X-Seb T Pearl

Drug overview for X-SEB T PEARL (salicylic acid/coal tar):

Generic name: SALICYLIC ACID/COAL TAR
Drug class:
Therapeutic class: Dermatological

Coal tar has keratoplastic and mild local irritant properties. Salicylic acid is a keratolytic agent.

Coal tar preparations are used topically alone or in combination with other Salicylic acid is used topically for its keratolytic effect in the drugs (e.g., salicylic acid, sulfur) for controlling dandruff, seborrheic management of acne and other skin conditions such as seborrheic dermatitis, dermatitis, or psoriasis. Although there are few well-controlled studies psoriasis, and dandruff; the drug also is used topically for the removal of demonstrating their efficacy, coal tar preparations are used and generally warts, corns, and calluses. considered effective for relieving the itching and scalp flaking associated Salicylic acid is not used systemically because of its severe irritating with dandruff; for relieving the itching, irritation, and skin flaking associated with seborrheic dermatitis; and for relieving the itching, effect on GI mucosa and other tissues.

(See the Salicylates General redness, and scaling associated with psoriasis. However, patient acceptance Statement 28:08.04.24.) of coal tar is very poor because it is extremely messy, malodorous, and stains skin and hair, and coal tar preparations have largely been replaced for many of these uses by other agents (e.g., topical antifungal agents, topical corticosteroids). Although coal tar has been further modified or refined to potentially provide more esthetically acceptable and pharmaceutically practical preparation, there currently are no published data showing that these modified or refined preparations of coal tar are superior to or even equal in clinical efficacy to coal tar. Coal tar and coal tar preparations have been used in the past under the supervision of a clinician in conjunction with ultraviolet (UV) or sunlight for controlling psoriasis (i.e., Goeckerman therapy+).

More recently, however, coal tar preparations have been replaced first by anthralin and then by lubricating bases in the Goeckerman regimen. Coal tar and coal tar preparations also have been used topically in the management of other dermatologic disorders (e.g., eczema+, atopic dermatitis+, chronic exudative or lichenoid dermatitis+).

DRUG IMAGES

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The following indications for X-SEB T PEARL (salicylic acid/coal tar) have been approved by the FDA:

Indications:
Dandruff
Psoriasis
Seborrheic dermatitis

Professional Synonyms:
Branny tetter
Dermatitis seborrheica
Dyssebacea
Dyssebacia
Pityriasis capitis
Pityriasis sicca
Pityriasis simplex
Scurf
Seborrhea corporis
Seborrhea furfuracea
Seborrhea sicca
Seborrheic eczema
Unna's disease

The following dosing information is available for X-SEB T PEARL (salicylic acid/coal tar):

Dosing
Administration
Dosing Information
Generic

Dosage of various coal tar preparations is not well established since well defined standards for specific contents of these preparations currently do not exist. (See Chemistry and Stability: Chemistry.)

For relief of itching and scalp flaking associated with dandruff; itching, irritation, and skin flaking associated with seborrheic dermatitis of the scalp; or itching, redness, and scaling associated with psoriasis of the scalp, coal tar preparations intended for use as a shampoo should be applied to wet hair and massaged vigorously into the scalp. Then, the scalp is rinsed thoroughly and application of the lotion and rinsing is repeated. Coal tar preparations intended for use as a shampoo usually are used twice weekly.

When coal tar preparations are used as a bath for relief of signs and symptoms associated with psoriasis or seborrheic dermatitis of the body or other dermatologic conditions of the body, an appropriate amount of these preparations should be diluted in lukewarm bath water. The coal tar preparation should be thoroughly mixed throughout the bath water. The patient should immerse himself into the bath and soak for 10-20 minutes.

Bathing with a coal tar preparation may be performed once daily to once every 3 days; the usual duration of therapy is 30-45 days. If the physician prescribes the Goeckerman treatment (coal tar and phototherapy) for psoriasis, all of the coal tar preparation should be removed from the skin prior to exposure to radiation. Phototherapy may begin 2-72 hours after bathing with the coal tar preparation.

A determination of the minimum phototoxic dose (MPD) of UVB, UVA, or UVA/B radiation should be made by the physician for each patient; the initial dosage of radiation should be suberythemal and should not exceed the MPD. The usual cautions associated with Goeckerman therapy should be followed. (See Cautions: Precautions and Contraindications.)

When coal tar preparations are applied directly to the skin for relief of signs and symptoms of psoriasis or seborrheic dermatitis of the body or other dermatologic conditions of the body, the coal tar preparation usually is applied topically to the affected area 1-4 times daily. When a coal tar preparation is applied once daily, it may be preferable to apply the preparation at bedtime. Coal tar preparations should be gently massaged into the area of application.

After several minutes, any excess amount of the preparation should be removed with tissues. Removing excess amounts of the preparation may minimize staining of the skin and clothing. Once the condition has been controlled, it may be possible to decrease the frequency of application to 2 or 3 times weekly.

If dryness of the skin occurs during use of the gel, an emollient may be applied to the treated area 1 hour after application of the coal tar gel or coal tar extract gel. If the physician prescribes the Goeckerman treatment for psoriasis, the coal tar preparation is applied once or twice daily at bedtime and/or at least 30-60 minutes prior to UV radiation. All of the coal tar preparation should be removed from the skin prior to radiation.

The dosage of UV radiation must be individualized for each patient by the physician. The usual cautions associated with Goekerman therapy should be followed. (See Cautions: Precautions and Contraindications.)

