FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Acunol Manufacturers
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Plymouth Pharmaceuticals Inc
Acunol | Plymouth Healthcare Products Llc
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 impairmentDosage 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.
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