Drug Interaction:
Increased drying effect with concomittant use of dermatological medications and
cosmetics that have irritant or strong drying effect.
Increased risk of photosensitivity with drugs known to be photosensitisers
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
84. Methoxsalen USP 20mg Tablet 07-03-08
i. For repigmentation of iduopathic vitiligo
along with phototherapy
ii. For symptomatic control of severe, recalcritant ,
disabling psoriasis in conjunction with phototherapy
Approved by U.S.FDA on 30-12-2008 (Ref- FDA approved List- 2008)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Methoxsalen USP 07-03-2008
20mg tablet
i.For Repimentation of idiopathic Vitiligo along with Phototherapy
ii. For Symptomatic Control of Severe , Recalcitrant, Disabling
Psoriasis inConjunction with Phototherapy
Psoriasis
Adverse Reaction:
Pruritus, burning/stinging, erythema , skin peeling,
Irritation, worsening of psoriasis, rash, dry skin,
Bleeding, localised edema,
Hyperglyceridaemia
Desquamation, contact dermatitis,
Discoloration of the skin, photosensitivity
Contra-Indications:
Pregnancy, lactation
Ezema, sunburnt conditions, hypersensitivity
Special Precautions/Warnings-
Avoid contact with the eyes., mouth, mucous membranes
Abraded skin.
Avoid exposure to sun or UV light.
Do not use > 10% of BSA.
Do not use with occlusive dressings
Wash hands after application.
Do not cream/gel in amounts more than instructed.
Women of child bearing potential should take birth control measures.
Negative pregnancy test to be obtained prior to initiation and start therapy during
normal menstrual period.
Dosages/ Overdosage Etc:
Indication-
Psoriasis
Dosage-
Adult - upto 0.6mg/kg body weight on alternate days. 2 hours before exposure to UV light
If no improvement after 6 months discontinue therapy
Children- Not recommended
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
methoxsalen. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2. Diet-
Eating certain foods while taking methoxsalen may increase your skins
sensitivity to sunlight. To help prevent this, avoid eating limes, figs,
parsley, parsnips, mustard, carrots, and celery while you are being
treated with this medicine.
2.Pregnancy-
Studies have not been done in humans or animals.
3. Breast-feeding-
Mothers who are taking this medicine and who wish to breast feed should discuss this
with their doctor.
4.Children-
Some of the side effects are more likely to occur in children under 12 years of age,
since these children are more sensitive to the effects of this medicine.
5.Older adults-
There is no specific information comparing use of methoxsalen in the elderly with use
in other age groups
6. Other medicines-
Tell your doctor if you are using any of the following -
Arsenicals or recent treatment with x-rays or cancer medicines or plans
to have X-rays in the near future-
Arsenicals and x-rays increase the chance of side effects from treatment
with PUVA
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Allergy or sun light or
Infection or
Lupus erythematous or
Porphyria or
Skin cancer or
Skin conditions or
Stomach problems - use of PUVA may make the conditions worse.
Methoxsalen is used along with untraviolet ( found in sunlight and
some special lamps ) in a treatment called PUVA to treat vilitigo,
a disease in which skin colour is lost, and psoriasis,a skin condition
associted with red and scaly patches.
Pregnancy and lactation:
Pregnancy
Women of child bearing potential should take birth control measures.
Lactation-
Negative pregnancy test to be obtained prior to initiation and start therapy during
normal menstrual period.
Manufacturer Details