Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
ciclopirox
Overview
What is Penlac?
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 gram of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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.
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 empirical formula CHNO and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:
What does Penlac look like?
What are the available doses of Penlac?
Sorry No records found.
What should I talk to my health care provider before I take Penlac?
Sorry No records found
How should I use Penlac?
(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 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 . 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.
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 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 ).
What interacts with Penlac?
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is contraindicated in individuals who have shown hypersensitivity to any of its components.
What are the warnings of Penlac?
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.
What are the precautions of Penlac?
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 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.
Information for Patients
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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 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 tumors at the application sites.
In human systemic tolerability studies following daily application (~340 mg of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31±28 ng/mL after two months of once daily applications. This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day.
The following genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames and assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative). In an Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg.
The following genotoxicity tests were conducted with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%: Ames test (negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay (positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of poly[methylvinyl ether/maleic acid] resin component, which also tested positive in this test. The cell transformation assay may have been confounded because of the film-forming nature of the resin. The resin component tested nonmutagenic in both the mouse lymphoma forward mutation assay with or without activation and unscheduled DNA synthesis assay in rat hepatocytes.
Oral reproduction studies in rats at doses up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day [equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] did not reveal any specific effects on fertility or other reproductive parameters. MRHTD (mg/m) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (~340 mg PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%) that will cover all the fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.
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 and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.
There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
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 to a nursing woman.
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 pediatric population.
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. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
What are the side effects of Penlac?
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 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 PENLAC Nail Lacquer (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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, (3/327) and vehicle (4/328).
A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, or the vehicle base. In a separate study of the photosensitization potential of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).
Use of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient's great toenail "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).
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Penlac?
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is contraindicated in individuals who have shown hypersensitivity to any of its components.
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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 Penlac?
Sorry No Records found
How should I store and handle Penlac?
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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701PENLAC 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.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).CAUTION: Flammable. Keep away from heat and flame.Rx only Manufactured for:Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH65926 Frankfurt am Main, GermanyReferences: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners.©2016 Valeant Pharmaceuticals North America LLCRev. 06/20169542701
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is contraindicated in individuals who have shown hypersensitivity to any of its components.PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.
Ondansetron does not itself appear to induce or inhibit the cytochrome P-450 drug-metabolizing enzyme system of the liver (see ). Because ondansetron is metabolized by hepatic cytochrome P-450 drug-metabolizing enzymes (CYP3A4, CYP2D6, CYP1A2), inducers or inhibitors of these enzymes may change the clearance and, hence, the half-life of ondansetron. On the basis of available data, no dosage adjustment is recommended for patients on these drugs. Apomorphine Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, concomitant use of apomorphine with ondansetron is contraindicated (see ). Phenytoin, Carbamazepine, and Rifampicin In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampicin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ondansetron is recommended for patients on these drugs. Serotonergic Drugs Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) (see ). Tramadol Although no pharmacokinetic drug interaction between ondansetron and tramadol has been observed, data from 2 small studies indicate that ondansetron may be associated with an increase in patient controlled administration of tramadol. Chemotherapy Tumor response to chemotherapy in the P-388 mouse leukemia model is not affected by ondansetron. In humans, carmustine, etoposide, and cisplatin do not affect the pharmacokinetics of ondansetron. In a crossover study in 76 pediatric patients, I.V. ondansetron did not increase blood levels of high-dose methotrexate. The coadministration of ondansetron had no effect on the pharmacokinetics and pharmacodynamics of temazepam.
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 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 PENLAC Nail Lacquer (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 PENLAC Nail Lacquer (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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, (3/327) and vehicle (4/328).
A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, or the vehicle base. In a separate study of the photosensitization potential of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).
Use of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient's great toenail "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).
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
517Total User Reviews
User Reviews
Learn about
User Reviews
Professional
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. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).