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Methoxsalen
Overview
What is Methoxsalen?
Methoxsalen Capsules, USP (Soft Gelatin Capsules) 10 mg (8-methoxypsoralen). Methoxsalen, USP is a naturally occurring photoactive substance found in the seeds of the (Umbelliferae) plant and in the roots of . It belongs to a group of compounds known as psoralens, or furocoumarins. The chemical name of methoxsalen, USP is 9-methoxy-7H-furo [3,2-g] [1] benzopyran-7-one; it has the following structure:
Each liquid filled soft-gelatin methoxsalen capsule contains 10 mg of Methoxsalen, USP and the following inactive ingredients: D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, methylparaben sodium, polyethylene glycol, propylparaben sodium, purified water, sorbital sorbitan solution and titanium dioxide.
What does Methoxsalen look like?
What are the available doses of Methoxsalen?
Sorry No records found.
What should I talk to my health care provider before I take Methoxsalen?
Sorry No records found
How should I use Methoxsalen?
Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen Capsules, USP (Soft Gelatin Capsules) are intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.
CAUTION:
What interacts with Methoxsalen?
Sorry No Records found
What are the warnings of Methoxsalen?
Sorry No Records found
What are the precautions of Methoxsalen?
Sorry No Records found
What are the side effects of Methoxsalen?
Sorry No records found
What should I look out for while using Methoxsalen?
Skin Burning
Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are exceeded.
Carcinogenicity
Animal studies
Topical or intraperitoneal methoxsalen has been reported to be a potent photocarcinogen in albino mice and hairless mice (Hakim et al., 1960). However, methoxsalen given by the oral route to Swiss albino mice suggests this agent exerts a protective effect against ultraviolet carcinogenesis; mice given 8-methoxypsoralen in their diet showed 38% ear tumors 180 days after the start of ultraviolet therapy compared to 62% for controls (O’Neal et al., 1957).
Human studies
A 5.7 year prospective study of 1380 psoriasis patients treated with oral methoxsalen and ultraviolet A photochemotherapy (PUVA) demonstrated that the risk of cutaneous squamous-cell carcinoma developing at least 22 months following the first PUVA exposure was approximately 12.8 times higher in the high dose patients than in the low dose patients (Stern et al., 1979, Stern et al., 1980, and Stern et al., 1984). 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., 1984. Increases appear greatest in patients who have pre-PUVA exposure to 1) prolonged tar and UVB treatment, 2) ionizing radiation, or 3) arsenic.
Roenigk et al., 1980, studied 690 patients for up to 4 years and found no increase in the risk of non-melanoma skin cancer, although patients in this cohort had significantly less exposure to PUVA than in the Stern et al. study. Recent analysis of new data in the Stern et al cohort (Stern et al., 1997) has shown that these patients have an elevated relative risk of contracting melanoma. The relative risk for melanoma in these patients was 2.3 (95 percent confidence interval 1.1 to 4.1). The risk is particularly higher in those patients who have received more than 250 PUVA treatments and in those whose treatment has spanned greater than 15 years earlier. These observations indicate the need for monitoring of PUVA patients for skin tumors throughout their lives.
In a study in Indian patients treated for 4 years for vitiligo, 12 percent developed keratoses, but not cancer, in the depigmented, vitiliginous areas (Mosher, 1980). Clinically, the keratoses were keratotic papules, actinic keratosis-like macules, nonscaling dome-shaped papules, and lichenoid porokeratotic-like papules.
Cataractogenicity
Animal Studies
Exposure to large doses of UVA causes cataracts in animals, and this effect is enhanced by the administration of methoxsalen (Cloud et al., 1960; Cloud et al., 1961 Freeman et al., 1969).
Human Studies
It has been found that the concentration of methoxsalen in the lens is proportional to the serum level. If the lens is exposed to UVA during the time methoxsalen is present in the lens, photochemical action may lead to irreversible binding of methoxsalen to proteins and the DNA components of the lens (Lerman et al., 1980). However, if the lens is shielded from UVA, the methoxsalen will diffuse out of the lens in a 24 hour period (Lerman et al., 1980). Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for the twenty-four (24) hour period following ingestion of methoxsalen whether exposed to direct or indirect sunlight in the open or through a window glass.
