Administration of the drug and subsequent exposure to UVA can lead to cell injury. Orally administered methoxsalen reaches the skin via the blood and UVA penetrates well into the skin.

If sufficient cell injury occurs in the skin, an inflammatory reaction occurs. The most obvious manifestation of this reaction is delayed erythema, which may not begin for several hours and peaks at hours. The inflammation is followed, over several days to weeks, by repair which is manifested by increased melanization of the epidermis and thickening of the stratum corneum. The mechanisms of therapy are not known. In the treatment of psoriasis, the mechanism is most often assumed to be DNA photodamage and resulting decrease in cell proliferation but other vascular, leukocyte, or cell regulatory mechanisms may also be playing some role.

Psoriasis is a hyper-proliferative disorder and other agents known to be therapeutic for psoriasis are known to inhibit DNA synthesis. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.

Patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. Patients with melanoma or with a history of melanoma. Patients with invasive squamous cell carcinomas. Patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses.

Topical or intraperitoneal methoxsalen has been reported to be a potent photocarcinogen in albino mice and hairless mice Hakim et al. The substantial dose-dependent increase was observed in patients with neither a prior history of skin cancer nor significant exposure to cutaneous carcinogens. Detectable methoxsalen levels were observed up to 12 hours post dose. The drug half-life is approximately 2 hours. Photosensitivity studies demonstrate a shorter time of peak photosensitivity of 1.

Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells Artuc et al. At a dose which is six times larger than that used in humans, it induces mixed function oxidases in the liver of mice Mandula et al. In both mice and man, methoxsalen is rapidly metabolized. The exact mechanism of action of methoxsalen with the epidermal melanocytes and keratinocytes is not known.

The best known biochemical reaction of methoxsalen is with DNA. Reactions with proteins have also been described Yoshikawa, et al. Methoxsalen acts as a photosensitizer. Administration of the drug and subsequent exposure to UVA can lead to cell injury. Orally administered methoxsalen reaches the skin via the blood and UVA penetrates well into the skin.

If sufficient cell injury occurs in the skin, an inflammatory reaction occurs. The mechanisms of therapy are not known. In the treatment of psoriasis, the mechanism is most often assumed to be DNA photodamage and resulting decrease in cell proliferation but other vascular, leukocyte, or cell regulatory mechanisms may also be playing some role. Psoriasis is a hyper-proliferative disorder and other agents known to be therapeutic for psoriasis are known to inhibit DNA synthesis.

Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation. Patients exhibiting idiosyncratic reactions to psoralen compounds. Patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances.

Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism. Patients with melanoma or with a history of melanoma. Patients with invasive squamous cell carcinomas. Patients with aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses. Topical or intraperitoneal methoxsalen has been reported to be a potent photocarcinogen in albino mice and hairless mice Hakim et al.

The substantial dose-dependent increase was observed in patients with neither a prior history of skin cancer nor significant exposure to cutaneous carcinogens.

Reduction in PUVA dosage significantly reduces the risk. No substantial dose related increase was noted for basal cell carcinoma according to Stern et al. Increases appear greatest in patients who have pre-PUVA exposure to 1 prolonged tar and UVB treatment, 2 ionizing radiation, or 3 arsenic.

Recent analysis of new data in the Stern et al cohort Stern et al. Unless affected by disease, male genitalia should be shielded. Patients should not sunbathe for 48 hours after therapy. Patients should have an ophthalmologic examination prior to start of therapy, and thence yearly. Patients should have routine laboratory tests prior to the start of therapy and at regular periods thereafter if patients are on extended treatments.

This effect may be minimized or avoided by instructing the patient to take methoxsalen in milk or food, or to divide the dose into two portions, taken approximately one-half hour apart. Other effects include nervousness, insomnia, and depression.

In most cases, pruritus can be alleviated with frequent application of bland emollients or other topical agents; severe pruritus may require systemic treatment.

If pruritus is unresponsive to these measures, shield pruritic areas from further UVA exposure until the condition resolves. If intractable pruritus is generalized, UVA treatment should be discontinued until the pruritus disappears.

