Terbinorm 250mg 14 tablets — Made in Romania — Free Delivery
(Terbinorm )
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Description Terbinorm 250mg 14 tablets — Made in Romania — Free Delivery
Indications
Fungal infections of the skin and nails caused by trichophyton (eg t. rubrum, t. mentagrophytes, t. verrucosum, t. violaceum), microsporum canis and epidermophyton floccosum. dermatophytosis lesions of the smooth skin of the trunk, perineum and feet, when the localization of the lesion, the severity or prevalence of the infection determine the appropriateness of oral therapy. onychomycosis.
Application
The preparationis intended for oral use. adults are prescribed 1 tablet (250 mg) 1 time per day. the duration of treatment depends on the nature and severity of the disease.
Skin infections. Recommended duration of treatment:
- tinea pedis (interdigital, plantar/moccasin type) — 2–6 weeks;
- trichophytosis of the smooth skin of the trunk - 4 weeks;
- trichophytosis of the perineum - 2-4 weeks.
The complete disappearance of symptoms of infection may occur only a few weeks after the absence of pathogens is detected using laboratory control.
Onychomycosis. The duration of treatment for most patients is from 6 weeks to 3 months. Treatment periods of less than 3 months are possible for patients with lesions of fingernails, toenails other than the thumb, or for younger patients. In the treatment of toenail lesions, 3 months is usually sufficient, although some patients may require therapy for 6 months or longer. Patients requiring longer treatment are identified by a reduced rate of nail growth during the first weeks of treatment. The complete disappearance of symptoms of infection may occur only a few weeks after the absence of pathogens is detected using laboratory control.
Patients with impaired liver function. Terbinorm tablets are not recommended for use in patients with chronic or active liver disease.
Patients with impaired renal function. The use of Terbinorm tablets in patients with impaired renal function has not been adequately studied and is therefore not recommended for this group of patients.
Elderly patients. There is no evidence that elderly patients need to change the dose of the preparation or that they have manifestations of adverse reactions that differ from those in younger patients. In this age group, when using the preparation, the possibility of impaired liver or kidney function should be considered.
Children. Data on the use of the preparation in children are limited, so its use is not recommended in patients of this age group.
Contraindications
Hypersensitivity to terbinafine or any auxiliary component of the preparation.
Side effects
To assess the frequency of occurrence of various adverse reactions, the following classification was used: very often (≥1/10); often (≥1/100, 1/10); infrequently (≥1/1000, 1/100); rarely (≥1/10,000, 1/1000); very rarely (1/10,000), the frequency is unknown (cannot be established from the available data).
On the part of the blood and lymphatic system: very rarely - neutropenia, agranulocytosis, thrombocytopenia; frequency unknown - anemia, pancytopenia.
From the immune system: very rarely - anaphylactoid reactions (including Quincke's edema), skin and systemic lupus erythematosus; frequency unknown - anaphylactic reactions, reactions similar to symptoms of serum sickness.
From the side of metabolism and nutrition: very often - loss of appetite.
On the part of the psyche: the frequency is unknown - anxiety and depressive symptoms secondary to taste disorders.
From the nervous system: often - headache; infrequently - a violation of the sense of taste, including loss of taste, usually recovers after a few weeks after stopping the preparation. Very rarely, long-term disturbance of taste has been reported, sometimes leading to a decrease in food intake and a significant decrease in body weight; rarely - paresthesia, hypesthesia, dizziness; frequency unknown - anosmia, including constant anosmia, hyposmia.
From the side of the organ of hearing and the vestibular apparatus: very rarely - vertigo; frequency unknown - hearing loss, hearing impairment, tinnitus.
From the side of the vessels: the frequency is unknown - vasculitis.
From the digestive system: very often - gastrointestinal symptoms (feeling of fullness in the stomach, dyspepsia, nausea, pain in the abdomen, diarrhea); frequency unknown - pancreatitis.
From the side of the liver and biliary tract: rarely - cases of serious violations of liver function, including liver failure, increased levels of liver enzymes, jaundice, cholestasis and hepatitis. With the development of liver dysfunction, treatment should be discontinued. Very rarely, there have been reports of serious liver failure (some cases were fatal or cases that required a liver transplant).
On the part of the skin and subcutaneous tissue: very often - mild forms of skin reaction (rash, urticaria); very rarely - serious skin reactions (for example, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis); photosensitivity (eg photodermatosis, photosensitivity reaction and polymorphic photodermatosis); alopecia; frequency unknown - psoriasis-like rash or exacerbation of psoriasis. Serious skin reactions (eg acute generalized exanthematous pustulosis).
From the musculoskeletal system and connective tissue: very often - reactions from the musculoskeletal system (arthralgia, myalgia); frequency unknown - rhabdomyolysis.
General disorders: rarely - malaise; frequency unknown - fatigue, flu-like illness, pyrexia.
The results of laboratory studies: the frequency is unknown - an increase in CPK in the blood.
special instructions
Concerning liver function. the preparation in tablets is not recommended for use in patients with chronic or active liver disease. Before prescribing terbinafine tablets, all pre-existing liver disease should be assessed.
Hepatotoxicity is possible in patients with and without pre-existing liver disease, so periodic monitoring of liver function is recommended (after 4–6 weeks of treatment). The use of the preparation Terbinorm should be immediately discontinued in case of an increase in the activity of indicators of functional liver tests.
