Nomides caps 75mg #10

Nomides instruction for use

You can buy Nomides here

Composition

active substance:
Oseltamivir phosphate: 39.40 mg 59.10 mg 98.50 mg
what corresponds to the content
Oseltamivir:
30.00 mg
45.00 mg
75.00 mg
Excipients:
Colloidal silicon dioxide (Aerosil) - 6.00 mg / 9.00 mg / 15.00 mg; Copovidone - 3.60 mg / 5.40 mg / 9.00 mg; pregelatinized starch - 65.60 mg / 98.40 mg / 164.00 mg; Croscarmellose sodium - 1,840 mg / 2,760 mg / 4,60 mg; sodium fumarate -0.920 mg / 1.380 mg / 2.30 mg; talc - 2.640 mg / 3.960 mg / 6.60 mg.
The composition of hard gelatin capsules:
For dosage of 30 mg:
capsule body: purified water - 14-15 mg, sodium lauryl sulfate - 0.12 mg, titanium dioxide - 2.0500 mg, gelatin - up to 100 mg;
capsule cap: purified water - 14-15 mg, sodium lauryl sulfate - 0.12 mg, titanium dioxide - 2.0500 mg, gelatin - up to 100 mg.
For dosage of 45 mg:
capsule body: purified water - 14-15 mg, sodium lauryl sulfate - 0.08 mg, titanium dioxide - 0.97524 mg, brilliant blue dye - 0.2626 mg, gelatin - up to 100 mg;
capsule cap: purified water - 14-15 mg, sodium lauryl sulfate - 0.08 mg, titanium dioxide - 0.97524 mg, dye brilliant blue - 0.2626 mg, gelatin - up to 100 mg.
For dosage 75 mg:
capsule body: purified water - 14-15 mg, sodium lauryl sulfate - 0.12 mg, titanium dioxide - 1.50038 mg, gelatin - up to 100 mg;
capsule cap: purified water - 14-15 mg, sodium lauryl sulfate - 0.12 mg, titanium dioxide - 1.50038 mg; Sunlight Sunset yellow dye E 110 - 1.2753 mg, crimson dye [Ponso 4R] E 124 - 0.2401 mg, gelatin - up to 100 mg.
Description:
For dosage 30 mg: hard gelatin capsules № "3", white body, white cap.
For dosage 45 mg: hard gelatin capsules № "2", blue body, blue cap.
For the dosage of 75 mg: hard gelatin capsules No. "1", white body, orange cap.
The contents of the capsules are white or white with a yellowish sheen powder.
Pharmacotherapeutic group:
antiviral agent.
ATH code:
J05AH02.

Pharmacodynamics

Antiviral drug, oseltamivir phosphate is a prodrug, its active metabolite (oseltamivir carboxylate, OK) is an effective and selective inhibitor of neuraminidase of influenza viruses A and B - an enzyme catalyzing the process of releasing newly formed virus particles from infected cells, their penetration into the epithelial cells of the respiratory tract and the further spread of the virus in the body. It inhibits the growth of the influenza virus in vitro and inhibits the replication of the virus and its pathogenicity in vivo, reduces the secretion of influenza A and B viruses from the body.
Studies of clinical isolates of the influenza virus showed that the concentration of OK required to inhibit neuraminidase by 50% (IC50) is 0.1-1.3 nM for the influenza A virus and 2.6 nM for the influenza B virus. According to published studies, the median The IC50 value for influenza B virus is slightly higher at 8.5 nM.