Among patients using proper eye protection, there is no evidence for a significantly increased risk of cataracts in association with PUVA therapy (Stern et al., 1979). Thirty-five of 1380 patients have developed cataracts in the five years since their first PUVA treatment. This incidence is comparable to that expected in a population of this size and age distribution. No relationship between PUVA dose and cataract risk in this group has been noted.
Actinic Degeneration
Exposure to sunlight and/or ultraviolet radiation may result in “premature aging” of the skin.
Basal Cell Carcinomas
Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinomas should be diligently observed and treated.
Radiation Therapy
Patients having a history of previous x-ray therapy or grenz ray therapy should be diligently observed for signs of carcinoma.
Arsenic Therapy
Patients having a history of previous arsenic therapy should be diligently observed for signs of carcinoma.
Hepatic Diseases
Patients with hepatic insufficiency should be treated with caution since hepatic biotransformation is necessary for drug urinary excretion.
Cardiac Diseases
Patients with cardiac diseases or others who may be unable to tolerate prolonged standing or exposure to heat stress should not be treated in a vertical UVA chamber.
Elderly Patients
Caution should be used in elderly patients, especially those with a pre-existing history of cataracts, cardiovascular conditions, kidney and/or liver dysfunction, or skin cancer.
Total Dosage
The total cumulative dose of UVA that can be given over long periods of time with safety has not as yet been established.
Concomitant Therapy
Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange.
What might happen if I take too much Methoxsalen?
In the event of methoxsalen overdosage, induce emesis and keep the patient in a darkened room for at least 24 hours. Emesis is most beneficial within the first 2 to 3 hours after ingestion of methoxsalen, since maximum blood levels are reached by this time.
How should I store and handle Methoxsalen?
Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Care should be exercised in the handling of REVLIMID. REVLIMID capsules should not be opened or broken. If powder from REVLIMID contacts the skin, wash the skin immediately and thoroughly with soap and water. If REVLIMID contacts the mucous membranes, flush thoroughly with water.Procedures for the proper handling and disposal of anticancer drugs should be considered. Several guidelines on the subject have been published. Dispense no more than a 28-day supply.Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015Methoxsalen Capsules, USP (Soft Gelatin Capsules) are supplied as follows: 10 mg – A green, soft-gelatin and oval-shaped capsule. It contains a green solution, which is free from foreign matter. Capsules have a good sheen and seal. Every capsule has printed in black ink “A325” on one side. The capsules are available in an amber glass bottle of 50 (NDC 45963-325-50) with a child-resistant closure.Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.BIBLIOGRAPHYManufactured by:US Generics Program, a division of Procaps S.A.Calle 80 No. 78 B – 201Barranquilla – ColombiaSouth AmericaDistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA200009716Revised – May 2015
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The combination treatment regimen of psoralen (P) and ultraviolet radiation of 320 to 400 nm wavelength commonly referred to as UVA is known by the acronym, PUVA. Skin reactivity to UVA (320 to 400 nm) radiation is markedly enhanced by the ingestion of methoxsalen. In a well controlled bioavailability study, Methoxsalen Capsules, USP (Soft Gelatin Capsules) reached peak drug levels in the blood of test subjects between 0.5 and 4 hours (Mean = 1.8 hours) as compared to between 1.5 and 6 hours (Mean = 3.0 hours) for regular methoxsalen when administered with 8 ounces of milk. Peak drug levels were 2 to 3 fold greater when the overall extent of drug absorption was approximately two fold greater for Methoxsalen Capsules, USP (Soft Gelatin Capsules) as compared to regular methoxsalen capsules. 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 1.5 to 2.1 hours vs. 3.9 to 4.25 hours for regular methoxsalen capsules. In addition, the mean minimal erythema dose (MED), J/cm, for the Methoxsalen Capsules, USP (Soft Gelatin Capsules) are substantially less than that required for regular methoxsalen capsules (Levins et al., 1984 and private communication).
