ASTEPRO- azelastine hydrochloride spray, metered

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

AZELASTINE HYDROCHLORIDE (UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)

Beschikbaar vanaf:

Meda Pharmaceuticals

INN (Algemene Internationale Benaming):

AZELASTINE HYDROCHLORIDE

Samenstelling:

AZELASTINE HYDROCHLORIDE 205.5 ug

Toedieningsweg:

NASAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

ASTEPRO Nasal Spray is indicated for the relief of the symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. None. Limited data from postmarketing experience over decades of use with ASTEPRO in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 4 times the clinical daily dose. Oral administration of azelastine hydrochloride to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 180 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.644 mg. However, the relevance of these findings in animals to pregnant women was considered questionable based

Product samenvatting:

ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is supplied as a 30-mL package (NDC 0037-0242-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is supplied as a 30-mL package (NDC 0037-0243-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [see Dosage and Administration (2.3) ], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. ASTEPRO should not be used after the expiration date “EXP” printed on the medicine label and carton. Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

Autorisatie-status:

New Drug Application

Productkenmerken

ASTEPRO- AZELASTINE HYDROCHLORIDE SPRAY, METERED
MEDA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASTEPRO SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ASTEPRO .
ASTEPRO (AZELASTINE HYDROCHLORIDE) NASAL SPRAY, FOR INTRANASAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
ASTEPRO is an H -receptor antagonist indicated for the relief of the
symptoms of:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Nasal spray solution available in two dosage strengths:
•
•
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥2% incidence) are: pyrexia,
dysgeusia, nasal discomfort, epistaxis, headache,
sneezing, fatigue, somnolence, upper respiratory infection, cough,
rhinalgia, vomiting, otitis media, contact dermatitis, and
oropharyngeal pain (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDA PHARMACEUTICALS
INC. AT 1-800-526-3840 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2018
®
®
1
Seasonal allergic rhinitis in patients 2 years of age and older. (1.1)
Perennial allergic rhinitis in patients 6 months of age and older.
(1.1)
For intranasal use only (2.3).
Seasonal allergic rhinitis:
▪
▪
▪
_2 to 5 years_: ASTEPRO 0.1%: 1 spray per nostril twice daily (2.1)
_6 to 11 years_: ASTEPRO 0.1% or ASTEPRO 0.15%: 1 spray per nostril
twice daily (2.1)
_Adults and adolescents 12 years of age and older_:
o
o
ASTEPRO 0.1% or ASTEPRO 0.15%: 1 or 2 sprays per nostril twice daily
(2.1), or
ASTEPRO 0.15%: 2 sprays per nostril once daily (2.1)
Perennial allergic rhinitis:
▪
▪
▪
_6 months to 5 years_: ASTEPRO 0.1%: 1 spray per nostril twice daily
(2.2)
_6 to 11 years_: ASTEPRO 0.1% or ASTEPRO 0.15%: 1 spray per nostril
twice daily (2.2)
_Adults and adolescents 12 years of age and older_: ASTEPRO 0.15%: 2
sprays per nostril twice dai