Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Aminolevulinic acid hydrochloride (UNII: V35KBM8JGR) (Aminolevulinic acid - UNII:88755TAZ87)
DUSA
Aminolevulinic acid hydrochloride
KIT
354 mg
PRESCRIPTION DRUG
The LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses (Grade 1 or 2, see table 2 for definition) of the face or scalp. The LEVULAN KERASTICK for Topical Solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is contraindicated in patients with cutaneous photosensitivity at wavelengths of 400-450 nm, porphyria or known allergies to porphyrins, and in patients with known sensitivity to any of the components of the LEVULAN KERASTICK for Topical Solution.
The LEVULAN KERASTICK for Topical Solution, 20%, is a single-unit dosage form, supplied in packs of 6. Each LEVULAN KERASTICK for Topical Solution applicator consists of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle. The other ampule contains 354 mg of aminolevulinic acid HCl. The applicator is covered with a protective cardboard sleeve and cap. Storage Conditions: Store between 20° - 25 °C (68° - 77 °F); excursions permitted to 15°- 30 °C (59° - 86 °F) [See USP Controlled Room Temperature]. The LEVULAN KERASTICK for Topical Solution should be used immediately following preparation (dissolution). Solution application must be completed within 2 hours of preparation. An applicator that has been prepared must be discarded 2 hours after mixing (dissolving) and a new LEVULAN KERASTICK for Topical Solution used, if needed. Rx LEVULAN®, KERASTICK®, BLU-U®, DUSA Pharmaceuticals, Inc.® and DUSA® are registered trademarks of DUSA Pharmaceuticals, Inc.® US Patents: 5,079,262, 5,211,938, 5,422,093, 5,954,703, 6,710,066 For more information please contact: 1-877-533-3872 or 1-978-657-7500 www.dusapharma.com
LEVULAN KERASTICK- AMINOLEVULINIC ACID HYDROCHLORIDE DUSA ---------- LEVULAN® KERASTICK® (AMINOLEVULINIC ACID HCL) FOR TOPICAL SOLUTION, 20% FOR TOPICAL USE ONLY NOT FOR OPTHALMIC USE DESCRIPTION LEVULAN® KERASTICK® (aminolevulinic acid HCl) for Topical Solution, 20%, contains the hydrochloride salt of aminolevulinic acid (ALA), an endogenous 5-carbon aminoketone. Aminolevulinic acid HCl (ALA HCl) is a white to off-white, odorless crystalline solid that is very soluble in water, slightly soluble in methanol and ethanol, and practically insoluble in chloroform, hexane and mineral oil. The chemical name for ALA HCl is 5-amino-4-oxopentanoic acid hydrochloride (MW = 167.59). The structural formula is represented below: The LEVULAN KERASTICK for Topical Solution applicator is a two component system consisting of a plastic tube containing two sealed glass ampules and an applicator tip. One ampule contains 1.5 mL of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol. The other ampule contains 354 mg of ALA HCl as a dry solid. The applicator tube is enclosed in a protective cardboard sleeve and cap. The 20% topical solution is prepared just prior to the time of use by breaking the ampules and mixing the contents by shaking the LEVULAN KERASTICK applicator. The term “ALA HCl” refers to unformulated active ingredient, “LEVULAN KERASTICK for Topical Solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK Topical Solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK” refers to the applicator only. CLINICAL PHARMACOLOGY PHARMACOLOGY The metabolism of aminolevulinic acid ( ALA) is the first step in the biochemical pathway resulting in heme synthesis. Aminolevulinic acid is not a photosensitizer, but rather a metabolic precursor of protoporphyrin IX (PpIX), which is a photosensitizer. The synthesis of ALA is normally tightly controlled by feedback in Olvassa el a teljes dokumentumot