Professional Information
Methoxsalen (Systemic)
VA CLASSIFICATION
Primary: DE801
Secondary: DE890; AN900
Note: Methoxsalen soft gelatin capsules should not be used interchangeably with the hard gelatin capsules, since the soft gelatin capsule dosage form exhibits significantly greater bioavailability and earlier photosensitization onset time than does the hard gelatin capsule dosage form. {03}
Commonly used brand name(s): 8-MOP; Oxsoralen; Oxsoralen-Ultra; Ultra MOP.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Repigmenting agent (systemic)—
antipsoriatic (systemic)—
antineoplastic—
hair growth stimulant, alopecia areata (systemic)—
Note: Methoxsalen is used in conjunction with ultraviolet light A (UVA). {03} {05} This mode of treatment is known as PUVA (psoralen plus ultraviolet light A). {03}
Methoxsalen soft gelatin capsules should not be used interchangeably with the hard gelatin capsules, since the soft gelatin capsule dosage form exhibits significantly greater bioavailability and earlier photosensitization onset time than does the hard gelatin capsule dosage form. {03}
Indications
Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.
Accepted
Mycosis fungoides (treatment)1—Photopheresis, using methoxsalen hard gelatin capsules {08} [or soft gelatin capsules] with ultraviolet radiation of white blood cells, is indicated for use with the UVAR System in the palliative treatment of the skin manifestations of mycosis fungoides (also known as cutaneous T-cell lymphoma) in persons who have not been responsive to other forms of treatment. {08} {12} [PUVA is also used in the treatment{12} of mycosis fungoides.]1
Psoriasis (treatment)—PUVA, using methoxsalen hard gelatin capsules {08} {14} or soft gelatin capsules, {03} {12} is indicated in the treatment of severe, refractory, disabling {01} {03} {08} psoriasis that has not responded to other therapy. {01} {03} {06} {08}
Vitiligo (treatment)—PUVA, using methoxsalen hard gelatin capsules {08} {14} [or soft gelatin capsules] , is indicated for repigmentation in the treatment of vitiligo {04} {06} {08}. PUVA is not effective in producing pigmentation in leukoderma of infectious origin or in albinism. Patients with albinism or patients who are intolerant to sunlight still may benefit from methoxsalen's ability to increase their tolerance to sunlight {08} {09}.
[Alopecia areata (treatment)]1
[Dermatitis, atopic (treatment)]
[Dermatoses, inflammatory (treatment)]1
[Eczema (treatment)]1
[Lichen planus (treatment)]1 or
[Skin intolerance to sunlight]—PUVA is also used in the treatment of alopecia areata {04}, atopic dermatitis {04} {14}, inflammatory dermatoses {11}, eczema {11}, and lichen planus {11}. Methoxsalen, with natural light or with UVA light, also is used to increase skin tolerance to sunlight {09}.
Unaccepted
The unsupervised use of methoxsalen to promote tanning is dangerous and should be discouraged.
1 Not included in Canadian product labeling.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
216.19 {07}
Mechanism of action/Effect:
Methoxsalen is a psoralen derivative with photosensitizing activity. Exact mechanism of erythemogenic, melanogenic, and cytotoxic response in the epidermis is unknown, but may involve increased tyrosinase activity in melanin-producing cells, as well as inhibition of DNA synthesis, cell division, and epidermal turnover. Successful pigmentation requires the presence of functioning melanocytes.
Absorption:
Methoxsalen is variably (approximately 95%) absorbed from the gastrointestinal tract. It has been postulated that poor response in some patients may be due to poor absorption.
Protein binding:
High.
Biotransformation:
Activated by long-wavelength UVA in the range of 320 to 400 {03} nanometers (nm). Further metabolism: hepatic {12}.
Half-life:
Hard gelatin capsule—1.1 hours.
Soft gelatin capsule—Approximately 2 hours. {03} {03}
Onset of action:
Vitiligo—Up to 6 months or longer.
Psoriasis—30 treatments (10 weeks or longer).
For intolerance of skin to sunlight—1 hour.
Tanning—Within a few days.
