What Is Tamiflu?

Tamiflu (oseltamivir phosphate capsule), the indication is 1. Influenza A and B treatment for adults and children aged 1 and older (oseltamivir phosphate is effective in treating influenza A and B, but clinical data on influenza B are not yet available). Patients should use it within 48 hours of the first symptoms. 2. For the prevention of influenza A and B in adults and adolescents 13 and older.

Duffy

(drug)

Drug Name: Duffy?

Drug type: Prescription drugs, medicines for medical workers' injuries
Use classification: Other antivirals

The main ingredient of this product is oseltamivir phosphate.
Chemical name: (3R, 4R, 5S) -4-acetamide-5-amino-3 (1-propoxyethyl) -1-cyclohexane-1carboxylic acid ethyl phosphate (1: 1)
Chemical Structure:

This product is an off-white and light yellow two-color capsule with the content of white to yellow-white powder.

1. Influenza A and B treatment for adults and children aged 1 and older (oseltamivir phosphate is effective in treating influenza A and B, but clinical data on influenza B are not yet available). Patients should use it within 48 hours of the first symptoms.
2. For the prevention of influenza A and B in adults and adolescents 13 and older.

75mg (based on oseltamivir).

Oseltamivir phosphate can be taken with or without food. However, in some patients, taking medication at the same time can increase the tolerance of the drug.
Influenza treatment < br Treatment should begin on the first or second day of the onset of flu symptoms (ideally within 36 hours).
Dosage Guidelines The recommended oral dose of oseltamivir phosphate capsules for adults and adolescents over 13 years is 75 mg twice daily for 5 days.
Children < br For children over 1 year old, it is recommended to take the following weight-dose table.
Recommended body weight (for 5 days)
15kg 30mg, twice daily> 15-23kg 45mg, twice daily> 23-40kg 60mg, twice daily> 40kg 75mg, twice daily Prevention of influenza Orthophosphate phosphate The recommended oral dose of tamivir for flu prevention after close contact with flu patients is 75 mg once daily for at least 7 days. It should also be started within 2 days after close contact. The recommended dose of oseltamivir phosphate for the prevention of influenza during the flu season is 75 mg once daily. Data show that the combination of drugs is safe and effective for 6 weeks. It has been preventive during the medication.
Medication guidance for special populations Influenza treatment: For patients with creatinine clearance greater than 60ml / min, there is no need to adjust the dose. For creatinine clearance greater than 30ml / min but not more than 60ml / min, the recommended dose reduction is 30mg each time, twice daily for 5 days. For creatinine clearance rate greater than 10ml / min but not more than 30ml / min, the recommended dose reduction is 30mg each time, once a day for 5 days. For regular hemodialysis patients, if flu symptoms worsen within 48 hours during the dialysis period, a starting dose of 30 mg can be given before dialysis begins. To maintain a therapeutic level of plasma concentration, a 30 mg dose should be given after each dialysis session. For peritoneal dialysis patients, it is recommended to give 30 mg of this product before dialysis begins, and then 30 mg daily for 3/15 treatments for 5 days (see [Pharmacokinetics] and [Cautions]). The pharmacokinetics of oseltamivir in patients with end-stage renal disease (ie, creatinine clearance [10ml / min) without dialysis have not been studied. Therefore, no advice can be given on the dosage of these patients.
Influenza prevention: No dose adjustment is necessary for patients with creatinine clearance greater than 60ml / min. For those with creatinine clearance greater than 30ml / min but not greater than 60ml / min, the recommended dose reduction is 30mg each time, once daily. For creatinine clearance greater than 10ml / min but not greater than 30ml / min, the recommended dose reduction is 30mg each time, once every other day. For regular hemodialysis patients, if flu symptoms worsen within 48 hours during dialysis, a starting dose of 30 mg can be given before dialysis begins. In order to maintain a therapeutic level of plasma concentration, a 30 mg dose should be given after every two dialysis sessions. For peritoneal dialysis patients, it is recommended to give 30mg of this product before dialysis starts, and then 30mg daily for 7 days for prevention (see [Pharmacokinetics] and [Cautions]). The pharmacokinetics of oseltamivir in patients with end-stage renal disease (ie, creatinine clearance [10ml / min) without dialysis have not been studied. Therefore, no advice can be given on the dosage of these patients.
Patients with hepatic insufficiency <br The dose does not need to be adjusted for the treatment and prevention of influenza in patients with mild to moderate hepatic insufficiency (see [Pharmacokinetics]). The safety and pharmacokinetics of this product for patients with severe liver dysfunction have not been studied.

