Item nanme:oseltamivir phosphate capsules Item character: This product is white.
Indication: 1. For the treatment of influenza A and B in adults and children aged 1 and above (oseltamivir phosphate can effectively treat influenza A and B, but the clinical application data of influenza B is not enough). Patients should use it within 48 hours of the first symptom.
2. For the prevention of influenza A and B in adults and adolescents aged 13 and over.
Item specifications:75mg*10ta/box
Usage and dosage:Oseltamivir phosphate can be taken with food or separately. But for some patients, taking medicine while eating can improve the drug tolerance.
Treatment of influenza
Treatment should begin on the first or second day (ideally within 36 hours) of the onset of influenza symptoms.
Dose guidance
Adults and adolescents
The recommended oral dose of oseltamivir phosphate capsules for adults and adolescents over 13 years old is 75 mg twice daily for 5 days.
children
The following weight dose table is recommended for children over 1 year old.
Recommended dose for body weight (5 days)
≤ 15kg 30mg, twice a day
>15-23kg 45mg, twice daily
>23-40kg, 60mg, twice a day
>40kg 75mg, twice daily
Prevention of influenza
The recommended oral dose of oseltamivir phosphate for influenza prevention after close contact with influenza patients is 75 mg once daily for at least 7 days. The drug should also be started within 2 days after close contact. The recommended dose of oseltamivir phosphate for influenza prevention during influenza season is 75 mg once a day. Some data show that continuous use of drugs for 6 weeks is safe and effective. It has a preventive effect all the time.
Medication guidance for special population
Patients with renal insufficiency
Influenza treatment: for patients with creatinine clearance rate greater than 60 ml / min, it is not necessary to adjust the dose. For those whose creatinine clearance rate is more than 30ml / min but less than 60ml / min, the recommended dosage is 30mg twice a day for 5 days. For those whose creatinine clearance rate is more than 10ml / min but less than 30ml / min, the recommended dosage is 30mg once a day for 5 days. For regular hemodialysis patients, if the symptoms of influenza worsen within 48 hours during the dialysis interval, the initial dose of 30mg can be given before dialysis. In order to maintain the therapeutic level of plasma concentration, 30mg dose should be given at the end of each dialysis. For peritoneal dialysis patients, it is recommended to give this product 30mg before dialysis, and then 30mg every day for a total of 5 days (see [pharmacokinetics] and [precautions]). The pharmacokinetics of oseltamivir in patients with end-stage renal disease (i.e., creatinine clearance [10ml / min)) without dialysis has not been studied. Therefore, it is not possible to recommend the dosage for this kind of patients.
Influenza prevention: for patients with creatinine clearance rate greater than 60 ml / min, it is not necessary to adjust the dose. For those whose creatinine clearance rate is more than 30ml / min but less than 60ml / min, the recommended dosage is 30mg once a day. For those whose creatinine clearance rate is more than 10ml / min but less than 30ml / min, the recommended dosage is 30mg every other day. For regular hemodialysis patients, if the symptoms of influenza worsen within 48 hours during the dialysis interval, the initial dose of 30mg can be given before dialysis. In order to maintain the therapeutic level of plasma concentration, 30mg dose should be given after every two dialysis. For peritoneal dialysis patients, it is recommended to give this product 30mg before dialysis, and then 30mg every day for a total of 7 days (see [pharmacokinetics] and [precautions]). The pharmacokinetics of oseltamivir in patients with end-stage renal disease (i.e., creatinine clearance [10ml / min)) without dialysis has not been studied. Therefore, it is not possible to recommend the dosage for this kind of patients.
Patients with liver dysfunction
The dosage 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 in patients with severe hepatic insufficiency have not been studied.
Adverse reactions Clinical research experience
Because the clinical trial of this product is carried out under various conditions, the incidence of adverse reactions of this product in the clinical trial can not be directly compared with that of other drugs in the clinical trial, and the incidence can not reflect the actual situation of this product in the treatment.
[u] Treatment study of adult subjects
A total of 1171 subjects who participated in the adult controlled clinical trials of influenza treatment received the treatment. The most frequently reported adverse events in these studies were nausea and vomiting. The occurrence of these events is generally mild to moderate, and usually occurs in the first two days of medication. Only less than 1% of the subjects withdrew from the clinical trial because of nausea and vomiting.
In the adult treatment study, among 1440 subjects who received placebo or 75 mg twice daily, the incidence of adverse events ≥ 1% is 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). Among the subjects taking this product, the reported incidence of events was statistically higher than that in the placebo group, including nausea, vomiting, bronchitis, insomnia and vertigo.
[u] Adult subjects prevention study
A total of 4187 subjects (adolescents, healthy adults and the elderly) participated in the prevention study. 1790 of them received the recommended dose of 75 mg once daily for 6 weeks. Despite the longer duration of administration, 4 / 15 of the adverse events were similar in nature to those observed in treatment studies (see Table 2). In the prevention study, the more frequently reported events (compared with the placebo group) and the more frequently reported events than in the treatment study were pain, rhinorrhea, dyspepsia and upper respiratory tract infection. However, the difference in the incidence of these events was less than 1% between the treatment group and the placebo group.