Resistance

Clinical researches

The risk of influenza viruses with reduced sensitivity or resistance to Nomides was studied in clinical studies. In all patients with OK-resistant virus, the carrier had a temporary character, did not affect the elimination of the virus and did not cause a deterioration of the clinical condition.
When taking oseltamivir for the purpose of postexposure prophylaxis (7 days), prophylaxis of contacts in the family (10 days) and seasonal prophylaxis (42 days) in patients with normal function of the immune system, no cases of drug resistance were noted. In a 12-week study on seasonal prophylaxis in immuno-impaired individuals, there were also no cases of resistance to occurrence. Separate clinical cases and observational studies
In patients who did not receive oseltamivir, mutations of influenza viruses A and B, which were found to have decreased sensitivity to oseltamivir, occurring in natural conditions were found. In 2008, a mutation by the type of substitution H275Y, leading to resistance, was detected in more than 99% of the 2008 H1N1 virus strains circulating in Europe. The 2009 H1N1 influenza virus (“swine flu”) was in most cases sensitive to oseltamivir. Oseltamivir-resistant strains were found in individuals with normal immune system function and in immunocompromised individuals taking oseltamivir. The degree of decrease in sensitivity to oseltamivir and the frequency of occurrence of such viruses may vary depending on the season and region. Resistance to oseltamivir was found in patients with pandemic H1N1 flu who received Nomides for treatment, HAC and for prophylaxis.
The incidence of resistance may be higher in younger patients and in immunocompromised patients. Oseltamivir-resistant laboratory strains of influenza viruses and influenza viruses from patients treated with oseltamivir have mutations of N1 and N2 neuraminidase. Resistance-causing mutations are often specific to the neuraminidase subtype. When deciding on the use of oseltamivir, the seasonal sensitivity of the influenza virus to Nomides should be taken into account (the latest information can be found on the WHO website).

Preclinical data

Preclinical data obtained on the basis of standard studies on the study of pharmacological safety, genotoxicity and chronic toxicity, revealed no particular danger to humans.
Carcinogenicity: The results of 3 studies on the identification of carcinogenic potential (2-year studies in rats and mice for oseltamivir and one 6-month study on transgenic Tg: AC mice for an active metabolite) were negative.
Mutagenicity: The standard genotoxic tests for oseltamivir and the active metabolite were negative.
Impact on fertility: oseltamivir at a dose of 1500 mg / kg / day did not affect the reproductive function of males and females of rats.
Teratogenicity: in studies on the teratogenicity of oseltamivir at a dose of up to 1500 mg / kg / day (in rats) and up to 500 mg / kg / day (in rabbits), no effect on embryonic development was found. In studies on the antenatal and postnatal periods of development in rats with the introduction of oseltamivir at a dose of 1500 mg / kg / day, an increase in the period of labor was observed: the safety limit between the exposure for humans and the maximum non-effect dose in rats (500 mg / kg / day) for oseltamivir is 480 times higher, and 44 times more for its active metabolite. The exposure of the fetus I was 15-20% of that of the mother.
Other: oseltamivir and the active metabolite penetrate the milk of lactating rats. According to limited data, oseltamivir and its active metabolite pass into human breast milk. According to the results of extrapolating the data obtained in animal studies, their amount in breast milk can be 0.01 mg / day and 0.3 mg / day, respectively.
In about 50% of the tested guinea pigs, when maximized doses of the oseltamivir active substance were administered, skin sensitization in the form of erythema was observed. Also revealed a reversible eye irritation in rabbits.
While very high oral single doses (657 mg / kg and higher) of oseltamivir phosphate had no effect on adult rats, these doses had a toxic effect on immature 7-day-old rat pups, incl. led to the death of animals. Undesirable effects were not observed with chronic administration at a dose of 500 mg / kg / day from 7 to 21 days of the postnatal period.

Pharmacokinetics.

Absorption

Oseltamivir phosphate is easily absorbed in the gastrointestinal tract and is highly converted into an active metabolite by the action of liver and intestinal esterases. The concentration of the active metabolite in plasma is determined within 30 minutes, the time to reach the maximum concentration of 2-3 hours, and more than 20 times the concentration of the prodrug. At least 75% of the ingested dose enters the system bed in the form of an active metabolite, less than 5% in the form of the original drug. Plasma concentrations of both prodrugs and the active metabolite are proportional to the dose and do not depend on food intake.

Distribution

The volume of distribution (Vss) of the active metabolite is 23 l.
According to animal studies, after ingestion of oseltamivir phosphate, its active metabolite was found in all major foci of infection (lungs, bronchial washings, nasal mucosa, middle ear and trachea) in concentrations that provide antiviral effect.
Communication of an active metabolite with proteins of plasma - 3%. The association of prodrugs with plasma proteins is 42%, which is not enough to cause significant drug interactions.