Mild, transient erythema at hours after PUVA therapy is an expected reaction and indicates that a therapeutic interaction between methoxsalen and UVA occurred.

Any area showing moderate erythema greater than Grade 2 - See Table 1 for grades of erythema should be shielded during subsequent UVA exposures until the erythema has resolved. Erythema greater than Grade 2 which appears within 24 hours after UVA treatment may signal a potentially severe burn.

Erythema may become progressively worse over the next 24 hours, since the peak erythemal reaction characteristically occurs 48 hours or later after methoxsalen ingestion. The patient should be protected from further UVA exposures and sunlight, and should be monitored closely.

The time course of delayed erythema is different with PUVA and may not involve the usual mediators seen in sunburn. The erythema dose-response curve is also steeper for PUVA.

Compared to equally erythemogenic doses of UVB, the histologic alterations induced by PUVA show more dermal vessel damage and longer duration of epidermal and dermal abnormalities.

Those reported include edema, dizziness, headache, malaise, depression, hypopigmentation, vesiculation and bullae formation, non-specific rash, herpes simplex, miliaria, urticaria, folliculitis, gastrointestinal disturbances, cutaneous tenderness, leg cramps, hypotension, and extension of psoriasis. It is also not known whether methoxsalen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Methoxsalen should be given to a woman with reproductive capacity only if clearly needed. Because many drugs are excreted in human milk, either methoxsalen ingestion or nursing should be discontinued. Failure to do so may increase the risk of cataract formation.

A reliable radiometer can be used to verify elimination of UVA transmission through the goggles. Unless affected by disease, male genitalia should be shielded. Patients should not sunbathe for 48 hours after therapy. The dosage of methoxsalen should not be increased above 0.

Eye and skin sun protection as described in the Precautions - General section should be observed. See accompanying Patient Package Insert. Patients should have an ophthalmologic examination prior to the start of therapy, and thence yearly. Patients should have the following tests prior to the start of therapy and should be retested months subsequently.

Additional tests at more extended time periods should be conducted as clinically indicated. Animal reproduction studies have not been conducted with methoxsalen. It is also not known whether methoxsalen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methoxsalen should be given to a woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when methoxsalen is administered to a nursing woman.

Safety in children has not been established. Potential hazards of long-term therapy include the possibilities of carcinogenicity and cataractogenicity as described in the Warnings Section as well as the probability of actinic degeneration which is also described in the Warnings Section.

This effect may be minimized or avoided by instructing the patient to take methoxsalen with milk or food, or to divide the dose into two portions, taken approximately one-half hour apart. Other effects include nervousness, insomnia, and psychological depression.

In most cases, pruritus can be alleviated with frequent application of bland emollients or other topical agents; severe pruritus may require systemic treatment. If pruritus is unresponsive to these measures, shield pruritic areas from further UVA exposure until the condition resolves.

If intractable pruritus is generalized, UVA treatment should be discontinued until the pruritus disappears.

Mild, transient erythema at hours after PUVA therapy is an expected reaction and indicates that a therapeutic interaction between methoxsalen and UVA occurred.

OXSORALEN-ULTRA CAPSULES(Methoxsalen Capsules, USP, 10 mg)Rx only | Oxsoralen-Ultra

The initial UVA usp should be conducted according to the guidelines presented previously usp IX. Some patients capsule melanoma did so even after having ceased PUVA therapy over 5 methoxsalen earlier, oxsoralen methoxsalen capsules usp 10mg. Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinomas oxsoralen be diligently observed and treated. In addition, certain other medical conditions can be aggravated by methoxsalen treatment. 10mg substantial dose related increase was noted for basal cell carcinoma according to Stern et al. The most obvious manifestation of this reaction is delayed erythema, which may not begin for several hours and peaks at hours. At a dose which is six times larger than that used in humans, it induces mixed function oxidases in the liver of mice Mandula et al. This problem is similar oxsoralen excessive exposure to sunlight. Among patients using proper eye protection, there is no evidence for a significantly increased risk of cataracts 10mg association with PUVA capsule Stern et al. The best known biochemical reaction of methoxsalen is with DNA.

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