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Indications & Uses
Vitilen is indicated for:
Pharmacology
Methoxsalen belongs to a treatment approach known as PUVA, which combines Psoralen (P) with UVA light (ultraviolet radiation in the 320 to 400 nm range). Taking Methoxsalen makes the skin more sensitive to UVA exposure. After it is taken by mouth, the drug reaches its highest levels in the blood within 1 to 3 hours, and this effect can persist for as long as 8 hours. Methoxsalen binds reversibly to serum albumin and is taken up preferentially by cells in the epidermis. Studies in both mice and humans show that it is broken down quickly by the body, with about 95% of the drug leaving the body as metabolites in the urine within 24 hours.
Exactly how Methoxsalen acts on epidermal melanocytes and keratinocytes is not fully understood. Its most well established biochemical interaction is with DNA: once activated by light, Methoxsalen forms covalent bonds with DNA, creating both single point (monofunctional) and cross linking (bifunctional) attachments. It has also been reported to react with proteins.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Methoxsalen capsules
Vitiligo therapy: Take two Methoxsalen capsules (10 mg each) in one dose, with milk or food, two to four hours before ultraviolet light exposure.
Light exposure: The time spent in sunlight should follow this guide.
Initial exposure: Light-15 min, Medium-20 min, Dark-25 min
Second exposure: Light-20 min, Medium-25 min, Dark-30 min
Third exposure: Light-25 min, Medium-30 min, Dark-35 min
Fourth exposure: Light-30 min, Medium-35 min, Dark-40 min
Subsequent exposure: Increase the time gradually, based on erythema and tenderness of the amelanotic skin.
Therapy should be on alternate days and never on two consecutive days.
Psoriasis therapy: Take the Methoxsalen capsules 2 hours before UVA exposure, with some food or milk. The dose depends on body weight, as in this table.
<30 kg body weight: 10 mg
30-50 kg body weight: 20 mg
51-65 kg body weight: 30 mg
66-80 kg body weight: 40 mg
81-90 kg body weight: 50 mg
91-115 kg body weight: 60 mg
>115 kg body weight: 70 mg
Methoxsalen Lotion: The physician applies the lotion to a well-defined area of vitiligo, and the area is then exposed to a suitable credit of UVA. The initial exposure time should be conservative and should not go beyond what is predicted to be one-half the minimal erythema dose. The gaps between treatments should be set by the erythema response. Once a week is generally recommended, or less often depending on results. The person applying the medicine should protect their hands and fingers with gloves or finger cots, to avoid photosensitization and possible burns.
Pigmentation may begin after a few weeks, but significant repigmentation may need 6 to 9 months of treatment. Periodic re-treatment may be necessary to keep all of the new pigment. Idiopathic vitiligo is reversible, but not equally so in every patient. Treatment must be individualized. Repigmentation will vary in how complete it is, when it starts and how long it lasts. It happens faster in fleshy areas such as the face, abdomen and buttocks, and slower over less fleshy areas such as the dorsum of the hands or feet.
Pediatric use: Safety in children has not been established.
Side Effects
Vitilen most commonly causes nausea, affecting around 10% of patients. This can usually be reduced or avoided by taking the medicine with milk or food, or by splitting the dose into two portions given about half an hour apart. Other reported effects include nervousness, insomnia, and psychological depression.
Cautions & Contraindications
Warnings & Precautions
Skin burning: Serious burns from UVA or from sunlight, even through window glass, can occur if the recommended dosage and exposure schedule are not carefully followed. Carcinogenicity: The risk of carcinoma appears higher among patients who are fair skinned or who have had prior PUVA exposure or prolonged treatment with tar UVB, ionizing radiation, or arsenic. Cataractogenicity: Among patients who use proper eye protection, there is no evidence of a significantly increased risk of cataracts with PUVA therapy. Patients must not sunbathe during the 24 hours before taking Vitilen and before UV exposure.
Contraindications
Patients with idiosyncratic reactions to psoralen compounds should not use this medicine. It is also not recommended for those with light-sensitive conditions such as lupus erythematosus, porphyria, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum or albinism, as well as patients with melanoma or a history of melanoma, invasive squamous cell carcinoma, or aphakia.
Pregnancy & Breastfeeding
Pregnancy Category C. Methoxsalen should only be used during pregnancy if it is clearly needed. Whether this drug passes into human breast milk is not known. Since many drugs do pass into breast milk, Methoxsalen should be used with caution in breastfeeding mothers.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
If someone has taken too much Methoxsalen, make them vomit and keep the person in a darkened room for at least 24 hours. Vomiting only helps within the first 2 to 3 hours after the dose, because the blood level of Methoxsalen reaches its maximum by then.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Methoxsalen below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Vitilen 10 mg
What is Vitilen 10 mg Capsule?
Vitilen 10 mg Capsule is a medicine that contains Methoxsalen. It is made by Ziska Pharmaceuticals Ltd. It belongs to the Methoxsalen preparation group of medicines.
What is Vitilen used for?
Vitilen is used for: Psoriasis.
What are the side effects of Vitilen?
Vitilen most commonly causes nausea, affecting around 10% of patients. This can usually be reduced or avoided by taking the medicine with milk or food, or by splitting the dose into two portions given about half an hour apart.
Can I take Vitilen during pregnancy or while breastfeeding?
Pregnancy Category C. Methoxsalen should only be used during pregnancy if it is clearly needed. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Vitilen?
If someone has taken too much Methoxsalen, make them vomit and keep the person in a darkened room for at least 24 hours. Vomiting only helps within the first 2 to 3 hours after the dose, because the blood level of Methoxsalen reaches its maximum by then. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Vitilen?
Store Methoxsalen below 30°C, and keep it away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Vitilen?
Some medicines can interact with Methoxsalen, for example: Dacarbazine, Nalidixic Acid, Coal Tar. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Vitilen is already among the lowest-priced brands of Methoxsalen at this strength.
Do I need a prescription for Vitilen?
Vitilen is a prescription (Rx) medicine. Take it as your doctor advises.