Patients taking Terbinorm should be warned that they should immediately inform the doctor about any signs or symptoms indicating abnormal liver function, such as itching, unexplained persistent nausea, loss of appetite, anorexia, jaundice, vomiting, increased fatigue, right-sided pain in upper abdomen, dark urine or discolored stools.
Patients with these symptoms should discontinue oral terbinafine and the patient's liver function should be evaluated immediately.
Taste disorder. When using the preparation, a violation and loss of taste was reported. This can lead to poor appetite, weight loss, anxiety, and depressive symptoms. If symptoms of taste disturbance occur, the preparation should be discontinued.
Olfactory disorders. Impairments and loss of smell have also been reported. These disturbances may disappear after cessation of therapy, but may also be long-term (1 year) or permanent. If there are violations of smell, the use of the preparation should be discontinued.
depressive symptoms. During treatment with the preparation, depressive symptoms may occur, which may require treatment.
Dermatological effects. Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported very rarely. In the event of progressive skin rashes, treatment with terbinafine tablets should be discontinued.
Terbinorm should be used with caution in patients with psoriasis, as there have been reports of very rare cases of exacerbation of psoriasis.
hematological effects. Very rarely, pathological changes in the blood (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported. It is necessary to evaluate the cause of any pathological change in the blood in patients and consider a possible change in the treatment regimen, including stopping treatment with the preparation.
Kidney function. The use of Terbinorm tablets in patients with impaired renal function (creatinine clearance 50 ml/min or plasma creatinine 300 µmol/l) has not been adequately studied and is therefore not recommended.
Other. Terbinorm should be used with caution in patients with lupus erythematosus, as there have been reports of very rare cases of exacerbation of this pathology.
Use during pregnancy or lactation. Experience with the use of terbinafine in pregnant women is very limited, therefore, the preparation should not be used during pregnancy, unless the clinical condition of the woman requires treatment with oral terbinafine and the expected benefit to the pregnant woman outweighs any potential risk to the fetus.
Do not use the preparation during breastfeeding, as terbinafine passes into breast milk.
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. There are no data on the effect of terbinafine on the ability to drive vehicles and work with mechanisms. Patients who develop dizziness as an undesirable reaction to the use of the preparation should avoid driving vehicles and working with other mechanisms.
Interactions
Effect of other medicinal products on terbinafine. Plasma clearance of terbinafine may be increased by preparations that induce metabolism and may be reduced by preparations that inhibit cytochrome p450. if concomitant treatment with such preparations is necessary, the dosage of terbinorm should be adjusted accordingly.
Medicinal products that may increase the effect or plasma concentrations of terbinafine. Cimetidine reduced the clearance of terbinafine by 30%.
Fluconazole increased Cmax and AUC of terbinafine by 52 and 69%, respectively, due to inhibition of CYP 2C9 and CYP 3A4 enzymes. The same increase is possible with the simultaneous use of preparations that suppress CYP 2C9 and CYP 3A4, such as ketoconazole and amiodarone, with terbinafine.
Medicinal products that may reduce the effects or plasma concentrations of terbinafine. Rifampicin increased the clearance of terbinafine by 100%.
Effect of terbinafine on other medicinal products. In vitro studies in healthy volunteers indicate that terbinafine has little potential to suppress or increase the clearance of preparations metabolized via the cytochrome P450 system (e.g. terfenadine, triazolam, tolbutamine, or oral contraceptives), except for those preparations that are metabolized by the cytochrome P450 system. participation of CYP 2D6.
Terbinafine does not affect the clearance of antipyrine or digoxin.
There was no effect of terbinafine on the pharmacokinetics of fluconazole. In addition, no clinically significant interactions have been identified between terbinafine and concomitant medicinal products with possible interaction potential, such as co-trimoxazole (trimethoprim and sulfamethoxazole), zidovudine, or theophylline.
Cases of menstrual irregularities (intermenstrual bleeding and irregular menstrual cycle) have been reported in patients who used terbinafine concomitantly with oral contraceptives, although the frequency of these disorders remains within the frequency of adverse reactions in patients taking only oral contraceptives.
Medicinal products whose effects or plasma concentrations may increase terbinafine levels. Terbinafine reduced the clearance of caffeine administered intravenously by 21%.
In vitro and in vivo studies have shown that terbinafine inhibits CYP 2D6-mediated metabolism. These data may be clinically important for patients receiving medicinal products that are metabolized by CYP 2D6, such as tricyclic antidepressants (TCAs), β-adrenergic blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmic preparations (including class 1A, 1B and 1C) and MAO inhibitors (MAO-Is) type B, when the preparation has a small therapeutic concentration range.
Terbinafine reduced the clearance of desipramine by 82%.
The use of terbinafine can lead to the replacement of the status of fast metabolizers of CYP 2D6 with the status of slow metabolizers.
Medicinal products whose effects or plasma concentrations may decrease terbinafine levels. Terbinafine increased the clearance of cyclosporine by 15%.
Overdose
Symptoms: headache, nausea, epigastric pain and dizziness.
Treatment: elimination of the preparation by the use of activated charcoal and symptomatic supportive therapy, if necessary.
Storage conditions
At a temperature not higher than 25 ° C.
Tags: Terbinorm
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