Flucaps capsules 30mg №10×1

Name:
Flucaps capsules 30mg N10. One capsule contains: oseltamivir 30 mg (as oseltamivir phosphate 39.4 mg); oseltamivir 45 mg (as oseltamivir phosphate 59.1 mg); oseltamivir 75 mg (as oseltamivir phosphate 98.5 mg). Excipients: pregelatinized starch, potato starch, povidone K 30, croscarmellose sodium, talc, sodium stearyl fumarate, colloidal silicon dioxide (aerosil 200). The composition of the capsule shell for a dosage of 30 mg: gelatin, purified water, titanium dioxide E-171. The composition of the capsule shell for dosages of 45 mg and 75 mg: gelatin, purified water, titanium dioxide E-171, yellow iron oxide E-172.
Description:
Capsules hard gelatin cylindrical shape with hemispherical ends, with a body and a cap of white color (dosage 30 mg). Capsules hard gelatin cylindrical shape with hemispherical ends, with a white body and a light yellow cap (dosage 45 mg). Capsules hard gelatin cylindrical shape with hemispherical ends, with a body and a cap of light yellow color (dosage 75 mg). The contents of the capsules are white or almost white powder. Pharmacotherapeutic group Antiviral agent for systemic use, neuraminidase inhibitors. ATX code: J05AH02 Pharmacological propertiesPharmacodynamicsOseltamivir phosphate is a prodrug of the active metabolite (oseltamivir carboxylate). The active metabolite is a selective inhibitor of virus neuraminidase enzymes, 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 those given in humans at 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. Clinical Studies Treatment of Influenza Virus Infection This indication is based on clinical studies of natural influenza cases in which influenza A was predominant. Oseltamivir is effective only in influenza virus infections. Therefore, analysis statistics are presented for influenza-infected patients only. In a pooled population study of positive and negative influenza virus (ITT) patients, primary efficacy declined in proportion to the number of influenza negative patients. In the entire treatment population, influenza infection is confirmed in 67% (range 46% to 74%) of recruited patients. Of all elderly patients, 64% were positive for influenza virus, and of all elderly patients with chronic heart failure and/or respiratory disease, 62% were positive for influenza virus. In all Phase III clinical trials, patients were only recruited during an influenza epidemic in the area. Adults and adolescents aged 13 years and older Patients were selected who reported onset of symptoms within 36 hours, who had a fever ≥37.8°C with at least one respiratory symptom (cough, nasal symptoms, sore throat ) and at least one systemic symptom (muscle pain, chills/sweats, malaise, weakness, or headache). In a pooled analysis of all influenza positive adults and adolescents (n=2413) enrolled in treatment studies, oseltamivir 75 mg twice daily for 5 days reduced the mean duration of influenza by one day compared with placebo, with 5.2 days (95% CI 4.9–5.5 days) to 4.2 days (95% CI 4.0–4.4 days; p≤0.0001). The proportion of patients who developed lower respiratory complications requiring antibiotic treatment (mainly bronchitis) decreased from 12.7% (135/1063) in the placebo group to 8.6% (116/1350) in patients treated with treatment with oseltamivir (p=0.0012). Treatment of influenza in high-risk populations The mean duration of influenza was not significantly reduced in elderly subjects (≥65 years) and in patients with chronic heart and/or respiratory disease treated with oseltamivir 75 mg twice daily for 5 days. In the oseltamivir treatment group, the duration of the fever period decreased by one day. In influenza positive elderly patients, oseltamivir significantly reduced the incidence of lower respiratory complications requiring antibiotic treatment (mainly bronchitis) from 19% (52/268) in the placebo group to 12% (29/ 250) in patients treated with oseltamivir (p=0.0156). In influenza virus-positive patients with chronic heart and/or respiratory disease, the combined incidence of lower respiratory tract infections requiring antibiotic treatment (mainly bronchitis) in the placebo group was 17% (22/133) and in the group who received oseltamivir – 14% (16/118) (p=0.5976). Treatment of Influenza in Pregnancy No controlled clinical studies have been conducted on the use of oseltamivir during pregnancy, however, there is evidence of benefit of this dosing regimen in this patient population based