AZELASTINE HYDROCHLORIDE spray, metered

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Wallace Pharmaceuticals Inc.

INN (Rahvusvaheline Nimetus):

AZELASTINE HYDROCHLORIDE

Koostis:

AZELASTINE HYDROCHLORIDE 205.5 ug

Manustamisviis:

NASAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Azelastine hydrochloride 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 azelastine hydrochloride nasal spray 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 pr

Toote kokkuvõte:

Azelastine Hydrochloride Nasal Spray 0.15% is supplied as a 30-mL package (NDC 51525-0234-3) 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. Azelastine hydrochloride nasal spray 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.

Volitamisolek:

New Drug Application Authorized Generic

Toote omadused

AZELASTINE HYDROCHLORIDE- AZELASTINE HYDROCHLORIDE SPRAY, METERED
WALLACE PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AZELASTINE HYDROCHLORIDE NASAL
SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AZELASTINE HYDROCHLORIDE NASAL
SPRAY.
AZELASTINE HYDROCHLORIDE NASAL SPRAY, FOR INTRANASAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Azelastine hydrochloride nasal spray is an H -receptor antagonist
indicated for the relief of the symptoms of:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Nasal spray solution available as:
•
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)
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:
o
o
o
_2 to 5 years: _Azelastine hydrochloride nasal spray 0.1%: 1 spray per
nostril twice daily (2.1)
_6 to 11 years: _Azelastine hydrochloride nasal spray 0.1% or
azelastine hydrochloride nasal spray 0.15%: 1 spray
per nostril twice daily (2.1)
_Adults and adolescents 12 years of age and older:_
▪
▪
Azelastine hydrochloride nasal spray 0.1% or azelastine hydrochloride
nasal spray 0.15%: 1 or 2 sprays
per nostril twice daily (2.1), or
Azelastine hydrochloride nasal spray 0.15%: 2 sprays per nostril once
daily (2.1)
Perennial allergic rhinitis:
o
o
o
_6 months to 5 years: _Azelastine hydrochloride nasal spray 0.1%: 1
spray per nostril twice daily (2.2)
_6 to 11 years: _Azelastine hydrochloride nasal spray 0.1% or
azelastine hydrochloride nasal spray 0.15%: 1 spray
per nostril twice daily (2.2)
_Adults