Acunol
Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, And Sulfur
Plymouth Healthcare Products Llc
Human Prescription Drug
NDC 61480-137Acunol also known as Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, And Sulfur is a human prescription drug labeled by 'Plymouth Healthcare Products Llc'. National Drug Code (NDC) number for Acunol is 61480-137. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Acunol drug includes Nickel Sulfate - 1 [hp_X]/1 Potassium Bromide - 1 [hp_X]/1 Sodium Bromide - 1 [hp_X]/1 Sulfur - 1 [hp_X]/1 Zinc Sulfate Anhydrous - 1 [hp_X]/1 . The currest status of Acunol drug is Active.
Drug Information:
| Drug NDC: | 61480-137 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Acunol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Nickel Sulfate, Potassium Bromide, Sodium Bromide, Zinc Sulfate Anhydrous, And Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Plymouth Healthcare Products Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | NICKEL SULFATE - 1 [hp_X]/1
POTASSIUM BROMIDE - 1 [hp_X]/1
SODIUM BROMIDE - 1 [hp_X]/1
SULFUR - 1 [hp_X]/1
ZINC SULFATE ANHYDROUS - 1 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 18 Apr, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jan, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | PLYMOUTH HEALTHCARE PRODUCTS LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0361480137052
|
| UPC stands for Universal Product Code. |
| UNII: | 4FLT4T3WUN
OSD78555ZM
LC1V549NOM
70FD1KFU70
0J6Z13X3WO
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 61480-137-05 | 90 TABLET in 1 BOTTLE (61480-137-05) | 18 Apr, 2006 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Acunol nickel sulfate, potassium bromide, sodium bromide, zinc sulfate anhydrous, and sulfur nickel sulfate nickel cation potassium bromide bromide ion sodium bromide bromide ion zinc sulfate anhydrous zinc cation sulfur sulfur off-white with green speckles ll
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
Indications and Usage:
Indications 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.
Warnings:
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, see precautions for hypersensitivity information. lactose intolerant patients may have gastrointestinal difficulty. this has very rarely been reported at the doses used.
Dosage and Administration:
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 â b.i.d. 1 â b.i.d. 46-68 101-150 1 â b.i.d. 2 â b.i.d. 69-90 151-200 1½ â b.i.d. 3 â b.i.d. 91+ 201+ 2 â b.i.d. 4 â 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 f
Read more...ollowed. 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:
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 )
Adverse Reactions:
Adverse reactions 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
Use in Pregnancy:
Pregnancy pregnancy category c animal reproduction studies have not been conducted with acunolâ¢. acunol⢠should not be given to a pregnant woman.
Pediatric Use:
Pediatric use carefully adjust dosage to weight when treating young children.
Overdosage:
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 acunolâ¢. 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 acunolâ¢. 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 acunolâ¢. (see below )
Description:
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.
Clinical Pharmacology:
Clinical pharmacology the active ingredients in acunol⢠are simple biochemical compounds. the exact mechanism of action is unknown; however, it is known that bromide enhances phagocytic and bactericidal activity of neutrophils. 31 potassium bromide & sodium bromide dissolve and dissociate in the digestive tract into their ionic constituents. each tablet contains approximately 30 mg of bromide (calculated). ionic bromide is rapidly and completely absorbed from the intestine and distributed almost exclusively in the extracellular fluids. 7,8 bromide is eliminated by the kidneys and the elimination half-life is 11-12 days. zinc sulphate dissolves and dissociates in the digestive tract into its ionic constituents. each tablet contains approximately 5 mg of zinc (calculated). zinc is an essential trace mineral necessary for protein synthesis, enzyme stimulation, and alkaline balance. 27,28 it is primarily absorbed from the duodenum and excreted via feces, urine, and sweat. 26 sulphur i
Read more...s a naturally occurring mineral that is an essential part of the human body. it exhibits anti-bacterial, anti-parasitic, fungicidal, and keratolytic properties. 26 each tablet contains approximately 5 mg of sulphur (calculated). sulphur is highly water soluble and as a result is easily excreted by the body via sweat and urine. 22 since the sulphur found in acunol⢠is a naturally occurring mineral, it is radically different from sulfa drugs (sulfonamide antibiotics). therefore, patients who are allergic to sulfa drugs can safely take acunol⢠. nickel sulphate dissolves and dissociates in the digestive tract into its ionic constituents. each tablet contains approximately 0.5 mg of ionic nickel (calculated). according to studies, 15% to 50% of ionic nickel is absorbed on a fasted stomach. 2 food markedly decreases the rate and extent of nickel absorption. 3,4 clinical studies show that serum concentrations of nickel are variable among patients after administering the same dosage. 5 peak serum nickel concentration is reached about two hours after oral administration. 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. 3,5 renal clearance is rapid and efficient, and nickel does not accumulate in the body. 6
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no studies have been done on the carcinogenesis, mutagenesis, or impairment of fertility of acunolâ¢. 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
Clinical Studies:
Clinical studies a variety of controlled clinical studies have been performed using various sources of both nickel and bromide in over 300 subjects. clinical efficacy and safety have been documented in a significant number of subjects. published and unpublished reports are available upon request. 9,20,21
How Supplied:
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
Information for Patients:
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.
Package Label Principal Display Panel:
Principal display panel - 90 tablet label ndc 61480-137-05 homeopathic medication acunol ® indicated for treatment of acne 600mg 90 tablets rx only for oral use only principal display panel - 90 tablet label