Desmopressin

Desmopressin is used in the treatment of:

• Diabetes Insipidus
• Enuresis
• Hemorrhage
• Thrombocytopenia

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Desmopressin may be found in some form under the following brand names:

• Ddavp

• Minirin

• Stimate

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Desmopressin is used to treat central cranial diabetes insipidus. This is a condition that causes the body to lose too much fluid and become dehydrated. It is also used to control bedwetting (nocturnal enuresis), and the frequent urination and increased thirst caused by certain types of brain injury or brain surgery.

Desmopressin is similar to a hormone that is produced in the body. It acts on the kidneys to reduce the flow of urine.

desmopressin is available only with your doctor's prescription.

Take desmopressin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Your doctor may limit the amount of fluid or water you drink. Follow the instructions carefully to prevent unwanted effects.

Dosing

The dose of desmopressin 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 desmopressin. 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 oral dosage form (tablets):
  • For treatment of bedwetting:
    • Adults and children 6 years of age or older—At first, 0.2 milligram (mg) as a single dose at bedtime. Your doctor may adjust your dose as needed. However, the dose is usually not more than 0.6 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For treatment of diabetes insipidus:
    • Adults and children 4 years of age and older—At first, 0.05 milligram (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1.2 mg per day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of desmopressin, 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Desmopressin ACETATE Injection 4 mcg/mL is contraindicated in individuals with known hypersensitivity to Desmopressin acetate or to any of the components of Desmopressin ACETATE Injection 4 mcg/mL.

Desmopressin ACETATE is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

Desmopressin ACETATE is contraindicated in patients with hyponatremia or a history of hyponatremia.

Injection:

Diabetes insipidus: Antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus; management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitations of use: Desmopressin is ineffective for the treatment of nephrogenic diabetes insipidus.

Hemophilia A: For use in patients with hemophilia A with factor VIII coagulant activity levels >5% to maintain hemostasis during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure and to also stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of use: Not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels ≤5%, for the treatment of hemophilia B, or in patients who have factor VIII antibodies. In certain clinical situations, it may be justified to try desmopressin with careful monitoring in patients with factor VIII levels between 2% and 5%.

Nocturia (Noctiva): Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Limitations of use: Has not been studied in patients <50 years of age.

Von Willebrand disease (type 1): For use in patients with mild to moderate classic von Willebrand disease (type 1) with factor VIII coagulant activity levels >5% to maintain hemostasis during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure and to stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of use: Patients with von Willebrand disease who are least likely to respond are those with severe homozygous von Willebrand disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels <1%; other patients may respond (variable) depending on the type of molecular defect they have. Check bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen during administration of desmopressin to ensure that adequate levels are being achieved. Not indicated for the treatment of severe classic von Willebrand disease (type I) or when there is evidence of an abnormal molecular form of factor VIII antigen.

Uremic bleeding (Octostim [Canadian product]): Prevention or treatment of bleeding in patients with uremia.

Intranasal:

Diabetes insipidus (DDAVP Rhinal tube): Antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus; management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitation of use: Desmopressin is ineffective for the treatment of nephrogenic diabetes insipidus.

Hemophilia A (Stimate; Octostim [Canadian product]): For use in patients with hemophilia A with factor VIII coagulant activity levels >5% and to stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, or mucosal bleeding.

Limitations of use: Not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels ≤5%, for the treatment of hemophilia B, or in patients who have factor VIII antibodies.

von Willebrand disease (type 1) (Stimate; Octostim [Canadian product]): For use in patients with mild to moderate classic von Willebrand disease (type 1) with factor VIII coagulant activity levels >5% and to stop bleeding due to spontaneous or trauma-induced injuries, such as hemarthroses, intramuscular hematomas, mucosal bleeding, or menorrhagia.

Limitations of use: Not indicated for the treatment of severe classic von Willebrand disease (type 1) or when there is evidence of an abnormal molecular form of factor VIII antigen.

Tablets:

Diabetes insipidus: Antidiuretic replacement therapy in the management of central diabetes insipidus; management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Limitation of use: Desmopressin is ineffective for the treatment of nephrogenic diabetes insipidus.

Nocturia (Nocdurna [Canadian product] only): Treatment of nocturia in adults with four or less nocturnal voids.

Primary nocturnal enuresis: Management of primary nocturnal enuresis, either alone or as an adjunct to behavioral conditioning or other nonpharmacologic intervention.

Blood pressure and pulse should be monitored during IV infusion

Note: For all indications, fluid intake, urine volume, and signs and symptoms of hyponatremia should be closely monitored especially in high-risk patient subgroups (eg, young children, elderly, patients with heart failure).

Diabetes insipidus: Urine specific gravity, plasma and urine osmolality, serum electrolytes

Hemophilia A: Factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII antigen levels, aPTT

von Willebrand disease: Factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII von Willebrand antigen levels, bleeding time

Nocturnal enuresis: Serum electrolytes if used for >7 days

Nocturia: Serum sodium concentrations at baseline, within 7 days, ~1 month after initiating therapy or increasing the dose, and periodically during therapy. More frequent monitoring in patients ≥65 years and those at increased risk of hyponatremia.

Uremic bleeding: Octostim [Canadian product]): Bleeding time before and 1 hour after IV infusion.

Consult your pharmacist.

How to use Desmopressin Powder

Consult your pharmacist.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.