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Psoriatec Cream (Sirius)

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  • Description
  • Chemical Structure
  • Clinical Pharmacology
  • Indications and Usage
  • Contraindications
  • Warnings
  • Precautions
  • Adverse Reactions
  • Dosage and Administration
  • How Supplied

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  • DESCRIPTION

    Psoriatec (anthralin cream 1.0%, USP) is a smooth, yellow cream containing 1% anthralin USP in an aqueous cream base of glyceryl monolaurate, glyceryl monomyristate, citric acid, sodium hydroxide and purified water. For topical dermatological use only.

    The chemical name of anthralin is 1,8-dihydroxy-9-anthrone. The structure is:

    CLINICAL PHARMACOLOGY

    Psoriatec contains anthralin, a synthetic compound whose precise mechanism of anti-psoriatic action is not yet fully understood. Numerous studies, however, have demonstrated anti-proliferative and anti-inflammatory effects of anthralin on psoriatic and normal skin. The anti-proliferative effects of anthralin appear to result from both an inhibition of DNA synthesis as well as from its strong reducing properties. Recently, anthralin's effectiveness as an anti-psoriatic agent has also been in part attributed to its abilities to inactivate epidermal 12-lipoxygenase and reduce levels of endothelial adhesion molecules which are markedly elevated in psoriatic patients. Inactivation of 12-lipoxygenase by anthralin substantially reduces levels of 12-hydroperoxyeicosatetraenoic acid and its inflammatory metabolites, which are present in high concentrations in psoriatic plaques. Anthralin does not appear to affect liver microsomal enzyme activity. Systemic absorption of anthralin after topical application of Psoriatec has not been determined in humans.

    INDICATIONS AND USES

    For the topical treatment of psoriasis.

    CONTRAINDICATIONS

    Psoriatec is contraindicated for patients with acute or actively inflamed psoriatic eruptions, or a history of hypersensitivity to any of the ingredients.

    WARNINGS

    For external use only. Avoid contact with the eyes or mucous membranes. Exercise care when applying Psoriatec cream to the face or intertriginous skin areas. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops. Keep out of the reach of children.

    PRECAUTIONS

    General:    To prevent the possibility of staining clothing or bed linen, it may be advisable to use protective dressings. To prevent discoloration of tub/shower, always rinse the tub/shower with cool to lukewarm water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the tub or shower. Contact with fabrics, plastics and other materials may cause staining and should be avoided. Always wash hands thoroughly after use.

    Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the carcinogenic potential of the drug. Although anthralin has been found to have tumor-promoting properties on mouse skin, there have been no reports to suggest carcinogenic effects in humans after many years of clinical use.

    Pregnancy:    Pregnancy Category C. Animal reproduction studies have not been conducted with Psoriatec cream. It is also not known whether Psoriatec cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Psoriatec cream 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 many drugs are excreted in milk and because of the potential for tumorigenicity shown for anthralin 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.

    Pediatric Use:    Safety and effectiveness in children have not been established.

    ADVERSE REACTIONS

    Very few instances of contact allergic reactions to anthralin have been reported. However, transient primary irritation of the normal skin or uninvolved skin surrounding the treated lesions is more frequently seen. If the initial treatment produces excessive soreness or if the lesions spread, reduce frequency of application and, in extreme cases, discontinue use and consult a physician.

    Psoriatec cream may stain skin, hair or fabrics. Some temporary discoloration of hair and fingernails may arise during the period of treatment but should be minimized by careful application. Staining of fabrics may be permanent, so contact should be avoided.

    DOSAGE AND ADMINISTRATION

    Generally, it is recommended that Psoriatec cream be applied once a day. Anthralin is known to be a potential skin irritant. The irritant potential of anthralin is directly related to the strength being used, the time of contact, and each patient's individual tolerance.

    Where the response to Psoriatec treatment has not previously been established, commence treatment using a short contact time for at least one week. When a short contact time is used initially, it can be increased stepwise to twenty to thirty minutes before removing the cream by washing or showering. The optimal period of contact will vary according to the patient's response to treatment. To open the tube, unscrew the cap and invert to puncture seal in tube. After use, replace cap in original position.

    For the Skin:    Apply sparingly only to the psoriatic lesions and rub gently and carefully into the skin. Avoid applying an excessive quantity which may cause unnecessary soiling and staining of the clothing and/or bed linen. At the end of each period of treatment, rinse the skin thoroughly with cool to lukewarm water before washing with soap. The margins of the lesions may gradually become stained purple/brown as treatment progresses, but this will disappear after cessation of treatment.

    For the Scalp:    Wash the hair with shampoo, rinse with water and apply Psoriatec cream while the hair is still damp. Rub the cream well into the psoriatic lesions. Keep Psoriatec cream away from the eyes. Care should be taken to avoid application of the cream to uninvolved scalp margins. Remove any unintended residue which may be deposited behind the ears. At the end of each period of contact, rinse hair and scalp thoroughly with cool to lukewarm water and then shampoo the hair and scalp to remove any surplus cream (which may have become red/brown in color). This treatment may be repeated on alternate days if necessary.

    HOW SUPPLIED

    Psoriatec (anthralin cream 1.0%, USP) is supplied in tubes.

    50g NDC 65880-415-50

    Keep container tightly capped when not in use. Avoid excessive heat.

    Store at controlled room temperature: 59°F to 86°F (15°C to 30°C).

    Rx only.

    Date of preparation or last review: July 2001

    Manufactured for:

    Sirius Laboratories

    100 Fairway Drive, Ste. 130

    Vernon Hills, IL 60061

    by Bioglan AB

    Sweden













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