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(aminolevulinic acid HCl) for Topical Solution, 20%
For Topical Use Only • Not for Ophthalmic Use
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 (aminolevulinic acid) 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 (aminolevulinic acid) applicator. The term “ALA HCl” refers to unformulated active ingredient, “LEVULAN KERASTICK (aminolevulinic acid) for Topical Solution” refers to the drug product in its unmixed state, “LEVULAN KERASTICK (aminolevulinic acid) Topical Solution” refers to the mixed drug product (in the applicator tube or after application), and “LEVULAN KERASTICK (aminolevulinic acid) ” refers to the applicator only.
What are the possible side effects of aminolevulinic acid (Levulan Kerastick)?
Serious side effects are not likely to occur. Stop using aminolevulinic acid and seek emergency medical attention if you experience an allergic reaction (shortness of breath; closing of your throat; swelling of your lips, face, or tongue; or hives).
You may experience some tingling, stinging, prickling, or burning of the area treated with aminolevulinic acid during the special light treatment. These feelings of discomfort should improve at the end of the light treatment. Following treatment, you will experience some redness, swelling, and scaling of the lesions, and...
Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Levulan Kerastick Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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