Ciclopirox Cream (Loprox Cream)
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Ciclopirox Cream (Loprox Cream)

Loprox® Cream
(ciclopirox) 0.77%

FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES

DRUG DESCRIPTION

LOPROX® Cream (ciclopirox) 0.77% is for topical use.

Each gram of LOPROX® Cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Mineral Oil USP, Stearyl Alcohol NF, Cocamide DEA, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.

LOPROX® Cream (ciclopirox cream) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1 -hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2.

The chemical structure is:

LOPROX (ciclopirox) Structural Formula Illustration

LOPROX® Cream (ciclopirox cream) has a pH of 7.

What are the possible side effects of ciclopirox topical (Loprox, Penlac Nail Lacquer)?

Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.

Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Loprox Cream »

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

LOPROX® Cream (ciclopirox cream) is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

DOSAGE AND ADMINISTRATION

Gently massage LOPROX® (ciclopirox) Cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with LOPROX® Cream (ciclopirox cream) the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED

Loprox® Cream (ciclopirox cream) is supplied in 15 gram (NDC 0039-0190-15), 30 gram (NDC 0039-0190-30), and 90 gram (0039-0190-90) tubes.

Store between 59? and 86?F (15? - 30?C ).

Prescribing Information as of December 1997. Hoechst Roussel Pharmaceuticals, Division of Hoechst Marion Roussel, Inc, Kansas city, MO 64137. FDA Rev date: 3/26/2003

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

In the controlled clinical studies with 514 patients using LOPROX® Cream (ciclopirox cream) and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of clinical signs and symptoms in another patient using the vehicle cream.

Read the Loprox Cream (ciclopirox cream) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

General

LOPROX® (ciclopirox) Cream is not for ophthalmic use.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of LOPROX® Cream (ciclopirox cream) , treatment should be discontinued and appropriate therapy instituted.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A carcinogenicity study in female mice dosed cutaneously 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 site.

The following in vitro and in vivo genotoxicity tests have been conducted with ciclopirox olamine: studies to evaluate gene mutation in the Ames Salmonella/Mammalian Microsome Assay (negative) and Yeast Saccharomyces Cerevisiae Assay (negative) and studies to evaluate chromosome aberrations in vivo in the Mouse Dominant Lethal Assay and in the Mouse Micronucleus Assay at 500 mg/kg (negative).

The following battery of in vitro genotoxicity tests were conducted withciclopirox: a chromosome aberration assay in V79 Chinese Hamster Cells, with and without metabolic activation (positive); a gene mutation assay in the HGPRT - test with V79 Chinese Hamster Cells (negative); and a primary DNA damage assay (i.e., unscheduled DNA Synthesis Assay in A549 Human Cells (negative)). An in vitro Cell Transformation Assay in BALB/C3T3 Cells was negative for cell transformation. In an in vivo Chinese Hamster Bone Marrow Cytogenetic Assay, ciclopirox was negative for chromosome aberrations at 5000 mg/kg.

Pregnancy Category B

Reproduction studies have been performed in the mouse, rat, rabbit, and monkey, via various routes of administration, at doses 10 times or more the topical human dose and have revealed no significant evidence of impaired fertility or harm to the fetus due to ciclopirox. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LOPROX® (ciclopirox) Cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

LOPROX Cream (ciclopirox cream) is contraindicated in indiciduals who have shown hypersensitivity to any of its components.

Last reviewed on RxList: 11/5/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and Malassezia furfur. Ciclopirox exhibits fungicidal activity in vitro against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, and Candida albicans.

Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm2 on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible.

Penetration studies with human cadaver skin from the back with LOPROX (ciclopirox) Cream with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations.

Audiographic studies with human cadaverous skin showed that ciclopirox penetrates into the hair and through the epidermis and hair follicles into the sebaceous glands and dermis, while a portion of the drug remains in the stratum corneum.

Draize Human Senistization Assay, 21 Day Cumulative Irritance Study, Phototoxicity study and Photo Draize study conducted in a total of 142 healthy male subjects showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photo-contact sensitization due to LOPROX Cream (ciclopirox cream) .

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The patient should be told to:

  1. Use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks.
  2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
  3. Avoid the use of occlusive wrappings or dressings.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

The patient should be told to:

  1. Use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks.
  2. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
  3. Avoid the use of occlusive wrappings or dressings.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Loprox® Cream
(ciclopirox) 0.77%

FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES

DRUG DESCRIPTION

LOPROX® Cream (ciclopirox) 0.77% is for topical use.

Each gram of LOPROX® Cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Mineral Oil USP, Stearyl Alcohol NF, Cocamide DEA, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.

LOPROX® Cream (ciclopirox cream) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1 -hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2.

The chemical structure is:

LOPROX (ciclopirox) Structural Formula Illustration

LOPROX® Cream (ciclopirox cream) has a pH of 7.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Loprox® Cream
(ciclopirox) 0.77%

FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES

DRUG DESCRIPTION

LOPROX® Cream (ciclopirox) 0.77% is for topical use.

Each gram of LOPROX® Cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Mineral Oil USP, Stearyl Alcohol NF, Cocamide DEA, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.

LOPROX® Cream (ciclopirox cream) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1 -hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2.

The chemical structure is:

LOPROX (ciclopirox) Structural Formula Illustration

LOPROX® Cream (ciclopirox cream) has a pH of 7.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Loprox® Cream
(ciclopirox) 0.77%

FOR DERMATOLOGIC USE ONLY
NOT FOR USE IN EYES

DRUG DESCRIPTION

LOPROX® Cream (ciclopirox) 0.77% is for topical use.

