Neo-medanine F. R.

Composition:
Each tablet contains:
Methoxsalen (Ammoidin)          10 mg

Pharmacological properties:
Neo-medanine acts as a photosensitizer. Administration of Neo-medanine F.R. tablets and subsequent exposure to UVA can lead to cell injury. Orally administered Neo-medanine reaches the skin via the blood and UVA penetrates well into the skin. Sufficient cell injury leads to inflammatory reaction and the inflammation is followed by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum. In the treatment of psoriasis, Neo-medanine conjugates with DNA, resulting in decrease in cell proliferation by DNA photodamage.

Indications:
Neo-medanine with UV radiation is indicated for the symptomatic control of severe, disabling psoriasis and vitiligo. Skin manifestations of cutaneous T-cell lymphoma in persons who have not been responsive to other forms of treatment.

Contraindications:

Neo-medanine is contraindicated in:
- Patients with hypersensitivity to methoxsalen or psoralen compounds.
- Patients with history of light sensitive disease states including lupus erythematosus and albinism.
- In patients exhibiting melanoma, squamous cell carcinomas or apnakia.

Warnings:    
- Skin burning from UVA or sunlight or premature aging of the skin if the recommended dosage of the drug &/or exposure scheduals are not maintained.
- Patients with hepatic insufficiency should be treated with caution since hepatic biotransformation is necessary for drug urinary excretion.

Drug interactions:
Special care should be exercised in treating patients who are receiving concomitant therapy with known photosensitizing agents such as griseofulvin, coaltar, phenothiazines or sulphonamides.

Precautions:
- Patients must not sunbathe during the 24 hours prior to Neo-medanine ingestion and UV exposure.
- UVA absorbing wrap around sunglasses should be worn during daylight for 24 hours after Neo-medanine ingestion.
- Abdominal skin, breast and other-sensitive areas should be protected from the light. .

Pregnancy:
Neo-medanine should be used in pregnant women if clearly needed.

Nursine mothers:
Caution should be exercised when Neo-medanine is administered to a nursing woman.

Side effects:
The most common side effects are nausea, pruritus, mild or transient erythema.

Overdosage:
Induce emesis and the patient is kept in a darkened room for at least 24 hours.

Dosage &administration:
-    Psoriasis :0. 7 mg / kg followed by UVA irradiation 1 ½ hours after ingestion of the dose.
-    Vitiligo: Oral treatment should start with 3 tablets daily divided into 2 doses (i. e 2 tablets & 1 tablet) for two to three weeks.
Then the dose is increased to 4 tablets daily divided into 2 doses (i.e. 1 tablet & 3 tablets) the bigger dose is given 1 ½ hours before exposure to solar or ultraviolet irradiation.
Exposure to solar or ultraviolet irradiation must begin for 5 min. daily at first then gradually increased to reach about 30 min. within two weeks.

Therapeutic category:
Dermatological drug.

Legal category: Prescription only medicine (POM).

Storage:

Store in a dry place at a temperature below 30° C, protect from light.

Package:

Boxes of 50 tablets.
Boxes of 1000 tablets.

 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.