Clinical research experience Because the clinical trials of this product are performed under various conditions, the incidence of adverse reactions in clinical trials of this product cannot be directly compared with the incidence of other drugs in clinical trials, and the occurrence of The rate cannot reflect the situation of this product in actual treatment.
[u] Study on Adult Subject Treatment [/ u]
A total of 1171 subjects who participated in an adult controlled clinical trial of influenza treatment received this product. The most commonly reported adverse events in these studies were nausea and vomiting. These events are usually mild to moderate and usually occur within the first 2 days of medication. Only less than 1% of subjects withdrew from the clinical trial early due to nausea and vomiting events.
In the adult treatment study, adverse events with a incidence of 1% in 1440 subjects receiving placebo or this product 75 mg twice daily are shown in Table 2. The summary included 945 healthy young adults and 495 "at-risk" subjects (elderly patients and patients with chronic heart or respiratory diseases). Subjects taking this product reported a higher number of events than nausea, vomiting, bronchitis, insomnia, and dizziness in the placebo group.
[u] Prevention study in adult subjects [/ u]
A total of 4,187 subjects (adolescents, healthy adults, and the elderly) participated in prevention studies, of which 1790 received a recommended dose of 75 mg once a day for 6 weeks. Although the dosing lasted longer, adverse events 4/15 were very similar in nature to those observed in treatment studies (see Table 2). In prevention studies, subjects receiving this product reported more frequently (compared to the placebo group), and more frequently reported events than treatment studies were pain, nasal fluid discharge, indigestion, and upper respiratory infections. However, the difference in the incidence of these events was less than 1% between the medicated and placebo groups.
There were no clinically relevant differences in safety characteristics between 942 elderly subjects receiving this product or placebo and younger adult patients.
Table 2 The most common adverse events in naturally-acquired influenza studies in subjects aged 13 years and older

Those who are allergic to any component of this product are prohibited.

1. Where oseltamivir phosphate-free granules are available, Duffy capsules can be used to formulate emergency oral suspensions. The following method is for emergency use only. Do not use this method to formulate suspensions for convenience or in the case of oseltamivir phosphate granules approved for marketing by the Food and Drug Administration.
Where oseltamivir phosphate-free granules are available, adults, adolescents, or children who cannot swallow capsules can obtain the appropriate dose by opening the capsule and mixing its contents with a small amount (up to 1 teaspoon) of suitable sweet foods to cover the bitterness. Oseltamivir phosphate, sweet foods such as chocolate syrup, low sugar chocolate syrup, corn syrup, caramel sauce and brown sugar water. The entire mixture should be administered to the patient after thorough mixing. The mixture should be swallowed immediately after preparation.
[u] Blend preparation instructions: [/ u]
For patients requiring a dose of 30-60 mg, please follow the method below to ensure the accuracy of the dose.
(1) Holding a Duffy 75 mg capsule over a small bowl, carefully open the capsule and pour the powder into the bowl.
(2) Add 5 ml of water to the bowl with a graduated syringe and stir for about 2 minutes.
(3) Use a syringe to draw the correct amount of the mixture from the bowl. The amount of mixture to be used is calculated based on the patient's weight, see the table below. It is not necessary to suck up undissolved white powder, as these are inactive ingredients. Push the plunger of the syringe and pour the mixture into the second small bowl. Unused mixtures should be discarded.

