ZITHRANOL-RR

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ZITHRANOL-RR

Classes

Topical Antipsoriasis Agents

Administration
Topical Administration

For topical dermatological use only. Avoid contact with the eyes or mucous membranes.
Due to the propensity of anthralin to stain and cause skin irritation, always wash hands thoroughly after use.
Apply with care to avoid staining clothing, bed linens, or other objects. Anthralin cream may permanently stain fabrics, and may cause discoloration of tubs/showers. Rinse tub/shower with lukewarm water and wash with a suitable cleanser if medication comes in contact with surface.
Avoid application to unaffected skin. In order to minimize contact with surrounding skin, it may be advisable to apply zinc oxide or petroleum jelly to edges of the affected area prior to application.

Cream/Ointment/Lotion Formulations

Anthralin cream:
Anthralin is a known skin irritant. When initiating therapy, use a short contact time (5—15 minutes) for at least 1 week. Contact time may be increased stepwise to 30 minutes before removing the cream by washing or showering depending on the patient's response to treatment.
Use caution when applying to the face or intertriginous skin areas as excessive irritation may develop.
For the skin: Apply sparingly to affected areas and rub in gently. Rinse skin thoroughly at the end of the treatment period with cool to lukewarm water before washing with soap.
For the scalp: Cleanse hair with shampoo and rinse. While the hair is still damp, apply sparingly and rub well into the affected areas. Remove any residue which may be deposited behind the ears. At the end of each treatment period, rinse hair and scalp thoroughly with cool to lukewarm water and then shampoo the hair and scalp to remove any surplus.
Anthralin shampoo:
Apply to wet scalp and lather. Leave on for 3—5 minutes and rinse thoroughly. Avoid contact with eyes.
No additional shampoo is necessary; however, a non-medicated shampoo or conditioner may be applied after anthralin shampoo, if desired.

Adverse Reactions
Mild

skin discoloration / Delayed / 1.0-10.0
photosensitivity / Delayed / 1.0-10.0
nail discoloration / Delayed / 1.0-10.0
hair discoloration / Delayed / 1.0-10.0
skin irritation / Early / 10.0

Common Brand Names

Dritho-Creme HP, ZITHRANOL

Dea Class

Rx

Description

Synthetic topical antipsoriatic agent; derivative of anthracene.
Used for quiescent or chronic psoriasis; also used off-label for alopecia areata.
May permanently stain clothing, hair.
Products are unapproved marketed drugs that have not been formally evaluated by the FDA.

Dosage And Indications
For the treatment of stable plaque psoriasis. For the treatment of skin psoriasis. Topical dosage Adults

Apply topically to the affected area(s) once daily. Topical anthralin for 8 to 12 weeks can be used for the treatment of mild to moderate psoriasis. Short contact (up to 2 hours/day) is recommended to limit adverse effects.

Infants†, Children†, and Adolescents†

Apply topically to the affected area(s) once daily. Long-term use (12 weeks or longer) of topical anthralin is recommended for the treatment of mild to moderate psoriasis. Short-contact anthralin protocols are recommended to limit adverse effects.

For the treatment of scalp psoriasis. Topical dosage (cream) Adults

Apply topically to the psoriatic scalp area(s) once daily. Topical anthralin for 8 to 12 weeks can be used for the treatment of mild to moderate psoriasis. Short contact (up to 2 hours/day) is recommended to limit adverse effects.

Topical dosage (shampoo) Adults

Apply topically to the psoriatic scalp area(s) 3 to 4 times weekly. Lather and leave in place for 3 to 5 minutes, then rinse thoroughly. Topical anthralin for 8 to 12 weeks can be used for the treatment of mild to moderate psoriasis. Short contact (up to 2 hours/day) is recommended to limit adverse effects.

Children and Adolescents 12 to 17 years

Apply topically to the psoriatic scalp area(s) 3 to 4 times weekly. Lather and leave in place for 3 to 5 minutes, then rinse thoroughly. Long-term use (12 weeks or longer) of topical anthralin is recommended for the treatment of mild to moderate psoriasis. Short-contact anthralin protocols are recommended to limit adverse effects.

For the treatment of alopecia areata†. Topical dosage Adults, Adolescents, and Children

Apply anthralin topically to affected areas once daily; initially leave on for 20—30 minutes and titrate as tolerated up to 60 minutes then shampoo off. Some patients tolerate overnight application. Some patients may fail to achieve cosmetically significant results. Various strengths ranging from 0.1% up to 2% have been described in the medical literature; some dermatologic formulations described in the literature may require extemporaneous compounding.

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

No dosage adjustment needed.

Renal Impairment

No dosage adjustment needed.

Drug Interactions

There are no drug interactions associated with Anthralin products.

How Supplied

Anthralin/Dritho-Creme HP Topical Cream: 1%
ZITHRANOL Topical Shampoo: 1%

Maximum Dosage
Adults

1 application/day to each affected area for cream; 1 application/day up to 4 days/week for shampoo.

Geriatric

1 application/day to each affected area for cream; 1 application/day up to 4 days/week for shampoo.

Adolescents

1 application/day to each affected area for cream; 1 application/day up to 4 days/week for shampoo.

Children

>= 12 years: Cream: 1 application/day up to 4 days/week for shampoo.
< 12 years: Cream: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

The exact mechanism of anthralin is unknown. However, anti-proliferative and anti-inflammatory effects of anthralin have been demonstrated 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 strong reducing properties. The effectiveness of anthralin as an anti-psoriatic agent has partly been attributed to its abilities to induce lipid peroxidation and to reduce levels of endothelial adhesion molecules, which are markedly elevated in psoriatic patients.

Pharmacokinetics

Anthralin is administered topically. Although the extent of systemic absorption after topical application has not been determined, no traces of anthraquinone metabolites were detected in the urine of treated subjects in a limited clinical study of anthralin cream. Anthralin does not inhibit hepatic microsomal enzyme activity.

Pregnancy And Lactation
Pregnancy

According to the FDA-approved labeling, it is not known if anthralin can cause fetal harm when administered to a pregnant woman. Due to the lack of human data, anthralin should be used during pregnancy only if clearly needed.[41587]

According to the manufacturer, a decision should be made whether to discontinue nursing or to discontinue anthralin, taking into account the importance of the drug to the mother. It is not known if anthralin is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.