Tabifun

Tabifun Uses, Dosage, Side Effects, Food Interaction and all others data.

Tabifun is an allylamine with a range of antifungal activity. It is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Tabifun is either fungicidal or fungistatic against yeasts, depending on the species. Tabifun interferes with fungal ergosterol biosynthesis by inhibiting squalene epoxidase in the fungal cell membrane at an early stage. This leads to a deficiency in ergosterol and to intracellular accumulation of squalene, resulting in fungal cell death. Tabifun is highly effective in fungal infections of the skin, hair and nails caused by Trichophyton spp., Microsporum spp. and Epidermophyton floccosum. It is also effective against yeast infections of the skin, principally those caused by the genus candida. Topical terbinafine appears to be effective in pityriasis versicolor due to Pityrosporum arbiculare.

Tabifun is an allylamine antifungal that inhibits squalene epoxidase (also known as squalene monooxygenase) to prevent the formation of ergosterol and cause an accumulation of squalene, weakening the cell wall of fungal cells. Tabifun distributes into tissues and has a long terminal elimination half life, so the duration of action is long. Overdose with terbinafine is rare, even above the therapeutic dose, so the therapeutic index is wide. Patients taking oral terbinafine should have liver function tests performed prior to treatment to reduce the risk of liver injury.

Trade Name Tabifun
Availability Prescription only
Generic Terbinafine
Terbinafine Other Names Terbinafina, Terbinafine, Terbinafinum
Related Drugs nystatin topical, clotrimazole topical, ketoconazole topical, itraconazole, miconazole topical, Lamisil, Lotrisone, ciclopirox topical, griseofulvin, Jublia
Type Tablet, Cream
Formula C21H25N
Weight Average: 291.4299
Monoisotopic: 291.198699805
Protein binding

Terbinafine is >99% bound to proteins in plasma, mostly to serum albumin, high and low density lipoproteins, and alpha-1-acid glycoprotein to a lesser extent.

Groups Approved, Investigational, Vet approved
Therapeutic Class Drugs for subcutaneous and systemic mycoses, Topical Antifungal preparations
Manufacturer Parax Impex
Available Country India
Last Updated: September 19, 2023 at 7:00 am
Tabifun
Tabifun

Uses

Tabifun cream is used for the treatment of the following dermatological infections: interdigital tinea pedis (Athlete’s foot), tinea cruris (jock itch) or tinea corporis (ring worm) due to susceptible organisms and planter tinea pedis (mocasin type) due to Trichophyton spp.

Tabifun tablet is used for the treatment of onychomycosis of the toe nail or finger nail due to dermatophytes and also by non-dermatophyte fungi.

Tabifun is also used to associated treatment for these conditions: Onychomycosis, Pityriasis versicolor, Sporotrichosis, Tinea Capitis, Tinea Corporis, Tinea Cruris, Tinea Pedis, Cutaneous candidiasis, Severe Tinea Corporis, Severe Tinea Cruris, Severe Tinea Pedis

How Tabifun works

Tabifun inhibits the enzyme squalene monooxygenase (also called squalene epoxidase), preventing the conversion of squalene to 2,3-oxydosqualene, a step in the synthesis of ergosterol. This inhibition leads to decreased ergosterol, which would normally be incorporated into the cell wall, and accumulation of squalene.

Generation of a large number of squalene containing vesicles in the cytoplasm may leach other lipids away from, and further weaken, the cell wall.

Dosage

Tabifun dosage

Topical application:

Tabifun cream to affected areas once or twice daily for 1-2 weeks may be adequate for fungal infections of the skin but certain infections may require oral Tabifun tablet therapy.Usual duration of treatment of Tabifun cream:

  • In Tinea corporis and Tinea cruris: 1-2 weeks.
  • In Tinea pedis: 2-4 weeks (One week of treatment will normally suffice if the cream is applied twice daily.).
  • In Cutaneous candidiasis: 1-2 weeks
  • In Pityriasis (tinea) versicolor: 2 weeks.

