Nickel Sulfate, Potassium Bromide, And Fumaric Acid

Description

DESCRIPTION PSORIZIDE ® Forte is a biochemical homeopathic medication indicated for the treatment of contact dermatitis due to nickel (metal/jewelry allergy), dyshidrotic hand/foot eczema, and mild to severe psoriasis . 1-3 The active ingredients in each PSORIZIDE ® Forte tablet consist of the following: Fumaric Acid (Fumaricum Acidum) 1X, Potassium Bromide (Kali Bromatum) 1X, and Nickel Sulphate (Niccolum Sulphuricum) 1X. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS). 4 Inactive ingredients: Lactose and Magnesium Stearate. Pharmacological Class: Homeopathic drug. Dosage form: Oral 600 mg scored tablet. May be swallowed whole, chewed or dissolved in the mouth and swallowed.

What Is Nickel Sulfate, Potassium Bromide, And Fumaric Acid Used For?

INDICATIONS PSORIZIDE ® Forte is indicated for the treatment of contact dermatitis due to nickel (metal/jewelry allergy,) dyshidrotic hand/foot eczema, and mild to severe psoriasis. It has been found to work well with a variety of combination therapies. Eczema, seborrhea and a variety of chronic pruritic inflammatory dermatoses generally respond well also.

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. Weight Starting Dose Max Daily Dose 40-80 lbs ½ tablet 1 ½ tablet 80-120 lbs 1 tablet 3 tablets 120-160 lbs 1 ½ tablets 4 ½ tablets 160-200 lbs 2 tablets 6 tablets 200-240 lbs 2 ½ tablets 7 ½ tablets Over 240 lbs 3 tablets 9 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 30-60 mcg/L. (Caution: post dose peak levels are unreliable.) Maintenance phase In order to maintain symptomatic relief, medication may be continued at the same or reduced initial phase dose level. Treatment duration depends on the individual. For allergic nickel dermatitis, continue 2 tablets 1 hour prior to breakfast for weeks 7 – 16. (Refer to Hypersensitivity section above). Some patients may require continued or intermittent repeated treatment to maintain nickel desensitization.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS PSORIZIDE ® Forte 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 PSORIZIDE ® Forte 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 PSORIZIDE ® Forte. PSORIZIDE ® Forte should not be given to a pregnant woman.

Nursing mothers It is not known whether this drug is secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when PSORIZIDE ® Forte is administered to a nursing woman.

Overdosage

OVERDOSAGE Fumaric acid toxicity The oral rat LD 50 is 9300mg/kg. 26 This is 3800 times the maximum dose recommended for PSORIZIDE ® Forte. Potassium bromide toxicity Indications of toxicity due to oral overdosage of bromide may include nausea and 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 1000mg. 31 This level is 67 times the dose received in one tablet of PSORIZIDE ® Forte. Nickel sulphate toxicity The oral rat LD 50 for nickel sulphate hexahydrate is 275mg/kg. 29 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. 30 The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight. 30 This is 138 times the maximum dose recommended for PSORIZIDE ® Forte (see below).

How Supplied

HOW SUPPLIED Scored tablets, off white in color with green speckles, with imprinted on one side and a score on the other , in child-resistant and tamperresistant bottles of 90 . NDC 61480-255-05 Symbol