Pregnancy < br Teratogenicity of the drug has not been observed in animal reproduction studies in rats and rabbits. In three studies before and after childbirth, oseltamivir phosphate was administered to female rats in toxic doses. Two studies showed growth retardation and prolonged labor in unweaned pups.
In fertility and reproductive toxicity studies in rats, the dose of oseltamivir used had no effect on fertility in rats.
Rat and rabbit embryos receive approximately 15% -20% of the drug exposure of female mice and female rabbits.
As no controlled trials have been conducted on pregnant women using this product, data from post-marketing and retrospective observation monitoring reports are limited. These data combined with the results of animal studies do not confirm that this product has a direct or indirect adverse effect on pregnancy, embryo / fetal or postpartum development. Existing safety information, the pathogenicity of the epidemic virus strain, and the basic conditions of pregnant women should be evaluated to determine whether pregnant women can take this product.
Lactation < br For lactating rats, oseltamivir and its active metabolites can be secreted from milk. There is very limited information on the breast milk of lactating infants and oseltamivir that are taken by mothers from human milk. Limited data demonstrate that oseltamivir and its active metabolites can be detected in human milk, but at very low concentrations, which are below the therapeutic dose for infants. In view of this, as well as the pathogenicity of the epidemic virus strain and the basic conditions of nursing mothers, oseltamivir may be considered.

For the dosage, see [Usage and Dosage].
The safety and effectiveness of oseltamivir phosphate in children under 1 year have not been determined.

Dosage adjustment is not required for treatment and prevention in elderly patients (see [Pharmacokinetics]).

Interaction with Influenza Vaccines: No evaluation of the interaction between oseltamivir phosphate and live attenuated influenza vaccines has been performed. However, due to possible interactions between the two, unless clinically required, oseltamivir phosphate should not be taken within two weeks of using a live attenuated influenza vaccine, and attenuated should not be used within 48 hours of taking oseltamivir phosphate. Live flu vaccine. Because oseltamivir as an antiviral drug may inhibit the replication of live vaccine viruses. The trivalent inactivated influenza vaccine can be used at any time before or after taking oseltamivir phosphate.
Data from pharmacological and pharmacokinetic studies indicate that there is essentially no significant clinically significant interaction between oseltamivir phosphate and other drugs.
Oseltamivir phosphate is rapidly converted into active metabolites (oseltamivir carboxylate) by esterases that are mainly distributed in the liver and intestines. Drug interactions related to competing esterases are rarely reported in the literature. The low protein binding rate of oseltamivir and its active metabolites suggests that drug interactions related to protein binding are unlikely to occur.
In vitro studies have shown that neither oseltamivir phosphate nor its active metabolite is a good substrate for P450 mixed function oxidase or glucuronyl transferase, see [Pharmacokinetics].
No mechanism of drug interaction with oral contraceptives.
Cimetidine is a non-specific inhibitor of cytochrome P450 isoenzyme, and can compete with tubular or alkaline substances for renal tubular secretion, but has no effect on the plasma concentration of oseltamivir or its active metabolites. Therefore, clinically relevant drug interactions related to changes in gastric pH (antacids) and to competitive clearance of the renal tubular secretion pathway are unlikely to occur. However, there is no in vivo study of the interaction of oseltamivir phosphate with antacids.
Drug interactions related to tubule competition and secretion are unlikely to have important clinical significance, because most drugs have a wide safety range. Excretion of active metabolites of oseltamivir phosphate includes glomerular filtration and tubule secretion. Pathway, and the clearance capacity of these two pathways is great. However, caution should be exercised in combination with drugs that are also secreted by the kidney and have a narrow safety range (such as chlorosulfuramide, methotrexate, and butazone).
Combined with probenecid, due to the decrease in the renal tubular secretion capacity, the body's availability of active metabolites is increased by a factor of two. However, due to the wide safety range of active metabolites, drug doses do not need to be adjusted when used with probenecid.
The combination with amoxicillin does not change the plasma concentrations of the two drugs, indicating that the competitive effect of anion pathway elimination is not significant.
Post-marketing surveillance has reported individual cases of interactions with ganciclovir, which is also secreted through the renal tubules.
In combination with paracetamol (acetaminophen), the plasma concentrations of oseltamivir and its active metabolites or paracetamol did not change.
Taking oseltamivir (75 mg twice daily for 4 days) and aspirin (900 mg single dose) at the same time did not find oseltamivir, its active metabolite (oseltamivir carboxylate) or aspirin Changes in pharmacokinetic parameters. Taking oseltamivir (single dose of 150 mg) and a single dose of antacids containing aluminum hydroxide and magnesium hydroxide or a single dose of antacids containing calcium carbonate did not find oseltamivir and its active metabolites (Austral The pharmacokinetic parameters of staveway carboxylate were changed.
In the phase III clinical study of influenza treatment and influenza prevention, oseltamivir phosphate was used in combination with some commonly used drugs, such as ACE inhibitors (enalapril, captopril), and thiazide diuretics (benzyl fluthizone). Azine), antibiotics (penicillin, cephalosporin, azithromycin, erythromycin, doxycycline), H2 blockers (ranitidine, cimetidine), beta blockers (propranolol) , Xanthines (theophylline), sympathomimetics (pseudoephedrine), opioids (codeine), steroid hormones, inhaled bronchodilators and analgesics (aspirin, ibuprofen and paracetamol). No adverse events were observed or altered in the frequency of oseltamivir phosphate in combination with these drugs.
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No overdose has been reported. It is estimated that acute overdose is most likely to manifest as nausea with or without vomiting. Studies have shown that after taking up to 1000 mg of oseltamivir phosphate in a single dose to 6 healthy volunteers, one volunteer developed nausea and the other volunteer had vomiting for 2 consecutive days. One box contains 10 capsules of oseltamivir phosphate. The total amount of oseltamivir is 750 mg.

