OXSORALEN CAPSULES (Methoxsalen 10mg)
COMPOSITION
Methoxsalen (8-methoxypsoralen)
Ultraviolet A (UVA) is a highly effective form of dermatology therapy. When a photoactive substance, in this case psoralen, combines with long ultraviolet light, the treatment is called PUVA. PUVA was first used for vitiligo in 1947 and for psoriasis in 1974 using oral 8-methoxy psoralen or 8-MOP. When oral and topical therapy fail, PUVA is a useful adjunct for treating severe, recalcitrant psoriasis and vitiligo. While PUVA Treatment is highly effective, it will only control the symptoms but will not cure the underlying condition. For many patients, up to 80%, this initial clearance course of treatment will successfully suppress the disease for at least six months.
ACTIONS
Oxsoralen sensitised skin will respond to sunlight, black light, Wood’s light and broad spectrum ultraviolet lamps available.
The mechanism by which PUVA improves psoriasis and vitiligo is not clearly understood.
In psoriasis the combination of UVA exposure with psoralen in dermal cells forms conjugates or inactive metabolites with cellular DNA. Epidermal synthesis of DNA is reduced and so cell division in basement membrane is also reduced. Fewer new cells migrate to the surface and so there is less scaling and less hyperplasia.
In vitiligo, the mechanism is different. The combination of oral psoralen and UVA will, after several months, stimulate or awaken dormant melanocytes to release more melanin and restore normal pigmentation to the skin.
INDICATIONS
Oxsoralen may be effective in many cases of vitiligo. The exposure time and intensity of ultraviolet light must be measured and controlled (see Warnings and Precautions). Oxsolaren can enhance skin pigmentation conditions but the use for sun tanning for purely cosmetic effect is not recommended or advisable.
CONTRAINDICATIONS
Hepatic insufficiency and diseases associated with photosensitivity, such as porphyria, acute lupus erythematosus, hydroa, polymorphic light eruptions, and in leukoderma or infectious origin. In albinism, Oxsolaren has no effect on pigmentation but appears to increase tolerance to sunlight in these patients.
ADVERSE EFFECTS
Side effects of PUVA therapy essentially parallel the symptoms of severe sunburn. Acute reactions are phototoxic erythema, pruritus and nausea. Chronic effects are photo aging - skin damage due to loss of collagen and elastin, skin cancer such as SCC but not melanoma, and pigmentation changes.
PSORIASIS THERAPY
Topical steroids Hydrocortisone (Cortef) and Betamethasone,(Betnovate and Diprosone) Tar Baths in hospital out-patients Dithranol short contact treatment UVB as narrow band B - most biologically active
PUVA - combination phototherapy
Methotrexate (Ledertrexate) Etretinate (Tigason) Like Dithranol these are antimitotic and used for severe intractable psoriasis. Therapy is terminated when lesions have resolved sufficiently.
Psoralens are a group of naturally occurring compounds which are structurally related and known as furocoumarins.
Trioxysalen 4,5,8-Trimethylpsoralen Trisoralen (discontinued) synthetic chemical
Methoxsalen 8-methoxypsoralen Oxsoralen Ammi majus seeds, celery, parsnips
Bergapten 5-methoxy psoralen Pentaderm or PentaTech Bergamot oranges, limes, cloves
When taken orally or applied topically without light activation, psoralens are innocuous. However when ingested, psoralens can increase patient's sensitivity to UVA radiation (320-400nm) up to 10 x
Oxsoralen 10mg by mouth is well absorbed with peak serum levels reached 1 - 2 hours after ingestion. Skin is most sensitive to UVA between 1 - 3 hours but may remain photo-reactive for 8 - 12 hours. Inflammation a may occur as painful "sunburn" followed by tanning that is increased pigmentation and thickening of the stratum corneum
DOSAGE
Oxsoralen tablets should be taken two hours before UVA exposure with food or milk at a dosage of 0.5mg / K
Weight
30K - 50 K 20mg or 2 tablets
51K- 65K 30mg 3 "
66K - 80K 40mg 4 tablets
Exposure
First day 15 minutes
Second 20 "
Third 25 "
Fourth 30 minutes
ADVERSE EFFECTS
The most common side effect is nausea occurring in 10% of patients.
PREGNANCY
Category C Drugs owing to their pharmacological effects may cause harmful effects on the foetus without causing malformation.
It is not known whether Oxsoralen causes foetal harm when administered to pregnant women and therefore should only be given when the need outweighs the risks.
LACTATION
It is not known whether this drug is excreted in human milk and therefore care should be exercised when administering to a nursing woman
CHILDREN
Safety in children 12 years and under has not been established.
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