on post-marketing and retrospective observational studies in terms of lower morbidity/mortality. The results of the pharmacokinetic analysis indicate a lower concentration of the active metabolite, however, dose adjustment during pregnancy for the purpose of treating or preventing influenza is not recommended (see sections “Pharmacokinetics” and “Special populations”). Treatment of influenza in children In a study of otherwise healthy children (65% positive for influenza infection) aged 1-12 years (mean age 5.3 years) who had a fever (≥37.8°C) along with cough or runny nose, 67% of influenza-infected patients were infected with influenza A and 33% with influenza B. Treatment with oseltamivir, initiated within 48 hours of the onset of symptoms, significantly reduced the time required to treat the disease (defined as the simultaneous restoration of normal health, activity, fever, cough and runny nose) by 1.5 days (95% CI 0.6-2.2 days; p<0.0001) compared with placebo. Oseltamivir reduced the incidence of acute otitis media from 26.5% (53/200) in the placebo group to 16% (29/183) in the oseltamivir group (p = 0.013). Another study included 334 asthmatic children aged 6-12 years, of which 53.6% were positive for the influenza virus. In the oseltamivir-treated group, the mean duration of illness did not decrease significantly. On day 6 (the last day of treatment), in this population, forced expiratory volume in 1 second increased by 10.8% in the oseltamivir group, compared with 4.7% in the placebo group (p = 0.0148). The European Medicines Agency (EMA) has deferred the need to report results from trials of oseltamivir in one or more subsets of the pediatric influenza population. See the "Dosage and Administration" section for information on use in the pediatric population. The indication for use in children under 1 year of age is based on extrapolation of efficacy data in older children; the recommended dosing regimen is based on pharmacokinetic modeling data (see the Pharmacokinetics section). Treatment of Influenza B Infection Overall, 15% of the influenza positive population were infected with influenza B; according to various studies, this proportion varied from 1 to 33%. The mean duration of illness in patients with influenza B did not differ significantly between treatment groups in the various studies. Data from all 504 influenza B patients included in all studies were pooled for analysis. Oseltamivir reduced the time to resolution of all symptoms by 0.7 days (95% CI 0.1-1.6 days; P=0.022) and the duration of fever (≥37.8°C), cough and runny nose by one day (95% CI 0.4-1.7 days; p<0.001), compared with placebo. Treatment of Influenza in Immunocompromised Adult Patients A randomized, double-blind study evaluating the safety and characterizing the effects of oseltamivir on the development of resistant influenza virus (primary analysis) in influenza-infected immunocompromised adults included 151 patients eligible for evaluating the efficacy of oseltamivir (secondary analysis). , not reinforced). The study included SOT solid organ transplant patients, HSCT hematopoietic stem cell transplant patients, HIV-positive patients with CD4+ cell counts <500 cells/mm3, patients receiving systemic immunosuppressive therapy, and patients with hematologic malignancies. These patients were randomized to treatment within 96 hours of symptom onset with standard dose (73 patients) or double dose (78 patients) of oseltamivir for 10 days. The median time to resolution of symptoms (TTRS) was similar between the standard dose group (103.4 hours 95% CI 75.4-122.7) and the double dose group (107.2 hours 95% CI 63.9-140, 0). The number of patients with secondary infections in the standard dose and double dose groups was comparable (8.2% vs. 5.1%). A pharmacokinetic and pharmacodynamic study was conducted in severely immunocompromised children (≤12 years, n=30) who received a standard dose (75 mg or weight-adjusted twice daily) versus a triple dose (225 mg or weight-adjusted twice daily). per day) of oseltamivir during an adaptive dosing period of 5 to 20 days depending on the duration of virus shedding (average duration of treatment: 9 days). None of the patients in the standard dose group and 2 patients in the triple dose group reported secondary bacterial infections (bronchitis and sinusitis). Influenza prophylaxis Efficacy of oseltamivir for in vivo prophylaxis of influenza has been demonstrated in a post-exposure