Studies on naturally acquired influenza Treatment of adult influenza In the 1997-1998 winter influenza epidemic, a phase III clinical trial was conducted in the northern hemisphere, and patients received oseltamivir phosphate treatment within 40 hours of symptoms. In these trials, 97% of patients had influenza A and 3% had influenza B. The results show that oseltamivir phosphate can shorten clinically flu-related symptoms and signs, shortening the course of disease by 32 hours. Among patients diagnosed with the flu, those taking oseltamivir phosphate had 38% less severe disease than those taking placebo. Moreover, oseltamivir treatment can reduce influenza complications in healthy young people by about 50%, and these complications include bronchitis, pneumonia, sinusitis, and otitis media. In these phase III clinical trials, the secondary efficacy index of the antiviral activity of oseltamivir phosphate also clearly confirmed its efficacy, that is, it can shorten the time to excrete the virus and the area under the curve of the virus titer.
Data from a treatment study in the elderly showed that oseltamivir phosphate treatment (75 mg twice daily for 5 days) shortened the median duration of disease, similar to treatment results for young people. In another study, influenza patients over 13 years of age with chronic heart or / and respiratory disease received oseltamivir phosphate or placebo, and found no significant difference in median time to remission of all symptoms between the two groups, but phosphate The duration of fever in the oseltamivir-treated group was shortened by about one day, and the proportion of patients who eliminated the virus at two and four days also decreased significantly. The safety of oseltamivir phosphate was not different between the high-risk population and the general population.
Treatment of childhood flu < br A double-blind, placebo-controlled study was conducted at the time of the epidemic in the population. A total of 695 children aged 1 to 12 years (average age 5.3 years) were included and all had fever (temperature) Greater than 37.8 degrees) plus symptoms of cough or runny nose. In this test, 69% of influenza infections were influenza A and 31% were influenza B. Oseltamivir phosphate was given within 48 hours of symptoms. Compared to the placebo group, oseltamivir treatment reduced the duration of disease (defined as remission of cough and nasal congestion symptoms, normal body temperature, and normalized health and activity) by 35.8 hours. Children taking oseltamivir phosphate experienced a 40% reduction in acute otitis media compared to the placebo group. A subgroup analysis of children over 5 years of age showed a 56% reduction in the incidence of otitis media and a 40% reduction in the use of antibiotics in the oseltamivir group compared with the placebo group. Children in the oseltamivir group returned to normal health and activity approximately 2 days earlier than in the placebo group.
Influenza prevention in adults and adolescents Oseltamivir Phosphate's role in preventing the natural acquisition of influenza A and B has been validated in the following three Phase III clinical trials.
1. Short-term prevention after close contact with influenza patients Adults and adolescents (greater than 13 years old) living in the same household who were exposed to influenza patients underwent a phase III clinical trial of oseltamivir phosphate for the prevention of influenza. Within 2 days after the symptoms of influenza patients (377 cases) living in the same family, 962 flu close contacts received oseltamivir phosphate to prevent influenza, 75 mg each time, once a day for 7 days. Closely contacted populations of virologically confirmed influenza in family members were included in the statistical analysis. 12% (24/461) of the placebo group had clinical influenza infections, while only 1% (2/294) of the oseltamivir phosphate group had clinical influenza infections. The incidence of influenza in China has dropped by 92%.
2. Seasonal prevention during an influenza epidemic In a double-blind placebo-controlled trial, a study group of healthy people aged 18-56 years who were not vaccinated against influenza showed that oseltamivir phosphate prevention (75 mg once daily, A total of 42 days) had a clinical influenza infection in 1.2% (6/520), while 4.8% (25/519) in the placebo group had clinical influenza infection. None of the population in this trial was in close contact with the flu.
Another double-blind placebo-controlled trial was conducted in a nursing home for the elderly. During the trial, 80% of the study subjects were vaccinated against influenza and 9 of the 31 participating nursing homes developed influenza infection. In these nursing homes, 0.4% (1/276) of the elderly who were prevented by oseltamivir phosphate (75 mg once daily for 42 days) had influenza, compared with 4.4% (12/272) of the elderly in the placebo group. Onset. Eleven of the 12 patients in the placebo-prevented group had received the flu vaccine before. The incidence of influenza-associated bronchitis, pneumonia, and sinusitis in this trial decreased significantly by 86%.
The results of these phase III clinical trials show that oseltamivir phosphate can significantly reduce the time to virus excretion and successfully prevent the virus from spreading in the home.
Influenza treatment in high-risk populations < br The median duration of the disease did not decrease significantly in the elderly (65 years or older) and people with chronic heart or / and respiratory disease after receiving oseltamivir phosphate treatment due to influenza . However, the duration of fever in patients treated with oseltamivir phosphate was shortened by about one day. For elderly influenza patients, oseltamivir phosphate treatment can reduce the incidence of lower respiratory tract complications (mainly bronchitis) requiring antibiotics compared to placebo, which were 12% (29/250) and oseltamivir phosphate group, respectively. 19% (52/268) in the placebo group (p = 0.0156).
For influenza patients with chronic heart or / and respiratory disease, the incidence of lower respiratory complications requiring antibiotics was 14% (16/118) in the oseltamivir group and 17% (22/133 in the placebo group). ) (P = 0.5976).
Reduced viral neuraminidase sensitivity [u] Clinical studies [/ u]: The risk of developing influenza viruses with reduced or tolerated oseltamivir was assessed in clinical studies sponsored by Roche. All patients with oseltamivir-resistant virus had a transient decrease in the neuraminidase sensitivity of the virus, and the virus could be eliminated normally without exacerbation of symptoms.

