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|Stimate Nasal Spray

DESMOPRESSIN (Systemic)

Some commonly used brand names are:

In the U.S.—

• DDAVP Injection
• DDAVP Nasal Spray
• DDAVP Rhinal Tube
• DDAVP Tablets
• Stimate Nasal Spray

In Canada—

• DDAVP Injection
• DDAVP Spray
• DDAVP Rhinyle Nasal Solution
• DDAVP Tablets
• Octostim

Generic name product may be available in the U.S.

Category

• Antidiuretic, central diabetes insipidus
• antidiuretic, primary nocturnal enuresis
• antihemorrhagic

Description

Desmopressin (des-moe-PRES-in) 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, in the following dosage forms:

• Nasal
• Nasal solution (U.S. and Canada)

• Oral
• Tablets (U.S. and Canada)

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

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 desmopressin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to desmopressin. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in pregnant women. Desmopressin has been used before and during pregnancy to treat diabetes insipidus and has not been shown to cause birth defects.

Breast-feeding—Desmopressin passes into breast milk in very small amounts. However, it has not been reported to cause problems in nursing babies.

Children—Infants may be more sensitive to the effects of desmopressin.

Older adults—Some side effects (confusion, continuing headache, drowsiness, problem with urination, weight gain) may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of desmopressin.

Other 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 health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Cystic fibrosis or
• Dehydration—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

• Kidney problems—Desmopressin should NOT be used.

• 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 This Medicine

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.

For patients using the nasal solution form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• 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.

Dosing—When you are using desmopressin, it is very important that you get the exact amount of medicine that you need. The dose of desmopressin will be different for different patients. Your doctor will determine the proper dose of desmopressin for you.

The number of doses you use each day, the time allowed between doses, and the length of time you use the medicine depend on the medical problem for which you are using desmopressin .

• For nasal dosage form (nasal solution):
  • For preventing or controlling diabetes insipidus (water diabetes):
    • Adults and teenagers—10 to 40 mcg used as a single dose or it may be divided into two or three doses a day.
    • Children 3 months to 12 years of age—The dose is usually 0.05 to 0.3 milliliters (mL) inhaled in each nostril one or two times a day.
    • Children up to 3 months of age—Dose must be determined by your doctor.
  • For controlling bed-wetting:
    • Adults, teenagers, and children 6 years of age or older—At first, 20 mcg inhaled into each nostril at bedtime. Then, your doctor may change the dose to 10 to 40 mcg a day.
    • Children up to 6 years of age—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—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 muscle, 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—0.4 mcg or 0.025 mcg per kg (0.011 mcg per pound) of body weight injected into a muscle, vein, or under the skin once a day.
  • For treating some bleeding problems such as hemophilia or von Willebrand"s disease:
    • 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 mcg per 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 mcg per 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 11 months of age—Use is not recommended.

Missed dose—If you miss a dose of this medicine and your dosing schedule is:

• One dose a day—Use the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—Use 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 doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store tablets in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Store as directed on the label or by your health care professional. Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Side Effects of This Medicine

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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

Additional Information

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.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.

Revised: 12/01/2005

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