Product Overview
【Drug Name】
Generic Name: Terbinafine Hydrochloride Tablets
Brand Name: Beijia
English Name: Terbinafine Hydrochloride Tablets
Pinyin: Yansuan Tebinaifen Pian
【Ingredients】
Terbinafine Hydrochloride
【Appearance】
This product is a white or off-white tablet.
【Indications】
This product is suitable for: 1. Infections of the skin, hair, and nails caused by Trichophyton (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucous, Trichophyton tonsurans, and Trichophyton violaceum, etc.), Microsporum canis, and Epidermophyton floccosum, etc.; 2. Various tinea infections (tinea corporis, tinea cruris, tinea pedis, and tinea capitis, etc.) and dermatophyte infections caused by Candida (Candida albicans, etc.); 3. Onychomycosis (nail fungal infection) caused by mold.
【Dosage and Administration】
Oral administration. Adults take 0.25g once daily. Treatment courses are as follows: Treatment courses for skin infections: Tinea pedis [interdigital and plantar types]: 2-6 weeks; Tinea corporis, tinea cruris: 2-4 weeks; Cutaneous candidiasis: 2-4 weeks. Complete normalization of skin appearance and disappearance of infection symptoms are seen several weeks after mycological cure. Treatment courses for hair and scalp infections: Tinea capitis: 4 weeks (most cases occur in children); Onychomycosis: The vast majority of patients require 6 weeks to 3 months of treatment. Younger patients may have a shorter treatment course due to normal nail growth, so treatment of less than 3 months may be sufficient except for thumb (toenail) infections. In other cases, the treatment course is usually only 3 months. Some patients, especially those with thumb (toenail) infections, may require 6 months or longer. Patients with slow nail growth observed in the first week of treatment may require more than 3 months of treatment. Several months after mycological cure and cessation, continued improvement can be seen until the nail plate appears completely normal, as healthy nail tissue takes time to grow. [Adverse Reactions] This product is well tolerated, with mild to moderate side effects, which are often transient. The most common side effects are gastrointestinal symptoms (bloating, loss of appetite, nausea, mild abdominal pain, and diarrhea) or mild skin reactions (rash, urticaria, etc.). Rare cases of severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported; if a progressive rash occurs, the drug should be discontinued. Rarely, taste changes, including loss of taste, may occur; the latter usually resolves within a few weeks after discontinuation. In very rare cases, hepatobiliary dysfunction has occurred; whether this is caused by the product is uncertain, but if such a condition occurs, the product should be discontinued. Neutropenia has been reported in very rare cases.
【Contraindications】
Terbinafine hydrochloride and any other component of this product are contraindicated in patients with known hypersensitivity to these substances.
【Precautions】
1. Patients with hepatic or renal insufficiency (liver anhydride clearance 50 ml/min, serum creatinine 300 u mol/L) should have their terbinafine dose reduced by 50% (see “Adverse Reactions”); this product should be kept out of reach of children; 2. Pregnancy and mammalian studies have shown that this product has no adverse effects on the fetus and fertility; however, due to extremely limited experience with its use in pregnant women, the benefits and risks should be weighed, and in principle, pregnant women should not use it; terbinafine is excreted in breast milk, therefore mothers receiving oral terbinafine treatment should not breastfeed; 3. Interaction studies have shown that terbinafine has almost no effect on the clearance of drugs metabolized by cytochrome P450 enzyme systems (such as cyclosporine, D860, or oral contraceptives); however, women using oral contraceptives should use this product with caution, as menstrual irregularities may occur in rare cases; in addition, hepatic enzyme inducers (such as rifampin) can accelerate the plasma clearance of terbinafine, while hepatic enzyme inhibitors (such as cimetidine) can inhibit its clearance. Therefore, if these drugs are required, the dosage of terbinafine needs to be adjusted appropriately. 4. This product is ineffective for tinea versicolor when taken orally.
【Special Populations】
Precautions for Children: Not yet clear.
Precautions for Pregnancy and Lactation: Studies in pregnancy and mammals show that this product has no adverse effects on the fetus and fertility. Because experience with this product in pregnant women is extremely limited, the benefits and risks should be weighed, and in principle, pregnant women should not use it. Terbinafine hydrochloride is excreted in breast milk; therefore, mothers receiving oral treatment with this product should not breastfeed.
Precautions for the Elderly: Not yet clear. [Drug Interactions] Interaction studies have shown that terbinafine has almost no effect on the clearance of drugs metabolized by cytochrome P450 enzyme systems (such as cyclosporine, D860, or oral contraceptives). However, women using oral contraceptives should use this product with caution, as menstrual irregularities may occur in rare cases. Furthermore, hepatic enzyme inducers (such as rifampin) can accelerate the plasma clearance of terbinafine, while hepatic enzyme inhibitors (such as cimetidine) can inhibit its clearance; therefore, if all of these are used, the dosage of terbinafine needs to be adjusted appropriately.
【Pharmacological Action】
Terbinafine hydrochloride is a broad-spectrum antifungal drug of the allylamine class. It specifically interferes with the early biosynthesis of fungal sterols, selectively inhibiting the activity of fungal squalene epoxidase, thus blocking the squalene epoxidation reaction during fungal cell membrane formation, thereby achieving the effect of killing or inhibiting fungi.
【Storage】
Store protected from light and in a tightly closed container.
【Specifications】
0.125g (calculated as terbinafine hydrochloride)
【Packaging Specifications】
0.125g
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H19980206
【Manufacturer】
Company Name: Baoding Tianhao Pharmaceutical Co., Ltd.
