País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TRIAMCINOLONE ACETONIDE
AVENTIS PHARMA - Indonesia
TRIAMCINOLONE ACETONIDE
0.055 MG
SEMPROT HIDUNG
DUS, BOTOL PLASTIK @ 120 DOSIS
AVENTIS PHARMA, HOLMES CHAPEL - United Kingdom
2020-01-07
120 sprays each delivering 55 micrograms triamcinolone acetonide This package insert is continually updated; please read carefully before using a new pack, in case of any question, please contact your physician or pharmacist. NASACORT® AQ NASAL SPRAY COMPOSITION Active ingredient: triamcinolone acetonide. Each actuation delivers 55 micrograms triamcinolone acetonide. Excipients: microcrystalline cellulose, carmellose sodium (Avicel CL-611), polysorbate 80, purified water, anhydrous glucose, benzalkonium chloride, disodium edentate, hydrochloride acid or sodium hydroxide (for pH adjustment). Nasacort AQ Nasal spray suspension is supplied as an unscented, thixotropic suspension of microcrystalline triamcinolone acetonide in an aqueous medium. Nasacort AQ Nasal spray suspension has a target pH of 5.0 within a range 4.5 – 6.0. PHARMACOLOGICAL PROPERTIES 1. PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: nasal corticosteroid, ATC code: R 01 AD. Triamcinolone acetonide is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective in the treatment of allergic diseases in man. NASACORT AQ does not have an intermediate effect on allergic sign and symptoms. An improvement in some patients symptoms may be seen within the first day of treatment with NASACORT AQ and relief may be expected in 3 or 4 days. When NASACORT AQ is prematurely discontinued symptoms may not recur for several days. In clinical studies performed in adults and children at doses up to 440 mcg/day intranasally, no suppression of the Hypothalmic-Pituitary-Adrenal (HPA) axis has been observed. 2. PHARMACOKINETIC PROPERTIES Single dose intranasal administration of 220 micrograms of NASACORT AQ in normal adult subjects and in adult patients with allergic rhinitis demonstrated low absorption on triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 ng/mL (range 0.1 to 1 n Leer el documento completo