Influcein - Instructions For Use, Price, Reviews, Capsule Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Influcein

Influcein: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Inflyucein

ATX code: J05AH02

Active ingredient: oseltamivir (Oseltamivir)

Producer: CJSC "Kanonfarma production" (Russia)

Description and photo update: 2019-05-07

Prices in pharmacies: from 520 rubles.

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Influcein is an antiviral agent.

Release form and composition

Dosage form - capsules: size No. 1, hard gelatinous, with a yellow cap and a white body; content - a mixture of granules and powder or a compressed mass that crumbles when lightly pressed, almost white in color (in a cardboard box 1 blister containing 10 capsules, and instructions for the use of Influcein).

Composition of 1 capsule:

• active substance: oseltamivir (in the form of phosphate) - 75 mg;
• auxiliary components: sodium stearyl fumarate, pregelatinized corn starch, croscarmellose sodium, talc, calcium hydrogen phosphate;
• capsule shell: body - gelatin, titanium dioxide; cap - gelatin, titanium dioxide, dyes sunset yellow and quinoline yellow.

Pharmacological properties

Pharmacodynamics

The active ingredient of Influcein is an antiviral agent.

Oseltamivir phosphate is a prodrug: under the action of hepatic and intestinal esterases, it is converted into oseltamivir carboxylate. This active metabolite is an effective selective inhibitor of neuraminidase of influenza A and B viruses, an enzyme that accelerates the release of newly formed viral particles from infected cells, their penetration into the epithelial cells of the respiratory tract and further spread of the virus in the body.

In vitro, the drug inhibits the growth of the influenza virus, in vivo - inhibits the replication of the virus and its pathogenicity. Also reduces the excretion of influenza A and B viruses from the body.

In studies of clinical isolates of the influenza virus, it was found that the concentration (IC ₅₀) of oseltamivir carboxylate required to suppress neuraminidase by 50% is: for influenza A virus - 0.1-1.3 nM, for influenza B virus - 2.6 nM. According to some published studies, the median IC ₅₀ values for influenza B virus are higher at 8.5 nM.

In the course of clinical studies, it was revealed that oseltamivir does not affect the formation of anti-influenza antibodies, including the production of antibodies in response to the administration of an inactivated influenza vaccine.

Research on natural influenza infection

Clinical studies were conducted during seasonal influenza infection. Patients started taking oseltamivir no later than 40 hours after the first signs of infection appeared. Influenza A virus was diagnosed in 97% of patients, influenza B virus in 3%.

Oseltamivir significantly reduced the period of clinical manifestations of influenza infection (by 32 hours).

The severity of influenza, expressed as the area under the curve for the cumulative symptom index, was 38% lower in oseltamivir-treated patients than in placebo-treated patients. In addition, in young patients without other concomitant diseases, Influcein approximately halved the incidence of complications of influenza requiring antibiotics (otitis media, sinusitis, bronchitis, pneumonia). In these phase III clinical trials, strong evidence was obtained with respect to secondary criteria for the antiviral efficacy of a drug: a decrease in the time of virus isolation from the body, a decrease in the area under the viral titers-time curve.

In elderly and senile patients who received oseltamivir 75 mg 2 times a day for 5 days, there was a decrease in the median, which determines the period of clinical manifestations of influenza infection, compared with that in younger patients, but the differences are not statistically significant.

Another study observed patients with influenza over the age of 13 years with concomitant chronic diseases of the respiratory system and / or cardiovascular system. One group of subjects took oseltamivir in the same dosage regimen, and the other took placebo. There were no differences between the groups in the median, which determines the period until the clinical manifestations of influenza infection decrease. However, in the oseltamivir group, the temperature rise period was reduced by about 1 day. The percentage of patients excreting the virus on the second and fourth day decreased significantly. The safety profile of oseltamivir in these patients did not differ from that in the general population of adult patients.

Influenza treatment in children

In a double-blind, placebo-controlled study, children aged 1 to 12 years with fever (> 37.8 ° C) and one of the symptoms of the respiratory system (rhinitis or cough) were observed during the circulation of the influenza virus. 67% were diagnosed with influenza A virus, 33% with influenza B.