Methoxsalen is reversibly bound to serum albumin and is also preferentially taken up by epidermal cells (Artuc et al., 1979). 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., 1978). In both mice and man, methoxsalen is rapidly metabolized. Approximately 95% of the drug is excreted as a series of metabolites in the urine within 24 hours (Pathak et al., 1977). 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. Methoxsalen, upon photoactivation, conjugates and forms covalent bonds with DNA which leads to the formation of both monofunctional (addition to a single strand of DNA) and bifunctional (crosslinking of psoralen to both strands of DNA) adducts (Dall’ Acqua et al., 1971; Cole, 1970; Musajo et al., 1974; Dall’ Acqua et al., 1979). Reactions with proteins have also been described (Yoshikawa, et al., 1979).
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 most obvious manifestation of this reaction is delayed erythema, which may not begin for several hours and peaks at 48 to 72 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 photo damage 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.
Non-Clinical Toxicology
Skin BurningSerious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are exceeded.
Carcinogenicity
Animal studies
Topical or intraperitoneal methoxsalen has been reported to be a potent photocarcinogen in albino mice and hairless mice (Hakim et al., 1960). However, methoxsalen given by the oral route to Swiss albino mice suggests this agent exerts a protective effect against ultraviolet carcinogenesis; mice given 8-methoxypsoralen in their diet showed 38% ear tumors 180 days after the start of ultraviolet therapy compared to 62% for controls (O’Neal et al., 1957).
Human studies
A 5.7 year prospective study of 1380 psoriasis patients treated with oral methoxsalen and ultraviolet A photochemotherapy (PUVA) demonstrated that the risk of cutaneous squamous-cell carcinoma developing at least 22 months following the first PUVA exposure was approximately 12.8 times higher in the high dose patients than in the low dose patients (Stern et al., 1979, Stern et al., 1980, and Stern et al., 1984). 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., 1984. Increases appear greatest in patients who have pre-PUVA exposure to 1) prolonged tar and UVB treatment, 2) ionizing radiation, or 3) arsenic.
Roenigk et al., 1980, studied 690 patients for up to 4 years and found no increase in the risk of non-melanoma skin cancer, although patients in this cohort had significantly less exposure to PUVA than in the Stern et al. study. Recent analysis of new data in the Stern et al cohort (Stern et al., 1997) has shown that these patients have an elevated relative risk of contracting melanoma. The relative risk for melanoma in these patients was 2.3 (95 percent confidence interval 1.1 to 4.1). The risk is particularly higher in those patients who have received more than 250 PUVA treatments and in those whose treatment has spanned greater than 15 years earlier. These observations indicate the need for monitoring of PUVA patients for skin tumors throughout their lives.
In a study in Indian patients treated for 4 years for vitiligo, 12 percent developed keratoses, but not cancer, in the depigmented, vitiliginous areas (Mosher, 1980). Clinically, the keratoses were keratotic papules, actinic keratosis-like macules, nonscaling dome-shaped papules, and lichenoid porokeratotic-like papules.
Cataractogenicity
Animal Studies
Exposure to large doses of UVA causes cataracts in animals, and this effect is enhanced by the administration of methoxsalen (Cloud et al., 1960; Cloud et al., 1961 Freeman et al., 1969).
Human Studies
It has been found that the concentration of methoxsalen in the lens is proportional to the serum level. If the lens is exposed to UVA during the time methoxsalen is present in the lens, photochemical action may lead to irreversible binding of methoxsalen to proteins and the DNA components of the lens (Lerman et al., 1980). However, if the lens is shielded from UVA, the methoxsalen will diffuse out of the lens in a 24 hour period (Lerman et al., 1980). Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for the twenty-four (24) hour period following ingestion of methoxsalen whether exposed to direct or indirect sunlight in the open or through a window glass.
Among patients using proper eye protection, there is no evidence for a significantly increased risk of cataracts in association with PUVA therapy (Stern et al., 1979). Thirty-five of 1380 patients have developed cataracts in the five years since their first PUVA treatment. This incidence is comparable to that expected in a population of this size and age distribution. No relationship between PUVA dose and cataract risk in this group has been noted.
Actinic Degeneration
Exposure to sunlight and/or ultraviolet radiation may result in “premature aging” of the skin.
