Product Overview
【Generic Name】
Terbinafine Hydrochloride Tablets
【Trade Name】
Mesasu
【English Name】
Terbinafine Hydrochloride Tablets
【Pinyin】
YanSuanTeBiNaiFenPian
【Ingredients】
Terbinafine Hydrochloride
【Appearance】
This product is a white or off-white tablet.
【Indications】
Suitable for: 1. Skin, hair, and nail infections caused by Trichophyton, Microsporum canis, and Epidermophyton floccosum; 2. Various tinea infections and cutaneous yeast infections caused by Candida; 3. Onychomycosis caused by fungi.
【Dosage and Administration】
Oral administration. Adults take 0.25g once daily. Treatment duration is as follows: 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 observed several weeks after mycological cure. Treatment course 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, due to normal nail growth, may have a shorter treatment course; therefore, except for thumb (toenail) infections, less than 3 months of treatment 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 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. Rare taste changes, including loss of taste, are possible; the latter usually resolves within a few weeks after discontinuation. In extremely rare cases, hepatobiliary dysfunction has occurred; whether this is caused by the drug is uncertain, but if this occurs, the drug 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. In patients with hepatic or renal impairment (liver anhydride clearance 50 ml/min, serum creatinine 300 μmol/L), the terbinafine dose should be reduced by 50% (see “Adverse Reactions”); 2. Keep out of reach of children; 3. Studies in pregnancy and mammals have shown no adverse effects on the fetus or fertility. However, due to very limited experience with its use in pregnant women, the risks and benefits should be carefully weighed, and pregnant women should generally not use this drug. Terbinafine is excreted in breast milk; therefore, mothers receiving oral terbinafine treatment should not breastfeed.4. 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 these drugs are required, the dosage of terbinafine should be adjusted appropriately.
5. This product is ineffective for tinea versicolor when taken orally.
[Precautions for Children]
Children over 2 years of age tolerate oral terbinafine well.
[Precautions for Pregnancy and Lactation]
Studies in pregnancy and mammals show that this product has no adverse effects on the fetus or 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 Elderly Patients]
There is no evidence that elderly patients require different dosages or experience different responses 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 enzymes (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 should be appropriately adjusted.
[Pharmacological Action]
Terbinafine hydrochloride is an allylamine broad-spectrum antifungal drug. It specifically interferes with the early biosynthesis of fungal sterols, selectively inhibits the activity of fungal squalene epoxidase, and blocks the squalene epoxidation reaction during fungal cell membrane formation, thereby achieving the effect of killing or inhibiting fungi.
【Storage】
Protect from light and store in a tightly closed container.
【Specifications】
0.125g (calculated as terbinafine hydrochloride)
【Packaging Specifications】
0.125g * 6 tablets
【Shelf Life】
24 months.
【Approval Number】
National Drug Approval Number H20103319
【Company Name】
Hubei Heng'an Pharmaceutical Co., Ltd.
