Lamisil online in Australia

Use

Therapeutic indications

• Onychomycosis,
• Cutaneous dermatophyties (in particular glamatous skin dermatophyty, palmoplantar keratoderma, interdigital-plantar intertrigo),
• Candidiasis of the skin,

when these last 2 infections cannot be treated locally due to the extent of the lesions or resistance to the usual antifungal treatments.

Orally administered terbinafine is ineffective in pityriasis versicolor and vaginal yeast infections.

Dosage and method of administration

Dose

Adults

One tablet per day, preferably with a meal.

Treatment duration.

The duration of treatment depends on the indication and severity of the infection. The usual treatment times are as follows:

• Finger intertrigos (interdigital, plantar / moccasin type): 2 - 6 weeks.
• Dermatophytia of the hairless skin, cutaneous candidiasis or genital or crural intertrigos: 2 to 4 weeks.
• Onychomycosis: the duration of treatment is generally between 6 weeks and 3 months. A 6-week treatment for fingernail onychomycosis is usually sufficient. For toenail onychomycosis, a 12-week treatment is usually sufficient, although some patients with slow nail growth may require longer treatment (6 months or more). The complete disappearance of clinical signs can occur only several months after stopping treatment. This corresponds to the time required for the growth of a healthy nail.

Special populations

Elderly patients

There is no evidence to suggest that elderly patients require different doses than those required in younger patients. The possibility of liver or kidney failure should be considered in this age group (see section 4.4).

Liver failure

This medication is not recommended in patients with chronic or active liver disease. In case of liver failure and in case the expected benefits outweigh the risks involved, it is recommended to start treatment with a lower dose. In patients with mild or severe pre-existing liver disease, the elimination of terbinafine may be reduced (see section Pharmacokinetic properties; see also sections Contraindications and warnings and precautions for use in patients with liver failure).

Renal insufficiency

Patients with reduced renal function (creatinine clearance minus 50 ml / min or serum creatinine plus 300 micromoles / L) should receive half the normal dose (see section 4.3).

Prescription and delivery conditions

List II

Duration and special precautions for conservation

Shelf life: 3 years.

Special precautions for storage: Store in its original packaging, protect from light.

Preclinical safety data

Long-term toxicity studies (up to 1 year) in rats and dogs have shown no apparent toxic effects in any of the species up to oral doses of approximately 100 mg / kg per day. At high oral doses, the liver has been identified as a possible target organ, as have the kidneys.

A two-year oral carcinogenicity study in mice revealed no neoplastic manifestations or other abnormalities that could be attributed to treatment up to doses of 130 (male) and 156 (female) mg / kg per day. A two-year carcinogenicity study in rats found no increase in the incidence of liver tumors at the highest dose of 69 mg / kg per day. The observed changes may be associated with a proliferation of peroxisomes and appear to be species-specific as they have not been observed in carcinogenicity studies in mice, dogs, or monkeys.

In studies with monkeys at high doses, refractive errors have been observed in the retina at higher doses (50 mg / kg non-toxic dose). These disorders have been associated with the presence of a terbinafine metabolite in eye tissue; they disappeared after the drug was finished. They were not associated with any histological alteration.

A standard series of in vitro and in vivo genotoxicity studies revealed no evidence of mutagenic or carcinogenic potential.

No adverse effects on fertility or other reproductive endpoints were observed in studies in rats or rabbits.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

This medication is contraindicated in the following cases:

• Hypersensitivity to the active substance or to any of the excipients included in the Composition section.
• Severe hepatic impairment (see section 4.4).
• Severe kidney failure (creatinine clearance below 30 ml / min).

This medicine is not recommended during lactation.

Pregnancy and lactation

Pregnancy

Animal studies have not shown any teratogenic effects. In the absence of a teratogenic effect in animals, a malformation effect is not expected in the human species.

In fact, to date, substances responsible for malformations in the human species have been shown to be teratogenic in animals during well-conducted studies in two species. In clinical practice, there is currently insufficiently relevant data to assess a possible malformation or fetotoxic effect of terbinafine when administered during pregnancy.

Accordingly, as a precaution, it is preferable not to use this product during pregnancy unless the mother's clinical condition requires oral terbinafine treatment and the expected benefit to the mother is greater than the risk incurred. by the fetus

Breastfeeding

Terbinafine is excreted in breast milk and the use of this product during lactation is not recommended.