Compared with placebo, oseltamivir (if taken within 48 hours after the onset of the first signs of illness) significantly (by 35.8 hours) reduced the duration of influenza infection, which was defined as the time until the nasal congestion was eliminated, cough and fever disappeared, and the return to normal activity. In the oseltamivir group, the incidence of acute otitis media was 40% lower than in the placebo group, and recovery occurred almost 2 days earlier.

Another study involved children aged 6 to 12 years with bronchial asthma. Influenza infection was detected in 53.6%, which was confirmed serologically and / or in culture. In the oseltamivir group, the median duration of illness was not significantly reduced. However, by the last, sixth, day of treatment with the drug, the forced expiratory volume in 1 sec (OFB ₁) increased by 10.8% compared to 4.7% in the placebo group.

Prevention of influenza in adults and adolescents

The prophylactic efficacy of Influcein against natural influenza A and B infections has been proven in three separate phase III clinical trials. In the oseltamivir group, about 1% of patients fell ill with influenza, with a decrease in the frequency of virus shedding and the frequency of transmission of the virus from one family member to another.

Patients who came into contact with a sick family member started taking oseltamivir no later than 2 days after the first symptoms of the disease in a family member and continued taking it for 7 days. It has been reliably established that Influcein reduced the incidence of influenza by 92%.

In unvaccinated and generally healthy adults aged 18 to 65 years who took oseltamivir during the influenza epidemic for 42 days, the incidence decreased by 76%.

In elderly and senile patients who were in nursing homes, 80% of whom were vaccinated before the season when the study was conducted, the incidence of influenza was significantly lower by 92%. In the same study, a significant (86%) reduction in the incidence of complications was noted: sinusitis, bronchitis and pneumonia. The patients took oseltamivir for 42 days.

Prevention of influenza in children

The prophylactic efficacy of Influcein against natural influenza infection, determined by the frequency of laboratory-confirmed illness, in children 1–12 years of age after contact with a sick person has been confirmed in studies. Children who did not initially develop the virus received the drug in the form of a suspension in doses of 30 to 75 mg once a day for 10 days. As a result, the incidence of laboratory-confirmed influenza decreased to 4% (2/47) compared to 21% (15/70) in the placebo group.

Prevention of influenza in immunocompromised individuals

With the prophylactic use of oseltamivir, a decrease in the incidence of laboratory-confirmed influenza accompanied by clinical symptoms was observed during the epidemic in immunocompromised patients who did not initially have the virus, to 0.4% (1/232) compared to 3% (7/231) in the placebo group.

Influenza infection with clinical symptoms, confirmed by laboratory, was diagnosed when a patient was diagnosed with acute rhinitis, cough and / or an increase in body temperature in the oral cavity to> 37.2 ° C, as well as when a positive result of reverse transcriptase polymerase chain reaction for RNA of the virus flu.

Resistance

In all patients who were carriers of the virus resistant to oseltamivir carboxylate, the carriage was temporary, did not affect the virus shedding and did not contribute to the deterioration of the clinical condition.

Patients with mutations leading to resistance:

• phenotyping *: adults and adolescents - 0.32% (4/1245), children 1–12 years old - 4.1% (19/464);
• geno - and phenotyping *: adults and adolescents - 0.4% (5/1245), children 1–12 years old - 5.4% (25/464).

* Complete genotyping was not performed in any of the studies.

When using Influcein for post-exposure prophylaxis (within 7 days), prophylaxis of family contacts (within 10 days) and seasonal prophylaxis (within 42 days), no cases of resistance to oseltamivir have been identified in individuals with normal immune system function. A similar situation was noted in the 12-week study on seasonal prevention.

