Psorizide Ultra

Potassium Bromide, Nickel Sulfate, and Zinc Bromide · Tablet · Oral

Prescription (Rx) Copper Absorption Inhibitor

Uses

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

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.

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 )

Warnings

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 PRECAUTIONS for hypersensitivity information. Lactose intolerant patients may have gastrointestinal difficulty. This has very rarely been reported at the doses used.

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 not have 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. Drug interactions There are no known drug interactions. 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. 10-12,17 No 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 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. Pediatric use Carefully adjust dosage to weight when treating young children.

Side effects

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.

Pregnancy

Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with PSORIZIDE ® ULTRA. PSORIZIDE ® ULTRA should not be given to a pregnant woman.

Pediatric use

Pediatric use Carefully adjust dosage to weight when treating young children.

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 ).

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.

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.

Patient information

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.

Label text from the FDA structured product label by PLYMOUTH HEALTHCARE PRODUCTS LLC (revised Jan 7, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Potassium Bromide in 1 product
Nickel Sulfate in 1 product
Zinc Bromide in 1 product

Psorizide Ultra NDC products (1)

NDC	Strength & form	Labeler	Type
61480-124	Potassium Bromide 1 [hp_X]/1; Nickel Sulfate 1 [hp_X]/1; Zinc Bromide 4 [hp_X]/1 Tablet	PLYMOUTH HEALTHCARE PRODUCTS LLC	UNAPPROVED HOMEOPATHIC

Frequently asked questions

What is Psorizide Ultra used for?

What are the side effects of Psorizide Ultra?

ADVERSE REACTIONS PSORIZIDE ® ULTRA contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information) See the full label for the complete list.

Who makes Psorizide Ultra?

Psorizide Ultra is listed by 1 labeler in the FDA NDC directory, including PLYMOUTH HEALTHCARE PRODUCTS LLC.