- October 14, 2018
- Dermatology
- Vitaly Vitalievich
In this article we will look at the instructions for use for Biafine cream, emulsion and ointment.
Medicines from this manufacturer are suitable for the treatment of 1st and 2nd degree burns and any other non-infected skin lesions (including the treatment of sunburn).
Biafine is produced in three forms - cream, ointment and emulsion. They work on the skin by providing intense hydration to optimize healing processes and protect wounds from contamination.
These medications are used for a variety of ulcerative lesions of the skin surface, for inflammatory phenomena provoked by radiation therapy, for various wounds and cuts as soft healing preparations.
Biafine cream and ointment have a more concentrated composition compared to the emulsion. They are recommended to be applied to wounds and various areas of ulcerative skin lesions. The emulsion is used when treating large areas of the body, for example, for sunburn.
Release form and composition
Release forms of Binafin:
- Tablets: round, biconvex, white to white with a yellowish tint (14 pieces in blisters, 1 blister in a cardboard box);
- Cream 1%: soft, homogeneous, white (in tubes of 10, 15 and 30 g, 1 tube in a cardboard box).
Active substance – terbinafine hydrochloride:
- 1 tablet – 125 or 250 mg;
- 1 g of cream – 10 mg.
Excipients:
- Tablets: microcrystalline cellulose, starch, povidone, colloidal silicon dioxide, sodium lauryl sulfate, sodium methylparaben, magnesium stearate, talc, sodium starch glycolate;
- Cream: ketosteryl alcohol, soft white paraffin, liquid paraffin, methylparaben, ketomacrogol, isopryl myristate, sodium acid phosphate, propylparaben, water.
Binafin. Analogues
Binafin itself is a budget analogue of Lamisil. The latter is produced in the UK, Germany and Switzerland and costs approximately 2.5 times more. Binafin is an Indian drug. The medicine also has domestic analogues.
The most common analogue drugs of Binafin:
- Terbinafine MFF. Russian remedy. Ointment. The active ingredient is terbinafine hydrochloride. Approximate price: 200-250 rubles.
- Exifin. Indian medicine. Tablets and cream. The active ingredient is terbinafine hydrochloride. The cost is approximately 1000 rubles.
- Terbinafine Teva. Israeli drug. Pills. The active ingredient is terbinafine hydrochloride. The cost is about 750 rubles.
- Terbizil. Produced in Hungary. Tablets and cream. The active ingredient is terbinafine. The cost is about 1100 rubles.
- Terbinafine-Sar. Pills. The active ingredient is terbinafine. Russian production. Price - around 450 rubles.
If you wish, you can save money and purchase the cheapest drug, but the doctor will prescribe the right remedy, since the choice depends on the characteristics of the body and the form of fungal organisms.
Pharmacological properties
Pharmacodynamics
The active component of Binafine, terbinafine, is a synthetic antimycotic agent of the allylamine class with a wide spectrum of antifungal action.
Terbinafine is active against pathological microflora that cause diseases of the skin, nails and hair: dermatophytes of the genus Trichophyton (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T.violaceum), Epidermophyton floccosum, Microsporum canis, as well as yeast-like fungi of the genus Candida (including Candida albicans) and Pityrosporum (Malassezia restricta and globosa).
In low doses, terbinafine exhibits fungicidal activity against molds, dermatophytes and some dimorphic fungi. Depending on their type, the effect on yeast-like fungi can be fungistatic or fungicidal.
Due to the ability of terbinafine to specifically inhibit the biosynthesis of sterols in the fungal cell, ergosterol deficiency and intracellular accumulation of squalene occur at an early stage, which causes the death of the fungal cell. The effect of terbinafine is based on its inhibition of the enzyme squalene epoxidase in the cell membrane of the fungus. Since the enzyme is not part of the cytochrome P450 system, terbinafine does not affect the metabolism of hormones and other drugs.
