Label: PSORIZIDE ULTRA- potassium bromide, nickel sulfate, and zinc bromide tablet
- NDC Code(s): 61480-124-05
- Packager: PLYMOUTH HEALTHCARE PRODUCTS LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 9, 2024
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DESCRIPTION
PSORIZIDE ®ULTRA is a biochemical homeopathic medication indicated for the treatment of eczema and seborrhea. 24-26The 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.
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CLINICAL PHARMACOLOGY
The active ingredients in PSORIZIDE ®ULTRA are inorganic soluble mineral salts. The exact mechanism of action is unknown; however, it is believed PSORIZIDE ®ULTRA addresses a primary genetic biochemical defect.
POTASSIUM BROMIDEdissolves 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. 7,8Bromide 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
NICKEL SULPHATEdissolves 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. 2Food markedly decreases the rate and extent of nickel absorption. 3,4Clinical studies show that serum concentrations of nickel are variable among patients after administering the same dosage. 5Peak 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. 3,5Renal clearance is rapid and efficient, and nickel does not accumulate in the body. 6
- CLINICAL STUDIES
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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.)
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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)
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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 PRECAUTIONSfor hypersensitivity information. Lactose intolerant patients may have gastrointestinal difficulty. This has very rarely been reported at the doses used.
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PRECAUTIONS
Carefully adjust dosage to weight when treating young children. Do not use in cases of kidney disease. If skin rash appears or if nervous symptoms persist, recur frequently, or are unusual, discontinue use.
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 (dyshidrosis, 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 nothave any untoward reaction to administration of PSORIZIDE ®ULTRA. 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*.
*Nickel desensitization schedule: Week Amount of Time to Take Medication Prior to Breakfast Week 1 With Breakfast Week 2 15 min Week 3 30 min Week 4 45 min Week 5 and thereon 1 hour If new pruritic rashes occur or persist, discontinue PSORIZIDE ®ULTRA and treat appropriately. Do not use if there is a history of extra-cutaneous hypersensitivity to nickel or bromide.
Information for patients
Patients using PSORIZIDE ®ULTRA should receive the following information and instructions:
- This medication is to be used as directed by a physician.
- It is important to take orally at the beginning of the day on an empty stomach (or any convenient time after having taken nothing but water for at least 7 hours) and to eat or drink nothing but water for at least one hour afterwards to avoid interference with absorption.
Carcinogenesis, mutagenesis, impairment of fertility
No studies have been done on the carcinogenesis or mutagenesis, or impairment of fertility of PSORIZIDE ®ULTRA. 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. 10-16
Effects of soluble potassium bromide
KBr is not listed as a carcinogen by the NTP, IARC, and OSHA. 18
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 never been known to induce carcinogenesis via any route of introduction including: oral, inhalation, cutaneous, IM, or IP. 10-12,17No adverse effects were noted on fertility or reproduction in a 3-generational 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. 17
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ADVERSE REACTIONS
PSORIZIDE ®ULTRA contains low doses of active ingredients. Therefore there are minimal known side effects.
(see PRECAUTIONSfor hypersensitivity information) -
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. 21This level is 67 times the dose received in one tablet of PSORIZIDE ®ULTRA.
Nickel sulphate toxicity
The oral rat LD 50for nickel sulphate hexahydrate is 275 mg/kg. 19Symptoms of toxicity due to oral overdosage of nickel sulphate may include nausea, vomiting, abdominal discomfort, diarrhea, giddiness, lassitude, headaches, cough, and shortness of breath. 20The lowest observed transitory toxic effects from human ingestion of soluble nickel salts is approximately 8 mg nickel/kg body weight. 20This is 80 times the maximum dose recommended for PSORIZIDE ®ULTRA. (See below).
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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 priorto 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.
- INACTIVE INGREDIENTS
- HOW SUPPLIED
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REFERENCES
- The Homeopathic Pharmacopoeia of the United States (HPUS), 8 thEdition, Falls Church, Virginia, 1979.
- Sunderman FW jr., Biological monitoring of nickel in humans. Scand J Work Environ Health 1993; 19 suppl 1:34-38.
- Sunderman FW jr., Hopfer SM, Sweeny KR, Marcus AH, Most BM, Creason J. Nickel absorption and kinetics in human volunteers, P.S.E.B.M. 1989; 191:5-11.
