Potassium Bromide, Nickel Sulfate, And Zinc Bromide

Description

DESCRIPTION PSORIZIDE ® ULTRA is a biochemical homeopathic medication indicated for the treatment of eczema and seborrhea . 24-26 The active ingredients in each PSORIZIDE ® ULTRA tablet consist of the following: Potassium Bromide (Kali Bromatum) 1X, Nickel Sulphate (Niccolum Sulphuricum) 1X and Zinc Bromide (Zincum Bromatum) 4x. These drug ingredients are listed in the Homoeopathic Pharmacopoeia of the United States (HPUS). 1 Inactive ingredients: Lactose 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 Zinc Bromide Used For?

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

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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS PSORIZIDE ® ULTRA 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 ® ULTRA 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 ® ULTRA. PSORIZIDE ® ULTRA 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 PSORIZIDE ® ULTRA 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. 21 This level is 67 times the dose received in one tablet of PSORIZIDE ® ULTRA. Nickel sulphate toxicity The oral rat LD 50 for nickel sulphate hexahydrate is 275 mg/kg. 19 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. 20 The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight. 20 This is 80 times the maximum dose recommended for PSORIZIDE ® ULTRA. (See below ).

How Supplied

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. NDC 61480-124-05.