Finished product reference

Desmopressin

Tablet · Sublingual · 25 µg

List code
52237
Salt form
Acetate
Boxed warning

WARNING: HYPONATREMIA Desmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death . Desmopressin acetate is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretic…

What it is and how it works

Mechanism of Action Desmopressin acetate increases plasma levels of factor VIII activity in patients with hemophilia and von Willebrand's disease Type I. The antidiuretic effects of desmopressin acetate are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin acetate is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus.

Indications

Desmopressin acetate injection is a vasopressin analog used for: Central Diabetes Insipidus - as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Hemophilia A - for patients with factor VIII coagulant activity levels greater than 5% to maintain hemostasis during surgical procedures and postoperatively or reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. von Willebrand's disease (Type I) - for patients with mild to moderate disease with factor VIII levels greater than 5% to maintain hemostasis during surgical procedures or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. Limitations of Use Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus.

Dosage and administration (summary)

Diabetes Insipidus: The daily dose is 2 mcg to 4 mcg administered as one or two divided doses by subcutaneous or intravenous injection. The dosage must be determined for each patient and adjusted according to the pattern of response. Hemophilia A and von Willebrand's Disease (Type I): 0.3 mcg/kg (to a maximum of 20 mcg) administered by intravenous infusion. Dilute dose as appropriate. See Full Prescribing Information for instructions on reconstitution, preparation, and administration . Pretreatment Testing and On-Treatment Monitoring Diabetes Insipidus Prior to treatment with desmopressin acetate, assess serum sodium, urine volume and osmolality.

Contraindications

Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection . Desmopressin acetate injection is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min . Hyponatremia or a history of hyponatremia .

Warnings and precautions

Hypotension and Hypertension : May cause hypotension with compensatory increase in heart rate or hypertension. Monitor blood pressure during desmopressin acetate administration, especially in patients with heart disease. Increased Risk of Thrombosis in Patients with von Willebrand's Disease Type IIB : Use of desmopressin acetate in patients with Type IIB von Willebrand's disease may cause thrombosis due to platelet aggregation. Hypersensitivity Reactions : Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs.

Pregnancy

Pregnancy Risk Summary Prolonged experience with desmopressin acetate injection in pregnant women over several decades, based on the available published literature and case reports, have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Storage and supply

Storage and Handling Store refrigerated between 2° and 8°C (36° and 46°F).

Source: Desmopressin Acetate (Desmopressin Acetate) — US FDA prescribing information, 2024-03-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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