Naftifine Hydrochloride: A Fighter Against Tinea Fungal Infections

Overview

A synthetic medication called Naftifine hydrochloride minimizes several fungal species. It is applied topically to treat fungus-related skin disorders such as ringworm, jock itch (fungal skin infection that appears as an itchy rash in body parts that are warm and moist), and athlete's foot (an infection caused by fungi that commonly starts between the toes). The names of these fungi include Epidermophyton floccosum, Trichophyton tonsurans, Trichophyton rubrum, and Trichophyton mentagrophytes. The United States Food and Drug Administration (USFDA) approved Naftifine Hydrochloride on June 27, 2013.

Drug Group:

Naftifine hydrochloride belongs to the antifungal group of medications that fights fungal infections brought on by specific fungi, such as the Tinea, Trichophyton, and Epidermophyton species.

Indications:

Naftifine hydrochloride cream is used to treat specific skin infections. It functions against Trichophyton rubrum, a fungus that causes ringworm, jock itch, and athlete's foot. Naftifine hydrochloride cream might, therefore, assist in solving any of these issues.

Contraindications:

Naftifine hydrochloride cream should not be used by people who are allergic to its ingredients.

Dosage Forms and Available Strengths: Naftifine hydrochloride is a compound that comprises 20 milligrams per gram of Naftifine hydrochloride cream, accounting for two percent of the cream's weight. The cream itself appears to be either white or somewhat off-white.

For Patients

What Is Tinea?

One type of fungal infection that affects the skin is called tinea. Even though it has nothing to do with worms, it is also known as ringworm because it can develop red, ring-shaped spots on the skin. Although tinea can affect any body area, it seems to be more common near hair and in moist areas. It is transmissible from one individual to another. Though it is most commonly associated with ring-shaped patches, it can also manifest in other body areas such as the nails, genitalia, or feet in diverse ways.

What Are the Clinical Uses of Naftifine Hydrochloride?

Naftifine is used to treat skin infections including ringworm (tinea), jock itch, and athlete's foot. It can treat other skin issues as well.

How Should Naftifine Hydrochloride Be Used?

Naftifine hydrochloride is an antiseptic cream or gel used topically to treat infections. For two to four weeks, the cream is applied once daily, and the gel is applied twice daily, in the morning and the evening. Occasionally, if the infection is severe, it may need to be used for up to six weeks.

One should pay close attention to the directions on the medication. They should ask the doctor or pharmacist for clarification if it is confusing. The patient must follow the directions properly when using Naftifine hydrochloride. The individual should use only the recommended amount and should only use less or less frequently than advised.

After thoroughly cleaning the affected area, one should allow it to dry. After that, massage the medication gently until most of it is absorbed. Use just enough amount of cream so that the region that is affected is covered. One should wash their hands after applying.

Even if the patient feels better, they should keep taking Naftifine hydrochloride. The patient should not stop taking it without first consulting with a doctor.

What Are the Side Effects of Naftifine Hydrochloride?

Naftifine hydrochloride cream may cause people to experience some discomfort. Informing the physician as soon as possible is crucial if one observes any of the following symptoms:

• Dryness.

• Burning.

• Itching.

• Redness.

• Rash.

• Irritation or stinging.

What Are the Things to Inform the Doctor Before Taking Naftifine Hydrochloride?

Before Naftifine hydrochloride cream use:

• If one is allergic to Naftifine or any other medication, let the doctor and pharmacist know.

• Tell the doctor if the patient is under any prescription and over-the-counter medication, including vitamins.

• Let the doctor know if the patient is nursing a baby, intends to get pregnant, or is already pregnant. Get in touch with the physician if one becomes pregnant while taking Naftifine hydrochloride.

Storage: Keeping medicinal products secure and out of children's reach is critical. Ensure the Naftifine hydrochloride cream is securely closed and stored in the original container. Store it at room temperature, out of direct sunlight, and dry. Keep it out of the bathroom, where there may be a lot of moisture.

Disposal: It is essential to dispose the medicine safely when it comes to unused medicines. Keep it out of the trash where kids or dogs might find it. It is also not a good idea to flush it down the toilet because it can damage the environment. Through a drug take-back scheme, medication can be disposed of most effectively. If that is not possible, ask the pharmacist or the neighborhood recycling or garbage service for advice on safe disposal practices in the region.

Missed Dose: Apply the missed dose as soon as it comes to mind. On the other hand, if the next dose is almost due, skip the one that was missed and stick to the usual dosage plan. Applying two doses to make up for a missing one is not advised.

For Doctors

Description: Naftifine hydrochloride cream is an off-white or white cream that is exclusively intended for external application on the skin. This cream contains 20 milligrams of synthetic Naftifine hydrochloride (two percent), an antifungal agent. The chemical name of Naftifine hydrochloride is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. Other constituents in the cream include purified water, cetyl alcohol, and benzyl alcohol, among others.

Pharmacodynamics: Naftifine hydrochloride cream's pharmacodynamics are unknown.

Mechanism of Action: Naftifine hydrochloride inhibits the enzyme squalene2, 3-epoxidase, which appears to interfere with sterol production, while the precise method of action against fungus remains unknown. Because of this suppression of enzyme activity, the cells accumulate squalene while sterol levels, particularly ergosterol, are reduced. Regarding resistance, no known mechanism of Naftifine resistance has been found yet. Most isolates of the following fungus have been demonstrated to be susceptible to Naftifine's activity in vitro and in clinical infections.

Pharmacokinetics:

• Naftifine Hydrochloride Cream Penetration: Naftifine hydrochloride cream has been shown in laboratory and human trials to penetrate the skin's outermost layer sufficiently to inhibit the growth of specific fungal species.

