DESMOPRESSIN ACETATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Desmopressin Acetate (UNII: XB13HYU18U) (desmopressin - UNII:ENR1LLB0FP)

Available from:

Amring Pharmaceuticals Inc.

INN (International Name):

Desmopressin Acetate

Composition:

Desmopressin Acetate 4 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 surgery in the pituitary region. Limitations of Use: Desmopressin acetate is ineffective and not indicated for the treatment of nephrogenic diabetes insipidus. Desmopressin acetate injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5% without factor VIII antibodies to: - Maintain hemostasis during surgical procedures and postoperatively - Reduce bleeding with episodes of spontaneous or traumatic injuries such as hemarthroses, intramuscular hematomas, or mucosal bleeding. Desmopressin acetate injection is indicated for patients with mild to moderate von Willebrand’s disease (Type I) with factor VIII levels greater than 5% to: - Maintain hemostasis during surgical procedures and postoperatively - Reduce bleeding with episodes of s

Product summary:

Desmopressin acetate injection is available as a sterile solution supplied as 4 mcg/mL in cartons of ten 1 mL single-dose, type 1 glass ampules (NDC 69918-899-10) and 40 mcg/10 mL (4 mcg/mL) in 10 mL multiple-dose vials, type 1 glass vial with rubber stopper and a flip off seal, (NDC 69918-901-10), each containing 4 mcg desmopressin acetate per mL. Store refrigerated 2° to 8°C (36° to 46°F).

Authorization status:

New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SOLUTION
AMRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN ACETATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DESMOPRESSIN
ACETATE INJECTION.
DESMOPRESSIN ACETATE INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1978
WARNING: HYPONATREMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DESMOPRESSIN ACETATE CAN CAUSE HYPONATREMIA, WHICH MAY BE
LIFE-THREATENING IF
SEVERE. (5.1)
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 DIURETICS OR
SYSTEMIC OR
INHALED GLUCOCORTICOIDS. (4, 5.1)
ENSURE SERUM SODIUM CONCENTRATION IS NORMAL BEFORE STARTING OR
RESUMING
DESMOPRESSIN ACETATE. MEASURE SERUM SODIUM WITHIN 1 WEEK AND
APPROXIMATELY 1
MONTH AFTER STARTING THERAPY AND PERIODICALLY DURING TREATMENT. MORE
FREQUENTLY
MONITOR SERUM SODIUM IN PATIENTS 65 YEARS OF AGE AND OLDER AND IN
PATIENTS AT
INCREASED RISK OF HYPONATREMIA. (2.1, 5.1)
IF HYPONATREMIA OCCURS, INTERRUPT OR DISCONTINUE DESMOPRESSIN ACETATE.
(5.1)
INDICATIONS AND USAGE
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
great