Time to peak photosensitivity
Hard gelatin capsule—3.9 to 4.25 hours. {03}
Soft gelatin capsule—1.5 to 2.1 hours. {03}
Mean minimal erythema dose (MED)
Substantially fewer Joules per square cm are required with the soft gelatin capsule dosage form than with the hard gelatin capsule dosage form. {03}
Peak serum concentration:
Hard gelatin capsule—1.5 to 6 hours (mean of 3 hours), when administered with 8 ounces of milk. {03}
Soft gelatin capsule—0.5 to 4 hours (mean of 1.8 hours), when administered with 8 ounces of milk. {03}
Duration of action:
Increased sensitivity of skin to sunlight—Approximately 8 hours {08}.
Elimination:
Renal—As metabolites (80 to 90% in 8 hours; 95% in 24 hours {03} {08}).
Fecal—4 to 10%.
Precautions to Consider
Carcinogenicity
Psoralens have been found to augment UVA-induced carcinogenicity in laboratory animals. {01} {03} {08} In addition, studies in humans treated with systemic methoxsalen plus UVA have shown an increase in the risk of squamous cell carcinoma. {01} The possibility of increased risk may exist also for topical methoxsalen and systemic trioxsalen. This risk appears to be greatest in patients with predisposing risk factors, such as fair skin {01} or a hypersensitivity to sunlight; a history of skin cancer {01}, exposure to ionizing radiation {01}, or excessive exposure to sunlight; or a history of treatment with tar and UVB (prolonged) {01}, arsenicals {01}, or topical nitrogen mustard. {11}
Pregnancy/Reproduction
Pregnancy—
Studies have not been done in humans.
Studies have not been done in animals.
FDA Pregnancy Category C. {01}
Breast-feeding
It is not known whether methoxsalen is distributed into breast milk. {03} However, problems in humans have not been documented.
Pediatrics
Children up to 12 years of age—Appropriate studies on the relationship of age to the effects of methoxsalen have not been performed; however, some side effects are more likely to occur in children up to 12 years of age, since these children may be more sensitive to the effects of methoxsalen.
Children 12 years of age and over—Appropriate studies on the relationship of age to the effects of methoxsalen have not been performed in this age group. However, no problems specific to this age group have been documented to date.
Geriatrics
Although appropriate studies on the relationship of age to the effects of methoxsalen have not been performed in the geriatric population, no geriatrics-specific problems have been documented to date.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Furocoumarin-containing foods, such as limes, figs, parsley, parsnips, mustard, carrots, and celery (although there have been no reports of serious reactions, caution and avoidance of these foods are recommended because of the risk of additive phototoxicity)
Photosensitizing medications, other{03} (concurrent use of methoxsalen with these medications, systemic or topical, may cause additive photosensitizing effects; concurrent use with coal tar or coal tar derivatives or with trioxsalen is not recommended)
(concurrent use of systemic methoxsalen with phenothiazines may potentiate intraocular photochemical damage to the choroid, retina, and lens)
» Caution should be used also in evaluating for treatment and subsequently treating{13} patients with a history of having taken arsenicals{03} or having received x-rays,{03} cytotoxic therapy, or coal tar and ultraviolet light B (UVB) therapy{03} because of the increased risk of skin cancer{01}{03}
Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
With physiology/laboratory test values
Hepatic function tests (abnormal hepatic function tests have been reported, but the relationship to the medication is not clear)
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problems exist
» Albinism or{01}{03}
» Hydroa or
» Leukoderma of infectious origin or
» Lupus erythematosus, acute or{01}{03}
Polymorphic light eruptions or
» Porphyria or{01}{03}
» Xeroderma pigmentosum{01}{03} (these conditions are associated with photosensitization)
» Aphakia (increased risk of retinal damage due to lack of lenses {01} {03})
Cardiovascular disease,{03} severe (because of the potential {13} heat stress or the prolonged standing associated with {01} each UVA treatment, patients with this problem should be carefully monitored and, if possible {13}, not treated in a vertical UVA chamber {01})
» Cataracts{03}
Gastrointestinal diseases
Hepatic function impairment{03} (metabolism may be impaired {01})
Infection, chronic
Sensitivity to methoxsalen
» Skin cancer, history of{01}{03}{08}
Sunlight allergy,{03} or family history of (PUVA may cause photoallergic contact dermatitis or precipitate sunlight allergy)
» Caution should be used also in evaluating for treatment and subsequently treating{13} patients with a history of having taken arsenicals{03} or having received x-rays{03} , cytotoxic therapy, or coal tar and ultraviolet light B (UVB) therapy{03} because of the increased risk of skin cancer{01}{03}
Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):
Antinuclear antibodies test and
Complete blood count and
Hepatic function tests and
Renal function tests (recommended prior to initiation of therapy {01} {11})
Monitoring for melanoma and other skin carcinomas (recommended in patients receiving methoxsalen for prolonged periods, since long-term safety has not been established)
Ophthalmic examination (recommended prior to initiation of therapy and yearly thereafter during therapy {01} {11})
Side/Adverse Effects
Note: Cataracts have been reported with psoralen use; however, risk is very low in patients who wear UVA-absorbing, wraparound sunglasses when exposed to sunlight or ultraviolet light during the 24 hours after taking methoxsalen.
