Product Overview
【Drug Name】
Generic Name: Terbinafine Hydrochloride Tablets
Brand Name: Aobang
English Name: Terbinafine Hydrochloride Tablets
Pinyin: YanSuanTeBiNaiFenPian(BangKeXin)
【Ingredients】
The main ingredient of this product is terbinafine hydrochloride. Molecular weight: C21H25NHCl
【Appearance】
This product is a white tablet.
【Indications】
Fungal infections of the skin and hair caused by dermatophytes such as Trichophyton rubrum (Trichophyton mentagrophytes, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton violaceum), Microsporum canis, and Epidermophyton floccosum. This product is only used to treat large-area, severe fungal skin infections (tinea corporis, tinea cruris, tinea pedis, tinea capitis) and yeast infections of the skin caused by Candida (such as Candida albicans). The necessity of oral administration is considered based on the site, severity, and extent of the infection. Onychomycosis caused by dermatophyte (filamentous fungus) infection
【Dosage and Administration】
Adjust the course of treatment according to the severity of the infection and indications.
Adults: 0.25g once daily.
Adolescents: Weight > 40kg (usually age > 12 years): 250mg once daily.
Children: Weight 20-40kg (usually age 5-12 years): 125mg once daily. (See inner packaging instructions for details.)
【Adverse Reactions】
Generally, this product is well tolerated, and side effects are usually mild to moderate. The most common are gastrointestinal symptoms (bloating, decreased appetite, indigestion, nausea, mild abdominal pain, and diarrhea) or mild skin reactions (rash, urticaria), and musculoskeletal reactions (arthralgia, myalgia). Less common: taste disturbances, including loss of taste, which often recover within several weeks after discontinuation of the drug. (See inner packaging instructions for details.)
【Contraindications】
Contraindicated in patients with known hypersensitivity to terbinafine hydrochloride or any other component of this product. 【Precautions】If a patient develops signs or suggestive symptoms of impaired liver function, such as unexplained nausea, anorexia, fatigue, jaundice, black urine, or colorless stools, these should be confirmed to be of hepatic origin, and treatment with this product should be discontinued (see Adverse Reactions). Single-dose pharmacokinetic studies in patients with pre-existing liver disease showed a 50% reduction in terbinafine hydrochloride clearance. No prospective clinical trials have been conducted on the use of terbinafine hydrochloride in patients with chronic or active liver disease; therefore, it is not recommended. (See package insert for details) Please read the package insert carefully and use as directed by your doctor.
【Special Populations】
Children's Precautions: This product is well tolerated in children over 2 years of age.
Pregnancy and Lactation Precautions: During pregnancy, this product should not be used if the benefits do not outweigh the risks (see package insert for details).
Elderly Precautions: Not yet clear.
【Drug Interactions】
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 a very small number may experience menstrual irregularities. 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 an allylamine drug with broad-spectrum antifungal activity. This product specifically interferes with the early biosynthesis of fungal sterols, selectively inhibiting fungal squalene epoxidase, thus hindering the squalene epoxidation reaction during fungal cell membrane formation, thereby achieving the effect of killing or inhibiting fungi.
【Storage】
Sealed.
【Specifications】
0.25g
【Packaging Specifications】
Pharmaceutical PVC rigid sheet/Pharmaceutical packaging PTP aluminum foil, 8 tablets/blister.
【Shelf Life】
36 months.
[Approval Number]
National Drug Approval Number H20094133 [Manufacturer] Company Name: Sichuan Aobang Pharmaceutical Co., Ltd.
