Flustop capsules 75mg №10×1

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Flustop caps.75mg in a cell. pack No. 10×1
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Hard gelatin capsules, number 0, white body, red cap. The main active ingredient Oseltamivir Release form Capsules Dosage 75 mg Pharmacological actionOseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate). The active metabolite is a selective inhibitor of the virus neuraminidase – glycoprotein enzymes located on the surface of the virion. The activity of the viral enzyme neuraminidase is important for the release of the formed viral particles from infected cells and further spread of the virus in the body. Oseltamivir carboxylate in vitro inhibits the neuraminidase of influenza A and B viruses. Oseltamivir phosphate inhibits the growth of the influenza virus and suppresses its replication in vitro. Oral oseltamivir inhibits influenza A and B virus replication and pathogenicity in vivo in animal models of influenza, at doses similar to the human dose of 75 mg twice daily. The antiviral activity of oseltamivir against influenza A and B has been confirmed by experimental studies with provocative tests in healthy volunteers. The value of the median inhibitory concentration (IC50) of oseltamivir in relation to the neuraminidase enzyme for clinically isolated influenza A ranged from 0.1 nM to 1.3 nM, for influenza B it was 2.6 nM. Published studies have reported higher IC50 values for influenza B, up to 8.5 nM. Indications for use Treatment of influenza in adults and children over 12 years of age (weighing more than 40 kg) with typical influenza symptoms in the mass spread of the influenza virus among the population. Efficacy was found in cases where treatment was started within 2 days of the first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza, mainly influenza A. Influenza prophylaxis: – post-exposure prophylaxis in adults and children over 12 years of age (weighing over 40 kg) after exposure to clinically diagnosed influenza in the event of a massive spread of influenza virus in the population . – The proper use of Flustop for the prevention of influenza should be determined on a case-by-case basis according to the circumstances and the needs of the population to be protected. In exceptional cases (for example, in the event of a mismatch between the circulating strain of the virus and the vaccine, as well as during a pandemic), seasonal prophylaxis may be considered in people aged 12 years (weighing more than 40 kg) and older. Flustop does not replace flu vaccination. The use of antiviral drugs for the treatment and prevention of influenza should be based on official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis should be made taking into account data on circulating influenza viruses, available information on patterns of drug susceptibility for each season, and the impact of the disease in different geographic regions and patient populations. Use during pregnancy and lactation Pregnancy Since no controlled clinical trials have been conducted with oseltamivir in pregnant women, there are only limited data from post-marketing reports and retrospective observational studies. Data from animal studies have shown no direct or indirect damaging effects on pregnancy, fetal/embryo development or postnatal development. Pregnant women may take Flustop, taking into account the available data on the safety, pathogenicity of the circulating strain of the influenza virus and the condition of the pregnant woman. Lactation In lactating rats, oseltamivir and its active metabolite were excreted in breast milk. Limited data on infants whose mothers took oseltamivir and on the excretion of oseltamivir in breast milk demonstrated that oseltamivir and its active metabolite were found in breast milk at very low doses, which are below the therapeutic dose for an infant. Given this information, the pathogenicity of the circulating influenza virus strain, and the condition of the mother, oseltamivir may be considered if there is potential benefit to the nursing mother. Fertility Based on preclinical data, there is no evidence of the effect of Flustop on male or female fertility. PrecautionsOseltamivir is effective only in diseases caused by influenza viruses. There is no evidence that oseltamivir is effective against diseases caused by agents other than the influenza virus. Flustop is not a substitute for the flu vaccine. The use of Flustop should not affect the determination of individuals for annual influenza vaccination. Protection against influenza lasts only while taking Flustop. Flustop should be used for the treatment and prevention of influenza only with reliable epidemiological data confirming the fact that influenza is circulating in the population. The sensitivity of circulating influenza strains to oseltamivir is highly variable. Therefore, prescribers should take into account the most recent information on the nature of susceptibility of currently circulating viruses to oseltamivir when deciding whether to use Flustop. Concomitant serious conditions There are no data on the safety and efficacy of oseltamivir