prophylaxis study in families and two seasonal prophylaxis studies. In all of these studies, the first measure of effectiveness was the incidence of laboratory-diagnosed influenza. Influenza virus virulence is unpredictable and varies within a region and from season to season, so the number needed to treat (NNT) varies as well. Post-exposure prophylaxis In one study, contacts of influenza patients (12.6% were influenza vaccinated) were initiated on oseltamivir 75 mg once daily within two days of the patient's symptoms onset and continued for 7 days . Influenza patients were confirmed in 163 of 377 cases. Oseltamivir significantly reduced the incidence of symptomatic influenza in contacts of confirmed influenza cases from 24/200 (12%) in the placebo group to 2/205 (1%) in the placebo group. oseltamivir (92% reduction 95% CI 6-16; p≤0.0001). Among contacts of confirmed influenza cases, the number needed to treat (NNT) was 10 (95% CI 9-12); and 16 in all study participants (ITT) (95% CI 15-19) regardless of influenza infection status of the source of infection. The efficacy of oseltamivir in vivo prevention of influenza has been demonstrated in a post-exposure prophylaxis study in families with adults, adolescents, and children aged 1 to 12 years, both as sources of infection and as contacts. The primary performance measure of this study was the incidence of laboratory and clinically diagnosed influenza in families. Prophylaxis with oseltamivir lasted 10 days. In the entire population, the incidence of laboratory and clinically diagnosed influenza in families decreased from 20% (27/136) in the group not receiving prophylaxis to 7% (10/135) in the group receiving prophylaxis (62.7% reduction 95% CI 26 0-81.2; p=0.0042). In families with sources of influenza infection, the incidence of influenza decreased from 26% (23/89) in the group not receiving prophylaxis to 11% (9/84) in the group receiving prophylaxis (58.5% reduction 95% CI 15.6-79 .6; p=0.0114). Based on a subgroup analysis of 1-12-year-olds who markedly decreased the incidence of laboratory and clinically diagnosed cases of influenza from 19% (21/111) in the non-prophylactic group to 7% (7/104) in the prophylaxis group (64.4% reduction 95% CI 15.8-85.0; p=0.0188). Among children who were not yet infected at baseline, the incidence of laboratory and clinically diagnosed influenza decreased from 21% (15/70) in the non-prophylactic group to 4% (2/47) in the prophylaxis group (80 .1% reduction (95% CI 22.0-94.9; p=0.0206)). In the pediatric population, the NNT was 9 (95% CI 7-24) for the overall study population (ITT) and 8 (95% CI 6, upper limit undetermined) in the pediatric contact population of confirmed sources of influenza virus infection. Post-exposure prophylaxis of influenza in infants under 1 year of age during a pandemic Influenza prophylaxis during a pandemic has not been studied in controlled clinical trials in children aged 0 to 12 months. See the Pharmacokinetics section for details on exposure modeling. Prevention during a community influenza epidemic In a pooled analysis of two studies in otherwise unvaccinated and otherwise healthy adults, oseltamivir 75 mg once daily for 6 weeks significantly reduced the incidence of symptomatic influenza from 25 /519 (4.8%) placebo to 6/520 (1.2%) oseltamivir (76% reduction (95% CI 1.6-5.7); p=0.0006) during outbreak influenza in the population. The NNT in this study was 28 (95% CI 24-50). In a study in older people living in nursing homes where 80% of participants were vaccinated in the respective season, oseltamivir 75 mg once daily for 6 weeks significantly reduced the incidence of clinically significant influenza from 12/272 (4.4 %) in the placebo group to 1/276 (0.4%) in the oseltamivir group (92% reduction 95% CI 1.5-6.6; p=0.0015). The NNT in this study was 25 (95% CI 23-62). Influenza prophylaxis in immunocompromised patients A double-blind, placebo-controlled, randomized trial of seasonal influenza prophylaxis was conducted in 475 immunocompromised patients (388 solid organ transplant patients (195 placebo, 193 oseltamivir), 87 hematopoietic stem cell transplant patients (43 placebo , 44 - oseltamivir), patients with other immunosuppressive conditions were not studied), including 18 children aged 1-12 years. The primary endpoint in this study was the incidence of laboratory and clinically diagnosed influenza as determined by viral culture and/or a 4-fold increase in HAI antibody