Tavanic tab n / 500mg film about 5 pc

$9.57

Tavanic tab n / 500mg film about 5 pc

Quantity:

Description

Composition
Active substance:
1 tablet contains: levofloxacin – 250,000 mg (corresponding to 256.230 mg of levofloxacin hemihydrate) or levofloxacin – 500,000 mg (corresponding to 512.460 mg of levofloxacin hemihydrate).
Excipients:
Hypromellose, crospovidone, microcrystalline cellulose; sodium fumarate; film coating: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, ferric oxide red (E 172) and iron oxide yellow (E 172).
Description:
Oblong biconvex tablets with a dividing notch on both sides, film-coated pale yellowish-pink color.
Product form:
Tablets, film-coated, 250 mg. 3, 5, 7 or 10 tablets in a blister made of PVC / aluminum foil. 1 blister together with instructions for use in a cardboard box.
Tablets, film-coated, 500 mg. 5, 7 or 10 tablets in a blister made of PVC / aluminum foil. 1 blister together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to levofloxacin or other quinolones, as well as any of the excipients Tavanik® preparation. Epilepsy. Gravis (myasthenia gravis) (see. Forums “Side effects”, “Special Instructions”). Defeat tendons while taking quinolones in history. Childhood and adolescence to 18 years (due to incomplete growth of the skeleton, as it is impossible to completely eliminate the risk of cartilage growth points). Pregnancy (can not completely exclude the risk of cartilage growth points in the fetus). breastfeeding period (you can not completely eliminate the risk of cartilaginous bone growth points of the child).
Carefully
Patients predisposed to the development of seizures [patients with previous lesions of the central nervous system (CNS) in patients concomitantly receiving drugs that reduce the seizure threshold of the brain availability, such as fenbufen, theophylline] (see. See “The interaction with other drugs “). Patients with latent or manifest deficiency of glucose-6fosfatdegidrogenazy (increased risk of hemolytic reactions in the treatment of quinolones). Patients with impaired renal function (requires mandatory monitoring of renal function as well as correction dosing regimen. See section “Dosage and Administration”). In patients with known risk factors for prolongation of the interval QT: elderly patients; in female patients, patients with uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); syndrome of congenital lengthening the interval QT; cardiac diseases (cardiac insufficiency, myocardial infarction, bradycardia); while taking drugs can extend the interval QT (antiarrhythmics of Class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see. the sections “Overdose”, “Interaction with other drugs,” “special instructions”). In patients with diabetes receiving oral hypoglycemic agents, e.g., glyburide or preparations of insulin (increasing the risk of hypoglycemia). Patients with severe adverse reactions to other fluoroquinolones such as severe neurological reaction (similar to an increased risk of adverse reactions when applying levofloxacin). Patients with psychosis or in patients with a history of mental illness (see. Section “Special Instructions”).
Indications
Bacterial infections are sensitive to levofloxacin, in adults with acute sinusitis; exacerbation of chronic bronchitis; community-acquired pneumonia; uncomplicated urinary tract infections; complicated with urinary tract infections (including pyelonephritis); chronic bacterial prostatitis; infections of skin and soft tissues; for the integrated treatment of drug-resistant tuberculosis; prevention and treatment of anthrax with droplet path infection. In applying the drug should be considered Tavanik® official national guidelines on the appropriate use of antimicrobials, as well as the sensitivity of the pathogen in a particular country (see. “Special Instructions” section).
Interaction with other drugs
Interactions requiring compliance with caution
With preparations containing magnesium, aluminum, iron and zinc, didanosine: preparations containing divalent or trivalent cations such as zinc or iron salts (drugs for the treatment of anemia) of magnesium and / or aluminum-containing preparations (such as antacids) , didanosine (only formulations containing as buffer aluminum or magnesium), it is recommended to take at least 2 hours before or 2 hours after administration Tavanik® tablets. Calcium salts have a minimal effect on the absorption of levofloxacin in its ingestion
Since sucralfate: Tavanik® drug action significantly attenuated while the use of sucralfate (the means to protect the gastric mucosa). Patients receiving levofloxacin and sucralfate, sucralfate advised to take 2 hours after receiving levofloxacin
With theophylline fenbufenom or similar medicaments from the group of non-steroidal anti-inflammatory drugs, which reduce the seizure threshold of the brain readiness: levofloxacin pharmacokinetic interaction with theophylline is not revealed. However, while the use of quinolones and theophylline, nonsteroidal antiinflammatory drugs, and other medications that lower seizure threshold of the brain availability, possibly marked reduction in seizure threshold of the brain availability. Levofloxacin concentration while taking fenbufen increased by only 13%.
