Niogermox in USA

Niogermox in USA

The information in Name of the Niogermox medicinal product is based on data from another medicine with the exact same composition as the Niogermox. Be cautious and specific in the section Name of the medicinal product in the instructions to the drug Niogermox from the package or from the pharmacist at the pharmacy.
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Qualitative and quantitative composition of Niogermox

The data in Qualitative and quantitative composition of Niogermox is based on data from another medicine with the same composition as Niogermox. Be cautious and specific in the section Qualitative and quantitative composition in the instructions to the drug Niogermox directly from the package or from the pharmacist at the pharmacy.
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Therapeutic uses for iclopirox

The information in Niogermox Therapeutic Indications is based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Therapeutic indications in the instructions to the drug Niogermox from the package or from the pharmacist at the pharmacy.
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(Please read the entire INDICATIONS AND USAGE section of the labelling to fully understand the indication for this product.)

Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% is indicated as a topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails due to Trichophyton rubrum as part of a comprehensive management programme. The comprehensive management programme includes the removal of unattached, infected nails on a monthly basis by a health care professional with special expertise in the diagnosis and treatment of nail disorders, including minor nail procedures.

There have been no studies to see if ciclopirox reduces the effectiveness of systemic antifungal agents for onychomycosis. As a result, using an 8 percent ciclopirox topical solution alongside systemic antifungal agents for onychomycosis is not advised.
Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should only be used as directed by a physician.
The effectiveness and safety of Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, have not been studied in the following populations. The clinical trials with Niogermox®NAIL LACQUER (ciclopirox) Topical Solution, which accounted for 8% of the total, excluded patients who were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV Patients with severe plantar tinea pedis (moccasin) were also excluded.
The safety and efficacy of using Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, daily for more than 48 weeks have not been proven.
Dosage (Posology) and administration method

The information provided in Niogermox Dosage (Posology) and Method of Administration is based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Dosage (Posology) and method of administration in the instructions to the drug Niogermox directly from the package or from the pharmacist at the pharmacy.
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Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be used as part of a comprehensive onychomycosis management programme. The removal of the unattached, infected nail by a health care professional on a monthly basis, weekly trimming by the patient, and daily application of the medication are all essential components of this therapy. Diabetes patients should be given careful consideration when selecting an appropriate nail management programme (see PRECAUTIONS).

Health Care Professionals Provide Nail Care

Professionals trained in the treatment of nail disorders should remove the unattached, infected nail as frequently as monthly, trim the onycholytic nail, and file away excess horny material.

Patient Nail Care

Patients should file away (with an emery board) loose nail material and trim nails as needed or as directed by a health care professional after removing Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% with alcohol.

Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied to all affected nails once daily (preferably at bedtime or eight hours before washing) with the provided applicator brush. The 8 percent Niogermox® NAIL LACQUER (ciclopirox) Topical Solution should be applied evenly over the entire nail plate.

If possible, apply Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% to the nail bed, hyponychium, and undersurface of the nail plate when it is free of the nail bed (e.g., onycholysis).

Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should not be used on a daily basis. Every seven days, apply a new coat over the previous one and remove it with alcohol. This cycle should be repeated throughout the course of treatment.

Contraindications

The information in Niogermox Contraindications is based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Contraindications in the instructions to the drug Niogermox from the package or from the pharmacist at the pharmacy.
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Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is not recommended for people who are allergic to any of its ingredients.

Special precautions and warnings for use

The information in Special warnings and precautions for Niogermox use is based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Special warnings and precautions for use in the instructions to the drug Niogermox directly from the package or from the pharmacist at the pharmacy.
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WARNINGS
Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is not intended for ophthalmic, oral, or intravaginal administration. Only apply to the nails and the skin immediately adjacent to them.

PRECAUTIONS
If a reaction suggesting sensitivity or chemical irritation occurs while using Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, treatment should be stopped and appropriate therapy instituted.

There has been no relevant clinical experience with patients with insulin-dependent diabetes or diabetic neuropathy to date. Before prescribing to patients with a history of insulin-dependent diabetes mellitus or diabetic neuropathy, the risk of the health care professional removing the unattached, infected nail and the patient trimming it should be carefully considered.

Patients’ Information

To maximise benefit from this product, patients should be given detailed instructions on how to use Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% as part of a comprehensive onychomycosis management programme.