There is an increased risk of skin cancer with psoralen use. {03} This risk appears to be greatest in patients with predisposing risk factors, such as fair skin {01} or a hypersensitivity to sunlight; a history of skin cancer {01}, exposure to ionizing radiation {01}, or excessive exposure to sunlight; or a history of treatment with tar and UVB (prolonged) {01}, arsenicals {01}, or topical nitrogen mustard.
Premature aging of the skin may occur as a result of prolonged PUVA therapy. This effect is permanent and is similar to the results of excessive exposure to sunlight. {03}
Toxic hepatitis has been reported in patients treated with methoxsalen, but the relationship to the medication is not clear.
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Symptoms of overdose or overexposure to ultraviolet light
Blistering and peeling of skin
reddened, sore skin
swelling, especially in feet or lower legs
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Itching of skin
nausea{01}
Incidence less frequent
Dizziness
headache
mental depression
nervousness
trouble in sleeping
Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).
Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Blistering and peeling of skin
reddened, sore skin
swelling, especially in feet or lower legs
Treatment of overdose
To decrease absorption:
Inducing emesis, if it can be accomplished within the first 2 to 3 hours after ingestion, since maximum blood levels are reached by that time. {08}
Specific treatment:
For overdosage of methoxsalen: Keeping patient in a darkened room for at least 24 hours following methoxsalen ingestion to prevent the possibility of sun exposure and subsequent burn injury {08}.
For overexposure to sunlight or ultraviolet light: Keeping patient in a darkened room for at least 24 hours following ingestion of methoxsalen to prevent the possibility of further sun exposure and subsequent burn injury while assessment of the extent of damage is made.
Monitoring:
Observing patient for erythema greater than Grade 2 (Grade 2 being marked erythema with no edema) occurring within 24 hours, which may signal the beginning of a potentially serious burn, since peak erythemal reaction to PUVA usually occurs approximately 48 hours following methoxsalen ingestion {08}.
Supportive Care:
Treating patient symptomatically for burns, depending on their extent and severity.