Pharmacokinetics
- absorption: due to a single oral dose of 250 mg of terbinafine, its maximum concentration (Cmax) in plasma is reached after 2 hours and is 0.97 mcg/ml; half-absorption period is 0.8 hours; Food intake does not affect the bioavailability of the substance. As a result of the use of the cream, <5% of the dose is locally absorbed, and therefore the systemic effect of the drug is minimal;
- distribution: up to 99% of terbinafine is bound to plasma proteins; its half-life is 4.6 hours; the substance quickly penetrates the dermis and accumulates in the lipophilic stratum corneum, and also has the ability to penetrate the secretions of the sebaceous glands, due to which, in the first few weeks, high (fungicidal) concentrations of the substance are created in the nails, hair follicles and skin rich in sebaceous glands;
- metabolism: rapid biotransformation of terbinafine occurs in the liver with the participation of cytochrome P450 isoenzymes CYP2C9, CYP1A2, CYP3A4, CYP2C8, CYP2C19, resulting in the formation of inactive metabolites;
- excretion: terbinafine is excreted mainly by the kidneys in the form of metabolites. Its half-life (T1/2) is ~ 17 hours; there is no evidence of accumulation of the substance in the body; Terbinafine is also excreted in breast milk.
No dependence of the steady-state concentration (Css) of terbinafine on age was detected.
If hepatic or renal function is impaired, the elimination rate of terbinafine may be slower, resulting in higher plasma concentrations. In pharmacokinetic studies, administration of a single dose of Binafine to patients with concomitant liver dysfunction showed the possibility of reducing the clearance of terbinafine by 50%.
Binafin in the treatment of fungus
The active substance of the composition (terbinafine) suppresses and stops the production of proteins in mycelial cells. This leads to a deficiency of elements vital for the fungus (ergosterol) and an excess of dangerous elements (squalene), due to which the parasitic microorganism dies.
Under the influence of the drug, the production of squalene epoxidase, which is important for the fungus, slows down, which destroys mycelial cells.
Binafin penetrates almost instantly into the infected area and already on the second day the concentration of the drug in the stratum corneum increases 10 times. On the 13th day, this parameter increases 7 times.
The period for removing the drug from the body is 24-150 days. This circumstance allows the infected area to receive support with medicinal elements for a long time.
When it enters the gastrointestinal tract, the main active ingredient is absorbed by more than 70 percent and after 2 hours it actively works against parasitic microorganisms.
Taking the medicine orally in a short time creates accumulations of useful substances in the skin, nails and hair, which throughout the entire therapeutic course supply the body's tissues with protective forces and gradually kill fungal cells.
Instructions for use of Binafin: method and dosage
Binafin tablets must be taken once a day.
A single dose is prescribed based on the patient’s body weight:
- Children weighing less than 20 kg – 62.5 mg (1/2 tablet of 125 mg);
- Children weighing from 20 to 40 kg – 125 mg;
- Children weighing more than 40 kg and adults – 250 mg.
No dose adjustment of Binafin is required in elderly patients, provided that they do not have symptoms of liver or kidney failure.
The duration of therapy depends on the severity of the disease:
- Skin infections – 2-6 weeks;
- Fungal infections of the scalp – 4 weeks;
- Fungal infections of the nail plates – from 6 to 12 weeks.
Binafin cream is prescribed to adults and children over 12 years of age. The drug is applied to previously cleaned and dried affected areas of the skin with light massaging movements 1-2 times a day. If the cream is used at night, the application site can be covered with a gauze bandage. The duration of treatment is 1-2 weeks.
Binafin. Who is the drug indicated for?
The drug in the form of a cream is prescribed in the following cases:
- ringworm (especially lichen versicolor);
- candidiasis on the skin and nails;
- dermatophytosis (molds).
The medicine in tablet form is prescribed for mycotic lesions of the nails, scalp and cutaneous dermatomycosis. When infected with parasites of the genus Candida, tablets are prescribed only when the disease is advanced and when the microorganisms are very widespread.
Pityriasis versicolor cannot be treated with tablets - only with external means.
