Dritho-Creme®

(anthralin 1.0%) 50 g tube   NDC 11086-037-01
Available by prescription only.

 

Easy Dritho-Creme^® Application Instructions

		1) Dritho-creme® can be applied to clean dry or damp skin. Be sure to remove any other residual medication before each application. 2) Wearing disposable latex gloves, apply Drithocreme directly to plaques and plaque rims by rubbing it in gently but thoroughly. 3) Be careful not to smear Drithocreme on unaffected skin. 4) If irritation or smearing becomes a problem, use a cotton swab to apply zincoxide or petroleum jelly to the edges of the plaque before applying Drithocreme. 5) Do not leave Drithocreme on any longer than directed by your dermatologist. Remove immediately when time is up. Note: since this product will permanently stain clothing and other fabrics, be sure to wear old clothing and cover any furniture to be used with an old sheet.* 6) Wipe off Drithocreme thoroughly with baby, mineral or vegetable oil using an old cloth or disposable towel. Note: failure to completely remove remaining product may cause irritation, especially in body folds and skin creases. 7) Shower or bathe with your normal soap. 8) Immediately clean the the tub or shower, rinsing thoroughly. Dishwashing detergent may help to remove residue. 9) Dry off with an old towel as staining of fabrics is permanent. 10) Apply oil or moisturizer to treated areas.

Important Information about Dritho-Creme^®

Warning
Dritho-Creme can cause severe irritation. Be careful to keep off skin not affected by psoriasis. Rinse immediately and completely with shampoo or soap and water after 5 minutes or the amount of time your doctor prescribed. If irritation occurs, discontinue use and call your doctor. Keep away from eyes.

Caution
Dritho-Creme can permanently stain clothing and bathroom fixtures. Dritho-Creme will also stain skin, but staining is temporary. Use only old clothing and old towels and linens while using Dritho-Creme. Any clothing or linens that come in contact with Dritho-Creme may become permanently stained. Rinse all bathroom fixtures immediately and thoroughly.

Dritho-Creme^®Product Information

Description
Dritho-Creme® is a pale yellow topical cream containing 1% anthralin USP in a base of white petrolatum, mineral oil, sodium lauryl sulfate, cetostearyl alcohol, ascorbic acid, salicylic acid, methylparaben and purified water. The chemical name of anthralin is 1,8-dihydroxy-9- anthrone. The structural formula is:

 

Clinical Pharmacology
Although the precise mechanism of anthralin's anti-psoriatic action is not fully understood, in vitro evidence suggests that its antimitotic effect results from inhibition of DNA synthesis. Additionally, the chemically reducing properties of anthralin may upset oxidative metabolic processes, providing a further slowing down of epidermal mitosis. Absorption in man has not been finally determined, but in a limited clinical study of anthralin cream, no traces of anthraquinone metabolites were detected in the urine of subjects treated; however, caution is advised in patients with renal disease.

Indications and Usage
An aid in the topical treatment of quiescent or chronic psoriasis. Treatment should be continued until the skin is entirely clear, i.e., when there is nothing to feel with the fingers and the texture is normal.

Contraindications
In patients with acute psoriatic eruptions or a history of hypersensitivity to any of the ingredients.

Warnings
Avoid contact with the eyes or mucous membranes. Dritho-Creme should not normally be applied to intertriginous skin areas and high strengths should not be used on these sights. Remove any unintended residue which may be deposited behind the ears. Avoid applying to the folds and creases of the skin. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas. Keep out of the reach of children.

Precautions
For external use only. Dritho-Creme may stain and should be applied sparingly and carefully to psoriatic lesions only. Contact with fabrics, plastics and other materials may cause staining and should be avoided. To prevent the possibility of discoloration, always rinse the bath/shower with hot water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the bath or shower. Always wash hands thoroughly after use, 15-30º C (59-86º F). 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. As long-term use of topical corticosteroids may destabilize psoriasis, and withdrawal may also give rise to a 'rebound' phenomenon, an interval of at least one week should be allowed between the discontinuance of such steroids and the commencement of Dritho-Creme therapy. Petrolatum or a suitably bland emollient may usefully be applied during the intervening period.

Pregnancy
Pregnancy Category C. Animal reproduction studies have not been conducted with Dritho-Scalp. It is also not known whether Dritho-Creme can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dritho-Creme 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 pediatric patients have not been established.

Adverse Reactions
Very few instances of contact allergic reactions to anthralin have been reported. However, transient primary irritation of uninvolved skin surrounding the treated lesions is more frequently seen and may occasionally be severe. Application of Dritho-Creme must be restricted to the psoriatic lesions. If the initial treatment produces excessive soreness or if the lesions spread, reduce frequency of application and, in extreme cases, discontinue use and consult physician. Some temporary discoloration of hair and fingernails may arise during the period of treatment but should be minimized by careful application. Dritho-Creme may stain skin, hair or fabrics. Staining of fabrics may be permanent, so contact should be avoided.

Dosage and Administration
Generally, it is recommended that Dritho-Creme be applied once a day or as directed by a physician. Anthralin is known to be a potential skin irritant. The irritant potential of anthralin is directly related to each patient's individual tolerance. Therefore, where the response to anthralin treatment has not previously been established, always commence treatment using a short contact time of 5 to 10 minutes for at least one week using Dritho-Creme. Contact time can be increased stepwise to twenty to thirty minutes, or as directed by a physician, before removing the cream by thoroughly washing or showering. Apply as directed by a physician. 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 pierce the membrane.

For the Skin
Apply sparingly only to the psoriatic lesions and rub gently and carefully into the skin until absorbed. It is most important to 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, a bath or shower should be taken to remove any surplus cream (which may have become red/brown in the color). The margins of the legions may gradually become stained purple/brown as treatment progresses, but this will dissapear after cessation of treatment.

Keep Dritho-Creme well away from the eyes.
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, wash the hair and scalp to remove any surplus cream (which may have become red/brown in color).

Always wash hands thoroughly after use.
Store at controlled room temperature, 15-30C (59-86F).

How Supplied
50g tube
Dritho-Creme 1.0% NDC 11086-037-01

Rx Only
Distributed by
Summers Laboratories, Inc.
Collegeville, PA 19426