titer. The incidence of laboratory and clinically diagnosed influenza was 2.9% (7/238) in the placebo group and 2.1% (5/237) in the oseltamivir group (95% CI 2.3%-4.1%; p = 0.772 ). Specific studies aimed at assessing the reduction in the risk of possible complications have not been conducted. Oseltamivir resistance Clinical studies The risk of influenza viruses emerging with reduced susceptibility or overt resistance to oseltamivir has been considered in clinical studies. The development of resistance to oseltamivir during treatment was more common in children than in adults, with the incidence of resistance ranging from less than 1% in adults to 18% in infants under 1 year of age. Children carrying oseltamivir-resistant virus generally shed virus for longer than those carrying oseltamivir-susceptible virus. However, resistance to oseltamivir that developed during treatment did not affect the effectiveness of treatment and did not cause long-term persistence of influenza symptoms. Overall, a higher incidence of resistance to oseltamivir was observed in immunocompromised adults receiving a standard dose or a double dose of oseltamivir for 10 days 14.5% (10/69) in the standard dose group and 2.7% (2/ 74) in the double dose group, compared with data from studies in otherwise healthy adult patients taking oseltamivir. Most of the patients who developed resistance were transplant recipients (8/10 patients in the standard dose group and 2/2 patients in the double dose group). Most patients with oseltamivir-resistant virus were infected with type A influenza and had a long-term shedding of the virus. Oseltamivir resistance rates in clinical trials Patient population Patients with susceptibility mutations (%) Phenotype determination* Geno- and phenotype determination* Adults and adolescents 0.88% (21/2377) 1.12% (27/2391) Children (1 -12 years) 3.89% (66/1698) 4.24% (72/1698) Infants (<1 year) 18.31% (13/71) 18.31% (13/71) *Complete genotyping not performed in all studies. Influenza prophylaxis To date, there is no evidence of drug resistance associated with the use of oseltamivir in clinical studies of post-exposure (7 days), post-exposure household (10 days) and seasonal (42 days) influenza prophylaxis in immunocompetent patients. No resistance was observed in immunocompromised patients during the 12-week prophylaxis study. Clinical and observational data Natural mutations associated with reduced susceptibility to oseltamivir in vitro have been found in influenza A and B viruses isolated from patients who did not receive oseltamivir. Resistant strains selected during oseltamivir treatment have been isolated from both immunocompetent and immunocompromised patients. Immunocompromised patients and young children are at higher risk of developing oseltamivir-resistant viruses during treatment. Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant laboratory strains of influenza viruses had neuraminidase N1 and N2 mutations. Resistance mutations tended to be specific to virus subtypes. Since 2007, naturally occurring resistance associated with the H275Y mutation of seasonal H1N1 strains has been sporadically detected. Susceptibility to oseltamivir and the spread of such viruses vary by season and locality. In 2008, H275Y was found in >99% of circulating H1N1 influenza strains in Europe. In 2009, H1N1 (“swine flu”) was almost uniformly susceptible to oseltamivir, with only sporadic reports of resistance in both curative and prophylactic regimens. Pharmacokinetics General information Absorption Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate (pro-drug) and is highly converted to the active metabolite (oseltamivir carboxylate) by hepatic esterases. At least 75% of the dose taken orally enters the systemic circulation in the form of an active metabolite. Prodrug concentrations are less than 5% of the active metabolite. Plasma concentrations of the prodrug and active metabolite are dose-proportional and independent of food intake. Distribution The volume of distribution of the active metabolite (oseltamivir carboxylate) in humans is approximately 23 L, a volume equivalent to that of extracellular body fluid. Since the activity of neuraminidase is of an extracellular nature, oseltamivir carboxylate is distributed at all points of spread of the influenza virus. Communication of an active metabolite with proteins of plasma is insignificant (about 3%). Metabolism Oseltamivir is almost completely