To prevent relapses in fungal infection, treatment should be continued for a adequate length of time. To apply Tabifun cream clean and dry the affected areas thoroughly and apply the cream once or twice a day to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections the application may be covered with a gauze strip, especially at night.

Oral administration:

Tabifun tablet is essential for hair or nail infections:

  • The usual oral dose: Tabifun 250 mg daily for 2 to 12 weeks depending upon the infection.
  • Finger nail onychomycosis: Tabifun 250 mg once daily for 6 weeks.
  • Toe nail onychomycosis: Tabifun 250 mg once daily for 12 weeks.

Side Effects

Tabifun Tablet: Abdominal discomfort, anorexia, nausea, diarrhoea, headache, rash and urticaria occasionally with arthralgia or myalgia. Less frequently taste disturbance. Rarely liver toxicity, photosensitivity, serious skin reactions etc.

Tabifun Cream: Redness, itching, or stinging; rarely allergic reactions.

Toxicity

The subcutaneous LD50 in rats and mice is >2g/kg. The TDLO for women is 210mg/kg/6W.

Overdose data with terbinafine is rare, however symptoms are expected to be nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache. Treat overdose with activated charcoal as well as symptomatic and supportive therapy.

Precaution

Terbifine cream is for external use only. Contact with eyes should be avoided.Good general hygiene is necessary in conjunction with the use of Tabifun in order to prevent reinfection (eg. from underwear, socks,shoes etc).

Tabifun tablet is not recommended for patients with chronic or active liver disease. Before prescribing terbinafine, pre-existing liver disease should be assessed. Hepatotoxicity may occur in patients with and without pre-existing liver disease. Pretreatment serum transaminase (ALT and AST) tests are advised for all patients before taking terbinafine tablets.

Interaction

In vivo studies have shown that terbinafine is an inhibitor of the CYP450 2D6 isozyme. Drugs predominantly metabolized by the CYP450 2D6 isozyme include the following drug classes: tricyclic antidepressants, selective serotonin reuptake inhibitors, beta-blockers, antiarrhythmics class 1C (e.g., flecainide and propafenone) and monoamine oxidase inhibitors Type B. Co-administration of terbinafine should be done with careful monitoring and may require a reduction in dose of the 2D6-metabolized drug.

Food Interaction

  • Limit caffeine intake. Tabifun may reduce the metabolism of caffeine by approximately 19%, monitor for increased effects of caffeine.
  • Take with or without food.

Volume of Distribution

A single 250mg oral dose of terbinafine has a volume of distribution at steady state of 947.5L or 16.6L/kg.

Elimination Route

Oral terbinafine is >70% absorbed but only 40% bioavailable after first pass metabolism, reaching a Cmax of 1µg/mL with a Tmax of 2 hours an an AUC of 4.56µg*h/mL. Over the course of a week, 1% topical terbinafine's Cmax increases from 949-1049ng/cm2

Half Life

Oral terbinafine has an effective half life of approximately 36 hours. However, the terminal half life ranges from 200-400 hours as it distributes into skin and adipose tissue. 1% topical terbinafine's half life increases over the first seven days from approximately 10-40 hours.

Clearance

A single 250mg oral dose of terbinafine has a clearance of 76L/h or 1.11L/h/kg.

Elimination Route

Tabifun is approximately 80% eliminated in urine, while the remainder is eliminated in feces. The unmetabolized parent drug is not present in urine.

Pregnancy & Breastfeeding use

Tabifun tablet: There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. After oral administration, terbinafine is present in breast milk of nursing mothers. Treatment with terbinafine in not recommended in nursing mothers.

Tabifun cream: Foetal toxicity and fertility studies in animals suggest no adverse effects. There is no clinical experience with terbinafine in pregnant women; therefore, unless the potential benefits outweigh any potential risk, terbinafine should not be administered. Tabifun is excreted in breast milk and therefore mothers should not receive terbinafine treatment whilst breast-feeding.