Fertility

Animal fertility studies suggest that oral terbinafine has no effect.

Warnings and precautions for use

Special warnings

Before starting treatment with terbinafine, the patient should be informed of the need to stop treatment immediately and consult a doctor or emergency department as soon as possible in case of signs or symptoms. persistent and without apparent cause such as: nausea, vomiting, decreased appetite, fatigue, vomiting, pain in the right hypochondrium, fever, angina or other infection, rapidly extensive skin damage, disseminated or affecting the mucous membranes, pruritus, asthenia, heavy urine , jaundice, dark, or discolored stools.

Liver function

Terbinafine is not recommended in patients with acute or chronic liver disease.

In the event that the expected benefits outweigh the risks involved, start treatment with a lower dose in case of liver failure.

Before starting treatment with terbinafine, a liver function test should be performed, as liver damage may occur in patients with or without pre-existing liver disease. Therefore, regular liver check-ups are recommended (after 4 to 6 weeks of treatment).

Oral terbinafine treatment should be discontinued and liver function tests should be performed immediately in patients with any of the following symptoms: nausea, decreased appetite, fatigue, vomiting, pain in the right hypochondrium, jaundice, dark urine, or discolored stool.

Terbinafine therapy should be discontinued immediately if there is an increase in liver enzymes.

Rare cases of severe liver failure have been reported in patients treated with terbinafine, some of which may have led to liver transplantation or death. In most of these cases, the patients had serious underlying conditions and the relationship with terbinafine was unclear (see section 4.8).

Dermatological effects

The appearance, at the start of treatment, of a generalized febrile erythema associated with pustules, should lead to suspicion of generalized exanthematous pustulosis (see section Undesirable effects); requires cessation of treatment and contraindicates any new administration.

Cases of severe skin reactions have been reported in patients treated with terbinafine, such as:

- rare frequency: Stevens Johnson syndrome, toxic epidermal necrolysis

- frequency not known: drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

Lupus erythematosus or pre-existing psoriasis

Terbinafine should be prescribed with caution in patients with pre-existing psoriasis or lupus erythematosus, as very rare cases of lupus erythematosus have been reported in patients treated with terbinafine. Furthermore, exacerbation of cutaneous and systemic psoriasis and lupus erythematosus have been reported since the marketing of terbinafine.

Hematological effects

Very rare cases of hematologic disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported in patients treated with terbinafine. The etiologic evaluation of a hematologic disorder occurring in terbinafine-treated patients should be carried out and should be considered as a modification of treatment, including discontinuation of treatment.

Renal insufficiency

In patients with renal impairment (creatinine clearance minus 50 ml / min or serum creatinine plus 300 micromoles / L), the use of oral terbinafine is not recommended as it has not been adequately studied (see Pharmacokinetic properties section).

Children

In the absence of specific studies, the use of oral terbinafine is not recommended.

Employment precautions

In rare cases, this medication may cause a reversible change or loss of taste; Terbinafine treatment is not recommended in people who use their taste faculties for professional purposes (see section 4.8).

Interaction with other medicinal products and other forms of interaction

Terbinafine clearance may be increased by the action of drugs that induce metabolism, and may be decreased by the action of molecules that inhibit cytochrome P450. If co-administration of such medicinal products is necessary, the dose of terbinafine should be adjusted accordingly.

Based on the results of studies conducted in vitro and in healthy volunteers, terbinafine has a negligible impact on the elimination of most drugs metabolized by cytochrome P450 enzymes, such as terfenadine, tolbutamide, triazolam, or oral contraceptives. they are metabolized by CYP2D6 (see below).

Associations not recommended

+ Atomoxetine

Risk of increased adverse effects of atomoxetine, due to a significant reduction in liver metabolism.

If combination, clinical monitoring and dose adaptation of atomoxetine cannot be avoided during treatment with the inhibitor and after discontinuation.

+ Mequitazine

Risk of increased undesirable effects of mequitazine, by inhibition of its metabolism by the enzyme inhibitor.

+ Tamoxifen

Risk of diminishing the effectiveness of tamoxifen, by inhibiting the formation of its active metabolite by terbinafine.

Associations subject to precautions for use.

+ Cyclosporine

Decreased blood levels of cyclosporine. Terbinafine increases the clearance of cyclosporine by 15%.