With indirect anticoagulants (vitamin K antagonists) in patients treated with levofloxacin in combination with indirect anticoagulants (eg, warfarin), there was an increase in prothrombin time / international normalized ratio and / or the development of bleeding, including, and heavy. Therefore, while the use of anticoagulants and levofloxacin requires regular monitoring of blood coagulation parameters
With probenecid and cimetidine: while the use of drugs that violate the renal tubular secretion, such as probenecid and cimetidine, and levofloxacin, caution, especially in patients with renal insufficiency. Excretion (renal clearance) of levofloxacin slows down under the action of cimetidine in 24% and 34% of probenecid. It is unlikely that this could be of clinical importance in the normal renal function.
Cyclosporin C: levofloxacin increased T1 / 2 ciclosporin 33%. Since it is clinically insignificant increase, correction cyclosporin dose when applied simultaneously with levofloxacin is required.
Since glucocorticosteroids: concomitant use of corticosteroids increases the risk of tendon rupture.
With drugs, prolong the interval QT: Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs, lengthening the interval QT (e.g., antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, antipsychotics).
other
Conducted clinical and pharmacological studies to investigate possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of levofloxacin, while the use of these drugs has not changed sufficiently that it had clinical significance.
Overdose
Symptoms of overdose: based on the data obtained in the toxicology studies conducted in animals, the most important expected symptoms of acute overdose of the drug Tavanik® are symptoms of the central nervous system (disturbance of consciousness including confusion, dizziness and cramps). When applied post-marketing drug overdose effects were observed in the central nervous system, including confusion, convulsions, hallucinations, and tremor. May develop nausea and occurrence of erosions of the mucous membrane of the gastrointestinal tract. At clinical-pharmacological studies carried out with doses of levofloxacin exceeding therapeutic observed lengthening the interval QT.
Treatment of overdose: In case of overdose requires careful observation of the patient, including ECG monitoring. Treatment is symptomatic. In the case of tablets Tavanik® acute overdose shown gastric lavage and administering antacid to protect the gastric mucosa. Levofloxacin is output by dialysis (hemodialysis, peritoneal dialysis and continuous ambulatory peritoneal dialysis). There is no specific antidote.
pharmachologic effect
Pharmacological group:
The antimicrobial agent, a fluoroquinolone.
Pharmacodynamics:
Tavanik® – a synthetic antibacterial agent of a broad spectrum fluoroquinolone, containing as active substance levofloxacin – laevorotatory isomer of ofloxacin. Levofloxacin blocking DNA gyrase and topoisomerase IV, and crosslinking gives supercoiling of DNA breaks, inhibits DNA synthesis, causes profound morphological change in the cytoplasm, the cell wall and membranes of the microbial cells. Levofloxacin is active against most strains of microorganisms in conditions in vitro, and in vivo.
In vitro
Sensitive organisms (MIC
Pregnancy and breast-feeding
Levofloxacin is contraindicated in pregnant and breast-feeding women.
Conditions of supply of pharmacies
Prescription.
side effects
The following side effects are presented according to the following gradation frequency of occurrence: very often (> 1/10); common (> 1/100,
special instructions
Nosocomial infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa), may require a combined treatment. The prevalence of acquired resistance sown microorganisms may vary depending on geographic region and over time. In this connection it is required for resistance to the drug in a specific country information. For treatment of severe infections or when treatment failure should be set microbiological diagnosis with the release of the pathogen and the determination of its susceptibility to levofloxacin
Methicillin-resistant Staphylococcus Streptococcus: there is a high probability that the methicillin-resistant staphylococcus aureus is resistant to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of established or suspected infections caused metitsillin- resistant Staphylococcus aureus, if laboratory tests have not confirmed the sensitivity of the organism to levofloxacin.