Selected clinical cases and observational studies

In patients who did not take oseltamivir, naturally occurring mutations of influenza viruses types A and B, which had a reduced sensitivity to oseltamivir, were identified. In 2008, more than 99% of the 2008 H1N1 virus strains circulating in Europe were found to have a resistance-induced H275Y substitution mutation. The 2009 H1N1 influenza virus (known as “swine flu”) was susceptible to oseltamivir in most cases.

Oseltamivir-resistant strains have been found in both immunocompromised patients and those with normal immune function who received Influcein. The degree of desensitization and frequency of occurrence of these viruses may vary from region to region and from season to season. Resistance to oseltamivir has been identified in patients with pandemic H1N1 influenza who were taking the drug for treatment or prevention.

In immunocompromised and younger patients, the incidence of resistance may be higher.

Resistant laboratory strains of influenza viruses and influenza viruses from oseltamivir-treated patients carry neuraminidase N1 and N2 mutations. Resistant mutations are often specific for the neuraminidase subtype.

When deciding on the appointment of oseltamivir, information on the seasonal sensitivity of the influenza virus to it should be taken into account (on the website of the World Health Organization).

Preclinical data

In the preclinical data obtained from the results of standard studies conducted with the aim of studying pharmacological safety, chronic toxicity and genotoxicity, no particular hazard to humans has been identified.

There were negative results from three studies to determine carcinogenic potential: two 2-year studies of oseltamivir in mice and rats, one 6-month study of oseltamivir carboxylate in transgenic Tg: AC mice.

Standard genotoxic tests to determine the mutagenicity of oseltamivir and its active metabolite were negative.

In studies on rats using the drug in a daily dose of 1500 mg / kg, there was no effect on the generative function of both males and females.

Influcein teratogenicity was studied in rats (using a daily dose of up to 1500 mg / kg) and rabbits (using a daily dose of up to 500 mg / kg): no effect on embryofetal development was found.

In studies in rats of antenatal and postnatal periods of development, an increase in the period of labor was noted with the introduction of oseltamivir at a daily dose of 1500 mg / kg. The safety margin between human exposure and the maximum non-effective dose in rats (500 mg / kg / day) is 480 times higher for oseltamivir and 44 times higher for its active metabolite. Fetal exposure was about 15–20% of that of the female.

Oseltamivir and its active metabolite pass into the milk of lactating rats and, according to limited information, into human breast milk. Transferring the data obtained in animal studies to humans, it can be assumed that their concentrations in mother's milk will be 0.01 mg / day and 0.3 mg / day, respectively.

Approximately 50% of the guinea pigs tested, which were injected with the maximum dose of the active substance oseltamivir, developed skin hypersensitivity in the form of erythema. Reversible eye irritation was found in rabbits.

Administration of very high oral single doses (from 657 mg / kg) of oseltamivir phosphate did not affect adult rats. At the same time, this had a toxic effect on immature 7-day-old rat pups, including their death. No undesirable effects were observed with chronic administration of daily doses of 500 mg / kg from the 7th to the 21st day of the postnatal period.

Pharmacokinetics

Phosphate is rapidly absorbed from the gastrointestinal tract of oseltamivir. Under the influence of hepatic (mainly) and intestinal esterases, it is highly biotransformed into AM (active metabolite), the plasma concentration of which is approximately 20 times higher than oseltamivir phosphate itself. In plasma, AM is determined after about 30 minutes, reaching a maximum within 2-3 hours.

At least 75% of the received dose enters the systemic circulation in the form of AM, and no more than 5% in the form of the initial drug substance. Plasma concentrations of the prodrug and its AM do not depend on food intake and are proportional to the dose of Influcein.

The volume of distribution (V _d) AM is 23 liters. According to the research results, oseltamivir and its AM are found in all major foci of infection (in the mucous membrane of the nasal cavity, middle ear, trachea, bronchial lavage, lungs) in concentrations that ensure the development of an antiviral effect.

AM binds to plasma proteins by about 3%, prodrug - by 42%. This connection is not enough for Influcein to enter into significant drug interactions.

Neither oseltamivir phosphate nor its AM are substrates or inhibitors of isoenzymes of the cytochrome P _{450 system}.