converted to oseltamivir carboxylate by liver esterases. In vitro studies demonstrate that oseltamivir and the active metabolite are not substrates or inhibitors of cytochrome P450 isoenzymes. In vivo studies did not reveal a second conjugation phase of any of the components. Withdrawal After absorption, oseltamivir is eliminated mainly (> 90%) by conversion to oseltamivir carboxylate. After reaching the peak concentration, the active metabolite has an elimination half-life of 6 to 10 hours. The active metabolite is completely excreted through the kidneys. The renal clearance (18.8 l/h) exceeds the glomerular filtration rate (7.5 l/h), which indicates that in addition to glomerular filtration, tubular secretion also occurs. Less than 20% of the radiologically labeled oral dose is excreted in the feces. Special Populations Pediatric Population Infants < 1 year of age The pharmacokinetics, pharmacodynamics, and safety of oseltamivir were evaluated in two uncontrolled, open-label studies that included influenza-infected children < 1 year of age (n=135). The level of clearance of the active metabolite, adjusted for body weight, decreased in patients younger than 1 year. Metabolite concentrations are also more variable in children of this age group. Available data show that a dose of 3 mg/kg in children 0-12 months of age achieves prodrug and active metabolite concentrations that are expected to provide efficacy and safety profiles comparable to those in older children and adults when taking oseltamivir at the recommended dosage. dose. Reported adverse reactions were comparable to the safety profile in older children. There are no data on post-exposure prophylaxis for influenza in children younger than 1 year of age. Prevention during an influenza epidemic has not been studied in children under 12 years of age. Post-exposure prophylaxis of influenza in infants under 1 year of age during a pandemic Modeling results of the use of the drug at a dosage of 3 mg/kg once a day in infants less than 1 year of age demonstrate that the exposure of the drug is in the same range as with the dosing regimen of 75 mg 1 time per day in adults, or exceeds it. The exposure of the drug does not exceed the exposure observed in the treatment of infants under 1 year (3 mg / kg 2 times a day), and it is expected that the safety profile will be comparable (see section "Side effect"). Clinical studies on the prevention of influenza in infants <1 year of age have not been conducted. Infants and children aged 1 year and older The pharmacokinetics of oseltamivir have been studied in single dose pharmacokinetic studies in infants, children and adolescents aged 1 to 16 years. The pharmacokinetics of repeated doses was studied in a small number of children who took part in a clinical study of the efficacy of the drug. In young children, the clearance of the prodrug and its active metabolite was higher than in adults, resulting in a lower concentration at a given mg/kg dose. At a dose of 2 mg/kg, the concentrations of oseltamivir carboxylate achieved were comparable to those obtained in adults after a single dose of 75 mg (approximately 1 mg/kg). The pharmacokinetics of oseltamivir in children and adolescents 12 years of age and older is similar to that in adults. Elderly patients The concentration of the active metabolite in elderly patients (aged 65-78 years) in the constant concentration phase was 25-35% higher than in adults in the age group under 65 who received oseltamivir in comparable doses. Elimination half-lives in the elderly were similar to those in young adults. Based on the concentration of the drug and tolerability, it is shown that elderly patients do not require dose adjustment, if there is no concomitant severe impairment of renal function (creatinine clearance ˂60 ml / min) (see section "Method of application and dose"). Renal insufficiency The use of oseltamivir phosphate 100 mg twice daily for 5 days in patients with varying degrees of renal insufficiency has demonstrated that the concentration of oseltamivir carboxylate is inversely proportional to the decrease in renal function. See dosing in the section "Method of application and doses". Hepatic insufficiency Based on an in vitro study, a significant increase in the concentration of oseltamivir or its active metabolites is not expected, and this has been confirmed in clinical studies in patients with hepatic insufficiency (see section "Method of