DESMOPRESSIN ACETATE injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Saatavilla:

Dr. Reddy's Laboratories Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 Injection 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 epi

Tuoteyhteenveto:

Desmopressin Acetate Injection, USP is available as a sterile solution supplied as 40 mcg/10 mL (4 mcg/mL) in 10 mL multiple-dose vials, type I glass vial with rubber stopper and a flip off seal, (NDC 43598-053-11), each containing 4 mcg desmopressin acetate, USP per mL. Store refrigerated 2° to 8°C (36° to 46°F).

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE INJECTION, SOLUTION
DR. REDDY'S LABORATORIES 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 INJECTION CAN CAUSE HYPONATREMIA, WHICH MAY BE
LIFE-
THREATENING IF SEVERE. (5.1)
DESMOPRESSIN ACETATE INJECTION 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 INJECTION. 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
INJECTION.(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 Willebr and's disease (Type I) - for patients with mil