The drug is excreted from the body mainly (more than 90%) in the urine in the form of AM. In the future, AM is not transformed and almost completely (more than 99% of the total circulating substance) is excreted by the kidneys through tubular secretion and glomerular filtration. Renal clearance is 18.8 l / h, glomerular filtration rate is 7.5 l / h. This indicates the predominant excretion of the drug by tubular secretion. Less than 20% of the dose received is excreted through the intestines.

The half-life (T _½) of oseltamivir carboxylate is 6-10 hours.

Pharmacokinetics in special cases:

• renal damage: in patients with varying degrees of renal impairment who took oseltamivir 100 mg 2 times a day for 5 days, the area under the concentration-time curve (AUC) was inversely proportional to the decrease in renal function. In patients with end-stage renal disease [creatinine clearance (CC) ≤ 10 ml / min], not receiving dialysis, the pharmacokinetics of Influcein have not been studied;
• liver damage: with mild and moderate impairment of hepatic function, there is no significant increase in the AUC of oseltamivir phosphate, as established in animal studies in vitro and confirmed in clinical studies. The pharmacokinetics and safety of the drug in patients with severe liver dysfunction have not been studied;
• advanced age: when equal doses are used in patients aged 65–78 years, the exposure to AM in the equilibrium state is approximately 25–35% higher than in younger patients, while T _½ differs insignificantly. No dose adjustment is required for the treatment and prevention of influenza in this category of patients;
• Childhood: Influcein parameters were studied in a large number of children from 1 to 16 years in a pharmacokinetic study with a single dose of oseltamivir and in a small number of children from 3 to 12 years in a clinical study on multiple doses of oseltamivir. The rate of excretion of AM, adjusted for body weight, is higher in young children than in adults, as a result of which the AUC values are lower in relation to a specific dose. In children, the same AUC as in adults after a single dose of 75 mg (approximately 1 mg / kg) provides Influcein at a dose of 2 mg / kg or in a single dose of 30 or 45 mg, depending on body weight. In children over 12 years of age, the pharmacokinetic characteristics of oseltamivir are similar to those in adults.

Indications for use

• influenza treatment in adults and children over 1 year old;
• prevention of influenza in children over 1 year old;
• prevention of influenza in adults and adolescents over 12 years old who are in groups at increased risk of infection (for example, in debilitated patients, in patients in large groups or military units, etc.).

Contraindications

Absolute:

• severe liver failure;
• end-stage renal failure (CC ≤ 10 ml / min);
• children's age up to 1 year;
• hypersensitivity to any component of the drug.

With caution, after assessing the benefits and risks, Influcein is used during pregnancy and lactation.

Influcein, instructions for use: method and dosage

Influcein capsules should be taken orally. The time of meals does not affect the effect of the drug, but its tolerance improves when taken with meals.

If signs of "aging" of the capsule appear (any disturbances in the physical condition, for example, increased fragility) and there are difficulties in swallowing it, the capsule can be opened and a suspension prepared from the contents. To hide the bitter taste, it is recommended to mix the powder with a sweetened food such as yogurt, chocolate syrup (normal or no sugar), sweetened condensed milk, sweet dessert, honey, applesauce, and table or light brown sugar dissolved in water. Stir the mixture thoroughly and take it whole. Such a mixture is not subject to storage, therefore it must be prepared immediately before taking.

Rules for the extemporal preparation of a suspension when prescribing a dose of Influcein 75 mg:

1. Take 1 capsule, carefully open it, holding it over a small container, and pour all the powder from the capsule into the container.
2. Add no more than 1 teaspoon of a suitable food item (listed above).
3. Mix well and take the mixture immediately. If there is any product left in the container, rinse it with a small amount of water and drink immediately.

