ZITHRANOL-RR

ZITHRANOL-RR — anthralin cream
Elorac Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

NDC 42783-101-45

ZITHRANOL-RR
anthralin microcrystalline encapsulated
cream, 1.2%
45 g

FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE

Rx only

Zithranol-RR microcrystalline encapsulated cream, 1.2% Container Label
(click image for full-size original)

ZITHRANOL-RR anthralin microcrystalline encapsulated cream, 1.2% 45 g Carton Label Principal Display Panel Text:

NDC 42783-101-45

ZITHRANOL-RR
anthralin microcrystalline encapsulated
cream, 1.2%
45 g

FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE

Rx only

Zithranol-RR Microcrystalline encapsulated cream, 1.2% Carton Label
(click image for full-size original)

ZITHRANOL-RR anthralin microcrystalline encapsulated cream, 1.2% 15 g Container Label Principal Display Panel Text:

NDC 42783-101-15

ZITHRANOL-RR
anthralin microcrystalline encapsulated
cream, 1.2%
15 g

FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE

Rx only

ZITHRANOL-RR Microcrystalline encapsulated cream, 1.2% 15 g Container Label
(click image for full-size original)

ZITHRANOL-RR anthralin microcrystalline encapsulated cream, 1.2% 15 g Carton Label Principal Display Panel Text:

NDC 42783-101-15

ZITHRANOL-RR
anthralin microcrystalline encapsulated
cream, 1.2%
15 g

FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE

Rx only

ZITHRANOL-RR Microcrystalline encapsulated cream, 1.2% 15 g Carton Label
(click image for full-size original)

Package Insert ZITHRANOL-RR anthralin microcrystalline encapsulated cream, 1.2%

Rx only

FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE

DESCRIPTION

Zithranol-RR contains 1.2% microcrystalline encapsulated anthralin in a green aqueous cream base containing glyceryl monolaurate, glyceryl monomyristate, citric acid, sodium hydroxide, FD&C Blue No. 1 and purified water. The anthralin in Zithranol-RR is microencapsulated into a proprietary formulation of surface active crystalline polar lipids to provide for rapid release, as well as to reduce irritation and staining frequently observed with nonencapsulated anthralin preparations. Since the monoglycerides comprising the microcrystalline matrix have significant antimicrobial properties, Zithranol-RR is resistant to microbial contamination or overgrowth without the need for a preservative agent. The chemical name of anthralin is 1,8-dihydroxy-9-anthrone and its structural formula is:

zithranol-5-01
(click image for full-size original)

CLINICAL PHARMACOLOGY

Zithranol-RR contains anthralin, a synthetic compound whose precise mechanism of anti-psoriatic action is not yet fully understood. However, numerous studies 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 induce lipid peroxidation and reduce levels of endothelial adhesion molecules which are markedly elevated in psoriatic patients. Unlike retinoids and PUVA, anthralin does not inhibit liver microsomal enzyme activity; consequently, the likelihood of adverse drug interactions is greatly reduced when other agents are administered concomitantly with anthralin.

Since Zithranol-RR’s proprietary microcrystalline delivery system rapidly releases anthralin into psoriatic plaques on contact with skin, Zithranol-RR is especially useful for short contact (5-15 minutes) therapy with anthralin.

INDICATIONS AND USAGE

For the topical treatment of patients with stable plaque psoriasis.

CONTRAINDICATIONS

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

WARNINGS

Avoid contact with the eyes or mucous membranes. Exercise care when applying Zithranol-RR cream to the face or intertriginous skin areas. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops.

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 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. Keep container tightly capped when not in use. Avoid excessive heat. For external use only. Keep out of the reach of children.

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
Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with Zithranol-RR cream. It is also not known whether Zithranol-RR cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Zithranol-RR 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. Transient primary irritation and staining of normal or uninvolved skin surrounding the treated lesions, which is frequently seen with other anthralin preparations is less common with Zithranol-RR due to microcrystalline coating of the anthralin particles. 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. 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.

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