Patients predisposed to the development of seizures: like other quinolones, levofloxacin should be used with caution in patients with a predisposition to seizures. Such patients include patients with previous lesions of the central nervous system such as stroke, severe traumatic brain injury; patients receiving both drugs that lower seizure threshold of the brain availability, such as fenbufen and other similar non-steroidal anti-inflammatory drugs or other drugs that lower seizure threshold, such as theophylline (see. See “The interaction with other drugs”).
Pseudomembranous colitis: evolved during or after treatment with levofloxacin diarrhea, particularly severe, persistent and / or blood, can be a symptom of pseudomembranous colitis caused by Clostridium difficile. In case of suspicion for the development of pseudomembranous colitis treatment with levofloxacin should be discontinued immediately, and immediately begin to specific antibiotics (vancomycin, teicoplanin or metronidazole inside). Drugs which inhibit peristalsis are contraindicated.
Tendonitis: tendinitis rarely observed in the application of quinolones, including levofloxacin, may lead to rupture of the tendon, including the Achilles tendon. This side effect may occur within 48 hours after the start of treatment and may be bilateral. Elderly patients are more likely to develop tendinitis. The risk of tendon rupture may be increased, while taking glucocorticoids. If tendinitis is suspected, immediately discontinue treatment with Tavanik® and start the appropriate treatment of the affected tendon, for example, to provide him with adequate immobilization (see. Sections “Contraindications” and “Side effects”).
Hypersensitivity reactions: levofloxacin can cause serious, potentially fatal hypersensitivity reactions (angioneurotic edema, anaphylactic shock), even when applying the initial dose (see “Side effect” section.). Patients should stop taking the drug and consult a doctor.
Severe bullous reactions: when receiving levofloxacin bullous observed cases of severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section “Side effect”.). In the case of any reaction on the part of the skin or mucous membranes of the patient should seek medical advice immediately and not continue to treat his advice.
Disorders of the liver and biliary tract: reported cases of hepatic necrosis, including the development of fatal liver failure when using levofloxacin, mainly in patients with serious underlying diseases, such as sepsis (see section “Side effect”.). Patients should be warned about the need to stop treatment and urgent referral to a physician in case of signs and symptoms of liver damage, such as anorexia, jaundice, dark urine, itching, and abdominal pain
Patients with renal insufficiency: since levofloxacin is excreted mainly by the kidneys in patients with impaired renal function requires mandatory monitoring of renal function, and a correction mode (see “Dosing and dose.”). In the treatment of elderly patients should be borne in mind that these patients are often marked by impaired renal function (see. The section “Method of administration and dose”).
Prevention of photosensitivity reactions, although photosensitivity when applied levofloxacin develops rarely, to prevent its development in patients is not recommended during treatment and for 48 hours after treatment with levofloxacin subjected unnecessarily to strong sunlight or to artificial ultraviolet light (e.g., the solarium).
Superinfection: As with other antibiotics, the use of levofloxacin, particularly during a long time may lead to an increased reproduction insensitive thereto microorganisms (bacteria and fungi), which may cause changes in the microflora, which is normally present in humans. As a result, may develop superinfection. Therefore, in the course of treatment required to reassess the patient’s condition and, in the case of superinfection during treatment, appropriate measures should be taken.
Lengthening of the QT interval: report very rare cases of QT prolongation in patients receiving fluoroquinolones, including levofloxacin. In applying fluoroquinolones, including levofloxacin, caution in patients with known risk factors for lengthening the interval QT: patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); syndrome of congenital lengthening the interval QT; cardiac diseases (cardiac insufficiency, myocardial infarction, bradycardia); while taking drugs can extend the interval QT, such as antiarrhythmics of Class IA and III, tricyclic antidepressants, macrolides, antipsychotics. Elderly patients and female patients may be more sensitive to the drug, prolongs the QT interval. It should therefore be used with caution in these fluoroquinolones, including levofloxacin (see. Forums ”
With caution “,” Dosage and Administration “” Side effect “and” Overdose “” The interaction with other drugs “).
Patients with deficiency of glucose-6-phosphate dehydrogenase deficiency: Patients with latent or manifest deficiency of glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions with quinolones treatment that should be taken into account when treating with levofloxacin.