administration and doses"). Pregnant women A pooled population pharmacokinetic analysis indicates that the oseltamivir dosing regimen described in the Dosage and Administration section results in lower concentrations (by an average of 30% over all trimesters) of the active metabolite in pregnancy compared to non-pregnant women. women. However, the predicted lower concentration exceeds the inhibitory concentration (IC 95 values) and is at a therapeutic level for a range of influenza virus strains. In addition, there is evidence for the benefit of this dosing regimen in this patient population based on observational data. Thus, dose adjustment during pregnancy for the purpose of treating or preventing influenza is not recommended (see section "Use during pregnancy and during breastfeeding"). Immunocompromised patients Population pharmacokinetic analysis indicates that treatment with oseltamivir in immunocompromised patients (as described in the Dosage and Administration section) results in an increased exposure (5% to 50%) of the active metabolite when compared with adults immunocompetent patients with comparable creatinine clearance. Due to the wide safety margin of the active metabolite, dose adjustment is not required in adult patients based on their immunocompromised status. However, for immunocompromised adult patients with impaired renal function, doses should be adjusted according to the Dosage and Administration section. Preclinical safety data Routine preclinical studies of safety pharmacology, chronic toxicity and genotoxicity have not demonstrated adverse effects in humans. Standard rat carcinogenicity studies have shown a dose-dependent trend in the incidence of some tumors that are typical of the rodent species included in the study. Comparing the exposure limits in rat studies with those expected at human doses, these findings do not change the risk/benefit ratio of oseltamivir for its registered indications. Teratogenicity studies have been performed in rats and rabbits at doses up to 1500 mg/kg/day and 500 mg/kg/day, respectively. There were no effects on fetal development. In female and male rats, a fertility study was conducted using doses up to 1500 mg/kg per day; no adverse effects were identified. In a pre- and postnatal study in rats, at a dose of 1500 mg/kg per day, prolongation of labor was noted: the difference in safety margins between the concentration achieved in humans and the maximum tolerated dose (500 mg/kg per day) in rats was for oseltamivir 480-fold and in the case of the active metabolite 44-fold. The concentration of the drug in the blood of the fetus of rats and rabbits was approximately 15-20% of the maternal. In lactating rats, oseltamivir and the active metabolite are excreted in breast milk. Limited data indicate that oseltamivir and its active metabolite are excreted in human breast milk. Extrapolating from animal data, derived values for humans are 0.01 mg per day and 0.3 mg per day of oseltamivir and the active metabolite, respectively. The possibility of developing skin allergic reactions when taking oseltamivir was investigated in guinea pigs using the "maximization" test. Approximately 50% of the animals treated with the pure active substance developed erythema. Rabbits have experienced transient eye irritation. In a toxicity study of single high doses of oseltamivir phosphate (up to 1310 mg/kg) taken orally, no adverse effects were found in adult rats, but these doses had a toxic effect on young 7-day-old rat pups, causing, among other things, deaths. These effects were noted at doses of 657 mg/kg and above. When using a dose of 500 mg / kg, no adverse effects were noted, including with long-term treatment (with the use of 500 mg / kg / day up to 7-21 days after birth). Indications for use - Treatment of influenza The drug is indicated for adults and children over 6 years of age, with symptoms typical of influenza, during the period of influenza virus circulation in the population. Efficacy has been proven when therapy is started within two days of the onset of influenza symptoms. - Influenza prophylaxis Post-exposure prophylaxis in adults and children aged 6 years and older after exposure to clinically diagnosed influenza in the event of a massive spread of influenza virus in the population. The appropriate use of Flucaps 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, and during a pandemic), seasonal prophylaxis may be considered for people