GOTER Terbinafine HCl Cream & Tablet ( For Fungal Infections Of Skin)

GOTER (Tablet)

Terbinafine

Terbinafine has in vitro activity against yeasts and a wide range of dermatophyte, filamentous, dimorphic, and dematiaceous fungi. It is fungicidal against dermatophytes, such as Trichophyton species, Microsporum species, and Epidermophyton floccosum, as well as against Aspergillus species, Scopulariopsis brevicaulis, Blastomyces dermatitidis, Cryptococcus neoformans, Sporothrix schenckii, Histoplasma capsulatum, Candida parapsilosis, and Pityrosporum yeasts. Terbinafine has also been shown to be active in vitro against the protozoal organisms Trypanosoma cruzi and Leishmania mexicana. However, clinical efficacy has not been demonstrated in the treatment of infections caused by B. dermatitidis, H. capsulatum, S. schenckii, C. neoformans, T. cruzi, and L. mexicana. Also, terbinafine is only fungistatic against Candida albicans.

Mechanism of action/Effect:

Terbinafine interferes with fungal ergosterol biosynthesis by inhibiting squalene epoxidase in the fungal cell membrane. This leads to a deficiency of ergosterol and an intracellular accumulation of squalene, thus disrupting fungal membrane function and cell wall synthesis, and resulting in fungal cell death.

Pharmacokinetics

Absorption:

·         Readily absorbed from gastrointestinal tract. Bioavailability is 70 to 80% and is not affected by the presence of food.

Distribution:

·         Goter is lipophilic and extensively distributed. It rapidly diffuses from the vascular system, passes through the dermis and epidermis, and concentrates in the lipophilic stratum corneum. It is also distributed via the sebum to hair follicles and sebum-rich skin, resulting in high concentrations in hair follicles, hair, sebum-rich skin, and the nail plate within the first few weeks of therapy. It is also highly distributed to adipose tissue.

Protein binding:

·         Very high (> 99%), with binding evenly distributed among all plasma fractions.

Half-life:
Approximately 0.8 hour.

Distribution Half life:

Approximately 4.6 hours.
Elimination:
Plasma: 11 to 17 hours.
Sebum: 3 to 5 days.
Stratum corneum: 3 to 5 days.

Elimination:
    Renal—Approximately 80% of an administered dose is excreted in the urine as metabolites.
    Fecal—Approximately 20% is eliminated in feces.

GOTER (Cream)

Terbinafine Hydrochloride

Goter cream contains the active ingredient terbinafine hydrochloride, which is an antifungal medicine used to treat infections caused by fungi. Terbinafine kills fungi and yeasts by interfering with their cell membranes. It works by stopping fungi from producing a substance called ergosterol, which is an essential component of fungal cell membranes. The disruption in production of ergosterol disrupts the cell membrane and causes holes to appear. The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As terbinafine causes holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi and hence clears up the infection. Goter cream is applied to the skin to treat a wide range of fungal skin infections. Improvement in symptoms is usually seen after a few days of treatment, but the prescribed course should be finished to ensure the infection is completely cured and prevent it returning.

What is it used for?

Fungal infections of the skin such as those below.

·         Athlete's foot (tinea pedis).

·         Fungal infection of the groin, i.e. jock itch (tinea cruris).

·         Ringworm (tinea corporis).

·         Pityriasis versicolor.

·         Yeast infections of the skin, eg Candida albicans.

Warning!

• This cream is for external use only.
• Clean and dry the affected area of skin thoroughly before applying the cream.
• Wash your hands after application.
• Avoid getting the cream in contact with the eyes. If it does accidentally enter the eyes, rinse immediately with plenty of water.
• Make sure you use this medicine regularly and complete the course as directed by your doctor. It is important to complete the course, even if your symptoms have cleared up, otherwise there is a risk of the infection returning.
• If there are no signs of improvement after two weeks, consult your doctor.

Not to be used in

• Breastfeeding.
• This medicine is not licensed for children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy, unless considered essential by your doctor. Seek medical advice from your doctor if you are pregnant.
• This medicine may pass into breast milk. It should not be used by breastfeeding mothers. Infants should not be allowed to come into contact with any treated skin, including the breasts. Seek further medical advice from your doctor.

STORAGE:

 Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and heat. Do not refrigerate. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.