Terbinafine Hydrochloride Tablets

Terbinafine hydrochloride is a broad-spectrum antifungal drug of the allylamine class. It can specifically interfere with the early biosynthesis of fungal sterols, selectively inhibit the activity of fungal squalene epoxidase, and hinder the squalene epoxidation reaction in the process of fungal cell membrane formation, thereby achieving the effect of killing or inhibiting fungi.

Terbinafine Hydrochloride

This product is white or off-white tablets.

Applicable to: 1. Infections of skin, hair and nails caused by Trichophyton, Microsporum canis and Epidermophyton floccosum; 2. Various ringworms and skin yeast infections caused by Candida; 3. Onychomycosis caused by mold fungi.

Oral administration, 0.25 g per time for adults, once a day, the course of treatment is as follows: Course of treatment for skin infections: tinea pedis and tinea manuum [interdigital and plantar types]: 2-6 weeks; tinea corporis, tinea cruris: 2-4 weeks; cutaneous candidiasis: 2-4 weeks. It will take several weeks after mycological cure to see the skin appear completely normal and the symptoms of infection disappear. Course of treatment for hair and scalp infections: Tinea capitis: 4 weeks, tinea capitis mostly occurs in children; Onychomycosis: The course of treatment for most patients is 6 weeks to 3 months, among which young patients can shorten the course of treatment due to normal nail growth, so less than 3 months of treatment may be sufficient except for thumb (toe) nails. In other cases, the course of treatment is usually only 3 months. Some patients, especially those with thumb (toe) nail infections, may need 6 months or longer. Patients with slow nail growth seen in the first week of treatment may need a course of treatment longer than 3 months. A few months after mycological cure and cessation, the condition can continue to improve until the appearance of the nail plate is completely normal, because it takes time for healthy nail tissue to grow.

This product is well tolerated, with mild to moderate side effects that are often transient. The most common are gastrointestinal symptoms (fullness, loss of appetite, nausea, mild abdominal pain and diarrhea) or mild skin reactions (rash, urticaria, etc.). Individual cases of severe skin reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. If progressive rash occurs, the drug should be discontinued. Rare taste changes, including loss of taste, can be recovered within a few weeks after discontinuation of the drug. In very rare cases, hepatobiliary dysfunction has occurred. Whether it is caused by this product has not yet been confirmed, but if the above situation occurs, this product should be discontinued. It has been reported that very few patients have neutropenia.

It is contraindicated for patients who are allergic to terbinafine hydrochloride and other ingredients of this product.

Precautions for children: Children over 2 years old tolerate terbinafine orally. Precautions for pregnancy and lactation: Studies on pregnancy and mammals have shown that this product has no adverse effects on the fetus and fertility. Since the experience of using this product in pregnant women is very limited, the pros and cons should be weighed, and in principle, pregnant women should not use it. Terbinafine hydrochloride can be excreted in breast milk, so mothers who receive oral treatment with this product should not breastfeed. Precautions for the elderly: There is no evidence to suggest that elderly patients need to take different doses or have different reactions than young patients. When prescribing, the possibility of liver and kidney damage in patients in this age group should be considered (see Precautions).

Interaction studies have shown that terbinafine has little effect on the clearance of drugs metabolized by the cytochrome P450 enzyme system (such as cyclosporine, D860 or oral contraceptives). However, women who use oral contraceptives should use this product with caution, because a very small number of people may have menstrual disorders. In addition, hepatic enzyme inducers (such as rifampicin, etc.) can accelerate the plasma clearance of terbinafine, while hepatic enzyme inhibitors (such as cimetidine, etc.) can inhibit its clearance. Therefore, if all of these are needed, the dose of terbinafine needs to be adjusted appropriately.

Keep in a light-proof and airtight container.

0.125g (calculated as terbinafine hydrochloride)

36 months.

Hubei Heng'an Fulin Pharmaceutical Co., Ltd.

• Founded in:

  2001-06-15

• Address:

  Hubei Yichang Hengan Pharmaceutical Biological Industrial Park

• Tax NO.:

  9142050072831140XW

• Registered Funds:

  60 million yuan

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