Coal tar preparations are applied topically to the scalp as a shampoo or to the skin as a bath, cake, cream, gel, lotion, ointment, or solution. Coal tar preparations are for external use only and contact with the eyes should be avoided. (See Cautions: Precautions and Contraindications.) Coal tar preparations should not be applied in or near the anogenital area unless otherwise directed by a physician.

(See Cautions: Carcinogenicity.) Salicylic acid is applied topically to the skin as a cake, cream, gel, lotion, ointment, pledget, plaster, shampoo, solution, or suspension. Topical preparations of salicylic acid are for external use only. Contact with the eyes should be avoided; if contact occurs, the affected eye(s) should be washed thoroughly with water.

Prior to topical application, the affected area(s) to be treated should be cleansed and allowed to dry. Prior to removal of warts, corns, and calluses, the affected area may be soaked in warm water for 5 minutes. Salicylic acid is commercially available in various preparations, some of which are intended for self-medication; the manufacturer's product labeling should be consulted for complete directions regarding appropriate dosage and administration of specific products.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for X-SEB T PEARL (salicylic acid/coal tar):

Contraindicated
Severe
Moderate

There are 0 contraindications.

There are 1 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
Cyclosporine/Coal Tar SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Concurrent use of cyclosporine and coal tar may result in excessive immunosuppression.(1) CLINICAL EFFECTS: Concurrent use of cyclosporine and coal tar may increase the risk of skin malignancy.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of cyclosporine states that concurrent use of cyclosporine and coal tar is contraindicated in psoriasis patients because of the possibility of increased risk of malignancies.(1) DISCUSSION: Tumors have been reported in 32 (2.2%) of 1439 psoriasis patients treated with cyclosporine in clinical trials. Tumors have been reported in an additional 7 patients in post-marketing reports. Sixteen of these reports involved skin malignancies. Coal tar was used by 3 of the patients.(1)	CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE

Drug Interaction

Drug Names

Cyclosporine/Coal Tar

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concurrent use of cyclosporine and coal tar may result in excessive immunosuppression.(1)

CLINICAL EFFECTS: Concurrent use of cyclosporine and coal tar may increase the risk of skin malignancy.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of cyclosporine states that concurrent use of cyclosporine and coal tar is contraindicated in psoriasis patients because of the possibility of increased risk of malignancies.(1)

DISCUSSION: Tumors have been reported in 32 (2.2%) of 1439 psoriasis patients treated with cyclosporine in clinical trials. Tumors have been reported in an additional 7 patients in post-marketing reports. Sixteen of these reports involved skin malignancies. Coal tar was used by 3 of the patients.(1)

CYCLOSPORINE, CYCLOSPORINE MODIFIED, GENGRAF, NEORAL, SANDIMMUNE

There are 0 moderate interactions.

The following contraindication information is available for X-SEB T PEARL (salicylic acid/coal tar):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 2 contraindications. Absolute contraindication.

Contraindication List
Aspirin exacerbated respiratory disease
Hemolytic anemia from pyruvate kinase and g6PD deficiencies

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Folliculitis
Large open wound

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Peripheral vascular disease

The following adverse reaction information is available for X-SEB T PEARL (salicylic acid/coal tar):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 12 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Burns Dyspnea Facial edema Hypersensitivity drug reaction Periorbital edema Pharyngeal edema Skin ulcer Superficial skin ulcer Syncope Throat constriction Urticaria

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
Stinging of skin	Dry skin Skin irritation Skin photosensitivity

Rare/Very Rare
Dermatitis due to topical drug Folliculitis Pruritus of skin Skin irritation Skin rash

The following precautions are available for X-SEB T PEARL (salicylic acid/coal tar):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Animal reproduction studies have not been performed with coal tar preparations. It is not known whether coal tar preparations can cause fetal harm when used topically by pregnant women. Coal tar preparations should be used during pregnancy only when clearly needed. There are no adequate and well-controlled studies of topical salicylic acid in pregnant women; the drug should be used during pregnancy only if the potential benefits justify the possible risks to the fetus.

It is not known whether topically applied coal tar is absorbed and/or distributed into milk. Because of the potential for serious adverse reactions (i.e., carcinogenicity) from coal tar preparations in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. Because of the potential for serious adverse reactions to salicylic acid in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. If used in nursing women, the drug should not be applied to the chest area to avoid accidental contamination of the infant.

No enhanced Geriatric Use information available for this drug.

The following icd codes are available for X-SEB T PEARL (salicylic acid/coal tar)'s list of indications:

Dandruff
L21.0	Seborrhea capitis
Psoriasis
L40	Psoriasis
L40.0	Psoriasis vulgaris
L40.1	Generalized pustular psoriasis
L40.2	Acrodermatitis continua
L40.3	Pustulosis palmaris et plantaris
L40.4	Guttate psoriasis
L40.5	Arthropathic psoriasis
L40.50	Arthropathic psoriasis, unspecified
L40.51	Distal interphalangeal psoriatic arthropathy
L40.52	Psoriatic arthritis mutilans
L40.53	Psoriatic spondylitis
L40.54	Psoriatic juvenile arthropathy
L40.59	Other psoriatic arthropathy
L40.8	Other psoriasis
L40.9	Psoriasis, unspecified
Seborrheic dermatitis
L21	Seborrheic dermatitis
L21.0	Seborrhea capitis
L21.1	Seborrheic infantile dermatitis
L21.8	Other seborrheic dermatitis
L21.9	Seborrheic dermatitis, unspecified