Each gram of LOPROX® Cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Mineral Oil USP, Stearyl Alcohol NF, Cocamide DEA, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative.

LOPROX® Cream (ciclopirox cream) contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1 -hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt.

The CAS Registry Number is 41621-49-2.

The chemical structure is:

LOPROX (ciclopirox) Structural Formula Illustration

LOPROX® Cream (ciclopirox cream) has a pH of 7.

Last reviewed on RxList: 11/6/2008
This monograph has been modified to include the generic and brand name in many instances.

Loprox Cream Patient Information Including Side Effects

Brand Names: Loprox, Penlac Nail Lacquer

Generic Name: ciclopirox topical (Pronunciation: sye kloe PEER ox)

What is ciclopirox topical (Loprox Cream)?

Ciclopirox is an antifungal medication. Ciclopirox topical prevents fungus from growing.

Ciclopirox topical cream and lotion formulations are used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections. Ciclopirox shampoo is used to treat seborrheic dermatitis (inflammatory skin condition) of the scalp. Ciclopirox topical nail lacquer is used to treat fungal infections of the toenails and fingernails.

Ciclopirox topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ciclopirox topical (Loprox Cream)?

Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.

Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Loprox Cream (ciclopirox cream) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ciclopirox topical (Loprox Cream)?

Avoid getting ciclopirox topical in the eyes, nose, or mouth.

Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Use ciclopirox topical nail lacquer on nails and immediately surrounding skin only.

Ciclopirox topical nail lacquer is flammable, keep it away from heat and flame.

Use ciclopirox topical for the full amount of time prescribed by your doctor. Your symptoms may improve before the infection is completely healed however, it is important to use the medication for the full amount of time.

Loprox Cream Patient Information including How Should I Take

What should I discuss with my healthcare provider before using ciclopirox topical (Loprox Cream)?

Do not use ciclopirox topical if you have had an allergic reaction to it in the past.

Before using ciclopirox topical, tell your doctor if you

  • have diabetes;
  • are immunosuppressed (e.g., have received an organ transplant or have AIDS);
  • take medication to control epilepsy or another seizure disorder;
  • use a topical corticosteroid on a regular basis; or
  • use a steroid inhaler on a regular basis.

You may not be able to use ciclopirox topical nail lacquer or you may require a dosage adjustment or special monitoring during your treatment .

Ciclopirox topical is the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use ciclopirox topical without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether ciclopirox passes into breast milk. Do not use ciclopirox topical without first talking to your doctor if you are breast-feeding a baby.

How should I use ciclopirox topical (Loprox Cream)?

Use ciclopirox topical exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

To use ciclopirox topical cream or lotion:

  • Wash your hands before and after using this medication, unless you are using ciclopirox topical to treat a hand condition.
  • Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks. Follow your doctor's instructions.
  • Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).
  • If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

To use ciclopirox shampoo:

  • Wet the hair and apply approximately 1 teaspoon (5 mL) of the shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on the hair and scalp for 3 minutes. A timer may be used. Rinse off the shampoo after 3 minutes have passed.
  • Avoid contact with the eyes, nose, and inside of the mouth.
  • Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If no improvement is seen after 4 weeks of treatment, contact your doctor.

To use ciclopirox topical nail lacquer:

  • Remove any loose nail or nail material using nail clippers or a nail file.
  • Apply ciclopirox topical nail lacquer once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, apply the nail laquer to the underside of the nail and to the skin beneath it. Allow the lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait 8 hours before taking a bath or shower.
  • Apply ciclopirox topical nail lacquer daily over the previous coat. Once a week, remove ciclopirox topical nail lacquer with alcohol. Remove as much as possible of the damaged nail using nail clippers or nail a file.
  • Use ciclopirox topical nail lacquer on nails and immediately surrounding skin only. Avoid contact with other areas.
  • Treatment with ciclopirox topical nail lacquer may require six months or more before initial improvement of symptoms is noticed. Up to 48 weeks of daily application of the nail lacquer, monthly removal of the unattached infected nail by a health care professional, and weekly trimming by the patient may be required for complete treatment.
  • To prevent the screw cap from sticking to the bottle, do not allow the solution to get into the bottle treads. To prevent the solution from drying out, close the bottle tightly after every use.

Use ciclopirox topical for the full amount of time prescribed by your doctor. Your symptoms may improve before the infection is completely healed however, it is important to use the medication for the full amount of time.

Avoid getting ciclopirox topical in the eyes, nose, or mouth.

Store ciclopirox topical at room temperature away from moisture and heat. Ciclopirox topical nail lacquer is flammable, keep it away from heat and flame. Protect the ciclopirox topical nail lacquer from light by storing the bottle in the carton after every use. Once a bottle of ciclopirox topical shampoo is opened, it should be used within 8 weeks.

Loprox Cream Patient Information including If I Miss a Dose

What happens if I miss a dose (Loprox Cream)?

Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of ciclopirox topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose (Loprox Cream)?

An overdose of ciclopirox topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that ciclopirox topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using ciclopirox topical (Loprox Cream)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox topical nail lacquer.

What other drugs will affect ciclopirox topical (Loprox Cream)?

Avoid using other topical products at the same time unless directed otherwise by your doctor. Other skin medications may affect the absorption or effectiveness of ciclopirox topical formulations.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox topical nail lacquer.

Drugs other than those listed here may also interact with ciclopirox topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

Your pharmacist has additional information about ciclopirox topical written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.04. Revision date: 12/15/2010.

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