Acunol

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.

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 )

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.

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

ADVERSE REACTIONS Acunol™ contains low doses of active ingredients. Therefore there are minimal known side effects. (see PRECAUTIONS for hypersensitivity information)

Pregnancy Pregnancy category C Animal reproduction studies have not been conducted with Acunol™. Acunol™ should not be given to a pregnant woman.