levulan kerastick- Aminolevulinic acid hydrochloride

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Aminolevulinic acid hydrochloride (UNII: V35KBM8JGR) (Aminolevulinic acid - UNII:88755TAZ87)

Saadav alates:

DUSA

INN (Rahvusvaheline Nimetus):

Aminolevulinic acid hydrochloride

Ravimvorm:

KIT

Koostis:

354 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

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

Toote omadused

LEVULAN KERASTICK- AMINOLEVULINIC ACID HYDROCHLORIDE
DUSA
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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