vein or under the skin. This dose is usually divided into two doses a day, one given in the morning, and the other given in the evening.
    • Children up to 12 years of age—Use and dose must be determined by your doctor .
  • For treating some bleeding problems such as hemophilia or von Willebrand's disease (Type I):
    • Adults, teenagers, and children 11 months of age or older weighing more than 10 kg (22 pounds)—The dose is based on body weight and must be determined by your doctor. It is usually 0.3 micrograms (mcg) per kilogram (kg) (0.14 mcg per pound) of body weight mixed in 50 milliliters (mL) of 0.9% sodium chloride. This solution is injected into a vein slowly over fifteen to thirty minutes. Your doctor may repeat this treatment if needed.
    • Children 3 months of age or older weighing 10 kg (22 pounds) or less—The dose is based on body weight and must be determined by your doctor. It is usually 0.3 micrograms (mcg) per kilogram (kg) (0.14 mcg per pound) of body weight mixed in 10 mL of 0.9% sodium chloride. This solution is injected into a vein slowly over fifteen to thirty minutes. Your doctor may repeat this treatment if needed.
    • Children up to 3 months of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it 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 doses.

Has a bulleted list describing how to handle missed doses for various possible dosing schedules.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store as directed on the label or by your health care professional.

Precautions While Using DDAVP

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects .

This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness .

Check with your doctor right away and stop using this medicine if you have fever, severe vomiting or diarrhea, or other conditions that may make you thirsty (such as during hot weather or having a strenuous exercise). This medicine may cause fluid or electrolyte imbalance which can lead to seizures and other serious conditions .

Do not take other medicines unless they have been discussed with your doctor, especially medicines that can make your mouth dry. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .

Desmopressin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you use this medicine .

DDAVP Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chills
• confusion
• convulsions (seizures)
• decreased urination
• drowsiness
• fast heartbeat
• fever
• headache (continuing)
• shortness of breath, tightness in chest, trouble in breathing, or wheezing
• skin rash, hives, or itching
• weight gain (rapid)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps
• flushing or redness of skin
• nausea
• pain in the vulva (genital area outside of the vagina)

• Cough
• nosebleed
• runny or stuffy nose
• sneezing
• sore throat

• Pain, redness, or swelling at place of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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