Control of cyclosporine blood levels and possible dose adjustment during and after treatment with terbinafine.

+ Flecainide

Risk of increased undesirable effects of flecainide, due to the reduction of its hepatic metabolism by terbinafine.

Clinical surveillance If necessary, adjust the dose of flecainide during treatment with terbinafine.

+ Metoprolol

In patients with heart failure, risk of increased undesirable effects of metoprolol, due to the reduction of their hepatic metabolism by terbinafine.

Clinical surveillance If necessary, adjust the dose of metoprolol during treatment with terbinafine.

+ Propafenone

Risk of increased adverse effects of propafenone, by decreasing its liver metabolism by terbinafine.

Clinical monitoring If necessary, adjust the dose of propafenone during treatment with terbinafine.

+ Rifampicin

Decreased plasma concentrations and efficacy of terbinafine, by increasing liver metabolism by rifampicin. Rifampin increases terbinafine clearance by 100%.

Caution

Undesirable effects

10% of patients who participated in clinical studies experienced adverse reactions.

The most common side effects are gastrointestinal disorders (5%).

The unwanted effects, reported with LAMISIL, either during clinical trials or after marketing of the drug (spontaneous reporting or literature), are presented in Table 1 by Classification of organ system and by frequency using the following categories: very common (≥ 1/10), common (≥ 1/100, minus 1/10), uncommon (≥ 1/1000, minus 1/100), rare (≥ 1/10000, minus 1/1000), very rare (minus 1/10000), frequency not known (cannot be estimated from the available data).

Table 1. Adverse Reactions Reported During LAMISIL Clinical or Post-Marketing Studies.

Infections and infestations.

Very rare :

pustular rash

Blood and lymphatic system disorders.

Infrequent

anemia

Very rare :

neutropenia, agranulocytosis, thrombocytopenia, pancytopenia

Immune system disorders.

Very rare :

anaphylactic reaction, angioedema, cutaneous and systemic lupus erythematosus

Metabolism and nutrition disorders.

Very common:

decreased appetite

Psychiatric disorders

Frequent:

depression

Infrequent

anxiety

Nervous system disorders

Very common:

headache

Frequent:

dysgeusia *, ageusia *, dizziness

Infrequent

paresthesia, hypoesthesia

Frequency not known:

anosmia

Eye conditions

Common: blurred vision, visual impairment.

Decreased visual acuity

Ear and labyrinth disorders.

Infrequent

tinnitus

Frequency not known:

Hearing loss, hearing impairment

Vascular disorders

Frequency not known:

vasculitis

Gastrointestinal disorders.

Very common:

bloating, dyspepsia, nausea, abdominal pain, diarrhea

Frequency not known:

pancreatitis

Hepatobiliary disorders.

Rare

liver failure, some of which have caused liver transplantation or death, hepatitis, jaundice, cholestasis, increased liver enzyme levels (see Warnings and Precautions for Use section)

Skin and subcutaneous tissue disorders.

Very common:

skin rash, hives

Infrequent

photosensitivity reactions, photodermatosis, allergic photosensitivity reaction, polymorphic lucitis

Very rare :

Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), generalized acute exanthematous pustulosis (PEAG), erythema multiforme, toxidermy, exfoliative or bullous dermatitis, vesicular eruption, psoriasiform eruption or exacerbation of psoriasis, alopecia

Frequency not known:

DRESS syndrome (drug hypersensitivity syndrome with hypereosinophilia and systemic symptoms).

Musculoskeletal and connective tissue disorders.

Very common:

arthralgia, myalgia

Frequency not known:

Rhabdomyolysis

General disorders and administration site conditions.

Frequent:

tired

Infrequent

fever

Frequency not known:

Flu-like illness

Research

Infrequent

weightloss**

Frequency not known:

Increased creatine phosphokinase

* Hypogeusia, including ageusia, which usually disappears in the weeks after treatment ends. Isolated cases of prolonged hypogeusia have been reported.

** Weight loss secondary to hypogeusia.

Overdose

Some cases of overdose (up to 5 g) have been reported, resulting in headache, nausea, pain in the upper abdomen and dizziness.

The recommended treatment for an overdose consists in the elimination of the product mainly through the administration of activated carbon and symptomatic treatment if necessary.

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