DESMOPRESSIN ACETATE spray

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Apotex Corp.

Οδός χορήγησης:

NASAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Desmopressin 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 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 nasal spray is contraindicated in patients with: - Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray. Severe

Περίληψη προϊόντος:

Desmopressin nasal spray, USP is available in a 5 mL bottle with a nasal spray pump dispenser with dust cover and patient instruction sheet delivering 50 sprays of 10 mcg (NDC 60505-0815-0). Store at 25°C (77°F) [see USP Controlled Room Temperature]; excursions permitted from 15°C to 30°C (59°F to 86°F).  AFTER ASSEMBLY, STORE UPRIGHT. Keep out of the reach of children.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SPRAY
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESMOPRESSIN NASAL
SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DESMOPRESSIN NASAL
SPRAY.
DESMOPRESSIN NASAL SPRAY
INITIAL U.S. APPROVAL: 1978
INDICATIONS AND USAGE
Desmopressin 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 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 at 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 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, 5.1)
Altered Absorption in Patients with Nasal Mucosa Abnorma