Pharmacological action Oseltamivir phosphate is a prodrug of its active metabolite, and its active metabolite (oseltamivir carboxylate) is a potent and selective inhibitor of influenza virus neuraminidase. Neuraminidase is a glycoprotein on the surface of the virus. Its activity is essential for the release of newly formed virus particles from infected cells and the further spread of infectious virus in the human body.
The active metabolite of oseltamivir phosphate can inhibit neuraminidase activity of influenza A and B viruses. The concentration of half inhibition of viral neuraminidase activity in vitro is as low as nanogram levels. Active metabolites were observed to inhibit influenza virus growth in vitro, and they were also observed to inhibit influenza virus replication and pathogenicity in vivo.
This product reduces the spread of influenza A or B virus by inhibiting the release of virus from infected cells.
Studies of naturally acquired and laboratory influenza have shown that the application of oseltamivir phosphate does not affect the body's normal humoral immune response to infection. The antibody response to the inactivated vaccine was not affected by oseltamivir treatment.
Toxicology research < br Preclinical research data show that according to the results of conventional safety pharmacology, multiple dose toxicity and genotoxicity studies, oseltamivir has no special harm to the human body.
Carcinogenicity: Three potential carcinogenicity studies (2-year oseltamivir study in rats and mice, and 6-month transgenic Tg: AC mouse test with active metabolites) The result is negative.
Mutagenicity: Oseltamivir and its active metabolites are negative in standard genotoxicity test combinations.
Impairment of fertility: Rats were tested for fertility at daily doses of up to 1500 mg / kg, and the results proved that this dose had no adverse effects on both females and males.
Teratogenicity: Teratology studies of daily doses of up to 1500 mg / kg and 500 mg / kg were performed on rats and mice, respectively. No effect on embryo-fetal development was found. Prenatal / postnatal rats were studied and found that the delivery time of the rats in the 1500 mg / kg / day dose group was prolonged: the human drug exposure of oseltamivir and its metabolites and the maximum non-acting dose of rats (500mg / kg / day) with a safety range of 480 times and 44 times, respectively. Rats and rabbits have about 15-20% of their maternal drug exposure.
Others: In lactating rats, oseltamivir and its metabolites are secreted in milk. It is unclear whether oseltamivir and its metabolites are secreted in human milk, but extrapolation of animal data has been estimated to be approximately 0.01 mg / day and 0.3 mg / day, respectively. The "maximum method" skin sensitization test with guinea pigs found that oseltamivir has potential skin sensitization. Induced animals are challenged and about 50% of the animals develop erythema after treatment with unformulated active ingredients. It has reversible irritation to rabbit eyes. Although a single oral high-dose oseltamivir phosphate has no effect on adult rats, this dose can be toxic to seven-day-old pups, including death. This effect is observed at doses of 657 mg / kg or higher. At a dose of 500 mg / kg, including continuous chronic treatment (500 mg / kg daily at 7-21 days after birth), no adverse effects were observed.

