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Methoxsalen
Overview
What is Oxsoralen-Ultra?
Oxsoralen-Ultra (methoxsalen capsules, USP) contains 10 mg. methoxsalen (8-methoxsalen). Methoxsalen occurs as white to pale yellow crystals and can be obtained naturally from seeds of and roots of or through synthesis. Methoxsalen is practically insoluble in water, freely soluble in chloroform, soluble in boiling alcohol, in acetone, in acetic acid, in propylene glycol, and in benzene, sparingly soluble in boiling water and in ether. The chemical name of methoxsalen is 9-methoxy-7H-furo [3,2-g] [1] benzopyran-7-one; its empirical formula is CHO and the molecular weight is 216.19. The structural formula is:
Oxsoralen-Ultra is available as soft gelatin capsules containing the following inactive ingredients: polyethylene glycol 400, sorbital special, gelatin, glycerin, water, titanium dioxide, methyl & propylparaben, D&C yellow 10, FD&C blue 1, FD&C yellow 6.
What does Oxsoralen-Ultra look like?
What are the available doses of Oxsoralen-Ultra?
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What should I talk to my health care provider before I take Oxsoralen-Ultra?
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How should I use Oxsoralen-Ultra?
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 is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.
PSORIASIS THERAPY
1. DRUG DOSAGE - INITIAL THERAPY: The methoxsalen capsules should be taken 1 1/2 to 2 hours before UVA exposure with some low fat food or milk according to the following table:
Elderly patients should generally be started at the low end of the dose recommended according to body weight and closely monitored during PUVA therapy. Although clinical experience has not identified differences in response between elderly and younger patients, the use of methoxsalen in older individuals may be affected by the presence or pre-existing medical conditions.
2. INITIAL EXPOSURE: The initial UVA exposure energy level and corresponding time of exposure is determined by the patient’s skin characteristics for sun burning and tanning as follows:
If the MPD is done, start at 1/2 MPD.
Additional drug dosage directions are as follows:
X. UVA RADIATION SOURCE SPECIFICATIONS & INFORMATION
A. IRRADIANCE UNIFORMITY:
The following specifications should be met with the window of the detector held in a vertical plane:
B. PATIENT SAFETY FEATURES:
The following safety features should be present: (1) Protection from electrical hazard: All units should be grounded and conform to applicable electrical codes. The patient or operator should not be able to touch any live electrical parts. There should be ground fault protection. (2) Protective shielding of lamps: The patient should not be able to come in contact with the bare lamps. In the event of lamp breakage, the patient should not be exposed to broken lamp components. (3) Hand rails and hand holds: Appropriate supports should be available to the patient. (4) Patient viewing window: A window which blocks UV should be provided for viewing the patient during treatment. (5) Door and latches: Patients should be able to open the door from the inside with only slight pressure to the door. (6) Non-skid floor: The floor should be of a non-skid nature. (7) Thermoregulation: Sufficient air flow should be provided for patient safety and comfort, limiting temperature within the UVA radiator cabinet to approximately less than 100° F. (8) Timer: The irradiator should be equipped with an automatic timer which terminates the exposure at the conclusion of a pre-set time interval. (9) Patient alarm device: An alarm device within the UVA irradiator chamber should be accessible to the patient for emergency activation. (10) Danger label: The unit should have a label prominently displayed which reads as follows:
DANGER - Ultraviolet Radiation - Follow your physician’s instructions - Failure to use protective eyewear may result in eye injury.
C. UVA EXPOSURE DOSIMETRY MEASUREMENTS:
The maximum radiant exposure or irradiance (within ± 15 percent) of UVA (320-400 nm) delivered to the patient should be determined by using an appropriate radiometer calibrated to be read in Joules/cmor mW/cm. In the absence of a standard measuring technique approved by the National Bureau of Standards, the system should use a detector corrected to a cosine spatial response. The use and recalibration frequency of such a radiometer for a specific UVA irradiator chamber should be specified by the manufacturer because the UVA dose (exposure) is determined by the design of the irradiator, the number of lamps, and the age of the lamp. If irradiance is measured, the radiometer reading in mW/cm is used to calculate the exposure time in minutes to deliver the required UVA in Joules/cm to a patient in the UVA irradiator cabinet. The equation is:
Overexposure due to human error should be minimized by using an accurate automatic timing device, which is set by the operator and controlled by energizing and de-energizing the UVA irradiator lamp. The timing device calibration interval should be specified by the manufacturer. Safety systems should be included to minimize the possibility of delivering a UVA exposure which exceeds the prescribed dose, in the event the timer or radiometer should malfunction.