Metabolism

Oseltamivir phosphate is highly converted into an active metabolite by the action of esterases, which are mainly in the liver. Neither oseltamivir phosphate nor the active metabolite are substrates or inhibitors of cytochrome P450 isoenzymes.

Removal

Excreted (> 90%) as an active metabolite predominantly by the kidneys. The active metabolite does not undergo further transformation and is excreted by the kidneys (> 99%) by glomerular filtration and tubular secretion. Renal clearance (18.8 l / h) exceeds the glomerular filtration rate (7.5 l / h), which indicates that Nomides is also excreted by tubular secretion. Less than 20% of the pleasant drug is excreted through the intestines. The half-life of the active metabolite is 6-10 hours.

Pharmacokinetics in Special Patient Groups

Patients with kidney damage

When using oseltamivir (100 mg twice a day for 5 days) in patients with varying degrees of kidney damage, the area under the plasma concentration of active metabolite – time curve (AUC of oseltamivir carboxylate) is inversely proportional to a decrease in kidney function.
The pharmacokinetics of oseltamivir in patients with end-stage renal disease (with a clearance of creagine <10 ml / min) who are not on dialysis has not been studied. In this regard, recommendations for dosing in this group of patients are not available.

Patients with liver damage

Data obtained in vitro and in animal studies on the absence of a significant increase in the AUC of oseltamivir phosphate in mild and moderately impaired liver function were also confirmed in clinical studies. The safety and pharmacokinetics of oseltamivir phosphate in patients with severely impaired liver function has not been studied.

Elderly and senile patients

In patients of elderly and senile age (65-78 years), the metabolite exposure in an equilibrium state is 25-35% higher than in younger patients when prescribing similar doses of oseltamivir. The half-life of Nomides in elderly and senile patients was not significantly different from that in younger patients. Given the data on the exposure of the drug Nomides and its tolerability in elderly and senile patients, dose adjustment is not required for treatment and prevention of influenza.

Children

In young children, the elimination of the prodrug and the active metabolite is faster than in adults, which leads to lower AUC with respect to the specific dose. Taking Nomides at a dose of 2 mg / kg provides the same AUC of oseltamivir carboxylate, which is achieved in adults after a single dose of a capsule with 75 mg of the drug Nomides (which is equivalent to about 1 mg / kg). The pharmacokinetics of oseltamivir in children over 12 years of age is the same as in adults.

Indications for use

Treatment of influenza in adults and children over the age of 3 years.
Prevention of influenza in adults and adolescents over the age of 12 years who are in groups of increased risk of infection with the virus (in large groups, in debilitated patients).
Prevention of influenza in children over 3 years.

Contraindications for Nomides

Hypersensitivity to oseltamivir phosphate or any component of Nomides, end-stage renal failure (creatinine clearance <10 ml / min), severe liver failure, children under 3 years of age.

Carefully

Pregnancy, breastfeeding period.

Use during pregnancy and during breastfeeding

Controlled studies in pregnant women have not been conducted. However, the results of post-marketing and observational studies have demonstrated the benefit of the proposed standard dosing regimen for this patient population. The results of the pharmacokinetic analysis showed a lower exposure to the active metabolite (approximately 30% during all trimesters of pregnancy) in pregnant women compared to non-pregnant women. However, the calculated exposure value remains above the inhibitory concentrations (IC95 value) and therapeutic values ​​for many strains of influenza virus. Changing the dosage regimen in pregnant women during therapy or prophylaxis is not recommended. No direct or indirect adverse effect of Nomides on pregnancy, fetal fetal or postnatal development was found (see “Preclinical data”). When prescribing oseltamivir, pregnant women should consider both safety data and the course of pregnancy and the pathogenicity of the circulating influenza virus strain.
During preclinical studies, oseltamivir and the active metabolite penetrated the milk of lactating rats. Data on the excretion of oseltamivir with breast milk in humans and the use of oseltamivir by nursing women is limited. Oseltamivir and its active metabolite in small quantities penetrate into breast milk (see “Preclinical data”), creating subtherapeutic blood concentrations in an infant. When prescribing oseltamivir, lactating women should also take into account the associated disease and the pathogenicity of the circulating influenza virus strain.
During pregnancy and during breastfeeding, oseltamivir is used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Dosage and administration

Nomides oseltamivir is taken orally, regardless of the meal or while eating.

