Potassium Bromide, Nickel Sulfate, and Sulfur

INDICATIONS ECZEMOL ® is indicated for the treatment of moderate to severe eczema and atopic dermatitis. It has been found to work well with a variety of combination therapies.

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. Kg lbs Starting dose Max Daily dose 5-11 11-25 ¼ ½ 12-22 26-50 ½ 1 23-45 51-100 1 2 46-68 101-150 2 4 69-90 151-200 3 6 91+ 201+ 4 8 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. (Caution: post dose peak levels are unreliable.) Treatment duration depends on the individual. Increase dose as needed on a monthly basis. Try b.i.d. dosing (upon rising and at bedtime) if max dose (see above ) is not effective; do not exceed max daily dose. Maintenance phase In order to maintain symptomatic relief, medication may be continued at the same or reduced initial phase dose level.

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.

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

Drug interactions There are no known drug interactions.

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

CLINICAL PHARMACOLOGY The active ingredients in ECZEMOL ® are simple biochemical compounds. The exact mechanism of action is unknown; however, it is believed ECZEMOL ® addresses a primary genetic biochemical defect. POTASSIUM BROMIDE dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 15 mg of bromide (calculated). Ionic bromide is rapidly and completely absorbed from the intestine and distributed almost exclusively in the extracellular fluids. 7,8 Bromide is eliminated by the kidneys and the elimination half-life is 11-12 days. "Once a day" dosing will lead to a steady state concentration in about seven weeks. 7 SULPHUR is a naturally occurring mineral that is an essential part of the human body. It exhibits anti-bacterial, anti-parasitic, fungicidal, and keratolytic properties. 26 Each tablet contains approximately 1.5 mg of sulphur (calculated). Sulphur is highly water soluble and as a result is easily excreted by the body via sweat and urine. 22 Since the sulphur found in ECZEMOL ® is a naturally occurring mineral, it is radically different from sulfa drugs (sulfonamide antibiotics). Therefore, patients who are allergic to sulfa drugs CAN safely take ECZEMOL ® . NICKEL SULPHATE dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 0.5 mg of ionic nickel (calculated). According to studies, 15% to 50% of ionic nickel is absorbed on a fasted stomach. 2 Food markedly decreases the rate and extent of nickel absorption. 3,4 Clinical studies show that serum concentrations of nickel are variable among patients after administering the same dosage. 5 Peak serum nickel concentration is reached about two hours after oral administration. "Once a day" dosing leads to steady state serum concentrations in approximately one week. Nickel is in its highly stable divalent cation state and is therefore not expected to be metabolized to any significant degree in the body. Absorbed nickel is primarily excreted in the urine and elimination half-life is about 21 hours. 3,5 Renal clearance is rapid and efficient, and nickel does not accumulate in the body. 6