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.

Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.