Treatment

Nomides should be started no later than 2 days from the onset of symptoms.

Adults and teenagers aged> 12 years

The recommended daily intake is 150 mg. The drug Nomides is prescribed in a dose of 75 mg (one capsule 75 mg or one capsule 30 mg + one capsule 45 mg) 2 times a day inside for 5 days.

Children weighing more than 40 kg or aged> 8 years

Children who are able to swallow capsules can also receive treatment, taking 75 mg (one capsule 75 mg or one capsule 30 mg + one capsule 45 mg) 2 times a day for 5 days.
Children aged> 3 years

Prevention

Nomides should be started no later than 2 days after contact with patients.

Adults and teenagers aged> 12 years

On 75 mg (one capsule of 75 mg or one capsule of 30 mg + one capsule of 45 mg) once a day inside for at least 10 days after contact with the patient. During the seasonal flu epidemic, 75 mg 1 time per day for 6 weeks. Preventive action lasts as long as taking Nomides.

Children weighing more than 40 kg or aged> 8 years

Children who can swallow capsules can also receive prophylactic therapy, taking 75 mg (one capsule 75 mg or one capsule 30 mg + one capsule 45 mg) once a day for 10 days.
Children aged> 3 years

Dosing in special cases

Patients with impaired renal function:

Treatment

Patients with creatinine clearance more than 60 ml / min dose adjustment is not required. In patients with creatinine clearance from 30 to 60 ml / min, the dose of oseltamivir should be reduced to 30 mg twice a day for 5 days.
In patients with creatinine clearance from 10 to 30 ml / min, the dose of oseltamivir should be reduced to 30 mg once a day for 5 days. Patients on permanent hemodialysis, oseltamivir in the initial dose of 30 mg can be taken before dialysis, if the symptoms of flu appear within 48 hours between dialysis sessions. To maintain plasma concentrations at the therapeutic level, oseltamivir should be taken at 30 mg after each session of dialysis. Patients on peritoneal dialysis, oseltamivir should be taken in an initial dose of 30 mg before dialysis, then 30 mg every 5 days.
The pharmacokinetics of oseltamivir in patients with end-stage chronic renal failure (with creatinine clearance <10 ml / min) who are not on dialysis has not been studied. In this regard, recommendations for dosing in this group of patients are not available.

Prevention

Patients with creatinine clearance more than 60 ml / min dose adjustment is not required. In patients with creatinine clearance from 30 to 60 ml / min, the dose of oseltamivir should be reduced to 30 mg once a day. In patients with creatinine clearance from 10 to 30 ml / min, it is recommended to reduce the dose of oseltamivir to 30 mg every other day. Patients on permanent hemodialysis, oseltamivir in the initial dose of 30 mg can be taken before the start of dialysis. To maintain plasma concentrations at the therapeutic level, oseltamivir should be taken at 30 mg after each subsequent odd dialysis session. Patients on peritoneal dialysis, oseltamivir should be taken in an initial dose of 30 mg before dialysis, then 30 mg every 7 days. The pharmacokinetics of oseltamivir in patients with end-stage chronic renal failure (with creatinine clearance less than 10 ml / min) who are not on dialysis has not been studied. In this regard, recommendations for dosing in this group of patients are not available.

Patients with impaired liver function

Dose adjustment in the treatment and prevention of influenza in patients with mild and moderately impaired liver function is not required. The safety and pharmacokinetics of oseltamivir in patients with severely impaired liver function has not been studied.

Elderly and senile patients

Dose adjustment for the prevention or treatment of influenza is not required.

Immunocompromised patients (after transplantation)

For seasonal prevention of influenza in patients with weakened immunity at the age of> 3 years - for 12 weeks, dose adjustment is not required.