in patients with any sufficiently severe or unstable medical conditions, in which the risk of hospitalization is considered imminent. Immunocompromised patients The efficacy of oseltamivir in both the treatment and prevention of influenza in immunocompromised patients has not been clearly established. Cardiac/Respiratory Disease The efficacy of oseltamivir in patients with chronic heart and/or respiratory disease has not been established. In these patients, there were no differences in the incidence of complications between the drug and placebo groups. Neuropsychiatric events Neuropsychiatric events have been reported during the administration of oseltamivir in patients with influenza, especially in children and adolescents. The same events were also observed in patients with influenza who did not take oseltamivir. Patients should be carefully monitored for behavioral changes and the benefits and risks of continuing treatment should be carefully assessed for each patient (see section “Side Effects”). Interactions with other drugs The pharmacokinetic properties of oseltamivir, such as low plasma protein binding and metabolism independent of CYP450 and the glucuronidase system, suggest that clinically significant interactions through these mechanisms are unlikely. Probenecid In patients with normal renal function, no dose adjustment is required when oseltamivir and probenecid are co-administered. Co-administration of probenecid, a potent inhibitor of renal tubular anionic secretion, resulted in an approximately two-fold increase in the concentration of the active metabolite of oseltamivir. Amoxicillin Oseltamivir has no pharmacokinetic interaction with amoxicillin, which is eliminated by the same route, and oseltamivir is expected to compete weakly for this elimination route. Renal Elimination Clinically significant drug interactions involving competition for renal tubular secretion are unlikely due to the known safety profile of most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and tubular anionic secretion), and due to their excretion mechanisms. However, caution should be exercised when prescribing oseltamivir to patients using drugs with a narrow therapeutic interval that are excreted by the same route (eg, chlorpropamide, methotrexate, phenylbutazone). Additional information No pharmacokinetic interactions have been observed between oseltamivir or its major metabolite when oseltamivir is co-administered with paracetamol, acetylsalicylic acid, cimetidine or antacids (magnesium and aluminum hydroxide and calcium carbonate), rimantadine, or warfarin (not in warfarin-stable patients). influenza patients). Contraindications Hypersensitivity to the active substance or any of the excipients listed in the “Composition” section of the drug. Active ingredient: oseltamivir – 75 mg (as oseltamivir phosphate), excipients: povidone, anhydrous lactose, croscarmellose sodium, talc, magnesium stearate, potato starch; composition of the capsule shell: gelatin, titanium dioxide (E 171), carmoisine dye (E 122). Dosage and administration Adolescents 13-17 years old and adults. Treatment The recommended oral dose is 75 mg oseltamivir twice daily for 5 days in adolescents (13-17 years) and adults. Treatment should be started as early as possible, but no later than 2 days after the onset of influenza symptoms. Post-exposure prophylaxis The recommended dose for influenza prophylaxis after close contact with an influenza patient is 75 mg oseltamivir once daily for 10 days in adolescents (13-17 years) and adults. Treatment should be started as early as possible, but no later than 2 days from the moment of contact with the patient. Prevention during an epidemic in the community To prevent influenza during an outbreak, oseltamivir 75 mg once daily for up to 6 weeks is recommended. Special groups: Hepatic insufficiency Dose adjustment in the treatment and prevention of influenza in patients with hepatic insufficiency is not required. Studies of pediatric patients with hepatic insufficiency have not been conducted. Renal failure Patients with a creatinine clearance of more than 60 ml / min dose adjustment is not required. With a creatinine clearance of less than 10 ml / min, the use of oseltamivir is contraindicated. With a creatinine clearance of less than 60 ml / min, this dosage form of the drug is contraindicated for use. Elderly patients No dose adjustment is required, except in patients with renal insufficiency. Patients with immunodeficiency For patients with immunodeficiency, the possibility of extending seasonal prophylaxis up to 12 weeks is considered. Method of administration Oseltamivir is taken orally. Overdose: Reports of oseltamivir overdose have been received from clinical trials and post-marketing monitoring. In most cases, reports of overdose, no adverse events were reported. Side effects reported in connection with overdose were similar in nature and frequency to those observed with oseltamivir at therapeutic dosages and are described in the section “Side Effects”. There is no specific antidote. Adverse Effects Overall Safety Profile The overall safety profile of oseltamivir is