If nails are damaged, cream is not prescribed - its composition is not able to reach the deep layers of the plate. However, parasites are able to invade nearby skin areas, then for nail fungus, cream is prescribed only under the following conditions:
- thickening and roughening of the skin;
- peeling of skin particles, appearance of peeling;
- the formation of itchy vesicular formations filled with liquid;
- cracking of the skin.
In other cases, the cream will not be effective. In general, the reviews from people who use Binafin for nail fungus are positive, and the price of the product is quite low compared to some similar medications.
Side effects
The use of Binafin may cause the following side effects:
- Lack of appetite, nausea, abdominal pain, diarrhea, impaired taste; in rare cases - liver failure;
- Arthralgia, myalgia;
- Agranulocytosis, neutropenia, thrombocytopenia;
- Allergic reactions: urticaria, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis.
If the skin rash progresses, drug treatment should be discontinued.
Overdose
There have been reports of several episodes of Binafin overdose, when a dose of up to 5 g of terbinafine was taken orally, resulting in nausea, headache, dizziness, and epigastric pain.
For the treatment of overdose, gastric lavage is recommended, followed by the intake of absorbents (activated carbon), and, if necessary, supportive symptomatic treatment.
There is no data on an overdose of Binafin cream for external use. If it is accidentally ingested, the same systemic adverse reactions can be expected to develop as for tablets.
Prevention of fungal diseases
Prevention of a disease such as onychomycosis lies in constant personal hygiene. It is recommended to wash your feet every day with soapy water and change your socks. In the store, it is best to purchase comfortable and high-quality shoes in which the skin can breathe. Narrow, tight and poorly breathable shoes can provoke the development of a fungal disease.
For excessive sweating of the feet, it is recommended to use special products that can be purchased at the pharmacy. In addition, it is important to avoid injuries and damage to the skin, as this can cause the development of onychomycosis. When visiting public places, saunas and swimming pools, you must wear rubber slippers. It is recommended to get manicures and pedicures in trusted salons, and at home to use only personal tools.
special instructions
If, during treatment with Binafin, the patient experiences persistent nausea, vomiting, lack of appetite, pain in the right hypochondrium, fatigue, darkening of the urine, lightening of the stool, then it is necessary to take a biochemical blood test for liver enzymes (ALT, AST) and discontinue therapy with this drug. The patient should be aware of the need to consult a doctor if such symptoms occur.
In patients with impaired renal function (serum creatinine concentration more than 300 µmol/l), it is recommended to reduce the dose of the drug by 50%.
Impact on the ability to drive vehicles and complex mechanisms
There are no reports of negative effects of Binafin on the ability to drive a car or operate complex machinery.
Drug interactions
Possible drug interactions with systemic use of terbinafine:
- tolbutamide, cycloserine, triazolam, oral contraceptives, other drugs metabolized by the cytochrome P450 system: terbinafine slightly reduces or increases their clearance;
- tricyclic antidepressants, β-blockers, monoamine oxidase inhibitors (MAO) type B, selective serotonin reuptake inhibitors (SSRIs), other drugs and substances metabolized by the cytochrome CYP2D6 isoenzyme: terbinafine, when administered simultaneously, can have a clinically significant effect on them due to the fact that inhibits the metabolism of this isoenzyme;
- oral contraceptives: patients simultaneously taking Binafin experience irregularities in the regularity of the menstrual cycle, which is within the range of values recorded when taking only oral contraceptives;
- rifampicin and other cytochrome P450 inducers: may increase the overall clearance of terbinafine; adequate adjustment of the dosage regimen may be required;
- cimetidine and other cytochrome P450 inhibitors: the overall clearance of terbinafine may be slowed down, and adequate dosage adjustment may be required.
Due to the low systemic absorption, there is no drug interaction with Binafin cream.
Reviews about Binafin
According to reviews, Binafin copes well with fungal infections of various origins and locations. Patients note the high effectiveness of the drug, but warn that they should be patient, since complete recovery in some cases requires quite a lot of time. The drug is recommended as a cheaper analogue of often advertised expensive drugs, which is in no way inferior to them in therapeutic effect. Indicate the economical use of cream.
