Acunol
Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, and Sulfur · Tablet · Oral
Uses
Acunol™ is indicated for the treatment of mild to moderate acne vulgaris, acne rosacea, peri-oral dermatitis, and folliculitis. It has been found to work well with a variety of combination therapies.
Dosage and administration
Take tablets twice a day (b.i.d.) for best results. Absorption of nickel sulphate is variable among individuals. For maximum nickel absorption, tablets should be taken orally upon rising at the beginning of the day and at the end of the day before bed. Take nothing but water for one hour after taking medication to aid nickel absorption. If taking Tetracycline or Levofloxacin allow at least two hours after taking Acunol. If taking a different Quinolone antibiotic, consult manufacturer's information. Kg lbs Starting dose Max Daily dose 23-45 51-100 ½ ∙ b.i.d. 1 ∙ b.i.d. 46-68 101-150 1 ∙ b.i.d. 2 ∙ b.i.d. 69-90 151-200 1½ ∙ b.i.d. 3 ∙ b.i.d. 91+ 201+ 2 ∙ b.i.d. 4 ∙ b.i.d. Increase dose only if needed on a monthly basis up to the max daily dose. Treatment dose and duration depends on the individual. In the setting of significant renal impairment Dosage should be adjusted and serum nickel and bromide levels should be followed. Steady state trough nickel 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 10-40 mcg/L. (Caution: post dose peak levels are unreliable.) Serum bromide assay by spectrophotometry is the historic standard. 36 Concentrations higher than 50 mg/dl may be compatible with toxicity. No therapeutic target levels exist for bromide.
Contraindications
Although there are no known contraindications, patients who are allergic to any Acunol™ 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, 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. Use cautiously in setting of kidney disease. (see Dosage and Administration ) 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 Acunol™. 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 Prior Week 3 30 min Prior Week 4 45 min Prior Week 5 and thereon 1 hour Prior If new pruritic rashes occur or persist, discontinue Acunol™ and treat appropriately. Do not use if there is a history of extra-cutaneous hypersensitivity to nickel or any ingredient in Acunol™ . Information for patients Patients using Acunol™ 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 and at the end of the day before bed; take nothing but water for one hour afterwards to avoid interference with absorption. Drug interactions There are no known drug interactions. Since copper deficiency in human nutrition has occasionally been induced by supplemental zinc therapy, copper has been added in order to minimize this rare occurrence. (see Inactive ingredients ) For Tetracycline or Quinolones co-administration with Acunol, see Dosage and Administration Carcinogenesis, mutagenesis, impairment of fertility No studies have been done on the carcinogenesis, mutagenesis, or impairment of fertility of Acunol™. 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. 10-14 Effects of soluble potassium bromide KBr is not listed as a carcinogen by the NTP, IARC, and OSHA. 16 Effects of sodium bromide NaBr is not listed as a carcinogen by the IARC, NTP, or OSHA. 35 Effects of zinc sulphate ZnSO 4 is not listed as a carcinogen by the ACGIH, IARC, NTP, or CA Prop 65. 29 Effects of sulphur Sulphur is not listed as a carcinogen by the ACGIH, IARC, NIOSH, NTP, or OSHA. 25 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 has never been known to induce carcinogenesis via any route of introduction including: oral, inhalation, cutaneous, IM, or IP. 10-12,15 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 per day Ni. 15 Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with Acunol™. Acunol™ 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 Acunol™ is administered to a nursing woman. Pediatric use Carefully adjust dosage to weight when treating young children.
Side effects
Acunol™ 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. Since copper deficiency in human nutrition has occasionally been induced by supplemental zinc therapy, copper has been added in order to minimize this rare occurrence. (see Inactive ingredients ) For Tetracycline or Quinolones co-administration with Acunol, see Dosage and Administration
Pregnancy
Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with Acunol™. Acunol™ should not be given to a pregnant woman.
Pediatric use
Pediatric use Carefully adjust dosage to weight when treating young children.
Overdosage
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 33 times the dose received in one tablet of Acunol™. Zinc sulphate toxicity Symptoms of acute toxicity of zinc due to oral overdoseage can include dehydration, stomach pain, lethargy, dizziness, muscular incoordination, and in severe cases renal failure. 26 Chronic zinc toxicity can occur at levels of 100-300 mg/d. 30 Sulphur toxicity The oral rat LD 50 for sulphur is reported to be greater than 5,000 mg/kg. 23 This is more than 11,000 times the maximum dose recommended for Acunol™. 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 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 Acunol™. (See below )
Description
Acunol™ is a biochemical homeopathic medication indicated for the treatment of acne. 32-34 The active ingredients in each Acunol™ tablet consist of the following: Potassium Bromide (Kali Bromatum) 1X, Sodium Bromide (Natrum Bromatum) 1X, Zinc Sulphate (Zincum Sulphuricum) 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, Magnesium Stearate, and Copper (II) Oxide. Pharmacological class: Homeopathic drug. Dosage form: Oral 600 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 imprinted on one side and a score on the other side , in child-resistant and tamper-resistant bottles of 90. NDC 61480-137-05 Symbol
Patient information
Information for patients Patients using Acunol™ 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 and at the end of the day before bed; take nothing but water for 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
- Nickel Sulfate in 1 product
- Potassium Bromide in 1 product
- Sodium Bromide in 1 product
- Zinc Sulfate Anhydrous in 1 product
- Sulfur in 1 product
Acunol NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 61480-137 | Nickel Sulfate 1 [hp_X]/1; Potassium Bromide 1 [hp_X]/1; Sodium Bromide 1 [hp_X]/1; Zinc Sulfate Anhydrous 1 [hp_X]/1;… Tablet | PLYMOUTH HEALTHCARE PRODUCTS LLC | UNAPPROVED HOMEOPATHIC |
Frequently asked questions
What is Acunol used for?
Acunol™ is indicated for the treatment of mild to moderate acne vulgaris, acne rosacea, peri-oral dermatitis, and folliculitis. It has been found to work well with a variety of combination therapies.
What are the side effects of Acunol?
Acunol™ 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 Acunol?
Acunol is listed by 1 labeler in the FDA NDC directory, including PLYMOUTH HEALTHCARE PRODUCTS LLC.