BUDESONIDE NASAL- budesonide spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Apotex Corp.

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 32 ug

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Budesonide nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older. Budesonide nasal spray is contraindicated in patients with hypersensitivity to any of its ingredients [see Warnings and Precautions (5.2) ]. Teratogenic Effects: Pregnancy Category B. The impact of budesonide on human pregnancy outcomes has been evaluated through assessments of birth registries linked with maternal usage of inhaled budesonide (i.e., PULMICORT TURBUHALER) and intranasally administered budesonide (i.e., Budesonide Nasal Spray). The results from population-based prospective cohort epidemiological studies reviewing data from three Swedish registries covering approximately 99% of the pregnancies from 1995- 2001 (i.e., Swedish Medical Birth Registry; Registry of Congenital Malformations; Child Cardiology Registry) indicate no increased risk for overall congenital malformations from the use of inhaled or intranasal budesonide during ea

Product summary:

Budesonide Nasal Spray, 32 mcg is available in an amber glass bottle with a metered-dose pump spray and a protection cap. Budesonide Nasal Spray, 32 mcg (NDC 60505-0839-2) provides 120 metered sprays after initial priming; net fill weight 8.6 g. The Budesonide Nasal Spray, 32 mcg bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after 120 sprays following initial priming, since the amount of budesonide delivered per spray thereafter may be substantially less than the labeled dose. Each spray delivers 32 mcg of budesonide to the patient.   Budesonide Nasal Spray should be stored upright at 20º to 25°C (68º to 77°F) [See USP controlled room temperature]. Do not freeze. Protect from light.   Shake gently before use. Do not spray in eyes.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE NASAL- BUDESONIDE SPRAY, METERED
APOTEX CORP.
----------
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:
Treatment of seasonal or perennial allergic rhinitis in adults and
children ≥ 6 years. (1.1)
DOSAGE AND ADMINISTRATION
For intranasal use only.
Starting dosage:
Adult and children 6 years of age and older: 64 mcg (one spray per
nostril) once daily. (2)
Maximum dosages:
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)
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
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 with caution in patients
with these infections. More serious or even a fatal
course of chickenpox or measles can occur in susceptible patients.
(5.3)
Hypercorticism and adrenal suppression: May occur with very high
dosages or at the regular dose in susceptible
individuals. If such changes occur, reduce treatment with budes