Melanocyl Ointment 25 Gm

MELANOCYL OINTMENT 25 GM by FRANCO-INDIAN PHARMACEUTICALS PVT. LTD.

Name

• Brand Name: Melanocyl Ointment

Composition

• Active Ingredients: Melanocyl Ointment contains a combination of Methoxsalen (0.75% w/w) and Aminobenzoic Acid (2% w/w).

Uses

Melanocyl Ointment is a dermatological medication primarily used for the management of:

• Vitiligo: It helps melanocytes (skin cells responsible for producing pigment) to resume their natural function, leading to repigmentation and restoration of natural skin color in areas with white patches.
• Sunburn Prevention: It helps protect against sunburn by absorbing harmful ultraviolet (UV) radiation.
• Anti-aging: It may help in slowing down the premature aging process of the skin.
• Other conditions: It may also be used to treat psoriasis, cutaneous T-cell lymphoma, lichen planus, alopecia totalis, photodermatitis, cutaneous mastocytosis, and atopic dermatitis.

Dosage and Administration

• Melanocyl Ointment is for external use only.
• Apply a small amount as a thin layer to the clean, dry affected area as directed by your doctor.
• Following application, the treated area should be exposed to sunlight or UV light for a duration advised by your doctor, typically after 2 hours.
• Wash your hands thoroughly before and after applying the ointment, unless your hands are the affected area.
• Avoid contact with eyes, nose, or mouth; if accidental contact occurs, rinse immediately with water.
• Do not cover the application site with a bandage unless specifically advised by a healthcare professional.

Side Effects

Common side effects may include:

• Irritation, burning sensation, itching, and redness at the application site.
• Hyperpigmentation (darkening of treated skin areas).
• Dry skin.
• Folliculitis (inflammation of hair follicles).
• Other reported side effects can include skin rash, flushing, headache, nausea, vomiting, and dizziness. Most common side effects are temporary and usually resolve over time. Consult your doctor if these persist or worsen.

Precautions

• Do not use if you are allergic to Methoxsalen, Aminobenzoic Acid, or any other ingredients in the ointment.
• Consult your doctor before use if you are pregnant, breastfeeding, or planning to conceive.
• This medication increases skin sensitivity to sunlight. Protect treated areas from unnecessary direct sunlight exposure by wearing protective clothing or using a sunscreen with an SPF of 15 or higher. Avoid UV sun lamps and tanning beds.
• Wear sunglasses to protect your eyes due to increased photosensitivity and the potential risk of cataracts.
• Inform your doctor if you have a history of melanoma or any other type of skin cancer, or photosensitivity diseases (e.g., porphyria, acute lupus erythematosus, xeroderma pigmentosum).
• Use with caution if you have pre-existing liver or kidney conditions.
• Melanocyl Ointment is not recommended for children under 12 years of age.
• Avoid applying the ointment to injured or infected skin.
• Inform your doctor about all other medications, topical products, or cosmetics you are using, especially other photosensitizing agents like thiazides, tetracyclines, fluoroquinolones, sulfonamides, or phenothiazines, as they may increase sensitivity to sunlight.

Storage

• Store in a cool and dry place, away from direct sunlight.
• Maintain storage temperatures between 10ºC to 25ºC or below 30ºC.
• Keep out of the reach and sight of children.

What is Melanocyl Ointment used for?

Melanocyl Ointment is primarily used to treat vitiligo, a skin condition characterized by white patches due to the loss of skin pigment. It is also used in conjunction with controlled ultraviolet (UV) light to manage other skin conditions such as psoriasis, cutaneous T-cell lymphoma, lichen planus, alopecia totalis, photodermatitis, cutaneous mastocytosis, and atopic dermatitis. Additionally, it helps protect against sunburn and may reduce early signs of skin aging.

How does Melanocyl Ointment work?

Melanocyl Ointment contains two active ingredients: Methoxsalen and Aminobenzoic acid. Methoxsalen is a psoralen compound that increases the skin's sensitivity to UV radiation. When activated by UVA light, it stimulates melanocytes, the cells responsible for producing skin pigment, to increase melanin production, thereby promoting repigmentation of white patches. Aminobenzoic acid also absorbs UV light and stimulates melanocytes, while offering some protection from UV radiation.

What is the usual dosage and application?

The dosage and frequency of application should always be as recommended by your doctor, who may adjust it based on your condition and response. Generally, it is for external use only. Clean and dry the affected skin area, then apply a thin film of the ointment, rubbing it in completely and allowing it to dry. After approximately 2 hours, the treated area is typically exposed to sunlight or UV light for a duration advised by your doctor. Always wash your hands thoroughly after applying the ointment.

What are the possible side effects of Melanocyl Ointment?

Common side effects can include skin irritation, sensitivity, dryness, redness (erythema), itching, burning sensation, and folliculitis (inflammation of hair follicles). Some individuals may experience hyperpigmentation, which is a darkening of the treated skin areas. Less common side effects may include headaches, nausea, vomiting, dizziness, and skin blistering. It's important to note that long-term or frequent exposure to sunlight during therapy may increase the risk of certain skin cancers.

Is Melanocyl Ointment safe during pregnancy or breastfeeding?

Pregnancy: Caution is advised when using Melanocyl Ointment during pregnancy. It is generally not recommended as there is evidence of risk to the developing baby, and should only be used if specifically advised by a doctor when the benefits outweigh the potential risks. Breastfeeding: Consult your doctor before using this medicine while breastfeeding. The safety in breastfeeding mothers is not fully established, and it is unknown if the ingredients are excreted in breast milk. It is advisable to avoid applying the ointment around the breast area to prevent ingestion by the infant.

Can Melanocyl Ointment be taken with other medications?

Melanocyl Ointment may interact with other photosensitizing agents, such as anthralin, coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, sulfanilamides, tetracyclines, thiazide diuretics, and aminolevulinic acid. Concomitant use with these medications can increase photosensitivity or toxicity. Additionally, using topical medicated soaps, shampoos, cleansers, or products with a high concentration of alcohol may increase skin irritation when used with Melanocyl Ointment. Always inform your doctor about all medications, supplements, and herbal products you are currently using.

What precautions should be taken while using Melanocyl Ointment?

Several precautions should be observed:

• Avoid applying the ointment to injured or infected skin.
• Protect treated areas from direct sunlight by wearing protective clothing or applying sunscreen with an SPF of 15 or higher, as the medication significantly increases skin sensitivity to light. Avoid UV sun lamps or tanning beds.
• Wear dark, UV-blocking sunglasses during and for several hours after sun exposure to protect your eyes, due to the increased risk of cataracts.
• Prevent contact with eyes, nose, or mouth. If accidental contact occurs, rinse thoroughly with water immediately.
• Inform your doctor if you have a history of skin cancer (e.g., melanoma, basal cell carcinoma) or photosensitivity disorders (e.g., lupus erythematosus, porphyria).
• Do not use the ointment if you have a known allergy to aminobenzoic acid, methoxsalen, or any other components.
• Unless specifically advised by your doctor, do not cover the application site with bandages or dressings.
• Consult a doctor before using Melanocyl Ointment in children under 12 years of age.

What happens if a dose is missed?

If you miss an application of Melanocyl Ointment, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not apply a double dose to make up for the missed application.

How should Melanocyl Ointment be stored?

Store Melanocyl Ointment in a cool, dry place, ideally at room temperature (between 10°C to 25°C or below 30°C). Keep it away from heat and direct sunlight, and out of the reach and sight of children and pets.