PENLAC Nail lacquer (2016)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-5180

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1. Description

PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each ...

2. Clinical Pharmacology

Microbiology Mechanism of Action The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested ...

3. Indications and Usage

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, as a component ...

4. Contraindications

PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is contraindicated in individuals who have shown hypersensitivity to any of its components.

5. Warnings

PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

6. Precautions

If a reaction suggesting sensitivity or chemical irritation should occur with the use of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, treatment should be discontinued and appropriate therapy ...

6.2. Information for Patients

Patients should have detailed instructions regarding the use of PENLAC Nail Lacquer (ciclopirox)Topical Solution, 8%, as a component of a comprehensive management program for onychomycosis in order ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity study was conducted with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in ...

6.7. Pregnancy

Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats ...

6.9. Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is administered ...

6.10. Pediatric Use

Based on the safety profile in adults, PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is considered safe for use in children twelve years and older. No clinical trials have been conducted in the ...

6.11. Geriatric Use

Clinical studies of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ...

7. Adverse Reactions

In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, and 7% (23/328) of patients treated with vehicle ...

10. Dosage and Administration

PENLAC Nail Lacquer (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 ...

11. How Supplied

PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is supplied in 6.6 mL (NDC 0187-5180-06) glass bottles with screw caps which are fitted with brushes. Manufactured for: Valeant Pharmaceuticals North ...

12. Storage and Handling

Protect from light (e.g., store the bottle in the carton after every use). PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, should be stored at room temperature between 59° and 86°F (15° and 30°C). ...

14. References

References: Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim-Forsch./Drug Res. 23:670–674. Niewerth et. al., 1998. Antimicrobial susceptibility ...