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Methoxsalen (Systemic) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to methoxsalen
Diet—Avoiding eating furocoumarin-containing foods (limes, figs, parsley, parsnips, mustard, carrots, celery)
Other medical problems, especially acute lupus erythematosus; albinism; aphakia; cataracts; hydroa; leukoderma of infectious origin; porphyria; xeroderma pigmentosum; history of skin cancer; history of having taken arsenicals; history of having received x-rays, cytotoxic therapy, or coal tar and ultraviolet light B (UVB) therapy
Not using for suntanning purposes
Proper use of this medication
Usually comes with patient instructions; reading carefully before using medication
» May take 6 to 8 weeks to work; importance of not increasing the dosage of medication or exposure to ultraviolet light because of the risk of serious burns
The hard capsule dosage form may be taken with food or milk (the soft capsule dosage form may be taken with low-fat food or low-fat milk) to reduce gastrointestinal irritation
» Proper dosing
Late or missed dose: Notifying physician for rescheduling of light treatment
» Proper storage
Precautions while using this medication
Importance of regular visits to physician to have progress checked, including eye examinations
» Protecting skin from sunlight, even through window glass or on cloudy days, for at least 24 hours before and 8 hours following treatment; protecting lips with sun block lipstick that has a skin protection factor (SPF) of at least 15
Possibility of continued skin sensitivity to sunlight because of medication; using extra precautions for at least 48 hours following each treatment; not sunbathing anytime during course of treatment {13}
» Wearing special sunglasses during daylight hours (even in indirect light, such as through window glass or on cloudy days) for 24 hours following each dose of medication
» Possibility of dry skin or itching; checking with physician before treating
» Possible long-term effects (cataracts, premature skin aging, carcinogenesis)
Side/adverse effects
Slight reddening of skin 24 to 48 hours after treatment is normal response to therapy
There is an increased risk of developing skin cancer. The body should be examined regularly and the physician shown skin sores that do not heal, new skin growths, and skin growths that have changed in appearance or feel
Premature aging of the skin may occur as a result of prolonged PUVA therapy. This effect is permanent and is similar to the results of excessive exposure to sunlight
Signs of potential side effects, especially blistering and peeling of skin; reddened, sore skin; swelling, especially in feet or lower legs
Note: Some side effects are more likely to occur in children.
General Dosing Information
Patients receiving methoxsalen should be under the supervision of a physician experienced in PUVA therapy. {03}
Although dosage of methoxsalen is generally based on body weight, usually no change in dose is necessary if the patient's weight changes. However, if the physician believes the weight change to be significant enough to warrant an alteration, adjustment of UVA exposure time should be made instead of adjustment of methoxsalen dosage.
Exposure to sunlight or ultraviolet light should be carefully controlled and adjusted on an individual basis according to skin type and tolerance. Exposure time to sunlight should be reduced at high altitudes or at midday.
Skin should be protected from sunlight, even through window glass or on a cloudy day, for at least 24 hours before and 8 hours following oral PUVA treatment by protective clothing, such as long-sleeved shirts, full-length slacks, wide-brimmed hat, and gloves and by using a sun block product that has a skin protection factor of at least 15 on body areas that cannot be covered by clothing. In addition, lips should be protected with a sun block lipstick that has a skin protection factor of at least 15. Also, since the skin continues to be sensitive to sunlight for some time after treatment, the patient should avoid overexposure to sunlight for 48 hours following administration of methoxsalen. {08} In addition, the patient should not sunbathe anytime during the course of treatment {13}.
If a scheduled treatment is missed, the dose of UVA at the next treatment should not be increased; if more than one treatment is missed, the subsequent dose of UVA should be reduced in proportion to the number of treatments missed to reduce the risk of painful erythema.
Repigmentation occurs most rapidly on fleshy areas (face, abdomen, buttocks) and more slowly on the extremities and bony areas (hands and feet).
Tolerance to the effects of methoxsalen may occur when pigmentation precedes erythema by a long period of time. Hyperpigmentation reduces subsequent responsiveness.
Use of psoralen derivatives to promote suntanning has resulted in serious reactions, including acute generalized dermatitis, blistering, and edema; residual edema of the legs and cutaneous damage have been reported.
For skin intolerance to sunlight
Treatment should be limited to 14 days, since methoxsalen's effect to stimulate any new pigment production will have been accomplished by that time {09}.
For treatment of psoriasis
Some clinicians recommend an increased dose in the treatment of psoriasis if there is no response after 15 treatments at the recommended dose. A lower-than-recommended dose eventually may produce the same effect, but it usually occurs more slowly.
Lack of response in psoriasis may be associated with a general phototoxic reaction; this may be confirmed by temporary withdrawal for 2 weeks, with subsequent improvement in the condition. If improvement does not occur, treatment with methoxsalen is considered to be a failure.
Patients with pre-existing erythrodermic psoriasis require special care because the erythema may obscure a possible treatment-related phototoxic erythema. These patients should be treated similar to patients with sun-sensitive skin types.
Diet/Nutrition
Methoxsalen hard gelatin capsules may be taken with food or milk (the soft gelatin capsules may be taken with low-fat food or low-fat {03} milk) to reduce gastrointestinal irritation, or the dose may be split in two and the two halves taken one-half hour apart.