Hypo- and giperlikemiya (dysglycemia): as well as the application of other quinolones, when using levofloxacin observed cases of hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with oral hypoglycemic agents (e.g. glibenclamide) or insulin preparations. Reported cases of hypoglycemic coma. In patients with diabetes require blood glucose monitoring (see. The section “Side effect”).
Peripheral neuropathy: patients receiving fluoroquinolones, including levofloxacin, marked sensory and sensory-motor peripheral neuropathy, the beginning of which can be rapid. If the patient has symptoms of neuropathy, the use of levofloxacin should be discontinued. Это минимизирует возможный риск развития необратимых изменений.
Обострение псевдопаралитической миастении (myasthenia gravis): фторхинолоны, включая левофлоксацин, характеризуются блокирующей нервно-мышечное проведение активностью и могут усиливать мышечную слабость у пациентов с псевдопаралитической миастенией. В постмаркетинговом периоде наблюдались неблагоприятные реакции, включая легочную недостаточность, потребовавшую проведение искусственной вентиляции легких, и смертельный исход, которые ассоциировались с применением фторхинолонов у пациентов с псевдопаралитической миастенией. Применение левофлоксацина у пациента с установленным диагнозом псевдопаралитической миастении не рекомендуется (см. раздел «Побочное действие»)
Применение при воздушно-капельном пути заражения сибирской язвой: применение левофлоксацина у человека по этому показанию основано на данных по чувствительности к нему Bacillus anthracis, полученных в исследованиях in vitro и в экспериментальных исследованиях, проведенных на животных, а также на ограниченных данных применения левофлоксацина у человека. Лечащие врачи должны обращаться к национальным и/или международным документам, которые отражают выработанную общими усилиями точку зрения по лечению сибирской язвы.
Психотические реакции: при применении хинолонов, включая левофлоксацин, сообщалось о развитии психотических реакций, которые в очень редких случаях прогрессировали до развития суицидальных мыслей и нарушений поведения с причинением себе вреда (иногда после приема разовой дозы левофлоксацина (см. раздел «Побочное действие»)). При развитии таких реакций лечение левофлоксацином следует прекратить и назначить соответствующую терапию. Следует с осторожностью назначать препарат пациентам с психозами или пациентам, имеющим в анамнезе психические заболевания
Нарушения зрения: при развитии любых нарушений зрения необходима немедленная консультация офтальмолога (см. раздел «Побочное действие»).
Влияние на лабораторные тесты: у пациентов, принимающих левофлоксацин, определение опиатов в моче может приводить к ложноположительным результатам, которые следует подтверждать более специфическими методами. Левофлоксацин может ингибировать рост Mycobacterium tuberculosis и приводить в дальнейшем к ложноотрицательным результатам бактериологического диагноза туберкулеза.
Влияние на способность управлять транспортными средствами или заниматься другими потенциально опасными видами деятельности Такие побочные эффекты препарата Таваник®, как головокружение или вертиго, сонливость и расстройства зрения (см. раздел «Побочное действие»), могут снижать психомоторные реакции и способность к концентрации внимания. Это может представлять собой определенный риск в ситуациях, когда эти способности имеют особое значение (например, при управлении автомобилем, при обслуживании машин и механизмов, при выполнении работ в неустойчивом положении).
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Таблетки Таваник® 250 мг или 500 мг принимают внутрь один или два раза в сутки. Таблетки следует проглатывать, не разжевывая и запивая достаточным количеством жидкости (от 0,5 до 1 стакана). При необходимости таблетки можно разламывать по разделительной бороздке. Препарат можно принимать перед едой или в любое время между приемами пищи, так как прием пищи не влияет на абсорбцию препарата (см. раздел «Фармакокинетика»). Препарат следует принимать не менее чем через 2 ч до или через 2 ч после приема препаратов, содержащих магний и/или алюминий, железо, цинк, или сукральфата (см. раздел «Взаимодействие с другими лекарственными средствами»). Учитывая то, что биодоступность левофлоксацина при приеме препарата Таваник® в таблетках равна 99-100 %, в случае перевода пациента с внутривенной инфузии препарата Таваник® на прием таблеток следует продолжать лечение в той же дозе, которая применялась при внутривенной инфузии (см. раздел «Фармакокинетика»).
