Ciclopirox 80 mg/mL
Ciclopirox · SOLUTION · Bryant Ranch Prepack
Ciclopirox is a solution containing ciclopirox at 80 mg/mL, taken topical. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Ciclopirox
- Generic Name
- Ciclopirox
- NDC Code (Product)
63629-8623- Manufacturer
- Bryant Ranch Prepack
- Strength
- 80 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA077623
- Drug Class
- Protein Synthesis Inhibitors [MoA]
- Marketing Start
- 09/19/2007
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Perrigo New York, Inc.
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
SUN PHARMA /TARO
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
G & W Laboratories, Inc.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Glenmark Pharmaceuticals Inc., USA
Defective Container: Firm received complaints of broken tube at the seal.
Taro Pharmaceuticals U.S.A., Inc.
Subpotent. drug
G & W Laboratories, Inc.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. • No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. • Ciclopirox Topical Solution, 8% should be used only under medical supervision as described above. • The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. The clinical trials with use of c…
Dosage & Administration
DOSAGE AND ADMINISTRATION Ciclopirox Topical Solution, 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. Ciclopirox Topical Solution, 8% should be appli…
Warnings
WARNINGS Ciclopirox Topical Solution, 8% is not for ophthalmic, oral, or intravaginal use. It is for use on nails and immediately adjacent skin only.
Contraindications
CONTRAINDICATIONS Ciclopirox Topical Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.
Adverse Reactions
ADVERSE REACTIONS In the vehicle-controlled clinical trials conducted in the United States, 9% (30/327) of patients treated with ciclopirox topical solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for skin and appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the ciclopirox topical solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site re…
Frequently Asked Questions
What is Ciclopirox used for?
Ciclopirox contains Ciclopirox. It is a solution taken topical. Consult your doctor for specific uses.
Is Ciclopirox a controlled substance?
Ciclopirox is not classified as a controlled substance by the DEA.
What is the generic name for Ciclopirox?
The generic name for Ciclopirox is Ciclopirox. There are 10 other brand versions of Ciclopirox.
What is the NDC code for Ciclopirox 80 mg/mL?
The NDC (National Drug Code) for Ciclopirox 80 mg/mL is 63629-8623, listed by Bryant Ranch Prepack.
Other Ciclopirox Dosages
Other Ciclopirox Brands
See all →- Ciclopirox Olamine7.7 mg/g72162-1397
- Ciclopirox Olamine7.7 mg/g80425-0225
- CICLOPIROX7.7 mg/g63629-8622
- Ciclopirox Olamine7.7 mg/100mL63629-8627
- Ciclopirox Olamine7.7 mg/100mL71335-2717
- Ciclopirox olamine7.7 mg/g71335-2865
- CICLOPIROX7.7 mg/g63629-8620
- Ciclopirox Olamine7.7 mg/g63629-8624
- CICLOPIROX7.7 mg/g63629-8621
- ciclopirox7.7 mg/g68462-455
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)