Rules for the extemporal preparation of a suspension when prescribing a dose of Influcein 30-60 mg:

1. Take 1 capsule, carefully open it, holding it over a small container, and pour all the powder from the capsule into the container.
2. Add 5 ml of water using a syringe and mix thoroughly (within 2 minutes).
3. Draw the required dose of the drug into the syringe: 2 ml of the mixture = 30 mg (for patients weighing ≤ 15 kg); 3 ml = 45 mg (for patients weighing 16-23 kg); 4 ml = 60 mg (for patients weighing 24-40 kg).
4. Pressing the plunger of the syringe, introduce the suspension into the second container. The remaining liquid cannot be stored and should be discarded.
5. Add no more than 1 teaspoon of suitable sweetened food to the second container.
6. Mix the resulting mixture thoroughly and take immediately. If there is any product left in the container, rinse it with a small amount of water and drink immediately.

When treating influenza, it is recommended to start taking Influcein no later than the second day after the onset of symptoms. The course of therapy is 5 days. Recommended doses:

• adults and adolescents from 12 years old: 75 mg 2 times a day;
• children 8–12 years old with body weight> 40 kg: 75 mg 2 times a day;
• children 1–8 years old and children weighing <40 kg: Influcein is used in the form of a suspension prepared according to the method described above, in doses depending on the weight of the child: 24–40 kg - 60 mg, 16–23 kg - 45 mg, ≤ 15 kg - 30 mg.

When taken prophylactically, the following dosing regimens are recommended:

• adults and adolescents from 12 years old: 75 mg once a day for at least 10 days in case of contact with a sick person or for 6 weeks during a seasonal flu epidemic;
• children 8–12 years old with a body weight> 40 kg: 75 mg once a day for 10 days;
• children 1–8 years old and children weighing <40 kg: the drug is used in the form of a suspension prepared according to the method described above, in doses depending on the weight of the child.

For preventive purposes, it is recommended to start taking Influcein no later than the second day after contact with a sick person. The effect of the drug lasts as long as it lasts.

Dosing in special cases

In immunocompromised patients (for example, after transplantation) over the age of 1 year, with seasonal prophylaxis of influenza for a period of up to 12 weeks, there is no need to change the dosage regimen.

Elderly and senile patients, patients with mild and moderate impaired liver function do not need to adjust the dose both in the treatment of influenza and in its prevention.

In case of impaired renal function, the Influcein treatment regimen is changed depending on the CC.

Recommended dosing regimens for patients with renal impairment in the case of prescribing a drug for the treatment of influenza:

• CC 30-60 ml / min: 30 mg 2 times a day for 5 days;
• CC 10-30 ml / min: 30 mg 1 time per day for 5 days.

For patients on continuous hemodialysis, if flu symptoms appear within 2 days between dialysis treatments, the first dose of 30 mg can be taken before the start of the session. To maintain the therapeutic plasma concentration of oseltamivir, Influcein 30 mg should be taken after each procedure. For patients on peritoneal dialysis, the initial dose of 30 mg should be taken before the session, then - 30 mg every 5 days.

Recommended doses for patients with renal insufficiency in case of prescribing a drug for the prevention of influenza:

• CC 30-60 ml / min: 30 mg once a day;
• CC 10-30 ml / min: 30 mg every other day.

For patients on continuous hemodialysis, the first dose of 30 mg can be taken before the start of the session. To maintain a therapeutic plasma concentration of oseltamivir, Influcein 30 mg should be taken after each odd dialysis treatment. For patients on peritoneal dialysis, the initial dose of 30 mg must be taken before the session, then 30 mg every 7 days.

Side effects

Clinical researches

In clinical studies on the treatment of influenza in adults and adolescents, such adverse reactions as nausea, vomiting, and headache most often occurred. They usually developed on the first or second day of taking Influcein and went away on their own within one to two days.

In clinical trials on the prevention of influenza in adults and adolescents, the most common adverse reactions that occurred were nausea, vomiting, pain, including headache. Vomiting predominated among adolescents. In most cases, the described phenomena did not require the abolition of Influcein.

Treatment and prevention of influenza in adolescents and adults, elderly and senile patients, in patients with weakened immunity

The studies involved patients without concomitant pathologies and patients with a high risk of developing complications of influenza (with chronic respiratory or heart diseases, in old or senile age).