- Solomons NW, Viteri F, Shuler TR, Nielsen FH. Bioavailability of nickel in man: Effects of foods and chemically-defined dietary constituents on the absorption of inorganic nickel. J Nutr 1982; (2); 112; 39-50.
- Christensen OB, Iagesson V. Nickel concentration of blood and urine after oral administration. Annals of Clinical and Laboratory Science 1981;2(2);119-125.
- Nielsen FH. Is nickel nutritionally important? Nutrition Today 1993;28(1):14-19.
- Vaiseman N, Koren G, Pencharz P. Pharmacokinetics or oral and intravenous bromide in normal volunteers. Clinical Toxicology 1986;24(5):403-413.
- Van Leeuwen FXR, Sangster B. The toxicology of bromide ion. CRC Critical Reviews in Toxicilogy 1987; 18(3):189-213.
- Smith SA. Oral supplementation of nickel and bromide in psoriasis vulgaris using nickel sulfate and sodium bromide. 1995 (unpublished report).
- Miller MJ, Bogdan KG, Leach JF, and Gray AJ. Ambient air criteria document, Bureau of Toxic Substance Assessment, New York Department of Health, Albany, NY 1989.
- US EPA, Environmental Criteria and Assessment Office, Office of Health and Environmental Assessment, health assessment document for nickel and nickel compounds. Washington DC, EPA/600/8-83/012FF.
- US EPA, Environmental Criteria and Assessment Office, Office of health and Environmental Assessment. Drinking water quantification of toxicological effects for nickel. ECAO-CIN-443.1991
- US FDA, Center for Food Safety and Applied Nutrition. Guidance document for nickel in shellfish. 1993.
- Buselmaier W. von, Rohrborn G, and Propping G. Mutagenitats – Untersuchugen mit Pestiziden im Host – Mediated Assay und mit dem Dominanten Letaltest an der Maus. Biol Zbl 1972; 91:311-325.
- IARC Monograph on the Evaluation of Carcinogenic Risk of Chemicals to Man. IRC Publication #11, Lyon, France 1976.
- Corbett TH, Heidelberger C, and Dove WF. Determination of mutagenic activity to bacteriiophage T4 or carcinogenic and non-carcinogenic compounds. Mol Pharmacol 1970;6:667-669.
- Ambrose AM, Larson PS, Borselleca JF, and Hennigar GR, Jr. Long term toxicologic assessment of nickel in rats and dogs. Journal of Food Science and Technology 1976;13:181-187.
- MSDS Sheet No. 247 Potassium Bromide. Schenectady, NY: Genium Publishing Corp 1991.
- MSDS Sheet No. 37 Nickel Sulfate. Schenectady, NY: Genium Publishing Corp 1993.
- Sunderman FW Jr., Dingle B, Hopfer SM, and Swift T. Acute nickel toxicity in electroplating workers who accidentally ingested a solution of nickel sulfate and nickel chloride. American Journal of Industrial Medicine 1988;14;257-266.
- Martindale: The Extra Pharmacopoeia 27 thed. Wade A, editor. The Pharmaceutical Press: London, 1977, pp273-274.
- Smith SA, et al, Improvement of Psoriasis Vulgaris with Oral Nickel Dibromide. Archives of Dermatology 1997; 133:661-663.
- Smith SA, Baker AE, etal. Effective Treatment of Seborrheic Dermatitis Using a Low Dose, Oral Homeopathic Medication... Alt Med Rev 2002; 7, pp59-67
- Reckeweg, Hans-Heinrich, Materia Medica, 1983, first English edition.
- Boericke, William, Materia Medica with Reperatory, 1927, ninth edition.
- Clarke, John Henry, A Dictionary of Practical Materia Medica, 1921, reprint edition 1996.
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INGREDIENTS AND APPEARANCE
PSORIZIDE ULTRA
potassium bromide, nickel sulfate, and zinc bromide tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61480-124 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 1 [hp_X] NICKEL SULFATE (UNII: 4FLT4T3WUN) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL SULFATE 1 [hp_X] ZINC BROMIDE (UNII: OO7ZBU9703) (ZINC CATION - UNII:13S1S8SF37) ZINC BROMIDE 4 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) 264.27 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 3 mg Product Characteristics Color white (off white with green speckles) Score 2 pieces Shape ROUND Size 9mm Flavor Imprint Code LL Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61480-124-05 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/1997 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/01/1997 Labeler - PLYMOUTH HEALTHCARE PRODUCTS LLC (079330314)
