DESMOPRESSIN ACETATE spray

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 10 ug in 0.1 mL

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desmopressin Acetate Nasal Spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older. Limitations of Use : Desmopressin Acetate Nasal Spray is not indicated for: - Treatment of nephrogenic diabetes insipidus, - Treatment of primary nocturnal enuresis [see Warnings and Precautions (5.1) ], - Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions (5.2)], - Use in patients with an impaired level of consciousness, - Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths (3)]. Desmopressin Acetate Nasal Spray is contraindicated in patients with: - Known hypersensitivity to desmopressin acetate or to any of the components of Desmopress

Product summary:

Desmopressin Acetate Nasal Spray is available as a 5 mL bottle containing an aqueous solution with the spray pump delivering 50 sprays of 10 mcg (0.1 mL) (NDC 69918-501-05). Store at Controlled Room Temperature 20 to 25ºC (68 to 77ºF) [see USP Controlled Room Temperature]. STORE BOTTLE IN UPRIGHT POSITION.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SPRAY
AMRING PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN ACETATE NASAL SPRAY
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DESMOPRESSIN ACETATE NASAL SPRAY.
DESMOPRESSIN ACETATE NASAL SPRAY
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
Desmopressin Acetate Nasal Spray is a vasopressin analog indicated as
antidiuretic replacement therapy in the
management of central diabetes insipidus for adults and pediatric
patients 4 years of age and older (1)
Limitations of Use:
Desmopressin Acetate Nasal Spray is not indicated for:
Treatment of nephrogenic diabetes insipidus (1)
Treatment of primary nocturnal enuresis (1, 5.1)
Use in patients with conditions that compromise intranasal route of
administration (1, 5.2)
Use in patients with an impaired level of consciousness (1)
Use in patients requiring doses less than 10 mcg or doses that are not
multiples of 10 mcg (1,3)
DOSAGE AND ADMINISTRATION
For intranasal use only (2.1)
Instruct patients to prime pump prior to use (2.1)
Adults: 10 mcg to 40 mcg daily (either as a single dose or divided
into two or three daily doses) (2.2)
Pediatrics: 10 mcg once daily into one nostril up to 30 mcg once daily
(or 30 mcg divided as 20 mcg during the morning
and 10 mcg night) (2.2)
See the Full Prescribing Information for recommendations for switching
between desmopressin acetate formulations
(2.3)
DOSAGE FORMS AND STRENGTHS
Nasal Spray: 10 mcg per 0.1 mL spray, available in a 5 mL bottle with
spray pump delivering 50 sprays (3)
CONTRAINDICATIONS
Known hypersensitivity to desmopressin acetate or to any of the
components of Desmopressin Acetate Nasal Spray (4,
6)
Patients with renal impairment (creatinine clearance below 50 mL/min)
(4, 8.6, 12.3)
Hyponatremia or a history of hyponatremia (4, 5.1)
WARNINGS AND PRECAUTIONS
_Hyponatremia:_ Instruct patients about proper fluid restriction and
monitor serum sodium as needed (2.1,