The safety profile of Influcein is approximately comparable in the groups without comorbidities and with the presence of risk. Similar data were obtained in the groups receiving the drug for treatment (within 5 days) and for prophylaxis (within 6 weeks), despite a longer period of administration. The same applies to immunocompromised patients, elderly and senile patients in comparison with patients with normal immunity or younger age.

Reported disorders in influenza treatment (frequency is indicated in% for two groups: oseltamivir; placebo):

• from the gastrointestinal tract: nausea (10%; 6%), vomiting (8%; 3%), diarrhea (6%; 7%), abdominal pain, including in the upper abdomen (2%; 3 %);
• from the nervous system: headache (2%; 1%), insomnia (1%; 1%);
• from the respiratory system: cough (2%; 2%), nasal congestion (1%; 1%);
• infections and invasions: bronchitis (3%; 4%), sinusitis (1%; 1%), herpes simplex (1%; 1%);
• general disorders: pain (<1%; <1%), dizziness (2%; 3%).

Identified violations in the prevention of influenza (frequency is indicated in% for two groups: oseltamivir; placebo):

• from the gastrointestinal tract: nausea (8%; 4%), vomiting (2%; 1%), diarrhea (3%; 4%), pain in the upper abdomen (2%; 2%), dyspepsia (1 %; 1%);
• from the nervous system: headache (17%; 16%), insomnia (1%; 1%);
• from the respiratory system: rhinorrhea (1%; 1%), nasal congestion (7%; 7%), cough (5%; 6%), tonsillitis (5%; 5%);
• from the musculoskeletal and connective tissue: back pain (2%; 3%), arthralgia (1%; 2%), myalgia (1%; 1%);
• from the genitals and mammary gland: dysmenorrhea (3%; 3%);
• infections and invasions: nasopharyngitis (4%; 4%), upper respiratory tract infections (3%; 3%), influenza infection (2%; 3%);
• general disorders: pain (4%; 3%), fatigue (7%; 7%), pyrexia (2%; 2%), flu-like illness (1%; 2%), dizziness (1%; 1%), pain in the limb (1%; 1%).

Treatment and prevention of influenza in children 1-12 years old without concomitant diseases and patients with bronchial asthma

Vomiting was a side effect that in the treatment and prevention of influenza infection in children 1–12 years of age occurred with a frequency of ≥ 1% and at least 1% more often compared with placebo.

In the prevention of influenza, the following disorders of the respiratory system were also noted (frequency is indicated in% for two groups: oseltamivir; placebo): nasal congestion (11%; 20%), cough (12%; 26%).

Other side effects observed in the treatment of influenza (their frequency is indicated in% for two groups: oseltamivir; placebo):

• from the gastrointestinal tract: diarrhea (9%; 9%), nausea (4%; 4%), abdominal pain, including in the upper abdomen (3%; 3%);
• infections and invasions: otitis media (5%; 8%), bronchitis (2%; 3%), pneumonia (1%; 3%), sinusitis (1%; 2%);
• from the respiratory system: asthma, including exacerbation (3%; 4%), epistaxis (2%; 2%);
• from the skin and subcutaneous tissues: dermatitis, including allergic and atopic (1%; 2%);
• on the part of the blood and lymphatic system: lymphadenopathy (<1%; 1%);
• on the part of the organ of hearing: pain in the ear (1%; 1%), damage to the eardrum (<1%; 1%);
• on the part of the organ of vision: conjunctivitis, including redness and pain in the eyes, discharge from the eye (1%; <1%).

