ASTELIN- azelastine hydrochloride spray, metered

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

AZELASTINE HYDROCHLORIDE

Kompozīcija:

AZELASTINE HYDROCHLORIDE 137 ug

Ievadīšanas:

NASAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Astelin® Nasal Spray 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. Astelin® Nasal Spray 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 Astelin® Nasal Spray 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. Keep your head tilted downward when spraying. Alternate s

Produktu pārskats:

Astelin® (azelastine hydrochloride) Nasal Spray, 137 mcg, (NDC 54868-5072-0 ) is supplied as a package containing 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. Patient instructions are also provided. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The Astelin® (azelastine hydrochloride) Nasal Spray, 137 mcg, 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 at controlled room temperature 20°-25°C (68°-77°F). Protect from freezing. U.S. Patents 5,164,194; D447,419.

Autorizācija statuss:

New Drug Application

Produkta apraksts

ASTELIN - AZELASTINE HYDROCHLORIDE SPRAY, METERED
PHYSICIANS TOTAL CARE, INC.
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ASTELIN
(AZELASTINE HYDROCHLORIDE)
NASAL SPRAY, 137 MCG
IN-023S6-07 REV. 1/09
FOR INTRANASAL USE ONLY
DESCRIPTION
Astelin (azelastine hydrochloride) Nasal Spray, 137 micrograms (mcg),
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 225°C 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 CIN O•HCl with the following
chemical structure:
Astelin Nasal Spray contains 0.1% azelastine hydrochloride in an
aqueous solution at pH 6.8 ± 0.3. It
also contains benzalkonium chloride (125 mcg/mL), edetate disodium,
hypromellose, citric acid, dibasic
sodium phosphate, sodium chloride, and purified water.
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. Astelin Nasal Spray 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 plasma concentrations (Cmax) are achieved in 2-3 hours.
Based on intravenous a