Side effects of Nomides

In adult / adolescent influenza treatment studies, nausea, vomiting, and headache were the most common adverse reactions (HP). Most of the HPs appeared on the first or second day of treatment and passed on their own within 1-2 days. In studies on the prevention of influenza in adults and adolescents, the most frequent HP was nausea, vomiting, headache and pain. Vomiting was most common in children. Described HP in most cases did not require discontinuation of Nomides.

Treatment and prevention of influenza in adults and adolescents

Table 1 shows the HP that occurred most frequently (> 1%) when taking the recommended dose of oseltamivir in studies on the prevention and treatment of influenza in adults and adolescents (75 mg 2 times a day for 5 days for treatment and 75 mg 1 time a day up to 6 weeks for prophylaxis), and the frequency of which is at least 1% higher than placebo. Patients with influenza treatment included adults / adolescents without comorbidities and at-risk patients, i.e. patients with a high risk of developing complications of influenza (elderly and senile patients, patients with chronic diseases of the heart or respiratory system). In general, the safety profile in patients at risk corresponded to that in adults / adolescent patients without comorbidities.
In studies on the prevention of influenza, the safety profile of patients who received the recommended dose of Nomides (75 mg 1 time per day for up to 6 weeks) did not differ from that in studies on treatment of influenza, despite the longer taking of the drug Nomides.
Disorders of the gastrointestinal tract (oseltamivir versus placebo):
treatment - diarrhea (6% vs. 7%), abdominal pain (including pain in the upper abdomen, 2% versus 3%);
prevention - diarrhea (3% versus 4%), pain in the upper abdomen (2% versus 2%), dyspepsia (1% versus 1%).
Infections and invasions (oseltamivir versus placebo):
treatment - bronchitis (3% versus 4%), sinusitis (1% versus 1%), herpes simplex (1% versus 1%);
prevention - nasopharyngitis (4% versus 4%), upper respiratory tract infections (3% versus 3%), influenza infection (2% versus 3%).
General disorders (oseltamivir versus placebo):
treatment - dizziness (including vertigo, 2% versus 3%);
prevention - fatigue (7% versus 7%), pyrexia (2% versus 2%), flu-like illness (1% versus 2%), dizziness (1% versus 1%), pain in the extremity (1% versus 1%).
Nervous system disorders (oseltamivir versus placebo):
treatment - insomnia (1% vs. 1%);
prevention of insomnia (1% vs. 1%).
Disorders of the respiratory system, chest and mediastinal organs (oseltamivir versus placebo):
treatment - cough (2% versus 2%), nasal congestion (1% versus 1%);
prevention - nasal congestion (7% versus 7%), angina (5% versus 5%), cough (5% versus 6%), rhinorrhea (1% versus 1%).
Musculoskeletal and connective tissue disorders (oseltamivir versus placebo):
prevention - back pain (2% versus 3%), arthralgia (1% versus 2%), myalgia (1% versus 1%).
Violations of the genital organs and the breast (oseltamivir versus placebo): prevention - dysmenorrhea (3% vs. 3%).
Treatment and prevention of influenza infection in the elderly
The safety profile of 942 elderly and senile patients who received oseltamivir or placebo was not clinically different from that of younger patients (up to 65 years).
Preventing influenza infection in immunocompromised patients
In a 12-week study on the prevention of influenza involving 475 immunocompromised patients (including 18 children aged 1 to 12 years), in patients taking oseltamivir (n = 238), the safety profile corresponded to that described earlier in studies on the prevention of influenza.
Treatment and prevention of influenza infection in children without comorbidities at the age of 1-12 years and patients with bronchial asthma
In studies on the treatment of natural influenza infection in children aged 1 to 12 years of age with oseltamivir (n = 858), marked with a frequency of> 1% and at least 1% more often than placebo (n = 622), there was vomiting. In children who received the recommended dose of Nomides 1 time per day as postexposure prophylaxis at home, vomiting was most common (8% in the oseltamivir group versus 2% in the group not receiving prophylactic treatment). Oseltamivir was well tolerated, the reported adverse events were as previously described in the treatment of influenza in children. The following are adverse events reported in children with a frequency of> 1% in influenza treatment studies (n = 858) or with a frequency of> 5% in influenza prevention studies (n = 148). These adverse events were more frequently observed in the placebo / no prophylaxis group, differences between oseltamivir and placebo / no prophylactic groups were less than 1%.
Disorders of the gastrointestinal tract (oseltamivir versus placebo):
treatment - diarrhea (9% versus 9%), nausea (4% versus 4%), abdominal pain (including pain in the upper abdomen, 3% versus 3%).
Infections and invasions (oseltamivir versus placebo):
treatment - otitis media (5% versus 8%), bronchitis (2% versus 3%), pneumonia (1% versus 3%), sinusitis (1% versus 2%).
Disorders of the respiratory system, chest and mediastinal organs (oseltamivir versus placebo):
treatment - asthma (including exacerbation, 3% versus 4%), epistaxis (2% versus 2%);
prevention - cough (12% versus 26%), nasal congestion (11% versus 20%).
Disorders of the skin and subcutaneous tissues (oseltamivir versus placebo):
treatment - dermatitis (including allergic and atopic dermatitis, 1% versus 2%).
Disturbances from the organ of hearing and labyrinth disorders (oseltamivir versus placebo):
treatment - earache (1% vs. 1%).
Violations by the organ of vision (oseltamivir versus placebo):
treatment - conjunctivitis (including eye redness, eye discharge and eye pain, 1% vs. <1%).
Additional adverse events noted during the treatment of influenza in children that did not meet the criteria described above.
Blood and lymphatic disorders (oseltamivir versus placebo):
treatment - lymphadenopathy (<1% vs. 1%).
Disturbances from the organ of hearing and labyrinth disorders (oseltamivir versus placebo):
treatment - damage to the eardrum (<1% vs. 1%).

