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Brand Name :
Ameluz, Levulan Kerastick
Synonyms :
Class :
Topical photo chemotherapeutics
Brand Name :
Ameluz, Levulan Kerastick
Synonyms :
Class :
Topical photo chemotherapeutics
Dosage Forms & StrengthsÂ
Topical solution (Levulan Kerastick)Â
20%Â
Topical gel (Ameluz)Â
10%Â
Apply illumination to specific areas, possibly for therapeutic purposes
The treatment session lasts for 8 weeks
If the treated lesions have not entirely resolved after the initial 8-week treatment session, a second treatment may be administered
One illumination dose and one application at the treatment site for eight weeks of treatment session
Duration: May be repeated for a second time if the lesions are not entirely resolved with treatment for eight weeks
Safety and efficacy are not seen in pediatricsÂ
Refer to the adult dosingÂ
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
ciprofloxacin increases toxicity of aminolevulinic acid topical by pharmacodynamic synergism. Avoid or use alternate drug. Coadministration of photosensitizing drugs may enhance the phototoxic reaction to photodynamic therapy with aminolevulinic acid.
when both drugs are combined, there may be an increased risk of adverse effect 
when both drugs are combined, there may be an increased risk or severity of adverse effects  
Actions and spectrum:Â
When aminolevulinic acid is applied to skin lesions, it builds up precursors called photoactive porphyrins, which are then exposed to light using a photodynamic lamp. These porphyrins are found in the lesions.Â
Frequency definedÂ
AmeluzÂ
Erythema (92%)Â
Irritation (72%)Â
Pruritis (34%)Â
Edema (35%)Â
Scab (19%)Â
Induration (12%)Â
Paresthesia (9%)Â
Erosion (3%)Â
Bleeding (1%)Â
Pustules (1%)Â
Hyperalgesia (5%)Â
Levulan KerastickÂ
Itching (1-25%)Â
Erosion on face (1-14%)Â
Erythema (100%)Â
Scaling and dryness (87%)Â
Edema (56%)Â
Hyperpigmentation (73%)Â
Hyper/hypopigmentation on the scalp (36%)Â
Black Box Warning Â
Intended for topical use only. Do not apply to eyes.Â
Contraindication/Caution:Â
Contraindication:Â
HypersensitivityÂ
Porphyria Â
Cutaneous photosensitivityÂ
Pregnancy consideration:Â Â
USFDA pregnancy category: data not availableÂ
Lactation:Â Â
The excretion of this drug into breast milk is not knownÂ
Pregnancy category:Â Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus `in either the first or second trimester.Â
Category B: There was a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category
Pharmacology:Â
Pharmacodynamics:Â
Pharmacokinetics:Â
AbsorptionÂ
Levulan KerastickÂ
Peak plasma time is 2hoursÂ
The peak plasma concentration is 249.9ng/mlÂ
The area under the curve is 669.9ng/mlÂ
AmeluzÂ
Peak plasma time is 3hoursÂ
The peak plasma concentration is 27.19ng/mlÂ
The area under the curve is 142.83ng/mlÂ
DistributionÂ
MetabolismÂ
Elimination and excretion Â
Half-life:Â
5.7 hours- Levulan KerastickÂ
Administration:Â
For topical administration onlyÂ
Not for oral or ophthalmic, or vaginal useÂ
A qualified medical practitioner should apply this productÂ
Patient information leafletÂ
Generic Name: aminolevulinic acid topical Â
Why do we use aminolevulinic acid topical?Â
Aminolevulinic acid topical is indicated in the treatment of actinic keratoses of the scalp, upper extremities, or face in combination with PDT(Photodynamic therapy)Â
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