Post-marketing surveillance

The frequency of the side effects described below and / or the causal relationship with the use of oseltamivir has not been established, since the true number of complaints is unknown due to the voluntary nature of the reports:

• on the part of the organ of vision: impaired visual perception;
• from the side of the heart: cardiac arrhythmia;
• from the liver and biliary tract: an increase in the activity of liver enzymes (in the treatment of influenza), jaundice, hepatitis, fulminant hepatitis, hepatic failure;
• from the gastrointestinal tract: gastrointestinal bleeding (possibly associated with hemorrhagic colitis);
• from the skin and subcutaneous tissues: hypersensitivity reactions - urticaria, eczema, skin rash, dermatitis, anaphylactic and anaphylactoid reactions, Quincke's edema, allergies, toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme;
• on the part of the neuropsychic sphere *: convulsions, delirium, including symptoms such as hallucinations, delirium, agitation, nightmares, abnormal behavior, impaired consciousness, anxiety, disorientation in time and space (mainly in children and adolescents). These cases were rarely accompanied by life-threatening actions. Similar neuropsychiatric disorders are also sometimes observed in patients with influenza who are not receiving oseltamivir.

* Influenza infection itself can be associated with various behavioral changes and neurological symptoms, including hallucinations, abnormal behavior, delusions. In some cases, they can be fatal. They can occur both against the background of the development of encephalitis or encephalopathy, and without the manifestation of these diseases.

Overdose

In most of the known cases, overdose was not accompanied by any adverse events. In some patients, the symptoms did not differ from the side effects that may occur when taking Influcein at usual doses.

Overdose treatment is symptomatic.

special instructions

Influcein is not a substitute for vaccination. Prophylactic administration of the drug is possible for epidemiological indications.

There is no data demonstrating the effectiveness of oseltamivir for any disease caused by pathogens other than influenza A and B.

There are known cases of the development of seizures, delirium and other similar neurological disorders in some patients (mainly in children and adolescents) who received Influcein in order to prevent influenza. Life-threatening complications were rare. The role of oseltamivir in the development of these reactions has not been reliably established. These neuropsychiatric disorders were also identified in patients with influenza who did not receive oseltamivir, so the risk of their occurrence is comparable. In this regard, during the period of therapy, it is recommended to carefully monitor the condition of patients, especially children and adolescents, for abnormal behavior. If such disorders appear, it is recommended to consult a doctor to assess the feasibility of continuing to take Influcein.

Influence on the ability to drive vehicles and complex mechanisms

Studies on the effect of oseltamivir on the psychophysical and cognitive functions of humans have not been conducted. Given the safety profile of the drug, it is unlikely that Influcein will adversely affect reaction rate and ability to concentrate.

Application during pregnancy and lactation

There have been no adequate and well-controlled studies of oseltamivir on its effects on pregnancy. However, according to the results of observational and post-marketing studies, the drug demonstrates benefits for this population, subject to the recommended dosage regimen. No direct or indirect adverse effects on the course of pregnancy, embryofetal or postnatal development have been identified. In the pharmacological analysis, a lower exposure of the active metabolite was established (by about 30% during all months of pregnancy) than in non-pregnant women. However, the calculated exposure remains above inhibitory concentrations and therapeutic values for many strains of influenza virus, so no change in the dose of Influcein for pregnant women is required. However, when prescribing the drug, the doctor must take into account the peculiarities of the course of pregnancy and the pathogenicity of the circulating strain.

In preclinical studies in rats, it was found that oseltamivir and its active metabolite penetrate into milk. Information on the excretion of the drug in breast milk in humans is limited. Penetrating into milk in small amounts, oseltamivir creates subtherapeutic concentrations in the blood of an infant. When prescribing Influcein, the physician should also take into account the concomitant disease and pathogenicity of the circulating strain of the influenza virus.

During pregnancy and lactation, the drug should be used if the expected benefit outweighs the potential risks.

Pediatric use

Influcein is not used to treat and prevent influenza in children under 1 year of age.

With impaired renal function

In renal failure, the dose is adjusted depending on the QC.

Influcein is contraindicated in patients with end-stage renal failure (CC ≤ 10 ml / min).

For violations of liver function

For mild and moderate liver dysfunctions, dose adjustment is not required.

The pharmacokinetics and safety of oseltamivir in patients with severe hepatic impairment have not been studied, therefore, taking Influcein capsules in such patients is contraindicated.

