Stock Supply Of Terbinafine Hydrochloride To Ensure The Quality Of Terbinafine Hydrochloride
Oral tablet editing broadcast
Oral tablets -- For deep fungal infections: Lamisic Novartis (prescription)
Terbinafine hydrochloride molecular structural formula
Terbinafine hydrochloride molecular structural formula
General name: Terbinafine hydrochloride tablet manufacturer name: Lanmeishu
English name: Terbinafine Hydrochloride Tablets
The chemical name of Terbinafine hydrochloride is: (E) -N- (6, 6-dimethyl-2-heptene-4-alkynyl) -n-methyl-1-formamide naphthalene. hydrochloride
Properties: This product is white tablet.
Pharmacological action editorial report
Terbinafine hydrochloride is an acrylamide with broad-spectrum antifungal activity. This product can specifically interfere with the early biosynthesis of fungal ergosterol, highly selectively inhibit the squalene cycoperoxidase of fungi, and prevent the epoxidation of squalene during the formation of fungal cell membrane, so as to achieve the effect of killing or inhibiting fungi.
The indications are edited
1. Infection of skin, hair and nail caused by trichophyton (trichophyton red, trichophyton trichophyton, Trichophyton warthoid, trichophyton broken and trichophyton purple, etc.), microspora Canis and trichophyton flocculus epidermoides.
2. All kinds of tinea disease (ringworm of the body, tinea, tinea manus and tinea capitis, etc.) and by candida (candida albicans, etc.) caused by yeast infections of the skin.
3. An onychomycosis (nail fungal infection) caused by dermosis.
This product is only used for the treatment of large-area and severe dermatomycetes infection (tinea corporis, tinea corporis, tinea pedis, tinea capitis) and dermatomycetes infection caused by Candida albicans (such as Candida albicans). Oral administration is necessary according to the site, severity and scope of infection. Dermatophyte (filamentous fungus) infection caused by tinea thyroid
[Usage and dosage] Adjust the course of treatment according to the severity of infection and indications.
Oral, adults each time 0.25 grams, once a day, the course of treatment is as follows: skin infection course: tinea pedis [toe (finger) and plantar type] : 2-6 weeks; Tinea corpora, tinea corpora: 2-4 weeks: skin infection with mycosis: 2-4 weeks. After a few weeks of mycological cure, the appearance of the skin is completely normal and the symptoms of infection disappear.
Adults: 1 tablet (0.25g) once daily
Adolescents, weight > 40kg (usual age > 12 years) : 1 tablet (0.25g) once a day
Children, weighing 20-40kg (usually aged 5-12 years) : one half tablet (0.125g) once a day
Children, weight < 20kg usual age < Age 5: There is very limited information available from controlled trials for this group of patients, so drugs should only be used if there are no other treatment options and the potential therapeutic benefits outweigh the possible risks.
This product is not recommended for use in children younger than 2 years of age because there is no experience with oral terbinafine
Recommended course of treatment:
Tinea pedis (intertoe, plantar/slipper) :2 to 6 weeks of ringworm of the body, jock itch :2 to 4 weeks
Cutaneous candidiasis: 2 to 4 weeks
Resolution of signs and symptoms of infection may not occur until several weeks after mycological cure.
Hair and scalp infections
Recommended course of treatment: Tinea capitis mainly seen in children
Tinea capitis: 4 weeks
Onychomycosis: For most patients, the treatment course is 6-12 weeks
Nail fungal disease: In most cases of nail fungal infection, the treatment course is 12 weeks. Some patients with poor nail growth require a longer course of treatment. Good clinical results are often seen after mycological cure and several months after discontinuation of treatment, which is related to the time required for healthy nails to grow.
