AZELASTINE HYDROCHLORIDE spray, metered

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

azelastine hydrochloride (UNII: 0L591QR10I) (azelastine - UNII:ZQI909440X)

Dostupné s:

Physicians Total Care, Inc.

INN (Mezinárodní Name):

azelastine hydrochloride

Složení:

azelastine hydrochloride 137 ug

Podání:

NASAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Azelastine hydrochloride nasal solution is indicated for the treatment of the symptoms of seasonal allergic rhinitis such as rhinorrhea, sneezing, and nasal pruritus in adults and children 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis, such as rhinorrhea, nasal congestion and postnasal drip in adults and children 12 years and older. Azelastine hydrochloride nasal solution is contraindicated in patients with a known hypersensitivity to azelastine hydrochloride or any of its components. FOR INTRANASAL USE ONLY   IMPORTANT:  FOLLOW INSTRUCTIONS CAREFULLY TO ENSURE PROPER DOSING. DOSING:   The dosage of azelastine hydrochloride nasal solution is 1 spray per nostril twice daily for pediatric patients (ages 5-11 years) with seasonal allergic rhinitis. For patients age 12 and older with seasonal allergic rhinitis the dosage is one or two sprays per nostril twice daily.  For patients age 12 and older with nonallergic vasomotor rhinitis the dosage is two sprays per nostril twice daily.

Přehled produktů:

Azelastine Hydrochloride Nasal Solution 0.1% (Nasal Spray), 137 mcg/spray, (NDC 54868-6131-0 ) is supplied as a package containing 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. A leaflet of patient instructions is also provided. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white plastic dust cover. The Azelastine Hydrochloride Nasal Solution 0.1% (Nasal Spray), 137 mcg/spray, bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. The bottle can deliver 200 metered sprays. Each spray delivers a mean of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. Storage Store upright at 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Protect from freezing. Keep bottle tightly closed and away from children. 241533 January 2009 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AZELASTINE HYDROCHLORIDE - AZELASTINE HYDROCHLORIDE SPRAY, METERED
PHYSICIANS TOTAL CARE, INC.
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AZELASTINE HYDROCHLORIDE NASAL SOLUTION 0.1% (NASAL SPRAY), 137
MCG/SPRAY
FOR INTRANASAL USE ONLY
DESCRIPTION
Azelastine Hydrochloride Nasal Solution 0.1% (Nasal Spray), 137
micrograms (mcg) per spray, is an
antihistamine formulated as a metered-spray solution for intranasal
administration. Azelastine
hydrochloride occurs as a white, almost odorless, crystalline powder
with a bitter taste. It has a
molecular weight of 418.37. It is sparingly soluble in water,
methanol, and propylene glycol and
slightly soluble in ethanol, octanol, and glycerine. It has a melting
point of about 225ºC and the pH of a
saturated solution is between 5.0 and 5.4. Its chemical name is
(±)-1-(2H)-phthalazinone,4-[(4-
chlorophenyl) methyl]-2-(hexahydro-1-methyl-1H-azepin-4-yl)-,
monohydrochloride. Its molecular
formula is C
H ClN O•HCl with the following chemical structure:
Azelastine hydrochloride nasal solution contains 0.1% azelastine
hydrochloride in an aqueous solution
at pH 6.8 ± 0.3. It also contains benzalkonium chloride (125 mcg/mL),
citric acid, dibasic sodium
phosphate, edetate disodium, hypromellose, purified water and sodium
chloride.
After priming, each metered spray delivers a 0.137 mL mean volume
containing 137 mcg of azelastine
hydrochloride (equivalent to 125 mcg of azelastine base). The bottle
can deliver 200 metered sprays.
CLINICAL PHARMACOLOGY
Azelastine hydrochloride, a phthalazinone derivative, exhibits
histamine H -receptor antagonist activity
in isolated tissues, animal models, and humans. Azelastine
hydrochloride nasal solution is administered
as a racemic mixture with no difference in pharmacologic activity
noted between the enantiomers in _in_
_vitro_ studies. The major metabolite, desmethylazelastine, also
possesses H -receptor antagonist activity.
PHARMACOKINETICS AND METABOLISM
After intranasal administration, the systemic bioavailability of
azelastine hydrochloride is approximately
40%. Maximum pl