X-Seb T Pearl (salicylic acid/coal tar)

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.)

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.

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.)

No dosing information is available for this tab.

No dosing information is available for this tab.

Although no known drug interactions have been reported to date, it is recommended that coal tar preparations not be used concomitantly with drugs (e.g., tetracyclines, psoralens, tretinoin) having phototoxic and/or photoactivating potential.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Coal Tar/Cyclosporine

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)

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

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

• Folliculitis
• Large open wound

• Peripheral vascular disease

There is no enhanced messaging for this drug.

Rare or Very Rare

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

More Frequent

• Stinging of skin

Less Frequent

• Dry skin
• Skin irritation
• Skin photosensitivity

Rare or Very Rare

• Dermatitis due to topical drug
• Folliculitis
• Pruritus of skin
• Skin irritation
• Skin rash

No enhanced messaging available.

No enhanced messaging available.

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.

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.

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.

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.

No enhanced messaging available.