CNL8 (ciclopirox topical solution 8%)Nail Lacquer

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Overview

What is CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

CNL8 (ciclopirox topical solution, 8%) nail lacquer.

For use on fingernails and toenails and immediately adjacent skin only.

Not for use in eyes.

CNL8 (ciclopirox topical solution, 8%) nail lacquer contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

Each gram of CNL8 (ciclopirox topical solution, 8%) nail lacquer contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application.

CNL8 (ciclopirox topical solution, 8%) nail lacquer is a clear, colorless to slightly yellowish solution.

The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is 29342-05-0. The chemical structure is:

What does CNL8 (ciclopirox topical solution 8%)Nail Lacquer look like?

What are the available doses of CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

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What should I talk to my health care provider before I take CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

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How should I use CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)

CNL8 (ciclopirox topical solution,8%) nail lacquer 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 Tricho-phyto 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.

CNL8 (ciclopirox topical solution, 8%) nail lacquer 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). : 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. 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 CNL8 (ciclopirox topical solution, 8%) nail lacquer is removed with alcohol. CNL8 (ciclopirox topical solution, 8%) nail lacquer should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided. CNL8 (ciclopirox topical solution, 8%) nail lacquer should be applied evenly over the entire nail plate. If possible, CNL8 (ciclopirox topical solution, 8%) nail lacquer 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). CNL8 (ciclopirox topical solution, 8%) nail lacquer 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.

What interacts with CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

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What are the warnings of CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

Array

Due to the occasional occurrence of drowsiness, patients should be alerted to the need for due precaution when engaging in activities where alertness is mandatory. The occurrence of hypersensitivity reactions to allopurinol may be increased in patients with decreased renal function receiving thiazides and allopurinol concurrently. For this reason, in this clinical setting, such combinations should be administered with caution and patients should be observed closely.

What are the precautions of CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

If a reaction suggesting sensitivity or chemical irritation should occur with the use of CNL8 (ciclopirox topical solution, 8%) nail lacquer treatment should be discontinued and appropriate therapy instituted. So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

What are the side effects of CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

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What should I look out for while using CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

CNL8 (ciclopirox topical solution, 8%) nail lacquer is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

What might happen if I take too much CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

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How should I store and handle CNL8 (ciclopirox topical solution 8%)Nail Lacquer?

StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CNL8 nail kit (ciclopirox topical solution, 8%), Swabplus nail lacquer remover, emery board – which contains 3 - 5 ml bottles of CNL8 (ciclopirox topical solution, 8%) nail lacquer (glass bottles with screw caps which are fitted with brushes), 25 - 0.15 ml nail lacquer remover swabs and 1 emery board (NDC 68712-027-01). CNL8 (ciclopirox topical solution, 8%) nail lacquer, single count 5 ml bottle (NDC 68712-027-03). Protect from light (e.g., store the bottle in the carton after every use).CNL8 (ciclopirox topical solution, 8%) nail lacquer should be stored at room temperature between 59° and 86° F (15° and 30° C).CNL8 nail kit (ciclopirox topical solution, 8%), Swabplus nail lacquer remover, emery board – which contains 3 - 5 ml bottles of CNL8 (ciclopirox topical solution, 8%) nail lacquer (glass bottles with screw caps which are fitted with brushes), 25 - 0.15 ml nail lacquer remover swabs and 1 emery board (NDC 68712-027-01). CNL8 (ciclopirox topical solution, 8%) nail lacquer, single count 5 ml bottle (NDC 68712-027-03). Protect from light (e.g., store the bottle in the carton after every use).CNL8 (ciclopirox topical solution, 8%) nail lacquer should be stored at room temperature between 59° and 86° F (15° and 30° C).CNL8 nail kit (ciclopirox topical solution, 8%), Swabplus nail lacquer remover, emery board – which contains 3 - 5 ml bottles of CNL8 (ciclopirox topical solution, 8%) nail lacquer (glass bottles with screw caps which are fitted with brushes), 25 - 0.15 ml nail lacquer remover swabs and 1 emery board (NDC 68712-027-01). CNL8 (ciclopirox topical solution, 8%) nail lacquer, single count 5 ml bottle (NDC 68712-027-03). Protect from light (e.g., store the bottle in the carton after every use).CNL8 (ciclopirox topical solution, 8%) nail lacquer should be stored at room temperature between 59° and 86° F (15° and 30° C).CNL8 nail kit (ciclopirox topical solution, 8%), Swabplus nail lacquer remover, emery board – which contains 3 - 5 ml bottles of CNL8 (ciclopirox topical solution, 8%) nail lacquer (glass bottles with screw caps which are fitted with brushes), 25 - 0.15 ml nail lacquer remover swabs and 1 emery board (NDC 68712-027-01). CNL8 (ciclopirox topical solution, 8%) nail lacquer, single count 5 ml bottle (NDC 68712-027-03). Protect from light (e.g., store the bottle in the carton after every use).CNL8 (ciclopirox topical solution, 8%) nail lacquer should be stored at room temperature between 59° and 86° F (15° and 30° C).

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology

CNL8 (ciclopirox topical solution, 8%) nail lacquer is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

If a reaction suggesting sensitivity or chemical irritation should occur with the use of CNL8 (ciclopirox topical solution, 8%) nail lacquer treatment should be discontinued and appropriate therapy instituted. So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with CNL8 (ciclopirox topical solution, 8%) nail lacquer 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 adverseevents: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with CNL8 (ciclopirox topical solution, 8%) nail lacquer (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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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