ASTELIN- azelastine hydrochloride spray, metered

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Meda Pharmaceuticals

Calea de administrare:

NASAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Astelin Nasal Spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. None. Limited data from postmarketing experience over decades of use with Astelin 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 5 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 270 times and higher than the maximum recommended human daily intranasal dose (MRHDID) of 1.096 mg. However, the relevance of these findings

Rezumat produs:

Astelin (azelastine hydrochloride) Nasal Spray, 137 mcg is supplied as a 30-mL package (NDC 0037-0241-30) 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. Astelin 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.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

ASTELIN- AZELASTINE HYDROCHLORIDE SPRAY, METERED
MEDA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASTELIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ASTELIN.
ASTELIN (AZELASTINE HYDROCHLORIDE) NASAL SPRAY
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Astelin Nasal Spray is an H -receptor antagonist indicated for the
treatment of the symptoms of seasonal allergic rhinitis in
adults and pediatric patients 5 years and older and for the treatment
of the symptoms of vasomotor rhinitis in adults and
adolescent patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Astelin Nasal Spray: 137 mcg of azelastine hydrochloride in each 0.137
mL spray. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (≥2% incidence) are: bitter taste,
headache, somnolence, dysesthesia, rhinitis, nasal
burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing,
nausea, dry mouth, fatigue, dizziness, and weight increase.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MEDA PHARMACEUTICALS
INC. AT 1-866-210-5954 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
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Seasonal Allergic Rhinitis
2.2 Vasomotor Rhinitis
2.3 Important Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS ®
1
For intranasal use only (2.3)
Seasonal allergic rhinitis:
•
•
Pediatric patients 5 to 11 years of age: 1 spray per nostril twice
daily (2.1)
Adults and adolescents 12 years of age and older: 1 or 2 sprays per
nostril twice daily (2.1)
Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and
adolescents 12 years of age and older (2.2)
Prime Astelin Nasal Spray before initial use and when it has not been
used for 3 or