Naftifine - Indications, Warnings, and Precautions

Overview:

Naftifine is a topical medicine for skin fungal infections. It inhibits fungus growth by blocking a key enzyme, and it also has some antibacterial and anti-inflammatory effects. It has a fungicidal effect against some fungi and molds, fungistatic against yeasts, and can treat bacterial skin issues. The body processes it within a few days, with byproducts that are not antifungal excreted in urine and feces. Food and Drug Administration approved the Naftifine on June 27, 2013.

Drug Group:

Naftifine belongs to the antifungal drug group. Naftifine has three benefits: it fights fungi and bacteria and reduces inflammation.

Available Doses and Dosage Forms:

Naftifine hydrochloride one percent comes in collapsible tubes and can be chosen from three different sizes:

Tube of Gel

• 40-gram (gm) tube.

• 60 gm tube.

• 90 gm tube.

Tube of Cream

• 15 gm tube.

• 30 gm tube.

• 60 gm tube.

• 90 gm tube.

For Patients

What Is an Athlete’s Foot?

Athlete's foot is a contagious fungal infection that leads to itchy skin problems on the feet. It causes an itchy, stinging, and burning rash. Treating athlete's foot can prevent the fungus from spreading and make it go away.

What Is Naftifine?

Naftifine is available as gel and cream. It is a particular skin cream that helps get rid of annoying skin infections. These infections can be like athlete's foot, jock itch, or ringworm, which can make the skin itchy and uncomfortable. When a person applies this gel to the affected area, it kills the fungus causing the infection so the skin can heal and feel better.

What Are the Uses of Naftifine?

• This medication treats athlete's foot, a fungal skin infection.

• It helps relieve the symptoms of athlete's foot, including redness, itching, and skin scaling.

• Naftifine is an antifungal medicine used to stop the fungus growth that causes infection.

How Is Naftifine Administered?

Apply an adequate amount of Naftifine cream, one percent, to the affected skin and the nearby areas, using gentle massage once daily. Remember to wash hands after applying the cream. If there is no noticeable improvement in the patient's condition after four weeks of using Naftifine cream one percent, it is advisable to have a follow-up evaluation. Administer a small quantity of the medication to the impacted region once or twice a day, as directed by the physician's instructions.

What Is the Purpose of Naftifine?

• Use this medication only on the skin.

• Make sure the skin is clean and dry in the area to be applied.

• Put a thin layer of the medication on the affected area and gently rub it in.

• Apply the medication once a day for two weeks.

• After using it, hands should be washed.

• Do not wrap, cover, or bandage the area unless the doctor advises. Do not use it in the eyes, nose, mouth, or inside the vagina. If it gets in these places, wash with water.

• Do not use it more often or for a longer time than the doctor said because it might cause problems.

• Use it at the same time every day to remember.

• Keep using it for the full treatment period, even if the symptoms go away early. Stopping too soon can bring the infection back.

• Talk to the doctor if the condition does not improve or worsen.

How to Use Naftifine?

• Naftifine comes in cream and gel forms for applying to the skin.

• Usually, use the cream once a day and the gel twice a day (morning and evening) for two to four weeks. Some infections may need up to six weeks of treatment.

• Follow the instructions on the prescription label carefully, and if unsure about anything, ask the doctor or pharmacist for clarification.

• Use Naftifine exactly as the doctors say. Use it sparingly or less, or use it more often than prescribed.

• Start by cleaning the infected area, let it dry, then gently rub the medicine in until most of it is absorbed. Use enough to cover the affected area. Wash hands after applying.

• Keep using Naftifine, even after starting to feel better. Only stop using it after talking to the doctor.

What Are the Side Effects of Naftifine?

Naftifine is a medicine that most people can use without any problems, but only a small number, less than five percent, might have some side effects. These side effects are usually mild and can include:

• Rash.

• Itching.

• Swelling (especially of the face, tongue, or throat).

• Severe dizziness.

• Trouble breathing.

• A very serious allergic reaction to this drug is rare.

• Mild irritation at the application site may occur. If this lasts or gets worse, tell the doctor or pharmacist promptly.

When a medication is taken, it can have both desired and undesired effects on the body. While not everyone experiences these side effects, they might require medical attention if they do happen. Tell the doctor right away if a person experiences:

• Uncommon: Skin sensations like burning, stinging, itching, redness, or irritation.

• Occurrence: Formation of blisters, skin crusting, or skin softening.

Some side effects may occur but usually do not need medical attention. They might go away as the body gets used to the medication. The healthcare provider can also advise on preventing or reducing these side effects. Do not hesitate to reach out to them if any of the following side effects persist, bother, or if any have questions:

• More common: Feeling dizzy or getting headaches.

• Less common: Skin dryness.

Other side effects that may affect some individuals could not be mentioned here. If a person experiences any unusual effects, consulting with a healthcare professional is a good idea.

Dietary Considerations:

Some medications should not be used with or after eating a specific food, as they can interact. Using alcohol or tobacco with certain medications can also lead to problems. It is essential to talk to the healthcare provider about how to take the medications concerning food, alcohol, or tobacco.

Missed Dose:

• If an individual forgets a dose, put it on as soon as they remember. But if it is close to the time for the next dose, skip the missed dose and stick to the regular schedule.

• Do not use extra medicine to make up for the missed dose.

Overdose: Taking too much of this medicine is unlikely to be immediately dangerous, but if someone suspects someone has taken an excessive amount, seek help or advice.

Storage:

• Naftifine is stored at room temperature.

• Make sure to seal the container tightly.

• Keep it away from heat.

• Avoid exposure to high humidity.

• Store it where it will not be exposed to bright light.