aged 6 years and older. Flucaps is not a substitute for 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 drug susceptibility patterns for each season, and the impact of the disease in various geographic regions and patient populations (see Pharmacodynamics section). Contraindications - Hypersensitivity to the active substance or any of the excipients listed in the "Composition" section of the drug. - Children's age up to 6 years. Route of administration and doses Route of administration For oral administration. Capsules should be swallowed whole with drinking water. Children under 6 years of age and adult patients who have difficulty swallowing capsules or who require a lower dose of the drug should receive treatment with oseltamivir in other dosage forms. mg and 75 mg. Adults and adolescents 13 years and older (weighing > 40 kg) Treatment The recommended oral dose is 1 capsule (75 mg) 2 times a day for 5 days. Body weight Recommended dose of oseltamivir for 5 days *Recommended dose of oseltamivir for 10 days for immunocompromised patients >40 kg 75 mg twice daily 75 mg twice daily *Recommended duration of treatment for immunocompromised adults and adolescents is 10 days. For more information, see Special Populations: Immunocompromised Patients. Treatment should begin no later than 2 days from the onset of influenza symptoms. Post-exposure prophylaxis The recommended dose for influenza prophylaxis after close contact with an influenza patient is 1 capsule (75 mg) once daily for 10 days. Body weight Recommended dose of oseltamivir for 10 days Recommended dose of oseltamivir for 10 days for immunocompromised patients >40 kg 75 mg once a day 75 mg once a day Prophylaxis should begin no later than 2 days from the moment of contact with the patient. Prevention during an influenza epidemic in the community For the prevention of influenza during an outbreak, use of 1 capsule (75 mg) once a day for 6 weeks, or up to 12 weeks in immunocompromised patients, is recommended (see sections “Precautions” “Side effect” and “Pharmacodynamics”). Body weight Recommended dose of oseltamivir for 6 weeks Recommended dose of oseltamivir up to 12 weeks for immunocompromised patients >40 kg 75 mg once daily 75 mg once daily Pediatric population Children 6 to 12 years of age Treatment Weight-adjusted regimens Dosages recommended for treating children are: Body weight Recommended dose of oseltamivir for 5 days Recommended dose of oseltamivir for 10 days for immunocompromised patients Drug Flucaps 10-15 kg 30 mg 2 times a day 30 mg 2 times a day 1 capsule (30 mg) 2 times a day >15-23 kg 45 mg 2 times a day 45 mg 2 times a day 1 capsule (45 mg) 2 times a day >23-40 kg 60 mg 2 times a day 60 mg 2 2 capsules (30 mg) 2 times a day >40 kg 75 mg 2 times a day 75 mg 2 times a day 1 capsule (75 mg) 2 times a day . Post-exposure prophylaxis The recommended dose for post-exposure prophylaxis is: Body weight Recommended dose for 10 days of oseltamivir Recommended dose of oseltamivir for 10 days for immunocompromised patients Drug Flucaps 10-15 kg 30 mg 1 time per day 30 mg 1 time per day 1 capsule (30 mg) 1 time per day >15-23 kg 45 mg 1 time per day 45 mg 1 time per day 1 capsule (45 mg) 1 time per day >23-40 kg 60 mg 1 time per day 60 mg 1 time per day 2 capsules (30 mg) 1 time per day >40 kg 75 mg 1 time per day 75 mg 1 time per day 1 capsule (75 mg) 1 time per day Prevention during an influenza epidemic in the community Prevention during an outbreak epidemic influenza has not been studied in children under 12 years of age. Special groups Hepatic insufficiency No dose adjustment is required in the treatment and prevention of influenza in patients with hepatic insufficiency. Studies of pediatric patients with hepatic insufficiency have not been conducted. Renal insufficiency Treatment of influenza In adults and adolescents (13-17 years) with moderate or severe renal insufficiency, dose adjustment is recommended. The table below details the recommended doses. Creatinine clearance Recommended dose of oseltamivir Drug Flucaps >60 (ml/min) 75 mg bid 1 capsule (75 mg) bid >30 to 60 (ml/min) 30 mg bid 1 capsule (30 mg) twice daily >10 to 30 (ml/min) 30 mg once daily 1 capsule (30 mg) once daily ≤10 (ml/min) Not recommended (data not available) Not recommended (data not available) Patients on hemodialysis 30 mg after each session of hemodialysis 1 capsule (30 mg) after each session of hemodialysis Patients on peritoneal dialy