Vitilen is used to promote repigmentation in patients with idiopathic vitiligo. It is also indicated for the symptomatic management of severe, persistent, and disabling psoriasis that has not responded adequately to other treatment options and where the diagnosis has been confirmed by biopsy.
Vitilen should not be used in patients with:
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Vitilen contains Methoxsalen, a photosensitizing agent that is used in combination with UVA light therapy (PUVA therapy). After oral administration, Methoxsalen enhances the skin’s sensitivity to UVA light (320–400 nm), allowing the treatment to stimulate skin pigmentation and manage certain skin disorders.
The medicine reaches peak blood levels within 1–3 hours and may remain active for up to 8 hours. It binds to serum albumin and is selectively absorbed by epidermal cells. Methoxsalen is rapidly metabolized, and approximately 95% is eliminated in the urine as metabolites within 24 hours.
Its exact mechanism is not fully understood, but upon activation by UVA light, Methoxsalen forms bonds with DNA, influencing cellular activity in melanocytes and keratinocytes, which contributes to repigmentation and therapeutic effects.
Suggested sunlight exposure schedule:
| Session | Light Skin | Medium Skin | Dark Skin |
|---|---|---|---|
| 1st | 15 min | 20 min | 25 min |
| 2nd | 20 min | 25 min | 30 min |
| 3rd | 25 min | 30 min | 35 min |
| 4th | 30 min | 35 min | 40 min |
Further exposure should be increased gradually depending on skin response, redness, and tenderness.
Capsules should be taken 2 hours before UVA exposure with food or milk.
| Body Weight | Dose |
|---|---|
| Less than 30 kg | 10 mg |
| 30–50 kg | 20 mg |
| 51–65 kg | 30 mg |
| 66–80 kg | 40 mg |
| 81–90 kg | 50 mg |
| 91–115 kg | 60 mg |
| More than 115 kg | 70 mg |
The most commonly reported adverse effect is nausea, affecting approximately 10% of patients. Taking the medication with food or milk may help reduce this effect.
Other possible side effects include:
The lotion should be applied by a healthcare professional to clearly defined vitiligo patches, followed by controlled UVA exposure. Initial exposure should be conservative and generally not exceed half of the minimal erythema dose. Treatments are usually given once weekly or less frequently, depending on the patient’s response.
Visible pigmentation may begin within a few weeks, but significant improvement often requires 6–9 months of treatment. Maintenance therapy may be necessary to preserve newly developed pigmentation.
Pediatric Use: Safety and effectiveness in children have not been established.
Individuals applying the lotion should wear gloves or finger protection to prevent accidental photosensitization and skin burns.
In the event of an overdose, vomiting may be induced if appropriate, and the patient should remain in a dark environment for at least 24 hours to minimize the risk of severe photosensitivity reactions. This measure is most effective within the first few hours after ingestion.
Pregnancy: Classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefits outweigh the possible risks.
Breastfeeding: It is unknown whether Methoxsalen passes into breast milk. Caution is advised when administering the medication to nursing mothers.
Store below 30°C, protected from light and moisture. Keep out of reach of children.
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At ePharma, we’re committed to providing accurate and accessible health information. However, all content is intended for informational purposes only and should not replace medical advice from a qualified physician. Please consult your healthcare provider for personalized guidance. We aim to support, not substitute, the doctor-patient relationship.