Terbix, spray 1% 30 g

Antifungal drug for external use with a broad spectrum of antifungal activity. In low concentrations, terbinafine has fungicidal activity against dermatophytes (Trychophyton rubrum Trychophyton mentagrophytes Trychophyton verrucosum Trychophyton violaceum Trychophyton tonsurans Microsporum canis Epidermophyton floccosum) molds (mainly Candida albicans) and certain dimorphs (Pityrosporum orbiculare). Activity against yeast fungi depending on their species can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and to intracellular accumulation of squalene which causes cell death of the fungus. The action of terbinafine is carried out by inhibiting the enzyme squaleneepoxidase located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and therefore on the metabolism of hormones or other drugs.

Pharmacokinetics: When applied externally, absorption is less than 5% has a slight systemic effect.

Indications

Treatment of fungal skin infections, including mycosis of the feet (“fungus” of the foot), inguinal athlete’s foot (tinea cruris), fungal infections of the smooth
body skin (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes,
Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis and Epidermophyton floccosum.
Diaper rash caused by mold fungi.
Ringworm (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Pharmacological effect

Pharmacotherapeutic group
Antifungal agent.
ATX code: D01AE15.
Pharmacological properties
An antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds and certain
dimorphic fungi. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.
Terbinafine specifically alters the early stage of sterol biosynthesis occurring in fungi. This leads to ergosterol deficiency and
intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine acts by inhibiting the enzyme
squalene epoxidase, located on the cell membrane of the fungus. Terbinafine has no effect on the cytochrome P450 system in humans and,
accordingly, on the metabolism of hormones or other drugs.
Pharmacokinetics
When applied externally, absorption is less than 5%, and therefore systemic bioavailability is low.

Special instructions

A decrease in the severity of clinical manifestations is usually observed in the first days of treatment. In case of irregular treatment or its premature termination, there is a risk of recurrence of infection. If after two weeks of treatment there are no signs of improvement, the diagnosis should be verified.
Caution should be used when applying Terbix® to damaged areas of the skin, as alcohol may cause irritation.
Terbix® spray is for external use only. Terbix® spray should not be used on the face. Avoid contact with eyes as it may cause irritation. If the drug accidentally gets into your eyes, they should be immediately rinsed with running water, and if persistent irritation develops, you should consult a doctor.
If the drug was accidentally introduced into the respiratory tract during inhalation, then in the event of any symptoms and, especially if they are persistent
preservation, you should consult your doctor.
If allergic reactions develop, the drug must be discontinued.
This product contains propylene glycol, which may cause skin irritation in some cases.
Impact on the ability to drive vehicles and machinery
After external use of Terbix® spray, no effects were reported that affected the ability to operate equipment or operate other mechanisms.

Active ingredient

Terbinafine

Composition

1 cylinder (30) contains
Active ingredient:
Terbinafine hydrochloride – 0.30 g
Excipients:
Isopropanol (isopropyl alcohol) – 10.50 g
1,2-propylene glycol – 4.84 g
Polysorbate 60 – 0.17 g
Macrogol-400 (polyethylene oxide 400) – 1.61 g
Purified water – up to 30 g

Pregnancy

Pregnancy
In experimental studies, the teratogenic properties of terbinafine were not identified. To date there have been no reports of any
developmental defects when using Terbix® spray.
Animal studies have not revealed any adverse effects on pregnancy or fetal health. However, since clinical
experience with the use of Terbix® spray in pregnant women is very limited; it should be used only under strict indications.
Breastfeeding period
Terbinafine is excreted in breast milk, so the drug should not be used by nursing mothers. Newborns should not come into contact with areas of skin on which the drug has been applied, including the breast.
If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

Contraindications

Hypersensitivity to terbinafine or to any of the excipients included in the drug, children (up to 18 years), breastfeeding.
With caution
Liver and/or renal failure, alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases,
occlusive vascular diseases of the extremities, pregnancy.

Side Effects

Adverse reactions are listed below according to organ system classes and frequency of occurrence. The frequency of adverse reactions is determined as follows: very often (≥1/10); often (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000);
very rare (< 1/10000) or frequency unknown (cannot be determined from available data).
Immune system disorders:
Not known: hypersensitivity reactions (rash).
Visual disorders:
Rare: eye irritation.
Skin and subcutaneous tissue disorders:
Common: skin peeling, itching.
Uncommon: skin breakdown, crusting, skin lesions, pigmentation disorder, erythema, burning sensation of the skin.
Rarely: feeling of dry skin, contact dermatitis, eczema.
Frequency unknown: rash.
General disorders and disorders at the injection site:
Uncommon: pain, pain at the application site, irritation at the application site.
Rare: exacerbation of disease symptoms.
In areas where the drug is applied, itching, peeling of the skin, pain, irritation, changes in skin pigmentation, burning,
erythema, crusts. These minor symptoms should be distinguished from hypersensitivity reactions, such as rash, which occur in rare cases and require discontinuation of therapy. In rare cases, the course of a fungal infection may worsen.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed
instructions, please inform your doctor.

Interaction

There are no known drug interactions for Terbix® Spray.
Since compatibility studies have not been conducted, it is not recommended to use the drug in combination with other external agents
applications.

Overdose

No cases of drug overdose have been reported.
Low systemic absorption of terbinafine for topical use virtually eliminates overdose when applying the drug to the skin.
Accidental ingestion of 30 ml Terbix® spray containing 300 mg terbinafine hydrochloride (equivalent to 264 mg terbinafine base),
comparable to taking one 250 mg terbinafine tablet (single oral dose for adults).
Symptoms:
Signs of overdose after ingestion of terbinafine may include headache, nausea, epigastric pain and dizziness.
Treatment:
The use of activated carbon, if necessary, symptomatic maintenance therapy. Further treatment should be carried out in
according to clinical indications.

Storage conditions

At a temperature not exceeding 30 °C. Avoid freezing. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date indicated on the package.

Manufacturer

Altaivitamins, Russia