based on data from clinical studies of 6049 adults/adolescents and 1473 pediatric patients treated with oseltamivir or placebo for the treatment of influenza, and 3990 adults/adolescents and 253 children treated with oseltamivir or placebo (or no treatment) for the prevention of influenza. Additionally, 475 immunocompromised patients (including 18 children, 10 on oseltamivir and 8 on placebo) received either oseltamivir or placebo for influenza prevention. In influenza treatment studies in adults/adolescents, side effects such as nausea and vomiting were more frequently described, in prevention studies, nausea was more often described. Most of these side effects were reported once on the first or second day of treatment, and they spontaneously resolved within 1-2 days. In children, vomiting was most often described as a side effect. In most cases, these side effects did not lead to discontinuation of treatment. The following serious adverse reactions to oseltamivir have been rarely reported since market launch: anaphylactic and anaphylactoid reactions, liver disease (fulminant hepatitis, abnormal liver function and jaundice), angioedema, Steven-Johnson syndrome, toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders . (See Precautions section for details on neuropsychiatric disorders.) Tabular list of side effects The adverse reactions listed in the table below fall into the following categories: very common (? 1/10); frequent (? 1/100 and < 1/10); infrequent (? 1/1000 and < 1/100); rare (? 1/10000 and < 1/1000); very rare (< 1/10000). Adverse events are added to the appropriate category of the table based on the combined analysis of clinical studies. Treatment and Prophylaxis in Adults and Adolescents In the treatment and prevention studies in adults and adolescents, the most commonly reported adverse reactions at recommended doses (75 mg twice daily for 5 days and 75 mg once daily for up to 6 weeks) were quantified similar to those in the treatment studies, despite the longer duration of dosing in the prevention studies. Table 1. Adverse effects in studies of oseltamivir for the treatment and prevention of influenza in adults and adolescents or during post-marketing surveillance Class of organ systems Adverse effects according to frequency Very common Often Uncommon Rare Infectious and parasitic diseases - often - Bronchitis, herpes simplex, nasopharyngitis, upper respiratory infections, sinusitis. Blood and lymphatic system disorders - rarely - Thrombocytopenia Immune system disorders, infrequently - Hypersensitivity reactions, - rarely - Anaphylactic reactions, anaphylactoid reactions. Mental disorders - rarely - Agitation, unusual behavior, anxiety, confusion, mania, delirium, hallucinations, nightmares, self-mutilation. Nervous system disorders - very often - Headache, often - Insomnia, infrequently - Clouding of consciousness, convulsions. Violations of the organ of vision - rarely - Visual disorder. Cardiac disorders - infrequently - Cardiac arrhythmia. Respiratory, thoracic and mediastinal disorders Common Cough, sore throat, rhinorrhea. Disorders of the gastrointestinal tract - very often - Nausea, often - Vomiting, abdominal pain (including pain in the upper abdomen), dyspepsia, rarely - Gastrointestinal bleeding, hemorrhagic rhinitis. Liver and biliary tract disorders - infrequently - Increased activity of liver enzymes, rarely - Fulminant hepatitis, renal failure, hepatitis. Skin and subcutaneous tissue disorders - infrequently - eczema, dermatitis, rash, urticaria, rarely - angioedema, erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis General disorders and administration site disorders - often - pain, dizziness (including vestibular ), fatigue, pyrexia, pain in extremities Further information on selected adverse reactions: Psychiatric and nervous system disorders Influenza may be associated with a variety of neurological and behavioral symptoms, which may include events such as hallucinations, delirium and unusual behavior, in some cases ended in death. These disorders may occur in the presence of encephalitis or encephalopathy, or in the absence of significant severe disease. Seizures and delirium (including symptoms such as clouding of consciousness, confusion, unusual behavior, mania, hallucinations, agitation, anxiety, nightmares) have been reported in patients with influenza treated with oseltamivir in the post-marketing period, which in very rare cases led to self-mutilation or fatality. These events have been reported mainly in children and adolescents; often they started suddenly and quickly passed. The role of oseltamivir in causing these disorders is unknown. Such neuropsychiatric manifestations have also been reported in patients with influenza who did not receive oseltamivir. Liver and biliary tract disorders Liver and biliary tract disorders, including hepatitis and elevated liver enzymes, in patients with influenza-like illness. They cover cases of fulminant hepatitis/liver failure with a fatal outcome. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25? Keep out of the reach of children. 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