Absorption < br After oral administration, oseltamivir phosphate is rapidly absorbed in the gastrointestinal tract, and is rapidly converted into active metabolites (oseltamivir carboxylate) by the liver or / and intestinal wall esterase. At least 75% of the oral dose enters the circulation in the form of active metabolites. Relative to the active metabolite, less than 5% of the drug exists as a prodrug. The plasma concentration of active metabolites is proportional to the dose taken and is not affected by eating (see [Dosage and Administration]).
Distribution < br The average volume of distribution (Vss) of active metabolites (oseltamivir carboxylate) in the human body is approximately 23 liters.
Studies on ferrets, rats and rabbits have shown that active metabolites of the drug can reach all sites of influenza virus infection. Studies have shown that active metabolites of oseltamivir phosphate can achieve effective antiviral levels in the lungs, bronchus, alveolar lavage fluid, nasal mucosa, middle ear and trachea.
The binding of active metabolites to human plasma proteins is negligible (about 3%).
Metabolism Oseltamivir Phosphate is almost completely converted into an active metabolite (oseltamivir carboxylate) by an esterase mainly located in the liver and intestinal wall. Neither oseltamivir phosphate nor its active metabolites are substrates or inhibitors of the major cytochrome P450 isoenzymes, so they will not trigger drug-drug interactions due to competition for these enzymes.
Elimination Oseltamivir absorbed by radon is mainly eliminated by conversion to active metabolites (] 90%). Active metabolites are no longer metabolized, but are excreted by the urine. After the active metabolites reach the peak concentration, the plasma concentration drop half-life is 6 to 10 hours. Over 99% of active metabolites are excreted by the kidneys. The renal clearance rate (18.8 liters / hour) exceeds the glomerular filtration rate (7.5 liters / hour), indicating that in addition to glomerular filtration, there is also a pathway of renal tubular secretion. Oral radiolabeled drug studies have shown that less than 20% of the dose is excreted in feces.
Specific population pharmacokinetics:
Patients with renal insufficiency <br 100 mg oseltamivir phosphate was administered to patients with varying degrees of renal insufficiency twice daily for 5 days. The results showed that the exposure dose of active metabolites was inversely proportional to the degree of reduction in renal function.
Flu treatment: No dose adjustment is necessary for patients with creatinine clearance greater than 60ml / min. For creatinine clearance greater than 30ml / min but not greater than 60ml / min, the recommended dose reduction is 30mg each time, twice daily for a total of 5 days. For creatinine clearance rate greater than 10ml / min but not more than 30ml / min, the recommended dose reduction is 30mg each time, once a day for 5 days. For regular hemodialysis patients, if flu symptoms worsen within 48 hours during the dialysis period, a starting dose of 30 mg can be given before dialysis begins. In order to maintain a therapeutic level of plasma concentration, a 30 mg dose should be given after the end of each dialysis. For peritoneal dialysis patients, it is recommended to give this product 30mg before dialysis, and then 30mg daily for 5 days for treatment (see [Dosage and Administration] and [Cautions]). The pharmacokinetics of oseltamivir in patients with advanced renal disease (ie, creatinine clearance [10ml / min) without dialysis have not been studied. Therefore, no advice can be given on the dosage of these patients.
