Eczemol® (Children 11 lbs. & Up)

Eczemol® Dosage Form: Oral 300 mg scored tablet. May be swallowed whole, chewed or dissolved in the mouth and swallowed.
How Supplied: Scored tablets, off white in color with green speckles, with LL and score imprinted on same side. In child-resistant and tamper-resistant bottles of 100 tablets.
Dosage & Administration: Once a Day Dosage. 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). Patient should take nothing but water for one hour after taking medication to aid absorption. Dosage is weight dependent:

Increase dose as needed on a monthly basis. Try b.i.d. dosing (upon rising and at bedtime) if maximum dose is not effective; do not exceed maximum daily dose. Treatment duration depends on the individual.

Maintenance Phase: In order to maintain symptomatic relief, medication may be continued at the same or reduced initial phase dose level.

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).

Eczemol® may interfere with the effects of oral antibiotics by reducing their absorption. If a patient is taking Tetracycline Antibiotics, allow at least two (2) hours after taking Eczemol® before taking a Tetracycline Antibiotic. If a patient is taking Quinolone Antibiotics, allow at least six (6) hours after taking Eczemol® before taking a Quinolone Antibiotic.

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.

The active ingredients in Eczemol® are simple biochemical compounds. The exact mechanism of action is unknown; however, it is believed these medications address a primary genetic biochemical defect.
Potassium Bromide dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 15 mg bromide (calculated). Ionic bromide is rapidly and completely absorbed from the intestine and distributed almost exclusively in the extracellular fluids. 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.
Nickel Sulphate dissolves and dissociates in the digestive tract into its ionic constituents. Each tablet contains approximately 1.5 mg of ionic nickel (calculated). According to studies, 15% to 50% of ionic nickel is absorbed on a fasted stomach. Food markedly decreases the rate and extent of nickel absorption. Clinical studies show that serum concentrations of nickel are variable among patients after administering the same dosage. 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. Renal clearance is rapid and efficient, and nickel does not accumulate in the body.
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. 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. 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®.

Precautions: Lactose Intolerant Patients: May have gastrointestinal difficulty. This has very rarely been reported at the doses used.
Pediatric Patients: Carefully adjust dosage to weight when treating young children.
Pregnancy: Pregnancy category C. Animal reproduction studies have not been conducted. Eczemol® should not be given to a pregnant woman.
Nursing Mothers: It is not known whether this drug is excreted in human milk. However, since many drugs are excreted in human milk, caution should be exercised when administered to a nursing mother.
General Precautions: Use cautiously in setting of kidney disease (see dosage & administration section). If skin rash appears or if nervous symptoms persist, recur frequently, or are unusual, discontinue patient use.
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 below).
Hypersensitivity: Caution should be used when administering to patients with a history of contact sensitivity to nickel (common metal exposure) or if there is a history of vesicular hand eczema (dyshidrotic, pomphylox). Nickel allergy may be confirmed by a positive nickel patch test. Most patients with hand eczema, positive nickel allergy history, or a positive nickel patch test do not have any untoward reaction to administration of Eczemol®. If there is a history of nickel sensitivity or dyshidrotic hand eczema, begin with a very low dose and slowly increase to a recommended starting dose over a period of 5 weeks as tolerated, thus allowing progressive GI absorption.
If new pruritic rashes occur or persist, discontinue and treat appropriately. Do not use if there is a history of extra-cutaneous hypersensitivity to nickel or any ingredient in Eczemol®.
Drug Interactions: There are no known drug interactions.
Carcinogenesis, mutagenesis, impairment of fertility: No studies have been done on the carcinogenesis, mutagenesis, or impairment of fertility. No carcinogenesis or mutagenesis has been reported in multiple animal studies for oral administration of soluble nickel and bromide salts (active ingredients) even at very high doses.
Effects of soluble nickel sulphate: Studies on experimental animals have never indicated that nickel, at any dose, is a carcinogen when introduced to the body orally. Furthermore, nickel sulphate and other highly water soluble nickel salts, have been known to induce carcinogenesis via any route of introduction including: oral, inhalation, cutaneous, IM, or IP. No adverse effects were noted on fertility or reproduction in a 3-generaltional study of albino Wistar rats fed up to 1000 ppm Ni per day, which is equivalent to 50 mg/kg body weight per day Ni.

Effects of soluble potassium bromide: KBr is not listed as a carcinogen by the NTP, IARC, and OSHA. Effects of Sulphur: Sulphur is not listed as a carcinogen by the ACGIH, IARC, NIOSH, NTP or OSHA.
Adverse reactions: Eczemol® contains low doses of active ingredients: therefore there are minimal known side effects (see precautions for hypersensitivity information).
Over Dosage:
Potassium bromide toxicity: Indications of toxicity due to oral over dosage of bromide may include nausea, vomiting, apathy and disturbed coordination, loss of memory, drowsiness and loss of emotional control, agitation, hallucination, tremors, depressed reflexes, stupor and coma. Acute toxic reactions in humans have been reported at doses as low as 1000 mg. This level is 67 times the dose received in one tablet of Eczemol®. Sulphur toxicity: The oral rat LD50 for Sulphur is reported to be greater than 5,000 mg/kg. This is more than 37,000 times the maximum dose recommended (see dosage). Ingestion of toxic levels of Sulphur can cause sore throat, nausea, headache, gastrointestinal irritation and possibly unconsciousness in severe cases. Sulphur poses such a remote risk that it is placed in the lowest toxic category possible, EPA Toxicity Category IV. Nickel sulphate toxicity: The oral rat LD50 for nickel sulphate hexahydrate is 275 mg/kg. Symptoms of toxicity due to oral over dosage of nickel sulphate may include nausea, vomiting, abdominal discomfort, diarrhea, giddiness, lassitude, headaches, cough and shortness of breath. The lowest observed transitory toxic effects from human ingestion of soluble nickel salts are approximately 8 mg nickel/kg body weight. This is 180 times the maximum dose recommended for Eczemol®.