• Adult Pharmacokinetics: The amount of Naftifine hydrochloride cream in the blood increased during a two-week therapy trial, including twenty-one adults, male and female, who used the cream once daily. Most people's blood still contained some of the medication even after two weeks of stopping the use of lotion.

• Adolescent Pharmacokinetics: The same result was shown in another trial with twenty children between thirteen to eighteen years of age who used the cream once daily for two weeks. Throughout treatment, more medication entered their bloodstream.

• Pharmacokinetics in Children and Young Adults: In a third research, the cream was taken once daily for two weeks by 27 children who were above two years but below 12 years. Even the youngest children displayed signs of blood medication ingestion. At the beginning and completion of the treatment, the older children's blood levels of the medication were comparable.

What Is the Prescribed Dosage and Method of Administration For Naftifine Hydrochloride?

Naftifine hydrochloride is meant for external use only. It is not intended for intravaginal, oral, or ocular usage. For two weeks, apply a thin coat of Naftifine hydrochloride cream once a day to the afflicted regions and a half-inch margin around the healthy skin.

Adverse Reactions:

Experience With Clinical Trials:

• Clinical trials are studies conducted to evaluate the safety and effectiveness of medications. The responses seen in these trials may differ from those noticed in real life.

• 903 participants used Naftifine cream during the studies. Naftifine hydrochloride cream was used to treat 564 of them who had fungal infections of the body, groin, or feet.

• Four hundred participants, predominantly men between the ages of 12 and 88, received two weeks of Naftifine hydrochloride cream treatment in two trials. Reactions to Naftifine hydrochloride cream were reported in about 17.5 percent of users, with itching being the most frequent. The majority of responses were modest. Those who used Naftifine hydrochloride cream experienced almost the same reactions as those who used a non-active cream.

• In a separate trial, Naftifine hydrochloride cream was used for two weeks to treat body fungus in 116 children ages two to under 18. Children utilizing Naftifine hydrochloride cream experienced roughly the same amount of reactions as those using a non-active cream.

• Naftifine hydrochloride cream was used by 49 kids with foot, groin, or body fungus between the ages of two and under 18 in two safety trials. Children's responses were comparable to adults.

Experience After Marketing: Following the Naftifine hydrochloride’s approval, a few additional people had headaches, edema, and redness. Scientists were not always able to determine the frequency of these reports or if the medication brings them on because they are voluntary and come from various sources.

Clinical Studies: Positive results were observed in trials assessing Naftifine hydrochloride cream's effectiveness in treating various fungal infections. Naftifine hydrochloride cream significantly outperformed a placebo cream in treating tinea cruris, or jock itch, in 146 participants; by week four, 25 percent of subjects had fully recovered, and 60 percent had received adequate treatment. Naftifine hydrochloride cream demonstrated efficacy in the 217-subject research on interdigital tinea pedis (athlete's foot), with 18 percent of patients reaching a full recovery by week six and 57 percent obtaining successful therapy. Similarly, Naftifine hydrochloride cream showed promising outcomes in the trial, including 184 pediatric individuals for tinea corporis (ringworm), with 46 percent of participants obtaining a full recovery by Day 21 and 58 percent reporting successful therapy. These results show that Naftifine hydrochloride cream successfully reduces symptoms and eradicates fungal infections in a significant proportion of treated patients with various fungal skin diseases.

Warnings and Precautions:

Stop using Naftifine hydrochloride cream if it causes any irritation or sensitivity. Tell the doctor if one has these problems after using the cream.

Non-clinical Toxicology: No long-term research has been conducted to determine whether Naftifine hydrochloride cream can cause cancer. In vitro experiments with Naftifine hydrochloride did not reveal any mutations or abnormalities in the cells. Even at doses up to 100 mg/kg/day (milligrams per kilogram per day), which is six times the maximum authorized human dose, it did not affect rats' growth, ability to procreate, or health when given by mouth during mating, pregnancy, delivery, and nursing.

Use in Specific Populations:

• Pregnancy: Limited information is known on the safety of taking Naftifine hydrochloride cream during pregnancy. Pregnant women have not participated in any research to evaluate the possible risk of miscarriage or birth abnormalities. Nonetheless, research on pregnant animals, rats, and rabbits in particular, has not revealed any negative effects on fetal development at doses significantly greater than those usually administered to people. These results point to a comparatively low risk, but before using Naftifine hydrochloride cream while pregnant, it is crucial to speak with a healthcare professional to assess the advantages and any hazards to the growing fetus.

• Lactation: There is insufficient information available to determine the effects of Naftifine hydrochloride cream on nursing babies or its presence in breast milk. It is challenging to evaluate the possible dangers to the nursing infant in the absence of this knowledge. When determining the best course of action for a nursing patient, medical professionals should take into account the benefits of breastfeeding as well as the mother's requirement for Naftifine hydrochloride cream.

• Use in Pediatrics: Naftifine hydrochloride cream has been demonstrated to be safe and effective for treating certain fungal infections in pediatric patients 12 years of age and older. Its usage in this age group is supported by studies conducted on both adults and children, and further safety information from open-label trials involving pediatric patients further supports its use in this age group. But, care must be taken because the safety and efficacy of treating certain fungal infections in children under the age of 12 and another type of fungal infection in children under the age of two have not been proven.

• Elderly Use: There are few data available regarding the usage of Naftifine hydrochloride cream in older individuals 65 years of age and above. There are not enough clinical studies with this age range of participants to find out whether there are any changes in how they react to the medicine compared to younger people. As a result, care should be taken when administering Naftifine hydrochloride cream to elderly patients, and careful observation might be required to guarantee both efficacy and safety.