Пропуск приема одной или нескольких доз препарата: если случайно пропущен прием препарата, то надо, как можно скорее, принять очередную дозу и далее продолжать принимать препарат Таваник® согласно рекомендованному режиму его дозирования.
Дозы и продолжительность лечения
Режим дозирования определяется характером и тяжестью инфекции, а также чувствительностью предполагаемого возбудителя. Продолжительность лечения варьирует в зависимости от течения заболевания
Рекомендуемые режим дозирования и продолжительность лечения у пациентов с нормальной функцией почек (КК >50 мл/мин)
Острый синусит: по 2 таблетки Таваник® 250 мг или по 1 таблетке Таваник® 500 мг 1 раз в сутки (соответственно по 500 мг левофлоксацина) – 10-14 дней.
Обострение хронического бронхита: по 2 таблетки Таваник® 250 мг или по 1 таблетке Таваник® 500 мг 1 раз в сутки (соответственно по 500 мг левофлоксацина) – 7-10 дней.
Внебольничная пневмония: по 2 таблетки Таваник® 250 мг или по 1 таблетке Таваник® 500 мг 1-2 раза в сутки (соответственно по 500-1000 мг левофлоксацина) – 7-14 дней.
Осложнённые инфекции мочевыводящих путей: по 2 таблетки Таваник® 250 мг 1 раз в сутки или по 1 таблетке Таваник® 500 мг 1 раз в сутки (соответственно по 500 мг левофлоксацина) – 7-14 дней
Пиелонефрит: по 2 таблетки Таваник® 250 мг 1 раз в сутки или по 1 таблетке Таваник® 500 мг 1 раз в сутки (соответственно по 500 мг левофлоксацина) – 7-10 дней.
Хронический бактериальный простатит: по 2 таблетки Таваник® 250 мг или по 1 таблетке Таваник® 500 мг 1 раз в сутки (соответственно по 500 мг левофлоксацина) – 28 дней.
Инфекции кожных покровов и мягких тканей: по 2 таблетки Таваник® 250 мг или по 1 таблетке Таваник® 500 мг 1-2 раза в сутки (соответственно по 500-1000 мг левофлоксацина) – 7-14 дней.
Комплексное лечение лекарственно-устойчивых форм туберкулеза: по 1 таблетке Таваник® 500 мг 1-2 раза в сутки (соответственно по 500-1000 мг левофлоксацина) – до 3-х месяцев.
Профилактика и лечение сибирской язвы при воздушно-капельном пути заражения: по 2 таблетки Таваник® 250 мг или по 1 таблетке Таваник® 500 мг (соответственно по 500 мг левофлоксацина) 1 раз в сутки в течение до 8 недель.
Режим дозирования у пациентов с нарушением функции почек (КК
Если рекомендуемая доза при КК >50 мл/мин: по 250 мг/24 ч, то режим дозирования при КК 50-20 мл/мин-первая доза: 250 мг затем по 125 мг/24 ч, при КК 19-10 мл/мин-первая доза: 250 мг затем по 125 мг/48 ч, при КК
Если рекомендуемая доза при КК >50 мл/мин: 500 мг/24 ч, то режим дозирования при КК 50-20 мл/мин-первая доза: 500 мг затем по 250 мг/24 ч, при КК 19-10 мл/мин-первая доза: 500 мг затем по 125 мг/24 ч, при КК
Если рекомендуемая доза при КК >50 мл/мин: 500 мг/12 ч, то режим дозирования при КК 50-20 мл/мин-первая доза: 500 мг затем по 250 мг/12 ч, при КК 19-10 мл/мин-первая доза: 500 мг затем по 125 мг/12 ч, при КК
Режим дозирования у пациентов с нарушениями функции печени: при нарушении функции печени не требуется коррекции режима дозирования, поскольку левофлоксацин лишь незначительно метаболизируется в печени
Режим дозирования у пациентов пожилого возраста: для пациентов пожилого возраста не требуется коррекции режима дозирования, за исключением случаев снижения КК до 50 мл/мин и ниже.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

SANOFI RUSSIA

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