Ciclopirox (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Ciclopirox topical solution, USP 8% should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS).

Nail Care By Health Care Professionals

Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders.

Nail Care By Patient

Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after ciclopirox topical solution, 8% is removed with alcohol.

Ciclopirox topical solution, 8% should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. The ciclopirox topical solution, 8% should be applied evenly over the entire nail plate.

If possible, ciclopirox topical solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

The ciclopirox topical solution, 8% should not be removed on a daily basis. Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

HOW SUPPLIED

Ciclopirox Topical Solution, USP 8% (Nail Lacquer) is supplied in 6.6 mL (NDC 42192-715-06) glass bottles with screw caps which are fitted with brushes.

Ciclopirox Topical Solution, USP 8% (Nail Lacquer) should be stored at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F). [See USP, “Controlled Room Temperature.”]

Protect from light (e.g., store the bottle in the carton after every use).

CAUTION: Flammable. Keep away from heat and flame.

Acella Pharmaceuticals, LLC

Ciclopirox Topical Solution, USP 8%

Manufactured by:

Groupe Parima 4450 rue Cousens Montreal, Quebec Canada H4S 1X6

IN-232759.R1

Manufactured for:

Acella Pharmaceuticals, LLC Alpharetta, GA 30005

1-800-541-4802

REFERENCES:

1. Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim-Forsch./Drug Res. 23:670-674.

2. Niewerth et. al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth micro dilution tests. Chemotherapy. 44:31-35.

3. Yang et. al. 1997. A new simulation model for studying in vitro topical penetration of antifungal drugs into hard keratin. J. Mycol. Med. 7:195-98.

Gantrez is a registered trademark of GAF Corporation

Rev 0419-02

Patient Information and Instructions

Rx Only

Ciclopirox Topical Solution, USP 8% (Nail Lacquer)

Patients should have detailed instructions regarding the use of ciclopirox topical solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. Discuss your treatment plan with your health care professional for regular removal of the unattached, infected nail.

Before using this medication, tell your doctor if you:

  • Are pregnant or nursing
  • Are an insulin dependent diabetic or have diabetic neuropathy
  • Have a history of immunosuppression
  • Are immunocompromised (e.g., received an organ transplant, etc.)
  • Require medication to control epilepsy
  • Use or require topical corticosteroids on a repeated monthly basis
  • Use steroid inhalers on a regular basis

Patient Information:

  • Use ciclopirox topical solution, 8% as directed by your health care professional.
  • Ciclopirox topical solution, 8% is for external use only.
  • Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided.
  • Avoid contact with the eyes and mucous membranes.
  • Removal of the unattached, infected nail, as frequently as monthly, by your health care professional is needed with use of this medication to obtain maximal benefit with use of this product. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material.
  • Inform your health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing).
  • Up to 48 weeks of daily applications with ciclopirox topical solution, 8% and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment time to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement). Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed.
  • A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a clear or almost clear toenail.
  • Do not use nail polish or other nail cosmetic products on the treated nails.
  • Avoid use near heat or open flame, because product is flammable

Patient Instructions

  1. Before starting treatment, remove any loose nail or nail material using nail clippers or nail files. If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material. (Figure 1A & Figure 1B)bffcf34b-figure-02bffcf34b-figure-03
  2. Apply ciclopirox topical solution, 8% once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, nail lacquer should also be applied to the underside of the nail and to the skin beneath it. Allow lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying medication, wait 8 hours before taking a bath or shower. (Figure 2)bffcf34b-figure-04
  3. Apply ciclopirox topical solution, 8% daily over the previous coat.
  4. Once a week, remove the ciclopirox topical solution, 8% with alcohol. Remove as much as possible of the damaged nail using scissors, nail clippers, or nail files. (Figure 3)bffcf34b-figure-05
  5. Repeat process (steps 2 through 4).

Please Note:

  1. To prevent screw cap from sticking to the bottle, do not allow solution to get into the bottle threads.
  2. To prevent the solution from drying out, bottle should be closed tightly after every use.
  3. To protect from light, replace bottle into carton after each use. (Figure 4)
bffcf34b-figure-06

Acella Pharmaceuticals, LLC

Ciclopirox Topical Solution, USP 8%

Manufactured by:

Groupe Parima 4450 rue Cousens Montreal, Quebec Canada H4S 1X6

IN-232759.R1

Manufactured for:

Acella Pharmaceuticals, LLC Alpharetta, GA 30005

1-800-541-4802

Rev. 0419-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bffcf34b-figure-07
(click image for full-size original)
CICLOPIROX
ciclopirox solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-715
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CICLOPIROX (CICLOPIROX) CICLOPIROX 80 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ETHYL ACETATE
ISOPROPYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-715-06 1 BOTTLE in 1 CARTON contains a BOTTLE
1 6.6 mL in 1 BOTTLE This package is contained within the CARTON (42192-715-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078172 11/04/2019
Labeler — Acella Pharmaceuticals, LLC (825380939)
Registrant — Acella Pharmaceuticals, LLC (825380939)
Establishment
Name Address ID/FEI Operations
Groupe Parima 252437850 MANUFACTURE (42192-715)

Revised: 10/2019 Acella Pharmaceuticals, LLC

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