Terbinafine Hydrochloride

Description

FungaBlend 10® is a topical cream formulated for the treatment of athlete's foot, containing 1% terbinafine hydrochloride as its active ingredient. This antifungal therapy is developed by podiatrists and is designed for professional strength application. The cream incorporates a blend of 10 potent plant medicines, enhancing its efficacy. FungaBlend 10® is packaged in a 2 fluid ounce (60 mL) container, intended for external use only.

Uses and Indications

This drug is indicated for the treatment of various dermatological fungal infections, specifically Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis). It effectively cures most cases of these conditions and provides symptomatic relief from associated symptoms, including itching, burning, cracking, and scaling.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and over should begin treatment by washing the affected skin with soap and water, ensuring the area is dried completely before application.

For the treatment of Athlete's Foot, a thin layer of FungaBlend10® Athlete's Foot Cream should be applied to the affected area twice daily (in the morning and evening) for a duration of 2 weeks, or as directed by a physician. It is recommended to wear ventilated shoes and to change socks and shoes daily. Hands should be washed thoroughly after each application.

In cases of Jock Itch and Ringworm, a thin layer of the cream should be applied once daily to the affected area for 1 week, or as directed by a physician. Hands should be washed after application, unless the hands are the area being treated. Care should be taken to keep treated hands away from the face and eyes.

Patients are advised to continue using FungaBlend10® Athlete's Foot Cream for the entire prescribed treatment period, even if symptoms improve or resolve after a few days. Discontinuing the medication prematurely may lead to a recurrence of the infection.

Contraindications

The product is contraindicated for use on nails, scalp, near the eyes or mouth, and for vaginal yeast infections. Direct contact with the eyes should be avoided; in the event of eye contact, rinse thoroughly with water. Discontinue use and consult a physician if excessive irritation occurs or worsens. Keep the product out of reach of children. In case of ingestion, seek medical assistance or contact the Poison Control Center at 800-222-1222.

Warnings and Precautions

The product is intended for external use only and should not be applied to nails, the scalp, near the eyes or mouth, or used for vaginal yeast infections. Care should be taken to avoid contact with the eyes; in the event of accidental eye contact, it is imperative to rinse thoroughly with water.

Healthcare professionals should advise patients to discontinue use and consult a physician if excessive irritation occurs or if the irritation worsens. It is crucial to keep this product out of the reach of children. In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center can be contacted at 800-222-1222 (POISONHELP.ORG).

Patients are encouraged to seek medical treatment if their condition does not improve within 4 weeks for Athlete's Foot or within 2 weeks for Jock Itch and Ringworm. Monitoring of symptoms and timely intervention is essential for effective management of these conditions.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to nails, the scalp, near the eyes or mouth, or used for vaginal yeast infections. Care should be taken to avoid contact with the eyes; in the event of eye contact, the affected area should be rinsed thoroughly with water.

In clinical use, patients are advised to discontinue use and consult a healthcare professional if excessive irritation occurs or if the irritation worsens. It is also important to keep this product out of reach of children. In the case of accidental ingestion, medical assistance should be sought immediately, or the Poison Control Center should be contacted at 800-222-1222.

Patients experiencing worsening conditions or lack of improvement should seek medical treatment. Specifically, if symptoms of Athlete's Foot do not improve within 4 weeks, or if symptoms of Jock Itch or Ringworm do not improve within 2 weeks, medical advice should be obtained.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Terbinafine Hydrochloride (terbinafine hydrochloride 1g in 100g). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older should wash the affected skin with soap and water and dry it completely before applying the medication. For the treatment of Athlete's Foot, a thin layer should be applied twice daily (AM and PM) to the affected area for 2 weeks or as directed by a physician. In cases of Jock Itch and Ringworm, a thin layer should be applied once daily for 1 week or as directed by a physician.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or the Poison Control Center (800) 222-1222 should be contacted.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of terbinafine hydrochloride during pregnancy has not been established. Terbinafine is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of terbinafine during pregnancy; therefore, it is essential for healthcare providers to be consulted for further information regarding these risks.

No specific dosage modifications for pregnant individuals are provided; however, caution is advised when considering the use of this medication. Pregnant women should avoid using this product unless directed by a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding the use of Terbinafine Hydrochloride in lactating mothers. Additionally, there is no information available about the potential for excretion of Terbinafine Hydrochloride in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, it is imperative to keep the medication out of reach of children to prevent accidental ingestion. Should ingestion occur, immediate medical assistance should be sought. Healthcare professionals are advised to contact the Poison Control Center at 800-222-1222 for guidance on managing the situation.

Prompt action is crucial in cases of suspected overdosage to mitigate potential health risks. It is essential to monitor the patient for any symptoms that may arise and to provide appropriate medical intervention as necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and contact dermatitis. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only. Patients should be instructed not to apply the product on nails, the scalp, near the eyes or mouth, or for vaginal yeast infections.

When using the product, patients must be cautioned to avoid contact with the eyes. In the event of eye contact, they should rinse thoroughly with water.

Patients should be informed to discontinue use and consult a doctor if they experience excessive irritation or if the irritation worsens.

It is essential to remind patients to keep the product out of reach of children. In case of accidental ingestion, they should seek medical assistance or contact the Poison Control Center at 800-222-1222.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 20-25°C (68-77°F) to ensure its stability and efficacy. Proper storage conditions must be adhered to, as deviations from the recommended temperature range may affect the product's quality.

Additional Clinical Information

For the treatment of Athlete's Foot, patients should apply a thin layer of FungaBlend10® Athlete's Foot Cream twice daily (AM and PM) to the affected area for a duration of 2 weeks, or as directed by a physician. In cases of Jock Itch and Ringworm, the cream should be applied once daily to the affected area for 1 week, or as directed by a physician.

Clinicians should counsel patients to complete the full treatment course, even if symptoms improve before the treatment period ends, as premature discontinuation may lead to a recurrence of the infection. Patients are advised to seek medical attention if their condition worsens or fails to improve within 4 weeks for Athlete's Foot, or within 2 weeks for Jock Itch and Ringworm.

Drug Information (PDF)

This file contains official product information for Terbinafine Hydrochloride, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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