Influenza prevention: No dose adjustment is necessary for patients with creatinine clearance greater than 60ml / min. For those with creatinine clearance greater than 30ml / min but not greater than 60ml / min, the recommended dose reduction is 30mg each time, once daily. For creatinine clearance greater than 10ml / min but not greater than 30ml / min, the recommended dose reduction is 30mg each time, once every other day. For regular hemodialysis patients, if flu symptoms worsen within 48 hours during dialysis, a starting dose of 30 mg can be given before dialysis begins. In order to maintain a therapeutic level of plasma concentration, a 30 mg dose should be given after every two dialysis sessions. For peritoneal dialysis patients, it is recommended to give 30mg of this product before dialysis starts, and then 30mg daily for a total of 7 days for prevention (see [Dosage and Administration] and [Cautions]). The pharmacokinetics of oseltamivir in patients with end-stage renal disease (ie, creatinine clearance [10ml / min) without dialysis have not been studied. Therefore, no advice can be given on the dosage of these patients.
Patients with liver dysfunction < br In vitro studies have shown that patients with liver dysfunction did not show significantly higher levels of oseltamivir in vivo or significantly lower levels of active metabolites (see [Dosage and Administration]).
Elderly people < br Given the same dose of oseltamivir phosphate, the body utilization of the steady-state active metabolites in the elderly (aged 65-78 years) is 25% to 35% higher than that of young people. The elderly and young people have similar drug half-lives. Taking into account the availability and tolerance of the body, the elderly do not need to adjust the dose (see [Dosage and Administration]).
Children A small sample single-dose oseltamivir pharmacokinetic study was performed in children 5-16 years old and 3-12 years old, and the results showed that young patients treated oseltamivir and its active metabolites ( Oseltamivir carboxylate) are cleared faster than adults, so children's availability is lower at the same dose based on body weight. The 2 mg / kg dose for children is comparable to the 75 mg capsule (approximately 1 mg / kg) dose for adults. The pharmacokinetics of oseltamivir in children over 12 years is similar to that in adults.
Data on drug metabolism in children without renal failure.

This product should be stored below 25 ° C. Do not take it after the expiry date (EXP) indicated on the package.
Keep medicines out of the reach of children.

10 pcs / box in aluminum-plastic packaging.

84 months.

JX20040215

Import Drug Registration Certificate Number: H20090377
Repacking approval number: National Medicine Standard J20090076

Hoffmai Roche GmbH

Roche Pharma (Schweiz) Ltd.

Shanghai Roche Pharmaceutical Co., Ltd.

September 5, 2006

November 14, 2006 March 22, 2007 August 24, 2007 March 26, 2008 February 11, 2009 April 30, 2009 September 30, 2009 July 03, 2012