Monograph: |
CETYLTAR DISTILLATE is purified and distilled finish of coal tarso properties are same for practical purposes
Coal Tar
Indications: Dermatitis, atopic; Dermatitis, seborrheic; Eczema; Psoriasis
DESCRIPTION:
Coal tar emulsion is a liquid for topical application, following dilution in aqueous media. Each ml contains 300 mg whole coal tar in polysorbates. It is a topical anti-eczematic. The complete chemical composition of coal tar has not been ascertained; components are grouped into six categories: aromatic hydrocarbons, acidic phenolic compounds, cyclic nitrogen compounds, organic sulfur compounds, non-acidic phenolics and nonbasic nitrogen compounds.
CLINICAL PHARMACOLOGY:
There is no confirmed scientific evidence as to the clinical pharmacologic effects of coal tar. Its actions in humans have been reported in the literature as antiseptic, antipruritic, antiparasitic, antifungal, antibacterial, keratoplastic and antiacanthotic. Vasoconstrictive activity of coal tar has also been reported.
INDICATIONS AND USAGE:
Coal tar emulsion is indicated for the relief of symptoms associated with generalized, persistent dermatoses, such as psoriasis, eczema, atopic dermatitis and seborrheic dermatitis.
CONTRAINDICATIONS:
Not to be used on open or infected lesions.
WARNINGS:
Application of coal tar may elicit a pustular eruption or a cyst (epidermal) like reaction.
Patients who have previously exhibited sensitivity to tars must be under careful and continuous supervision by the physician.
PRECAUTIONS:
For external (topical) use only. Keep away from eyes. When used in the bath, add lukewarm water (not hot water). For 72 hours following treatment with coal tar, patients should avoid exposure to either direct sunlight or sunlamps (ultra-violet A and/or B) unless directed by physician, as this drug may photoactivate the skin. Prior to exposure to sunlight, completely remove all tar from skin. Sensitization or dermatitis may occur after prolonged use. If irritation develops or increases, discontinue use and consult physician. Keep out of the reach of children.
Carcinogenesis: Coal tar applied to the skin of mice resulted in an increase in epidermal carcinomas. Painting rabbit ears with coal tar appears to increase self-limiting keratoacanthomas. To date, existing reports do not suggest an increased incidence of skin cancer in psoriatics treated with coal tar.
Pregnancy Category C: Animal reproduction studies have not been conducted with Coal tar emulsion. It is also not known whether coal tar emulsion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Coal tar emulsion should be given to a pregnant woman only if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the tumorigenicity shown for coal tar in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
DRUG INTERACTIONS:
While no known drug interactions have been reported pertaining to the clinical use of this drug in patients, the concomitant use of drugs with phototoxic and/or photoactivating potential is not recommended (i.e., tetracyclines, psoralens, topical retinoic acid).
ADVERSE REACTIONS:
Application of coal tar may result in superficial folliculitis. Patients hypersensitive to coal tar may exhibit a pustular or keratocystic response.
DOSAGE AND ADMINISTRATION:
Add 3 to 5 teaspoonfuls of coal tar emulsion to a bath of lukewarm water. This is mixed throughout the bath. The patient immerses in the bath for 15 to 20 minutes. The interval recommended between dosing is from once-a-day to once every third day, and usual duration of treatment is 30 to 45 days.
If the physician decides to administer supplemental ultraviolet irradiation (Goeckerman treatment) to the patient (ultraviolet B; A or A/B), this may be accomplished between 2 and 72 hours. A determination of minimal erythemal dosage (MED) should be made for each patient; initial irradiation should be suberythemal, not to exceed MED.
Compounding: Coal tar emulsion may be utilized in compounding prescriptions in aqueous based vehicles requiring coal tar. Each ml of coal tar Emulsion contains 300 mg whole coal tar.
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