Postmarket ingovoy observation

The following are undesirable effects when using oseltamivir, which were observed during the post-marketing observation period. The frequency of these adverse events and / or causation with the use of Nomides can not be established, since the true population size is not known due to the voluntary nature of the messages.
Violations of the skin and subcutaneous tissues:
hypersensitivity reactions -dermatitis, skin rash, eczema, urticaria, erythema multiforme exudative, Stevens-Johnson syndrome and toxic epidermal necrolysis, allergies, anaphylactic and anaphylactoid reactions, Quincke edema.
Disorders of the liver and biliary tract:
hepatitis, an increase in liver enzyme activity in patients with flu-like symptoms who received oseltamivir; fulminant hepatitis (including fatal outcome), liver failure, jaundice.

Violations of the neuropsychic sphere

Influenza infection may be associated with various neurological symptoms and behavioral changes, including symptoms such as hallucinations, delusions and abnormal behavior. In some cases, they can be fatal. Such phenomena can occur both against the background of the development of encephalopathy or encephalitis, and without the manifestation of these diseases.
Seizures and delirium symptoms (including symptoms such as impaired consciousness, disorientation in time and space, abnormal behavior, delirium, hallucinations, agitation, anxiety, nighttime) were reported in patients (mainly children and adolescents) who took oseltamivir for the treatment of influenza. nightmares). These cases were rarely accompanied by life-threatening actions. The role of oseltamivir in the development of these phenomena is unknown. Similar neuropsychiatric disorders were also noted in patients with influenza who did not receive oseltamivir.
Violations of the gastrointestinal tract:
gastrointestinal bleeding after taking oseltamivir (in particular, the relationship between hemorrhagic colitis and taking oseltamivir cannot be ruled out, since these phenomena disappeared both after the patient recovered from the flu and after Nomides was discontinued).
Violations of the organ of vision: blurred vision.
Heart disorders: arrhythmia.

Overdose

In most cases, overdose during clinical trials and post-marketing use of oseltamivir was not accompanied by any adverse events. In other cases, the symptoms of overdose corresponded to adverse events presented in the section “Side Effects”.