Use in the elderly

Elderly and senile patients do not require dose adjustment either in the treatment of influenza or in its prevention.

Drug interactions

According to pharmacological and pharmacokinetic studies, the development of clinically significant drug interactions is unlikely.

Under the influence of esterases, located mainly in the liver, oseltamivir phosphate is highly converted to an active metabolite. Literature sources have limited data on drug interactions due to competition for binding with active centers of esterases. Given the low degree of binding of oseltamivir and its active metabolite to plasma proteins, there is no reason to assume the development of interactions due to the displacement of drugs from the connection with proteins.

Under in vitro conditions, oseltamivir and its active metabolite are not the preferred substrates for polyfunctional oxidases of the cytochrome P _{450 system} and for glucuronyl transferases. These research results disprove possible interactions with oral contraceptives.

Cimetidine, which is a non-specific inhibitor of isoenzymes of the cytochrome P _{450 system}, competing with cations and alkaline-type drugs in the process of tubular secretion, does not have any effect on the concentration of oseltamivir and its active metabolite.

The development of clinically significant drug-drug interactions associated with competition for tubular secretion is unlikely, which is due to the safety margin of most such drugs, the routes of excretion of the active metabolite of oseltamivir (anionic tubular secretion and glomerular filtration), as well as the excretory capacity of each of the pathways.

Paracetamol does not have any effect on the plasma concentration of oseltamivir.

Oseltamivir does not interact with acetylsalicylic acid, paracetamol, rimantadine, amantadine, warfarin, cimetidine, antacids (calcium carbonate, magnesium and aluminum hydroxide).

Amoxicillin does not affect the concentration of oseltamivir in plasma, because it weakly competes for excretion by anionic tubular secretion.

Due to a decrease in active tubular secretion in the kidneys, probenecid approximately doubles the AUC of the active metabolite of oseltamivir. However, given its safety margin, dose adjustment is not required.

In phase III clinical trials oseltamivir taken in conjunction with the following commonly used drugs: antibiotics (penicillin, erythromycin, doxycycline, azithromycin, cephalosporins), thiazide diuretics (bendroflumethiazide), beta-blockers (propranolol), blockers of H ₂ histamine receptor (cimetidine, ranitidine), angiotensin-converting enzyme inhibitors (enalapril, captopril), inhaled bronchodilators, corticosteroids, sympathomimetics (pseudoephedrine), xanthines (theophylline), non-narcotic analgesics (paracetamol, ibuprofen, acetylsalicylic acid), opiate Changes in the nature or frequency of adverse events were not observed with combined therapy.

Influcein should be used with caution in combination with drugs with a narrow therapeutic effect, for example, simultaneously with methotrexate, chlorpropamide or butadione.

Analogs

Influcein analogs are: Nomides, Relenza, Tamiflu, Antigrippin-Maximum, Kagocel, Triazavirin, Ergoferon, Orvitol NP and others.

Terms and conditions of storage

Store in its original packaging at a temperature not exceeding 25 ° C, out of reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Influcein

According to reviews, Influcein is a good antiviral drug that helps both in the treatment of influenza and in its prevention. An important condition is to start taking it no later than the second day after the onset of symptoms of the disease or after contact with a sick person. Most patients choose oseltamivir because it is one of the few that is proven to be effective, in contrast to most marketed antiviral drugs. Users point out that Influcein helps to avoid influenza during the epidemic season, and, if infected, prevents the development of frequent complications that require antibiotic therapy.

Of the undesirable reactions, nausea and headache are most often mentioned.

At the same time, some patients find vaccination more appropriate than taking a drug. This is explained by the fact that Influcein "does not work" if the reception is not started on time, while it is not cheap, and the vaccination, if there is a vaccine in outpatient clinics, can be done free of charge.

Influcein price in pharmacies

Depending on the region of sale and the pharmacy network, the price of Influcein for 10 capsules of 75 mg each can range from 450 to 730 rubles.

Influcein: prices in online pharmacies

Drug name Price Pharmacy

Influcein 0.075 g 10 pcs. RUB 520 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!