Introduction About MELANOCYL OINTMENT

MELANOCYL OINTMENT contains Methoxsalen which belongs to the group of medicines called Antipsoriatics. It is used along with controlled ultraviolet light for the effective management of certain skin diseases like vitiligo and psoriasis. In psoriasis, the skin cells in the body grow too rapidly and form scales and dry patches, mostly on the scalp, elbows, knees, and lower back. In vitiligo, pale white patches develop on the skin, commonly on the face, neck, and hands, and in skin creases, due to the lack of melanin (a skin pigment).

MELANOCYL OINTMENT can also be used to manage cutaneous T cell lymphoma (certain white blood cells become cancerous and affect the skin, causing different types of skin lesions), lichen planus (inflammation of skin and mucous membranes), alopecia totalis (complete hair loss of the scalp), photodermatitis (dermatitis caused due to light sensitivity), cutaneous mastocytosis (gathering of excessive number of mast cells in the skin) and atopic dermatitis (itchy skin inflammation).

MELANOCYL OINTMENT is not recommended for use in patients having aphakia (not having a lens inside the eye), existing or history of melanoma, invasive squamous cell carcinoma, and photosensitivity diseases (Ex. porphyria, acute lupus erythematosus, xeroderma pigmentosum). Avoid exposure to the sun as it may lead to a high risk of burning.

Before using MELANOCYL OINTMENT, inform your doctor if you have or ever had multiple basal cell carcinoma or a history of basal cell carcinoma, previous arsenic therapy, previous x-ray or Grenz ray therapy, heart, GI or liver diseases, chronic infection, or if you are unable to tolerate prolonged standing or exposure to heat stress.

MELANOCYL OINTMENT should be used with caution in pregnant and breastfeeding women. In young women, it is recommended to use contraception throughout the duration of therapy. Contact your doctor if you experience any unusual side effects or if any of the symptoms deteriorate.

Uses Of MELANOCYL OINTMENT

It is used along with controlled ultraviolet light to manage certain skin diseases like:

• vitiligo
• psoriasis
• cutaneous T cell lymphoma
• lichen planus
• alopecia totalis
• photodermatitis
• cutaneous mastocytosis
• atopic dermatitis

How MELANOCYL OINTMENT Works

MELANOCYL OINTMENT works by increasing skin reactivity to UV rays, bonds covalently to DNA and inhibits DNA synthesis, thus suppressing excessive cell division and the time taken for the epidermis (outermost skin layer) to replace itself.

How to use MELANOCYL OINTMENT

Apply MELANOCYL OINTMENT as directed by your physician. It is for external use only. Your doctor will decide an appropriate dose and duration of therapy for you according to your age, body weight and disease condition.

Side Effects Of MELANOCYL OINTMENT

Warning & Precautions

Pregnancy

MELANOCYL OINTMENT should be avoided in pregnant women as there is no proper information about its use in this population. Consult your doctor before using it.

Breastfeeding

MELANOCYL OINTMENT should be used with caution in breastfeeding women. Consult your doctor before using it.

Liver

MELANOCYL OINTMENT should be used with caution in patients having liver impairment. Consult your physician before using it.

Allergy

Do not use MELANOCYL OINTMENT if you are allergic to Methoxsalen or to any of the other ingredients of this medicine.

Heart Disease

MELANOCYL OINTMENT should be used with caution in patients having heart diseases. Consult your physician before using it.

Interactions

A. Drug-Drug interactions:

Before using MELANOCYL OINTMENT, inform your doctor if you are taking any of the following medicines:

• other medicines used to manage psoriasis (photosensitizing agents) Ex. coal tar or its derivatives, anthralin

Overdosage:

If you or anyone else accidentally use too much of MELANOCYL OINTMENT, consult your doctor immediately or visit the nearby hospital. The symptoms of overdosage may include severe burning and blistering of skin.

Synopsis

More Information

• Keep MELANOCYL OINTMENT out of reach of children
• Store below 30°C

FAQs About MELANOCYL OINTMENT

Can MELANOCYL OINTMENT be used on infants?

No. MELANOCYL OINTMENT is used for adults and not recommended for children and adolescents. Consult your child’s doctor for advice. The doctor will determine an appropriate dose or select a suitable alternative management for your child.

When not to use MELANOCYL OINTMENT?

MELANOCYL OINTMENT is not recommended to use if you have or had Aphakia (not having a lens inside the eye), existing or history of melanoma, invasive squamous cell carcinoma, or photosensitivity diseases (Ex. porphyria, acute lupus erythematosus, xeroderma pigmentosum). MELANOCYL OINTMENT should not be used for cosmetic purposes or tanning. Consult your physician before taking it.

Is it safe to take MELANOCYL OINTMENT in patients with heart problems?

MELANOCYL OINTMENT should be used with caution in patients having heart diseases. Consult your physician before using it. Your doctor will decide the appropriate dose or select a suitable alternative management for you.

Can MELANOCYL OINTMENT be used in pregnant women?

MELANOCYL OINTMENT should be avoided in pregnant women as there is no proper information about its use in this population. If you are pregnant, think you may be pregnant or are planning for pregnancy, consult your doctor before taking it.

Can I take other medicines during MELANOCYL OINTMENT management?

Before using MELANOCYL OINTMENT, inform your doctor if you are taking, have taken, or might take any other medicine, including prescription, over the counter or any herbal medicine, as these might lead to serious side effects by interacting with each other.

References

1. Matthew J. Sewell, Craig N. Burkhart, and Dean S. Morrell. Dermatological Pharmacology. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. New York McGraw Hill Medical 2018. Page – 1278.

2. K.D. Tripathi. Drugs Acting on Skin and Mucous Membranes. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 890.

3. Fulton JE, Leyden J, Papa C. Treatment of Vitiligo With Topical Methoxsalen and Blacklite. JAMA Dermatology. August 1969. [Accessed on 13th July 2022] https://jamanetwork.com/journals/jamadermatology/article-abstract/531102

4. IARC Working Group on the Evaluation of Carcinogenic Risks to Humans. Pharmaceuticals. Lyon (FR): International Agency for Research on Cancer. Methoxsalen plus Ultraviolet A Radiation.NIH National Library of Medicine, National center for biotechnology information. 2012. [Accessed on 13th July 2022] https://www.ncbi.nlm.nih.gov/books/NBK304315/

5. CLS Pharma. Meladinine (Methoxsalen). [Accessed on 13th July 2022] https://www.clspharma.fr/images/CLS_PHARMA/documents/meladinine_10mg_en.pdf

6. Nulife Pharma. Methoxsalen. [Accessed on 13th July 2022] http://www.nulifepharma.com/p-products/salen-capsules-solution

7. MIMS. Methoxsalen. [Accessed on 13th July 2022] https://www.mims.com/india/drug/info/methoxsalen?type=full&mtype=generic