There was no clinically relevant difference in the safety characteristics between 942 elderly subjects receiving the product or placebo and the younger adult patients.
Taboo: It is forbidden for people who are allergic to any component of this product.
Matters needing attention: 1. When oseltamivir phosphate granules are not available, Tamiflu capsules can be used to prepare emergency oral suspension. The following methods are only used in emergency situations. This method should not be used for convenience or when oseltamivir phosphate granules approved by the food and drug administration can be purchased.
In the absence of oseltamivir phosphate granules, adults, adolescents or children who are unable to swallow the capsules may open the capsules and mix their contents with a small amount (up to 1 The sweet foods include chocolate syrup, low sugar chocolate syrup, corn syrup, caramel sauce and brown sugar water. All the mixture should be given to the patient after full mixing. The mixture should be swallowed immediately after preparation. 2. Psychoneuro adverse events, influenza may cause many neurological and behavioral symptoms, including hallucinations, delirium and behavioral abnormalities, and in some cases, fatal results. These events may occur in the context of encephalitis or encephalopathy, but they can also
It can be found in the absence of significant serious diseases.
Post market reports of delirium and behavioral abnormalities that lead to injury have occurred in influenza patients who received the drug (mainly from Japan), and some cases also lead to fatal results. Since these events were reported spontaneously in clinical use, no evaluation of the frequency of occurrence was made, but according to the drug use data, these events were not common. These events were reported mainly in children's patients, and are usually emergencies and rapidly subside. It has not been determined whether the product has any impact on these events. The abnormal signs of behavior should be monitored closely. If there are psychoneurotic symptoms, the risk benefit assessment for each patient to continue treatment should be performed.
3. there is no evidence that oseltamivir phosphate is effective for diseases other than influenza A and influenza B.
4. the safety and effectiveness of oseltamivir in the treatment of influenza in children under 1 year old have not been determined.
5. the safety and effectiveness of oseltamivir in the prevention of influenza in children under 13 years old have not been determined.
6. there is no information on the safety and effectiveness of oseltamivir in patients with poor or unstable health status who must be admitted.
7. the safety and effectiveness of oseltamivir in the treatment and prevention of influenza in immunosuppressive patients are uncertain.
8. the efficacy of oseltamivir in the treatment of influenza in patients with chronic heart or / or respiratory diseases is not yet determined. There was no difference in the incidence of complications observed in the treatment group and placebo group in these groups.
9. oseltamivir phosphate cannot replace influenza vaccine. The use of oseltamivir phosphate should not affect the annual vaccination of influenza. The preventive effect of oseltamivir phosphate on influenza is only available when using the drug. Oseltamivir phosphate is considered for the treatment and prevention of influenza only after reliable epidemiological data show that influenza virus infection has occurred in the community.
10. for dose adjustment of renal dysfunction patients, please refer to the guidance of special population (see [pharmacokinetics] and [usage of dosage].
11. data of drug dose in children without renal failure.
12. no effect of the drug on the patient's ability to drive a vehicle or operate a machine was observed. But the impact that flu itself can have must be considered.
13. patients with influenza, especially children and adolescents, who used this product have reported similar neuropsychiatry events such as convulsions and delirium. In very few cases, these incidents can result in accidental injury. It is not clear whether the product is the cause of these events, and there are also reports of such incidents in patients who do not take the product. Three independent large-scale epidemiological studies have confirmed that the risk of neuropsychiatric events in influenza patients taking this product does not increase compared to those who do not take the product (see post market experience for adverse reactions). The abnormal behavior symptoms of patients should be observed closely, especially for children and adolescents.
14. severe skin reaction / allergic reaction. The experience of this product after listing reported allergic reaction and severe skin reaction, including toxic epidermal necrosis and lysis, Stevens Johnson syndrome and polymorphous erythema. If allergic reactions occur or if allergic reactions are suspected, Tamiflu should be stopped and treated appropriately.
Medication for pregnant and lactating women: gestation
In the animal reproduction study of rats and rabbits, no teratogenicity was observed. In three studies before and after delivery, the rats were given toxic dose of oseltavir phosphate. Two studies showed that the growth of weaned young rats was delayed and the labor process was prolonged.
In the study of reproductive and reproductive toxicity in rats, the dose of oseltamivir did not affect the fertility of rats.
The exposure of drugs to embryos of rats and rabbits was about 15% to 20% of that of female and female rabbits.
Since no control trials were conducted on pregnant women, data from post market and retrospective observation monitoring reports were limited. These data combined with animal studies can not confirm that the product has direct or indirect adverse effects on pregnancy, embryo / fetus or postpartum development. The 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
For lactation rats, ostavir and its active metabolites can be secreted from milk. There is limited information on the breastfeeding infants and oseltamivir secreted in human milk by mothers taking this product. Limited data show that oseltamivir and its active metabolites can be detected in human milk, but the concentration is very low, which is lower than the treatment dose for infants. In view of this, as well as the pathogenicity of the epidemic strain and the basic conditions of the lactating mother, oseltavir may be considered.
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