• Keep this medicine out of reach of children.

For Doctors

Indications:

1. Naftifine is used topically to treat fungal infections.

2. It is specifically indicated for three types of fungal infections:

• Tinea pedis (athlete's foot).

• Tinea cruris (jock itch).

• Tinea corporis (ringworm).

3. Naftifine is a pharmaceutical agent with broad-spectrum antifungal activity effective against various cutaneous fungal infections.

4. In clinical trials, Naftifine has demonstrated non-inferior or superior efficacy compared to alternative antifungal agents such as Econazole and Clotrimazole.

5. It exhibits a more rapid symptom relief onset than other antifungal topical preparations.

6. Naftifine is available in both cream and gel formulations for topical administration, with a recommended application frequency of once or twice daily.

7. It can be applied daily once in cases of mild infections, particularly tinea pedis affecting the toe webs.

What Are the Pharmacological Aspects of Naftifine?

Pharmacology:

Naftifine comprises the synthetic, wide-ranging, antifungal substance known as naftifine hydrochloride. This gel is intended for external use only.

Chemical Composition:

• Chemical Name: (E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride.

• Naftifine hydrochloride has the empirical formula C21H21N•HCl and a molecular weight of 323.86.

Active Ingredient: Contains one percent Naftifine hydrochloride.

Inactive Ingredients: Inactive components in Naftifine one percent, include polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium, alcohol (52 volume/ volume percentage (%v/v)), and purified water.

Pharmacodynamics:

Naftifine is a synthetic antifungal agent belonging to the allylamine class with a broad spectrum of activity. In laboratory tests (in vitro), Naftifine has demonstrated its ability to kill various fungi, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum. It also inhibits the growth of Candida species, particularly Candida albicans. However, in clinical practice, Naftifine is typically used to treat only the specific fungal infections mentioned in its approved indications.

Mechanism of Action:

Naftifine's precise antifungal mechanism still needs to be fully elucidated, but it is believed to disrupt sterol biosynthesis by inhibiting the squalene 2,3-epoxidase enzyme. This inhibition leads to reduced sterol levels, notably ergosterol, and an increased squalene concentration within the cells.

Pharmacokinetics:

In terms of bioavailability, both laboratory (in vitro) and live organism (in vivo) studies on Naftifine have demonstrated its ability to effectively penetrate the stratum corneum, which is the protective outer layer of the skin. This penetration allows Naftifine to reach concentrations sufficient for inhibiting the growth of dermatophytes, which are fungi responsible for various skin infections. When administered as a single topical application of 3H-labeled Naftifine gel one percent on the skin of healthy individuals, it was observed that up to 4.2 percent of the applied dose was absorbed into the body. Naftifine and its metabolites are excreted from the body through urine and feces, with a half-life of approximately two to three days.

Toxicity:

The genetic toxicity assessment of Naftifine showed no evidence of mutagenic or clastogenic potential based on in vitro and in vivo tests. Repeat dose toxicity studies in various animals indicated varied effects, with some minimal adverse findings. These included dose-dependent effects on body weight, hematology, and clinical chemistry. Most studies reported no significant histopathological changes, and the No Observed Adverse Effect Levels (NOAEL) ranged from 7.5 mg/kg/day to 200 mg/kg/day, depending on the species and route of administration.

Clinical Studies:

Naftifine demonstrates wide in vitro antimicrobial activity and is effective against various dermatophytes, yeasts, and saprophytes. It has also shown significant vivo efficacy in animal studies against T. mentagrophytes.

What Are the Contraindications of Naftifine?

Hypersensitivity to Naftifine.

Warnings and Precautions:

Warnings:

• Naftifine is indicated for dermal application and should not come into contact with the eyes.

• While taking Naftifine, if someone experiences a rash, itching, swelling, severe dizziness, or difficulty in breathing, seek medical help.

• Naftifine is for external use only, so make sure not to swallow it.

Precautions:

• This gel is for external use exclusively.

• Prior to Naftifine use, it is crucial to disclose any allergies to it or other antifungal medications like Terbinafine to the healthcare provider.

• Note that this product may contain inactive components capable of eliciting allergic reactions or other adverse effects. Any allergies to specific ingredients should also be reported.

• Share the medical history with the healthcare provider before commencing Naftifine treatment.

• If skin irritation or sensitivity arises, discontinue use and seek medical consultation.

• Before initiating gel application, ensure that a fungal infection diagnosis is confirmed by a healthcare provider, either through microscopic examination or a culture test.

• For pregnant patients, Naftifine should only be employed when deemed necessary, with a thorough discussion of potential risks and benefits with the healthcare provider.

• Breastfeeding individuals should consult with their healthcare provider before using this medication.

Adverse Drug Reactions:

• Naftifine is generally well-tolerated by the majority of individuals.

• Fewer than five percent of patients may experience adverse effects, which are typically mild and may manifest as a rash, itching, swelling (especially of the face, tongue, or throat), severe dizziness, or difficulty breathing.

• Severe allergic reactions to this medication are exceedingly rare.

• Mild irritation at the application site may occur, and if it persists or worsens, it is advisable to promptly inform a healthcare professional.

• It is important to note that this is not an exhaustive list of potential side effects, and any other unlisted effects should be reported to a healthcare provider or pharmacist.

Special Considerations:

• Inform the healthcare provider and pharmacist about any allergies an individual has to Naftifine or other medications.

• Provide a list of both prescribed and over-the-counter drugs, along with any vitamin supplements they are using.

• If they are pregnant, planning pregnancy, or breastfeeding, it is important to notify the doctor.

• In case the person becomes pregnant while using Naftifine, contact the healthcare provider.