The adverse reaction editor reports
Frequency estimation: very common ≥10%, common 1%-10%, uncommon 0.1%, rare 0.01%-0.1%, very rare < 0.01%
Terbinafine is generally well tolerated, with mild to moderate adverse reactions. The most common are gastrointestinal symptoms (bloating, decreased appetite, indigestion, nausea, mild abdominal pain, diarrhea), mild skin reactions (rash, hives), skeletal muscle reactions (arthralgia, myalgia)
Uncommon: Taste disturbances, including loss of taste, usually recover within weeks of discontinuation
Rare: There have been reports of hepatobiliary dysfunction (actually primary cholestasis type) associated with terbinafine therapy, including very rare liver failure (see Precautions)
Very rare: severe skin reactions (e.g., Steven-Johnson syndrome, toxic epidermal necrosis) and anaphylaxis have been reported. Treatment with terbinafine should be discontinued if progressive rash occurs
Very rare: hematological disorders such as neutropenia, granulocytosis, or thrombocytopenia have been reported
Very rarely, hair loss has been reported, although the etiological relationship has not been determined
【 Contraindication 】 Patients who are allergic to Terbinafine hydrochloride and other components of this product should not be allowed
Notes Editorial broadcast
Hepatic origin should be confirmed and terbinafine should be discontinued if the patient develops signs or suggestive symptoms of liver insufficiency, such as unexplained nausea, anorexia, or lethargy, or jaundice, dark urine, or colorless stool (see adverse reactions). In a single dose pharmacokinetic study in patients with pre-existing liver disease, terbinafine clearance was reduced by 50%. Terbinafine has not been studied in prospective clinical trials in patients with chronic or active liver disease, so it is not recommended. Patients with impaired renal function (creatinine clearance of less than 50ml/ min or serum creatinine of more than 300umot/l) should receive half the normal dose. In vitro studies have shown that terbinafine inhibits the metabolism of CYP2D6. Therefore, drugs that are metabolized primarily by this enzyme should be treated with caution when the treatment window is narrow. (See Drug interactions)
Oral administration of this product has no effect on tinea versicolor
[Drug use for pregnant and lactating women] Fetal toxicity and fertility animal experiments found no adverse reactions. Due to very limited clinical experience in pregnant women, medications should not be used during pregnancy if the benefits do not outweigh the risks. Terbinafine can be secreted into breast milk, so mothers treated with oral terbinafine should not breastfeed.
Oral terbinafine was well tolerated in children over 2 years of age
[Medication for Elderly patients] There is no evidence to suggest that elderly and young patients should take different doses or react differently. The possibility of liver and kidney damage in this age group should be taken into account when prescribing (see precautions).
[Drug interactions] Terbinafine has been shown to inhibit cytochrome P45 in most neurons, according to in vitro studies and studies in healthy volunteers
Contraindications: Patients who are allergic to Terbinafine hydrochloride and other components of this product should not be allowed.
Points to note:
1. Hepatic or renal insufficiency (creatinine clearance < 50ml/ min, serum creatinine > At 300u mol/ L), terbinafine dose should be reduced by 50%(see "Adverse reactions").
2. Pregnancy and mammalian studies have shown no adverse effects on the fetus and fertility. Due to the very limited experience of using this product for pregnant women, the pros and cons should be weighed and in principle should not be used by pregnant women. Terbinafine can be excreted through breast milk, so mothers receiving oral treatment with Terbinafine should not breastfeed.
3. Interaction studies have demonstrated that Terbinafine has little effect on the clearance of drugs metabolized by the cytochrome P450 enzyme line, such as cyclosporine, D860 or oral contraceptives. However, women using oral contraceptives should use them with caution, as very few may have menstrual disorders. In addition, the plasma clearance of terbinafine can be accelerated by liver enzyme inducers (e.g. Rifamequine) and inhibited by liver enzyme inhibitors (e.g. Cimetidine). Therefore, the dosage of terbinafine should be adjusted appropriately if the above drugs are required.
4. Oral administration of this product has no effect on tinea versicolor.
5. Keep this product out of reach of children.