The patient should be instructed to:

As directed by a health care professional, apply Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%. Contact with the eyes and mucous membranes should be avoided. Avoid contact with skin other than the skin immediately surrounding the treated nail(s). Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is only intended for external use.
The 8 percent Niogermox® NAIL LACQUER (ciclopirox) Topical Solution should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, apply Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% to the nail bed, hyponychium, and undersurface of the nail plate when it is free of the nail bed (e.g., onycholysis). Contact with the surrounding skin may cause minor, temporary irritation (redness).
With the use of this medication, the unattached, infected nail must be removed by a health care professional on a monthly basis. Inform a health care professional if you have diabetes or numbness in your toes or fingers so that the appropriate nail management programme can be considered.
Inform a health care professional if the area of application becomes irritated (redness, itching, burning, blistering, swelling, oozing).
The full treatment required to achieve a clear or nearly clear nail is up to 48 weeks of daily applications of Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, and professional removal of the unattached, infected nail as frequently as monthly (defined as 10 percent or less residual nail involvement).
Six months of therapy with professional removal of the unattached, infected nail may be required before symptoms improve.
This medication may not result in a completely clear nail. In clinical trials, less than 12% of patients were able to achieve a completely clear or nearly clear toenail.
Use the medication only for the disorder for which it was prescribed.
On the treated nails, do not use nail polish or other nail cosmetic products.
Because the product is flammable, it should not be used near heat or an open flame.
Carcinogenesis, Mutagenesis, and Fertility Impairment
There was no carcinogenicity study with the Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polythene glycol 400) in female mice dosed topically twice per week for 50 weeks, followed by a 6-month drug-free observation period prior to necropsy, revealed no evidence of tumours at the application sites.

In human systemic tolerability studies, the average maximal serum level of ciclopirox after two months of once-daily application (340 mg of Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%) in subjects with distal subungual onychomycosis was 31 28 ng/mL. In rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day, this level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose.

With ciclopirox, the following in vitro genotoxicity tests were performed: gene mutation evaluation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation evaluation in the HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/ (negative). At 5,000 mg/kg, ciclopirox tested negative for chromosome aberrations in an in vivo Chinese hamster bone marrow cytogenetic assay.

Niogermox ®NAIL LACQUER (ciclopirox) Topical Solution, 8% was subjected to the following in vitro genotoxicity tests: Ames Salmonella test was negative; unscheduled DNA synthesis in rat hepatocytes was negative; cell transformation assay in BALB/c3T3 cells was negative (positive). The lacquer formulation’s positive response in the BALB/c3T3 test was attributed to its butyl monoester of poly[methylvinyl ether/maleic acid] resin component (Gantrez® ES-435), which also performed well in this test. The film-forming nature of the resin may have confounded the cell transformation assay. Gantrez® ES-435 was found to be nonmutagenic in both the in vitro mouse lymphoma forwards mutation assay with or without activation and the rat hepatocyte unscheduled DNA synthesis assay.

Oral reproduction studies in rats at doses of up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day [equivalent to about 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] revealed no specific effects on fertility or other reproductive parameters. MRHTD (mg/m2) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (340 mg Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%), which will cover all fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximum of 50%.

Pregnancy

Teratogenic effects: Pregnancy Category B Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), revealed no significant foetal malformations.

There have been no adequate or well-controlled studies of ciclopirox topically applied in pregnant women. During pregnancy, Niogermox ®NAIL LACQUER (ciclopirox) Topical Solution, 8% should be used only if the potential benefit outweighs the potential risk to the foetus.

Mothers who are breastfeeding

It is unknown whether this medication is excreted in human milk. Because many drugs are excreted in human milk, a nursing woman should exercise caution when using Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%.

Use in Children

Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% is considered safe for use in children twelve years and older based on the safety profile in adults. There have been no clinical trials in the paediatric population.

Geriatric Application

Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, clinical studies did not include a sufficient number of subjects aged 65 and up to determine whether they respond differently than younger subjects. Other clinical studies have found no differences in responses between elderly and younger patients.

Unwanted consequences

The information in Unwanted effects of Niogermox is based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Unwanted effects in the instructions to the drug Niogermox directly from the package or from the pharmacist at the pharmacy.
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In vehicle-controlled clinical trials conducted in the United States, 9 percent (30/327) of patients treated with Niogermox ®NAIL LACQUER (ciclopirox) Topical Solution, 8 percent (8/328) of patients treated with vehicle, and 7 percent (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. Except for Skin and Appendages, the incidence of these adverse events was similar across treatment groups: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups, respectively, reported at least one adverse event. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported 8 percent, (5 percent [16/327]) more frequently in patients treated with Niogermox® NAIL LACQUER (ciclopirox) Topical Solution than in patients treated with vehicle (1 percent [3/328]). Nail disorders such as shape change, irritation, ingrown toenail, and discoloration were also thought to be causally related.