Interaction with other drugs

Clinically significant drug interactions are unlikely according to pharmacological and pharmacokinetic studies. Oseltamivir phosphate is highly converted into an active metabolite under the action of esterases, mainly located in the liver. Drug interactions due to competition for binding to the active centers of esterases are not widely represented in the literature. The low degree of binding of oseltamivir and the active metabolite with plasma proteins does not suggest the existence of interactions associated with the exclusion of drugs from the association with proteins.
In vitro studies show that neither oseltamivir phosphate nor its active metabolite is the preferred substrate for polyfunctional oxidases of the cytochrome P450 system or for glucuronyltransferases. There is no reason to interact with oral contraceptives.
Cimetidine, a non-specific inhibitor of the isoenzyme of the cytochrome P450 system and competing in the process of tubular secretion with alkaline preparations and cations, does not affect the plasma concentrations of oseltamivir and its active metabolite.
Clinically significant interdrug interactions associated with competition for tubular secretion are unlikely, taking into account the safety margin for most of these drugs, the route of elimination of the active metabolite oseltamivir (glomerular filtration and anionic tubular secretion), as well as the outputting capacity of each of the pathways.
Probenecid leads to an increase in the AUC of the active metabolite of oseltamivir by about 2 times (due to a decrease in the active tubular secretion in the kidneys). However, dose adjustment with simultaneous use with probenecid is not required, given the safety margin of the active metabolite.
Simultaneous administration with amoxicillin does not affect plasma concentrations of oseltamivir and its components, demonstrating weak competition for elimination by anionic tubular secretion.
Simultaneous administration with paracetamol does not affect plasma concentrations of oseltamivir and its active metabolite or paracetamol.
Pharmacokinetic interactions between oseltamivir and its main metabolite were not detected when taken simultaneously with paracetamol, acetylsalicylic acid, cimetidine or antacid agents (magnesium and aluminum hydroxide, calcium carbonate), warfarin, rimantadine or amantadine.
When using the ovaltemvir adrenergic blockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opiates (codeine), glucocorticosteroids, inhaled bronchodilators and non-narcotic analgesics (acetylsalicylic acid ta, ibuprofen and paracetamol), changes in the nature or frequency of adverse events were not observed.
It is necessary with caution to use oseltamivir in combination with drugs that have a narrow breadth of therapeutic action (for example, chlorpropamid, methotrexate, butadione).

special instructions

Mental disorders

Seizures and delirium-like neuropsychiatric disorders were recorded in patients (mostly children and adolescents) who took oseltamivir to treat the flu. These cases were rarely accompanied by life-threatening actions. The role of oseltamivir in the development of these phenomena is unknown. Similar neuropsychiatric disorders were also noted in patients with influenza who did not receive oseltamivir. The risk of neuropsychiatric disorders in patients receiving oseltamivir does not exceed that in patients with influenza who do not receive antiviral drugs.
It is recommended to carefully monitor the condition and behavior of patients, especially children and adolescents, in order to identify signs of abnormal behavior and assess the risk of continued drug administration during the development of these phenomena.
Data on the effectiveness of oseltamivir in any diseases caused by other pathogens, except for influenza viruses A and B, no.
Oseltamivir is not a substitute for vaccination.
Prophylactic administration of Nomides is possible according to epidemiological indications. Recommendations for dose adjustment in patients with renal impairment are presented in the subsection "Dosing in special cases" (also see "Pharmacokinetics in Special Groups of Patients").

Influence on ability to drive vehicles and mechanisms

Studies on the effect of Nomides on the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and psychomotor speed were not conducted. Based on the safety profile, the effect of oseltamivir on these activities is unlikely.

Release form

30 mg capsules; 45 mg; 75 mg.
Primary packaging of Nomides.
On 5 or 10 capsules in a blister strip packaging from a film of a polyvinyl chloride and aluminum foil printed lacquered.
20, 30 capsules in a plastic jar with a lid tensioned with control of the first opening. Free space is filled with medical cotton wool. On banks stick labels from paper label or writing or from polymeric materials, self-adhesive.
Secondary packaging of the drug Nomides.
On 1 or 2 blister strip packaging together with the application instruction is placed in a pack from a cardboard for consumer packaging. Packs are placed in a multi-pack.
On 1 bank together with the application instruction are placed in a pack from a cardboard for a consumer container. Packs are placed in a multi-pack.

Storage conditions

Store in the original packaging of the manufacturer at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 3 years. Do not use after the expiration date printed on the package.

Terms of sell

You can buy Nomides without a prescription.