Potassium Bromide, Nickel Sulfate, And Sulfur

Description

DESCRIPTION ECZEMOL ® is a biochemical homeopathic medication indicated for the treatment of eczema. 27,29 The active ingredients in each ECZEMOL ® tablet consist of the following: Potassium Bromide (Kali Bromatum) 1X, Sulphur 1X, and Nickel Sulphate (Niccolum Sulphuricum) 1X. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS). 1 Inactive ingredients: Lactose, Fumaric Acid, and Magnesium Stearate. Pharmacological class: Homeopathic drug. Dosage form: Oral 300 mg scored tablet. May be swallowed whole, chewed or dissolved in the mouth and swallowed.

What Is Potassium Bromide, Nickel Sulfate, And Sulfur Used For?

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

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.

Side Effects (Adverse Reactions)

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

Drug Interactions

Drug interactions There are no known drug interactions.

Contraindications

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)

Pregnancy and Breastfeeding

Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with ECZEMOL ® . 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 ECZEMOL ® is administered to a nursing woman.

Overdosage

OVERDOSAGE Potassium bromide toxicity Indications of toxicity due to oral overdosage of bromide may include nausea, vomiting, apathy, disturbed coordination, loss of memory, drowsiness, 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. 19 This level is 67 times the dose received in one tablet of ECZEMOL ® . Sulphur toxicity The oral rat LD 50 for sulphur is reported to be greater than 5,000 mg/kg . 23 This is more than 37,000 times the maximum dose recommended for ECZEMOL ® . (see Dosage ) Ingestion of toxic levels of sulphur can cause sore throat, nausea, headache, gastrointestinal irritation, and possibly unconsciousness in severe cases. 24,25 Sulphur poses such a remote risk that it is placed in the lowest toxic category possible, EPA Toxicity Category IV. 23 Nickel sulphate toxicity The oral rat LD 50 for nickel sulphate hexahydrate is 275 mg/kg. 17 Symptoms of toxicity due to oral overdosage of nickel sulphate may include nausea, vomiting, abdominal discomfort, diarrhea, giddiness, lassitude, headaches, cough, and shortness of breath. 18 The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight. 18 This is 180 times the maximum dose recommended for ECZEMOL ® . (See below )

How Supplied

HOW SUPPLIED Scored tablets, off white in color with green speckles, with and score imprinted on same side, in child-resistant and tamper-resistant bottles of 100. NDC 61480-127-05 Symbol