METHOXSALEN TABLETS
METHOZSALEN TOPICAL SOLUTION U.S.P
METHOXSALEN AND AMINOBENZOIC ACID OINTMENT
MELANOCYL®
VITILIGO: The term vitiligo which for the Latin people meant the spotted skin of the calf-vitellus has been often used for a very long time to indicate different types of Leukoderma.
Vitiligo is an acquired amelanosis of unknown cause that affects all races and is the term referred to an acquired idiopathic, macular, total loss of pigmentation.
Vitiligo is a great social and aesthetic problem. In India, vitiligo is widespread and the percentage is higher than in western countries.
What is MELANOCYL ®? MELANOCYL® contains Methoxsalen (also called Ammoidine, Xanthotoxine or 8-Methoxpsoralen) and is marketed in the form of tablets, ointment and solution.
Oral Treatment: The recommended dose is 0.7mg per kilogram body weight, to be taken on alternate days on an empty stomach preferably with a glass of milk or bland diet in a single dose to be followed two hours later by exposure to sunlight as peak blood levels of 8-MOP are 3 hours after digestion.
We recommended for:
Men : between 51 to 65 kgs 30 mgs or 3 tablets
between 66 to 80 kgs 40 mgs or 4 tablets
Women : between 30 to 50 kgs 20 mgs or 2 tablets
Between 51 to 65 kgs 30 mgs or 3 tablets
Children : up to 30kgs 10 mgs or 1 tablet
Between 30 to 50 kgs 20 mgs or 2 tablets
IRRADIATION OR SOLAR EXPOSURE:
In case of oral treatment only, the following exposure schedules are recommended for treatment and maintenance of Psoriasis and Vitiligo
PSORIASIS
No. of Exposure
Day
Exposure to sunlight
In minutes
1
2
3
4
5
6
7
8
9
10
11
12
Upto the recommended number of exposure or remission.
1
4
6
8
10
12
14
16
18
20
22
24
5 mins.
10 mins
15 mins
20 mins.
25 mins
30 mins
30 mins
30 mins
30 mins
30 mins
30 mins
30 mins
MAINTENANCE THERAPY FOR PSORIASIA:
Psoriatic patients should be given one exposure per week gradually frequency of exposure should be reduced. Those patients who develop moderate or gross recurrence during the maintenance treatment should be put on initial treatment again.
VITILIGO
No. of Exposure
Day
Light Dose in minutes
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Upto the recommended exposure
1
4
6
8
10
12
14
16
18
20
22
24
26
28
30
32
34
5 mins.
5 mins
5 mins
7 mins
7 mins
7 mins
10 mins
10 mins
10 mins
12 mins
12 mins
12 mins
15 mins
15 mins
15 mins
20 mins
22 mins
MAINTENANCE THERAPY FOR VITILIGO
Patients with VITILIGO are given 3 exposures per week in the initial period and depending upon the response, the duration of exposure is to be adjusted.
The best exposure time is when the sun is at its zenith. We would suggest between 11.00 a.m. and 3.00 p.m. The position of the patient must be lying down. If the patient has a tendency to sleep, someone must wake him or the patient must use an alarm clock. It should be noted that leukodermic patches over the face, eyelids, nasal or buccal orifices or scrotum are treated only with tablets. For leukodermic patches on the hands, tablets only are advised; but if gloves can be worm, local/topical treatment can be advised simultaneously. Oral treatment for the above areas of the body is recommended because these areas are normally exposed to sunrays throughout the day or are very sensitive. The over-exposure may give rise to severe erythema if local treatment is used.
Use of PARAMINOL®: PARAMINOL® should be applied on the periphery of the vitiligenous patch to protect the area of normal skin.
RESULTS:
With such regimen, repigmentary response in most cases and cosmetically acceptable repigmentation is achieved in 75% of cases. Repigmentation may begin after a few weeks; however, significant results may take as long as six to nine months and repigmentation, at the optimum level, may, in some cases, require maintenance dosage to retain the new pigment.
TOXICITY:
Extensive clinical experience has shown that orally administered Methoxsalen is virtually non-toxic; these are no reported cases of an adverse effect.
Side effects may occur in a few patients. If symptoms like nausea, vomiting, etc. occur half the dose should be given 2 ½ hours before exposure to sunrays. Thus, two oral doses can be given at an interval of half an hour.
PRECAUTIONS:
The patients should wear optical dark glasses during sun exposure to be kept on for 4 to 5 hours thereafter.
Special instruction for only local/topical treatment:
To be used strictly under medical supervision
Local/ topical treatment with MELANOCIL® SOLUTION or OINTMENT can be used in serious renal or hepatic diseases, diabetes, blood dyscrasias or if oral treatment has not been well tolerated. Sleeplessness or irritability may be indications of intolerance to the drug.
The schedule of exposure to be followed very accurately is as follows:
- Half a minute per day for the first week.
- One minute per day for the second week.
- Two minutes per day for the third week.
This exposure provokes usually a slight erythema (irritation blister). The exposure could be increased in duration according to the patient’s tolerance. Within a few months, the threshold of erythema (irritation blister) can be reached in 5-6 minutes. After every exposure, the patient should cover all the treated leukodermic patches or apply over them PARAMINOL® OINTMENT. These protective measures are essential as most of the local reactions are due to inadvertent exposure and additional solar radiation.
MELANCYL® SOLUTION:
Should be applied one hour before exposure very gently with brush provided. Rubbing is not necessary. For the first 15 days, it is advisable to use a weaker solution by diluting upto 1:10 with eau de Cologne.
MELANOCYL® OINTMENT
MELANOCYL® OINTMENT is as effective as MELANOCYL® SOLUTION and may be used especially for tender skins.
SYMPTOMS AND REACTIONS:
In case an inflammatory reaction occurs, the application of MELONOCYL® should be interrupted. The inflammation can be treated in the same way as an ordinary burn of the first degree. Usually, application of Calamine lotion is sufficient.
PRESENTATION:
MELANOCYL TABLETS- Blister pack of 40 tabs. containing 10mg of Methoxsalen U.S.P. per tablet.
MELANOCYL SOLUTION- Bottle of 25 ml containing 1.0 % w/w Methoxsalen U.S.P.
MELANOCYL OINTMENT- Tube of 25 ml containing 0.75 % w/w Methoxsalen U.S.P and 2% w/w Aminobenzoic Acid B.P.
Kindly note that when going out, you are exposed to ultra-violet radiation and you may get burnt when local/ topical application with Solution or Ointment is made. After every exposure, the patient should cover all the treated leukodermic patches or apply over them PARAMINOL® OINTMENT.
Manufactured by:
WARDEX PHARMACEUTICALS PVT. LTD.
C-15, A-48/1 & A-48/10 Industrial Area, Site No. 4,
Sahidabad-201010, Dist. Ghaziabad, (U.P.).
Regd. Office: 55, Nelson Manickam Road, Aminjikarai,
Chennai-600029.
(Registered User of the Trade-marks®)