The prevalence of nail disorders was comparable across treatment groups (2 percent [6/327] in the Niogermox® NAIL LACQUER (ciclopirox) Topical Solution group, 8% in the group, and 2% [7/328] in the vehicle group). Furthermore, application site reactions and/or skin burning occurred in 1% of patients treated with Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% (3/327), and 4% (4/328).

Under semi-occlusion conditions, a 21-day cumulative irritancy study was carried out. Mild reactions were observed in 46 percent of patients treated with Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8 percent with the vehicle, 32 percent with the negative control, and 2 percent with the vehicle, but all were mild transient erythema. There was no evidence of allergic contact sensitisation with Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8% or the vehicle base. In a separate study of the photosensitization potential of Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, no photoallergic reactions were observed in 8% of the subjects in a maximised test design that included the occluded application of sodium lauryl sulphate. Localized allergic contact reactions were observed in four subjects. In the vehicle-controlled studies, one patient (8%) who received Niogermox® NAIL LACQUER (ciclopirox) Topical Solution discontinued treatment due to a rash on the palm (causal relation to test material undetermined).

An open-label extension study in patients previously treated in vehicle-controlled studies looked at the use of Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, for 48 weeks. Three percent (9/281) of subjects treated with Niogermox® NAIL LACQUER (ciclopirox) Topical Solution experienced at least one TEAE that the investigator suspected was caused by the test material. Mild periungual erythema (1 percent [2/281]) and nail disorders (1 percent [4/281]) were the most commonly reported. TEAEs caused the withdrawal of four patients. Two of the four patients experienced events that were thought to be related to the test material: one patient’s great toe “broke away,” and another had an elevated creatine phosphokinase level on Day 1. (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).

Overdose

The information in Niogermox Overdose is based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Overdose in the instructions to the drug Niogermox from the package or from the pharmacist at the pharmacy.
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There is no information provided.

Pharmacokinetic characteristics

The data in Pharmacokinetic properties of Niogermox are based on data from another medicine with the exact same composition as Niogermox. Be cautious and specific in the section Pharmacokinetic properties in the instructions to the drug Niogermox from the package or from the pharmacist at the pharmacy.
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According to animal and human pharmacokinetic studies, ciclopirox olamine is rapidly absorbed after oral administration and completely eliminated in all species via faeces and urine. The majority of the compound is excreted unchanged or as glucuronide. Within 12 hours of administering 10 mg of radiolabeled drug (14C-ciclopirox) orally to healthy volunteers, approximately 96 percent of the radioactivity was excreted renally. Glucuronides accounted for 94% of the radioactivity excreted by the kidney. As a result, glucuronidation is the primary metabolic pathway for this compound.

After applying Niogermox (ciclopirox topical solution) ® NAIL LACQUER (ciclopirox) Topical Solution, 8 percent, to all 20 digits and adjacent 5 mm of skin once daily for six months, systemic absorption of ciclopirox was determined in 5 patients with dermatophytic onychomycoses. Random serum concentrations and 24-hour urinary excretion of ciclopirox were determined two weeks, one, two, four, and six months after treatment initiation and four weeks after treatment. The serum levels of ciclopirox in this study ranged from 12-80 ng/mL. According to urinary data, the mean absorption of ciclopirox from the dosage form was 5% of the applied dose. Serum and urine ciclopirox levels were below the limit of detection one month after treatment was stopped.

Patients applied Niogermox® NAIL LACQUER (ciclopirox) Topical Solution, 8%, to all toenails and affected fingernails in two vehicle-controlled trials. 24 of 66 randomly chosen patients on active treatment had detectable serum ciclopirox concentrations at some point during the dosing interval (range 10.0-24.6 ng/mL). It should be noted that eleven of these 24 patients were taking ciclopirox olamine (Loprox® Cream, 0.77 percent) concurrently.

In an in vitro study, the penetration of the Niogermox® NAIL LACQUER (ciclopirox) Topical Solution was 8 percent. Radiolabeled ciclopirox was applied once to avulsed onychomycotic toenails and demonstrated penetration to a depth of approximately 0.4 mm. As expected, nail plate concentrations decreased as nail depth increased. The clinical significance of these nail plate findings is unknown. The concentrations in the nail bed were not determined.

Niogermox cost

We have no information on the drug’s price.
We will, however, provide data for each active ingredient.
Ciclopirox 8 percent costs about 5.76$ to 13.4$ per unit in online pharmacies, and about 51$ to 148$ per package.

References:

https://www.drugs.com/search.php?searchterm=niogermox
https://pubmed.ncbi.nlm.nih.gov/?term=niogermox
Countries where it is available
In Italy, Niogermox