Vitilen Capsules: Each box contains 4 x 8’s capsules in a alu-alu blister pack

Each Vitilen capsule contains Methoxsalen USP 10 mg

The  combination  treatment  regimen  of  Psoralen  (P)  and UVA (Ultraviolet  radiation of 320-400  nm wavelength)  is  commonly  known  as  PUVA.  Skin  reactivity  to  UVA  radiation  is  enhanced  by  the  ingestion  of  Methoxsalen.  The  drug  reaches  its  maximum  bioavailability  1-3hours  after  oral  administration and may last for up to 8 hours. Methoxsalen is reversibly bound to serum albumin and is  also  preferentially  taken  up  by  epidermal  cells.  In  both  mice  and  man,  Methoxsalen  is  rapidly  metabolized. Approximately 95% of the drug is excreted as a series of metabolites in the urine within
24 hours. 

MECHANISM OF ACTION
The exact mechanism of action of Methoxsalen with the epidermal melanocytes and keratinocytes is not known. The  best  known  biochemical reaction  of  Methoxsalen is with DNA. Methoxsalen, upon photoactivation, conjugates  and  forms covalent bonds  with DNA (both monofunctional and bifunctional). Reactions with proteins have also been described.

It is indicated for the repigmentation of idiopathic vitiligo. It is also indicated for the symptomatic control of  severe,  recalcitrant,  disabling  psoriasis  not  adequately  responsive  to  other  forms  of  therapy  and  when the diagnosis has been supported by biopsy

VITILIGO THERAPY : Two Vitilen capsules (10 mg each) in one dose taken with milk or food two to four hours before ultraviolet light exposure.

LIGHT EXPOSURE: The exposure time to sunlight should comply with the following guide

SUBSEQUENT EXPOSURE: Gradually increase exposure based on erythema and tenderness of the amelanotic skin. Therapy should be on alternate days and never two consecutive days.

PSORIASIS  THERAPY:  The  Vitilen   capsules  should  be  taken  2  hours  before  UVA  exposure  with  some food or milk, according to the following table:

SKIN BURNING:
 Serious burns from either UVA or sunlight (even through window glass) can result
if the recommended dosage of the drug and/or exposure schedules are not maintained.  

CARCINOGENICITY:
 The increasing risk of carcinoma appears great among patients who are fair
skinned or had pre-PUVA exposure or prolong treatment with tar UVB, ionizing radiation or arsenic.

CATARACTOGENICITY:
 Among patients using proper eye protection, there is no evidence for a  
significantly increased risk of cataracts in association with PUVA therapy

Patients  must  not  sunbathe  during  the  24  hours  prior  to  Methoxsalen  ingestion  and  UV
exposure.

•    Patient with idiosyncratic reactions to psoralen compounds
•    Patient possessing light sensitive disease including lupus erythematosus, porphyria,erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism
•    Patient with melanoma or possessing a history of melanoma
•    Patient with invasive squamous cell carcinomas
•    Patient with aphakia

Pregnancy  Category  C.  Methoxsalen  should  be  given  to  a  woman  only  if  clearly  needed.  It  is  not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Methoxsalen is administered to a nursing woman

Things to know

1. Treatment usually starts with 2 applications in a week.
2. The hands and fingers of the person applying the medication should be protected by gloves to avoid photosensitization and possible burns.
3. Patient should go to the sun exposure at the same time every day.
4. The exposure time should not be increased any longer after treatment because serious burn may result.
5. A sunblock with SPF 15 or above should be applied to the surrounding areas of normal skin that will be exposed to the sunlight.
6. A sunblock of SPF 15 or above should be used all times during the day & continue doing so until about a week after stopping PUVA treatment.

The  most  commonly  reported  side  effect  of  Methoxsalen  alone  is  nausea,  which  occurs  with approximately 10% of all patients. This effect may be minimized or avoided by instructing the patient  to  take  Methoxsalen  with  milk  or  food,  or  to  divide  the  dose  into  two  portions,  taken  approximately  one-half hour apart. Other effects include nervousness, insomnia and psychological depression.

In the event of Methoxsalen overdosage, induce emesis and keep the patient in a darkened room for at least 24 hours. Emesis is beneficial only within the first 2 to 3 hours after ingestion of Methoxsalen, since maximum blood levels are reached by this time

Safety in children has not been established

Store at 25°C; excursions permitted to 15°C-30°C