D. UVA SPECTRAL OUTPUT DISTRIBUTION:
The spectral distributions of the lamps should meet the following specifications:
XI. PUVA TREATMENT PROTOCOL
INTRODUCTION:
The Oxsoralen-Ultra Capsules reach their maximum bioavailability in 1 1/2 to 2 hours after ingestion.
On average, the serum level achieved with Oxsoralen-Ultra is twice that obtained with 8-MOP (formerly Oxsoralen) and reach their peak concentration in less than 1/2 the time of the 8-MOP capsules.
As a result the mean MED J/cm for the Oxsoralen-Ultra Capsules is substantially less than that required for 8-MOP (Levins et al., 1984 and private communication).
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.
A. INITIAL EXPOSURE:
B. CLEARING PHASE:
C. ALTERNATIVE EXPOSURE SCHEDULE:
As an alternative to increasing the UVA exposure at each treatment, the following schedule may be followed; this schedule may reduce the total number of Joules/cm received by the patient over the entire course of therapy.
D. MAINTENANCE PHASE:
The goal of maintenance treatment is to keep the patient as symptom-free as possible with the least amount of UVA exposure.
What interacts with Oxsoralen-Ultra?
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What are the warnings of Oxsoralen-Ultra?
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What are the precautions of Oxsoralen-Ultra?
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What are the side effects of Oxsoralen-Ultra?
Sorry No records found
What should I look out for while using Oxsoralen-Ultra?
A.
B.
C.
D.
E.
A. SKIN BURNING:
B. CARCINOGENICITY:
C. CATARACTOGENICITY:
D. ACTINIC DEGENERATION:
E. BASAL CELL CARCINOMAS:
F. RADIATION THERAPY:
G. ARSENIC THERAPY:
H. HEPATIC DISEASES:
I. CARDIAC DISEASES:
J. ELDERLY PATIENTS:
K. TOTAL DOSAGE:
L. CONCOMITANT THERAPY:
What might happen if I take too much Oxsoralen-Ultra?
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 Oxsoralen-Ultra?
Vials should be stored refrigerated at 2-8°C (36-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first).Protect from light until administration.Vials should be stored refrigerated at 2-8°C (36-46°F). Vials may be transferred to room temperature storage for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first).Protect from light until administration.Oxsoralen-Ultra Capsules, each containing 10 mg of methoxsalen (8-methoxypsoralen) are available in green soft gelatin capsules in white plastic bottles of 50 (NDC 0187-0650-42), with VRX imprinted on one side of the capsule and 650 imprinted on the other side.Store at 25°C (77°F); excursions permitted to 15°C- 30°C (59°F- 86°F). Oxsoralen-Ultra Capsules, each containing 10 mg of methoxsalen (8-methoxypsoralen) are available in green soft gelatin capsules in white plastic bottles of 50 (NDC 0187-0650-42), with VRX imprinted on one side of the capsule and 650 imprinted on the other side.Store at 25°C (77°F); excursions permitted to 15°C- 30°C (59°F- 86°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The combination treatment regimen of psoralen (P) and ultraviolet radiation of 320-400 nm wavelength commonly referred to as UVA is known by the acronym, PUVA. Skin reactivity to UVA (320-400 nm) radiation is markedly enhanced by the ingestion of methoxsalen. In a well controlled bioavailability study, Oxsoralen-Ultra 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 Oxsoralen 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 Oxsoralen-Ultra Capsules as compared to regular Oxsoralen 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 Oxsoralen capsules. In addition, the mean minimal erythema dose (MED), J/cm, for the Oxsoralen-Ultra Capsules is substantially less than that required for regular Oxsoralen 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 48-72 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 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.
Non-Clinical Toxicology
A.B.
C.
D.
E.
A. SKIN BURNING:
B. CARCINOGENICITY:
C. CATARACTOGENICITY:
D. ACTINIC DEGENERATION:
E. BASAL CELL CARCINOMAS:
F. RADIATION THERAPY:
G. ARSENIC THERAPY:
H. HEPATIC DISEASES:
I. CARDIAC DISEASES:
J. ELDERLY PATIENTS:
K. TOTAL DOSAGE:
L. CONCOMITANT THERAPY:
See Section.
A. 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.
B. COMBINED METHOXSALEN/UVA THERAPY:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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