Contraindication

Hypersensitivity to Tabifun or any of the excipients in thepreparation

Special Warning

Use in Children: Tabifun cream appears to be an effective and well-tolerated treatmenr of tinea corposis and tinea cruris in children.

Use in Elderly: Tabifun appears to be safe in the elderly. The dose should be reduced by half if significant hepatic or renal impairment is present.

Acute Overdose

Clinical experience regarding overdose with terbinafine tablets is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

Storage Condition

Store in a cool and dry place, protected from light.

Innovators Monograph

You find simplified version here Tabifun

Tabifun contains Terbinafine see full prescribing information from innovator Tabifun Monograph, Tabifun MSDS, Tabifun FDA label

FAQ

What is Tabifun prescribed for?

Tabifun are used to treat fungal infections of the toenails and fingernails. Tabifun is in a class of medications called antifungals.

How safe is Tabifun?

As with most classes of drugs, Tabifun can potentially lead to liver problems.however Tabifun is safer than perhaps it is perceived, and minor side effects are far more likely for most patients than serious liver damage.

What are the side effects of Tabifun?

Common side effects are include:

  • rash.
  • headache.
  • diarrhoea.
  • feeling or being sick (nausea or vomiting)
  • a smaller appetite than usual.
  • stomach ache.
  • indigestion.
  • muscle or joint pain

How fast does Tabifun work?

Tabifun work within 1 week after starting therapy and persist for at least 30 weeks after the completion of treatment.

Is Tabifun safe during pregnancy?

Tabifun can be used relatively safely in both oral and topical formulations during pregnancy.

Can I take Tabifun during breastfeeding?

Tabifun tablets are generally not recommended if you're breastfeeding. There are other antifungal medicines that are safer. Your doctor will recommend the best medicine for you.

Can I drink alcohol with Tabifun?

Yes, you can drink alcohol while using or taking Tabifun.

Can I drive after taking Tabifun?

Some people have reported feeling dizzy or giddy while they are taking Tabifun. If you feel like this, you should not drive or operate machinery.

What is the best time of day to take Tabifun?

Take Tabifun tablets at the same time each day, either in the morning OR in the evening.

What is the best time of day to take Tabifun?

Take Tabifun tablets at the same time each day, either in the morning or in the evening.You can take Tabifun with or without food.

Does Tabifun affect the heart?

Tabifun can affect your blood cells and your liver. You may need blood tests before you start and while you are taking Tabifun to check your blood cells and see how well your liver is working.

What happen If I missed Tabifun?

If you forget to take your dose, take it as soon as you remember that day. If it's nearly time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take 2 doses at the same time.

Will Tabifun affect my fertility?

No effect of Tabifun on fertility has been seen in animal studies and there are no data to suggest an effect on fertility in humans.

How long does Tabifun stay in my system after stop taking Tabifun ?

A terminal half-life of 200-400 hours may represent the slow elimination of Tabifun from tissues such as skin and adipose.

What should I avoid while taking Tabifun?

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking Tabifun.

What happens when I stop taking Tabifun?

If you stop taking Tabifun too soon, your symptoms may return. Tabifun works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.

Does hair grow back after Tabifun?

Hair will grow back by itself once a person stops taking Tabifun.

Is Tabifun bad for my liver?

Some people taking Tabifun have developed severe liver damage leading to liver transplant or death.

How fast does Tabifun work?

Tabifun is rapidly absorbed and widely distributed to body tissues including the poorly perfused nail matrix.

How long do side effects from Tabifun last?

Tabifun may resolve within several weeks after discontinuation of treatment, but may be prolonged,or may be permanent.

Does Tabifun affect periods?

You may have problems, such as bleeding between periods, while you are taking Tabifun . You may need to take different amounts of your medicines or you may need to take different medicines.

*** Taking medicines without doctor's advice can cause long-term problems.
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