Product Overview
【Drug Name】
Generic Name: Terbinafine Hydrochloride Tablets
Brand Name: Chenggong
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 dermatophytes.
【Dosage and Administration】
Oral administration. Adults take 0.25g once daily. Treatment courses are as follows:
* Skin infections: Tinea pedis/manuum [interdigital and plantar types]: 2-6 weeks; Tinea corporis/jock itch: 2-4 weeks; Cutaneous candidiasis: 2-4 weeks. Complete normalization of skin appearance and disappearance of symptoms are typically observed several weeks after mycological cure.
* 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, due to normal nail growth, may have a shorter treatment course; therefore, except for thumb (toenail) infections, treatment of less than 3 months may be sufficient. 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 discontinuation, continued improvement can be observed 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. Rare taste changes, including loss of taste, are possible, but these usually resolve 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 it occurs, the product should be discontinued. Neutropenia has been reported in very rare cases.
【Contraindications】
Terbinafine hydrochloride is contraindicated in patients with known hypersensitivity to any of its components.
【Precautions】
1. Patients with hepatic or renal insufficiency (creatinine clearance 50 ml/min, or serum creatinine 300 μmol/L) should have their dose reduced by 50%. Keep out of reach of children.
2. Pregnancy and mammalian studies have shown that this product has no adverse effects on the fetus or fertility. Because experience with this product in pregnant women is extremely limited, it should not be used by pregnant women unless the potential benefits outweigh any potential risks. Terbinafine is excreted in breast milk; therefore, mothers receiving oral treatment with this product should not breastfeed.
3. Interaction studies have shown that terbinafine has little 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 these drugs are used concurrently, the dosage of this product should be adjusted accordingly.
4. Oral administration of this product is ineffective against tinea versicolor.
【Special Populations】
Precautions for Children: Oral administration of this product is well tolerated in children over 2 years of age.
Pregnancy and Lactation Precautions: Studies in pregnancy and mammals show that this product has no adverse effects on the fetus or fertility. Due to extremely limited experience with this product in pregnant women, 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: There is no evidence that elderly patients require different dosages or experience different side effects compared to younger patients. When prescribing, the possibility of liver or kidney impairment in this age group should be considered (see Precautions).
【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. 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 all of these are needed, the dosage of terbinafine must 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 and selectively inhibits 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】
0.25g (calculated as terbinafine hydrochloride)
【Packaging Specifications】
0.25g*12 tablets/box
【Shelf Life】
36 months.
【Execution Standard】
WS1-(X-119)-2004Z
【Approval Number】
National Drug Approval Number H20083377
【Manufacturer】
Nanjing Chenggong Pharmaceutical Co., Ltd.