Basal Cell Carcinomas
Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinomas should be diligently observed and treated.
Radiation Therapy
Patients having a history of previous x-ray therapy or grenz ray therapy should be diligently observed for signs of carcinoma.
Arsenic Therapy
Patients having a history of previous arsenic therapy should be diligently observed for signs of carcinoma.
Hepatic Diseases
Patients with hepatic insufficiency should be treated with caution since hepatic biotransformation is necessary for drug urinary excretion.
Cardiac Diseases
Patients with cardiac diseases or others who may be unable to tolerate prolonged standing or exposure to heat stress should not be treated in a vertical UVA chamber.
Elderly Patients
Caution should be used in elderly patients, especially those with a pre-existing history of cataracts, cardiovascular conditions, kidney and/or liver dysfunction, or skin cancer.
Total Dosage
The total cumulative dose of UVA that can be given over long periods of time with safety has not as yet been established.
Concomitant Therapy
Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics, halogenated salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange.
See Section.
Before Methoxsalen Ingestion
Patients must not sunbathe during the 24 hours prior to methoxsalen ingestion and UV exposure. The presence of a sunburn may prevent an accurate evaluation of the patient’s response to photochemotherapy.
After Methoxsalen Ingestion
UVA-absorbing wrap-around sunglasses should be worn during daylight for 24 hours after methoxsalen ingestion. The protective eyewear must be designed to prevent entry of stray radiation to the eyes, including that which may enter from the sides of the eyewear. The protective eyewear is used to prevent the irreversible binding of methoxsalen to the proteins and DNA components of the lens. Cataracts form when enough of the binding occurs. Visual discrimination should be permitted by the eyewear of patient well-being and comfort.
Patients must avoid sun exposure, even through window glass or cloud cover, for at least 8 hours after methoxsalen ingestion. If sun exposure cannot be avoided, the patient should wear protective devices such as a hat and gloves, and/or apply sunscreens which contain ingredients that filter out UVA radiation (e.g., sunscreens containing benzophenone and/or PABA esters which exhibit a sun protective factor equal to or greater than 15). These chemical sunscreens should be applied to all areas that might be exposed to the sun (including lips). Sunscreens should not be applied to areas affected by psoriasis until after the patient has been treated in the UVA chamber.
During Puva Therapy
Total UVA-absorbing/blocking goggles mechanically designed to give maximal ocular protection must be worn. 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.
Abdominal skin, breasts, genitalia, and other sensitive areas should be protected for approximately 1/3 of the initial exposure time until tanning occurs.
Unless affected by disease, male genitalia should be shielded.
After Combined Methoxsalen /UVA Therapy
UVA-absorbing wrap-around sunglasses should be worn during daylight for 24 hours after combined methoxsalen/UVA therapy.
Patients should not sunbathe for 48 hours after therapy. Erythema and/or burning due to photochemotherapy and sunburn due to sun exposure are additive.
Methoxsalen
The most commonly reported side effect of methoxsalen alone is nausea, which occurs with approximately 10% of all patients. 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.
Combined Methoxsalen /UVA Therapy
Pruritus
This adverse reaction occurs with approximately 10% of all patients. 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.
Erythema
Mild, transient erythema at 24 to 48 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 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.
Important Differences Between Puva Erythema and Sunburn
PUVA-induced inflammation differs from sunburn or UVB phototherapy in several ways. The percent transmission of UVB varies between 0% to 34% through skin whereas UVA varies between 1% to 80% transmission; thus, UVA is transmitted to a larger percent through the skin. (Diffey, 1982). The DNA lesions induced by PUVA are very different from UV-induced thymine dimers and may lead to a DNA crosslink. This DNA lesion may be more problematic to the cell because crosslinks are more lethal and psoralen-DNA photoproducts may be “new” or unfamiliar substrates for DNA repair enzymes. DNA synthesis is also suppressed longer after PUVA. The time course of delayed erythema is different with PUVA and may not involve the usual mediators seen in sunburn. PUVA-induced redness may be just beginning at 24 hours, when UVB erythema has already passed its peak. 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.
Other Adverse Reactions
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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