Bioequivalence information
Methoxsalen soft gelatin capsules should not be used interchangeably with the hard gelatin capsules, since the soft gelatin capsule dosage form exhibits significantly greater bioavailability and earlier photosensitization onset time than does the hard gelatin capsule dosage form. {03}
For treatment of adverse effects
Recommended treatment consists of the following: • Burning or blistering of skin—Temporary withdrawal of therapy is recommended.
• Hepatic function impairment—Reduction in dosage or withdrawal of methoxsalen therapy.
Oral Dosage Forms
Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.
METHOXSALEN CAPSULES (XXI) (HARD GELATIN) USP
Usual adult and adolescent dose
[Dermatitis, atopic] or
Psoriasis or
Mycosis fungoides1
Oral, 600 mcg (0.6 mg) per kg of body weight, two {08} hours before measured periods of high-intensity UVA exposure, two or three times a week or as determined by the patient's schedule for UVA exposures (at least forty-eight hours apart) {08}. Dose may be increased by 10 mg after the fifteenth treatment, according to directions in the manufacturer's labeling {08}. Exposure time should be based on skin type and response to therapy, according to the manufacturer's directions for the specific light source being used. Frequency of exposure may be gradually reduced for maintenance treatment; UVA exposure may be adjusted according to response.
Note: A commonly used dosage schedule according to weight is {08}:
| Weight (kg) |
Dose (mg) |
|---|---|
| < 30 |
10 |
| 30–50 |
20 |
| 51–65 |
30 |
| 66–80 |
40 |
| 81–90 |
50 |
| 91–115 |
60 |
| > 115 |
70 |
Vitiligo
Oral, 20 mg a day, two to four hours before measured periods of UVA exposure, two or three times a week (at least forty-eight hours apart) {08} {09}.
Sunlight—Initial exposure time should not exceed fifteen minutes for light skin colors, twenty minutes for medium skin colors, or twenty-five minutes for dark skin colors; may subsequently be increased five minutes each treatment, based on erythema and tenderness. {08} {09}
Artificial light—Initial exposure time should not exceed one-half of that producing erythema after sunlight exposure, or should be based on the minimal phototoxic dose (MPD) and manufacturer's directions for the specific light source being used. The MPD can be determined by irradiating several areas of skin 2 cm in diameter; a range of light exposure times is used and the time that produces erythema at seventy-two hours after exposure is the MPD.
[Skin intolerance to sunlight]
Orally, 20 mg a day one hour before measured exposure to sunlight or to ultraviolet A light, for up to fourteen days {14}.
Sunlight—Initial exposure time should not exceed fifteen minutes for light skin colors, twenty minutes for medium skin colors, or twenty-five minutes for dark skin colors; subsequently may be increased by five minutes for each treatment, depending on degree of erythema and tenderness. {14}
Note: A commonly used dosage schedule according to weight is {14}:
| Weight (kg) |
Dose (mg) |
|---|---|
| < 30 |
10 |
| 30–50 |
20 |
| 51–65 |
30 |
| 66–80 |
40 |
| 81–90 |
50 |
Usual pediatric dose
Children up to 12 years of age—Dosage has not been established {08}.
Children 12 years of age and over—See Usual adult and adolescent dose.
Strength(s) usually available
U.S.—
10 mg (Rx) [8-MOP (tartrazine){08}{10}]
Canada—
10 mg (Rx) [Oxsoralen{14}]
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F) unless otherwise specified by manufacturer. Store in a tight, light-resistant container. {02}
Auxiliary labeling:
• Take with food or milk.
Note: Methoxsalen soft gelatin capsules should not be used interchangeably with the hard gelatin capsules. {03}
METHOXSALEN CAPSULES (XXII) (SOFT GELATIN) USP
Usual adult and adolescent dose
[Dermatitis, atopic] or
Psoriasis
Oral, 400 mcg (0.4 mg) {12} per kg of body weight, one and one-half to two hours {03} before measured periods of high-intensity UVA exposure, two or three times a week or as determined by the patient's schedule for UVA exposures (at least forty-eight hours apart) {03}. Exposure time should be based on skin type and response to therapy, according to the manufacturer's directions for the specific light source being used. Frequency of exposure may be gradually reduced for maintenance treatment; UVA exposure may be adjusted according to response.
