Psorizide Ultra

INDICATIONS PSORIZIDE ® ULTRA is indicated for the treatment of moderate to severe eczema, atopic dermatitis, seborrhea and seborrheic dermatitis. It has been found to work well with variety of combination therapies. Psoriasis also responds, but generally has a more favorable response to PSORIZIDE ® Forte (NDC 61480-255-05.)

DOSAGE AND ADMINISTRATION Absorption of nickel sulphate is variable among individuals. For maximum absorption, tablets should be taken orally at the beginning of the day (or any convenient time after having taken nothing but water for at least 7 hours). Take nothing but water for one hour after taking medication to aid absorption. Weight Starting Dose Max. Dose 50-100 lbs ½ tablet 1 tablet 100-150 lbs 1 tablet 2 tablets 150-200 lbs 2 tablets 4 tablets over 200 lbs 3 tablets 6 tablets In the setting of renal impairment, dosage should be adjusted and serum nickel and bromide levels should be followed. Steady state trough level should be drawn prior to ingesting the day's dose after one week of dosing or at appropriate intervals. Target trough serum nickel level is 20-40 mcg/L. (Warning: post dose peak levels are unreliable.) Treatment duration depends on the individual. Increase dose as needed on a monthly basis. Maintenance phase In order to maintain symptomatic relief, medication may be continued at the same or reduced initial phase dose level.

CONTRAINDICATIONS Although there are no known contraindications, patients who are allergic to any PSORIZIDE ® ULTRA ingredient should consult a physician prior to taking the medication. (Refer to Section on Hypersensitivity )

WARNING Do not use if imprinted seal under bottle cap is missing or broken. Do not use if pregnant or nursing. If allergic to nickel or metal objects such as jewelry or if there is a history of blistering hand eczema, see PRECAUTIONS for hypersensitivity information. Lactose intolerant patients may have gastrointestinal difficulty. This has very rarely been reported at the doses used.

Drug interactions There are no known drug interactions.

ADVERSE REACTIONS PSORIZIDE ® ULTRA contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information)

Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with PSORIZIDE ® ULTRA. PSORIZIDE ® ULTRA should not be given to a pregnant woman.