Terbinafine hydrochloride

Uses and Indications

This drug is indicated for the treatment of various fungal skin infections, specifically:

Fungal Infections

• Cures most athlete's foot (tinea pedis).

• Cures most jock itch (tinea cruris).

• Cures most ringworm (tinea corporis).

Symptomatic Relief

• Provides relief from itching, burning, cracking, and scaling associated with these conditions.

Limitations of Use

• The effectiveness of the drug on the bottom or sides of the foot for athlete's foot is unknown.

• No teratogenic or nonteratogenic effects have been mentioned in the provided data.

Dosage and Administration

Adults and children 12 years and older should use the tip of the cap to break the seal and open the tube. Prior to application, the affected skin must be washed with soap and water and dried completely.

For athlete's foot, it is recommended to wear well-fitting, ventilated shoes and to change shoes and socks at least once daily. The application schedule varies based on the location of the infection:

• For application between the toes, a thin layer should be applied twice a day (morning and night) for 1 week or as directed by a doctor.

• For application on the bottom or sides of the foot, a thin layer should be applied twice a day (morning and night) for 2 weeks or as directed by a doctor.

For jock itch and ringworm, a thin layer should be applied once a day (morning or night) for 1 week or as directed by a doctor.

It is essential to wash hands after each use.

For children under 12 years, it is advised to consult a doctor before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on nails or scalp.

• Use in or near the mouth or eyes.

• Treatment of vaginal yeast infections.

Due to the potential for irritation, it is advised to avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water.

Warnings and Precautions

For external use only.

Do Not Use:

• On nails or scalp.

• In or near the mouth or eyes.

• For vaginal yeast infections.

When Using This Product:

• Do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use and Ask a Doctor If:

• Too much irritation occurs or gets worse.

• Side effects occur. You may report side effects to the FDA at 1-800-FDA-1088.

Keep Out of Reach of Children:

• If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

General Precautions:

• Seek medical treatment if your condition worsens or does not improve within 4 weeks for athlete's foot and within 2 weeks for jock itch and ringworm.

• Do not puncture or incinerate; contents under pressure. Do not expose to heat or store at temperatures above 120°F (49°C).

Side Effects

Patients using topical antifungal creams should be aware of the following adverse reactions and warnings associated with these products:

Warnings

• For external use only.

• Do not use on nails or scalp, in or near the mouth or eyes, or for vaginal yeast infections.

• If eye contact occurs, rinse thoroughly with water.

Adverse Reactions

• Patients should stop use and consult a doctor if:

  • Too much irritation occurs or worsens.

  • Side effects occur.

Additional Safety Information

• Keep out of reach of children. If swallowed, seek medical help or contact a poison control center immediately.

• Patients are encouraged to report side effects to the FDA at 1-800-FDA-1088.

Clinical Considerations

• If the condition does not improve within 4 weeks for athlete's foot or within 2 weeks for jock itch and ringworm, medical treatment should be sought.

These precautions are essential to ensure safe and effective use of topical antifungal treatments.

Drug Interactions

There is no available information regarding drug interactions for the following products: Cvs, Lamisil at Cream, Lamisil at Terbinafine Hydrochloride, Lamisil at Spray, Terbinafine Hydrochloride, Athletes Foot, Cvs Pharmacy, and Walgreens. All labels indicate that no drug interactions or laboratory test interactions have been reported.

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before using any of the following products: Cvs, Lamisil at Cream, Lamisil at Terbinafine Hydrochloride, Lamisil at Spray, Terbinafine Hydrochloride, Athletes Foot, and Walgreens Cream.

For children aged 12 years and older, these products can be used as directed. Specific dosing instructions for this age group are provided in the respective product labeling.

It is important to note that no specific dosing instructions for children under 12 years are available, and medical consultation is required prior to use in this population.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the following formulations: Cvs, Lamisil at Cream, Lamisil at Terbinafine Hydrochloride, Lamisil at Spray, Terbinafine Hydrochloride Cream, and Athletes Foot Cream. As such, healthcare professionals should exercise caution and consider individual patient factors when prescribing these medications to geriatric patients, given the lack of targeted data in this population. Regular monitoring for efficacy and safety is recommended.

Pregnancy

The safety of terbinafine hydrochloride, including its formulations such as cream and spray, during pregnancy has not been established. Terbinafine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those who may become pregnant should avoid using this medication unless directed by a healthcare provider.

There may be risks associated with the use of terbinafine hydrochloride during pregnancy, and it is recommended that pregnant patients consult their healthcare provider for further information. Special precautions or dosage modifications may be necessary for pregnant individuals, and healthcare providers should be consulted to weigh the potential benefits against the risks before use.

Lactation

Nursing mothers are advised to consult a healthcare provider before using products containing terbinafine hydrochloride, such as creams and sprays. There is a potential for excretion of terbinafine in breast milk; however, the effects of this medication on breastfed infants are not well studied. Due to the lack of specific data regarding the safety and potential risks to nursing infants, caution is recommended when administering these products during lactation.

While some labels indicate no specific warnings or recommendations for nursing mothers, the general consensus emphasizes the importance of consulting a doctor prior to use. Given the uncertainty surrounding the effects of terbinafine on infants, healthcare providers should weigh the benefits against potential risks when considering treatment options for lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosing adjustments, monitoring requirements, or safety considerations outlined in the available product inserts for various topical formulations, including creams and sprays. The reviewed labels, including those for Lamisil at, Terbinafine Hydrochloride, and other antifungal products, consistently lack information regarding the impact of reduced kidney function on the use of these medications.

As such, healthcare professionals should exercise caution when prescribing these products to patients with renal impairment, given the absence of guidance on potential alterations in pharmacokinetics or safety profiles. It is advisable to monitor these patients closely for any adverse effects, as the lack of specific recommendations does not preclude the possibility of altered drug metabolism or excretion in this population.

Hepatic Impairment

Patients with hepatic impairment may not have specific dosage adjustments, monitoring requirements, or precautions outlined in the drug inserts for the various formulations of the products reviewed. The available information indicates that there are no specific recommendations or restrictions for patients with liver problems across multiple brands and formulations, including creams and sprays.

As such, healthcare providers should exercise caution and consider individual patient factors when prescribing these medications to patients with hepatic impairment, despite the absence of explicit guidance in the product labeling. Regular monitoring of liver function may be prudent in these cases, although specific lab values or parameters are not detailed in the provided information.

Overdosage

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a poison control center. If the product is swallowed, individuals should be directed to call the Poison Control Center at 1-800-222-1222 or their local emergency number without delay.

Symptoms of overdose may not be explicitly detailed in the available data; however, it is essential to monitor for any unusual reactions or adverse effects following ingestion. Given the nature of these products, which are primarily topical antifungals, ingestion may lead to gastrointestinal distress or other systemic effects.

To ensure safety, all products should be kept out of reach of children. In the case of accidental ingestion, prompt medical evaluation is recommended to assess the situation and provide appropriate care.

Nonclinical Toxicology

Teratogenic Effects

No information is available regarding teratogenic effects for the products listed.

Non-Teratogenic Effects

No information is available regarding non-teratogenic effects for the products listed.

Animal Toxicology

No information is available in the nonclinical toxicology sections for the products listed.

Storage and Handling

Products are supplied in cream and spray forms, packaged in tubes. It is essential to ensure that the seal on the tube is intact and visible before use.

All products should be stored at a controlled room temperature between 20° to 25°C (68° to 77°F). Users are advised to check the carton or tube crimp for the lot number and expiration date to ensure product integrity and safety.

Tamper-evident packaging is utilized; therefore, products should not be used if the seal on the tube is punctured or not visible.