BUDESONIDE spray metered

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

Предлага се от:

AstraZeneca Pharmaceuticals LP

INN (Международно Name):

BUDESONIDE

Композиция:

BUDESONIDE 32 ug

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

New Drug Application

Данни за продукта

BUDESONIDE- BUDESONIDE SPRAY, METERED
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
_THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL_
_PRESCRIBING INFORMATION FOR BUDESONIDE NASAL SPRAY. _
BUDESONIDE NASAL SPRAY 32 MCG.
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Budesonide Nasal Spray is a corticosteroid indicated for:
•
DOSAGE AND ADMINISTRATION
For intranasal use only.
Starting dosage:
•
Maximum dosages:
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DOSAGE FORMS AND STRENGTHS
Nasal Spray: 32 mcg budesonide in each metered spray. (3)
Supplied in 8.6 g bottle providing 120 metered sprays after initial
priming. (16)
CONTRAINDICATIONS
Hypersensitivity to ingredients. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1–800–236–9933 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2017
Treatment of seasonal or perennial allergic rhinitis in adults and
children ≥ 6 years. (1.1)
Adult and children 6 years of age and older: 64 mcg (one spray per
nostril) once daily. (2)
Adults 12 years of age and older: 256 mcg (four sprays per nostril)
once daily. (2)
Pediatric patients (6 to <12 years of age): 128 mcg (two sprays per
nostril) once daily. (2)
Local Nasal Effects: Epistaxis, _Candida albicans_ infections, nasal
septal perforation, impaired wound healing. Monitor
patients periodically for signs of adverse effects on the nasal
mucosa. Avoid use in patients with recent nasal ulcers,
nasal surgery, or nasal trauma. (5.1)
Hypersensitivity reactions: Anaphylaxis, urticaria, rash, dermatitis,
angioedema and pruritus may occur after
administration of Budesonide Nasal Spray. (5.2)
Immunosuppression: Potential worsening of infections (e.g., existing
tuberculosis, fungal bacterial, viral, or parasitic
infections; or ocular herpes simplex). Use