듀레신구강용해필름0.2mg(데스모프레신아세트산염)

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. ( 1.1 ) 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. ( 1.2 ) 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. ( 1.3 ) Limitations of Use Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. ( 1.3 ) von Willebrand’s disease (severe Type I) - not indicated for the treatment of patients with severe Type I von Willebrand’s disease and when there is evidence of an abnormal molecular form of factor VIII antigen. ( 1.3 ) 1.1 Central Diabetes Insipidus Desmopressin acetate injection is indicated 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 …

Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6 ), Description ( 11 )] . 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 [see Use in Specific Populations ( 8.5 , 8.6 ) and Clinical Pharmacology ( 12.3 )]. Hyponatremia or a history of hyponatremia [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.4 , 8.5 )] . Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions ( 5.1 )] . Polydipsia [see Warnings and Precautions ( 5.1 )]. Concomitant use with loop diuretics [see Boxed Warning ] . Concomitant use with systemic or inhaled …

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. ( 5.2 ) 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. ( 5.3 ) Hypersensitivity Reactions: Severe reactions have occurred. Monitor for reactions during administration and interrupt if reaction occurs. ( 5.4 ) Fluid Retention: Fluid retention can worsen underlying conditions that are susceptible to volume status. Not recommended in patients at risk for increased intracranial pressure or with a history of urinary retention. ( 5.5 ) 5.1 Hyponatremia Desmopressin acetate injection can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death [see Boxed Warning ]. Desmopressin acetate injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances [see Contraindications ( 4 ), Drug Interactions ( 7 )] . Avoid concomitant treatments that also cause hyponatremia. Prior to …

Pediatric Use: Initiate fluid intake restriction to prevent possible hyponatremia and water intoxication. ( 8.4 ) Geriatric Use: Carefully select dose and monitor renal function more frequently. ( 8.5 ) See 17 for PATIENT COUNSELING INFORMATION. 8.1 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. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were …