Note: The soft capsule dosage form exhibits significantly greater bioavailability and earlier photosensitization onset time than the hard capsule dosage form. When this dosage form is used, the patient's minimum phototoxic dose (MPD) and phototoxic peak time after drug administration should be determined prior to initiation of photochemotherapy. The manufacturer's directions should be consulted for full information concerning dosage and administration. {03}
[Skin intolerance to sunlight]
Orally, 20 mg a day one hour before measured exposure to sunlight or to ultraviolet A light, for up to fourteen days {04}.
Sunlight—Initial exposure time should not exceed fifteen minutes for light skin colors, twenty minutes for medium skin colors, or twenty-five minutes for dark skin colors; subsequently may be increased by five minutes for each treatment, depending on degree of erythema and tenderness. {04}
Note: A commonly used dosage schedule according to weight is {14}:
| Weight (kg) |
Dose (mg) |
|---|---|
| < 30 |
10 |
| 30–50 |
20 |
| 51–65 |
30 |
| 66–80 |
40 |
| 81–90 |
50 |
[Vitiligo]
Oral, 20 mg a day, one hour before measured periods of ultraviolet light exposure or black fluorescent light, two or three times a week (at least forty-eight hours apart) {04}.
Sunlight—Initial exposure time should not exceed fifteen minutes for light skin colors, twenty minutes for medium skin colors, or twenty-five minutes for dark skin colors; subsequently may be increased five minutes each treatment, based on degree of erythema and tenderness. {04}
Artificial light—Initial exposure time should not exceed one half of that producing erythema after sunlight exposure, or should be based on the minimal phototoxic dose (MPD) and manufacturer's directions for the specific light source being used. The MPD can be determined by irradiating several areas of skin 2 cm in diameter; a range of light exposure times is used and the time that produces erythema at seventy-two hours after exposure is the MPD.
Usual pediatric dose
Children up to 12 years of age—Dosage has not been established. {03}
Children 12 years of age and over—See Usual adult and adolescent dose.
Strength(s) usually available
U.S.—
10 mg (Rx) [Oxsoralen-Ultra{03}]
Canada—
10 mg (Rx) [Ultra MOP{04}] [Oxsoralen-Ultra{09}]
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light. {02}
Auxiliary labeling:
• Take with low-fat food or milk.
Note: Methoxsalen soft gelatin capsules should not be used interchangeably with the hard gelatin capsules. {03}
Revised: 07/08/1998
References
Note: References used in the development and subsequent revisions of this monograph have not yet been incorporated into the database and, therefore, are not listed below.
- Oxsoralen (hard capsules) package insert (Elder—US), Rev 7/93, Rec 5/87.
- The United States pharmacopeia. The national formulary. USP 23rd revision (January 1, 1995). NF 18th ed. (January 1, 1995). Rockvillle, MD: The United States Pharmacopeial Convention Inc; 1995. p. 987.
- Oxsoralen-Ultra (Methoxsalen, ICN). In: PDR Physicians' desk reference. 52nd ed. 1998. Montvale, NJ: Medical Economics Company Inc; 1998. p. 1257-60.
- Ultra-MOP product monograph (Canderm Pharmacal—Canada), Rec 06/20/89.
- Panel comment, 3/87.
- Panel comments, 8/27.
- Canada JR, editor. The USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 463.
- 8-MOP (hard capsules) package insert (ICN—US), Rev 3/95, Rec 1/20/98.
- Oxsoralen Ultra product monograph (ICN—Canada), Rev 9/29/93, Rec 5/30/96.
- Personal communications (Elder—US), 8/8/1989.
- Panel comments, 12/86.
- Panel comments, 10/88.
- Panel comment, 7/89.
- Oxsoralen (hard capsules) product monograph (ICN Canada), Rev 1/94, Rec 5/30/96.
| Link to this page |  |
Printable Version |  |
Email Page |
