Nomides

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

Nomides: instructions for use and reviews

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

Latin name: Nomides

ATX code: J05AH02

Active ingredient: oseltamivir (Oseltamivir)

Producer: Pharmasintez, JSC (Irkutsk) (Russia)

Description and photo update: 2019-27-09

Prices in pharmacies: from 290 rubles.

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Nomides is an antiviral drug.

Release form and composition

Dosage form - capsules: gelatinous solid, inside filled with white or white powder with a yellowish sheen; dosage of 30 mg - size No. 3, with a white body and lid; with a dosage of 45 mg - size No. 2, with a blue body and lid; a dosage of 75 mg - size No. 1, with a white body and an orange lid (in a cardboard box 1 or 2 blister packs containing 5 or 10 capsules, or 1 polymer can containing 20 or 30 capsules, as well as instructions for the use of Nomides) …

Composition of 1 capsule (30/45/75 mg, respectively):

active substances: oseltamivir phosphate - 39.4 / 59.1 / 98.5 mg (corresponds to the content of oseltamivir - 30/45/75 mg);
auxiliary components: talc - 2.64 / 3.96 / 6.6 mg; sodium stearyl fumarate - 0.92 / 1.38 / 2.3 mg; croscarmellose sodium - 1.84 / 2.76 / 4.6 mg; pregelatinized starch - 65.6 / 98.4 / 164 mg; copovidone - 3.6 / 5.4 / 9 mg; colloidal silicon dioxide (aerosil) - 6/9/15 mg.

The composition of the capsule shell (30/45/75 mg, respectively):

body: gelatin - up to 100/100/100 mg; titanium dioxide - 2.05 / 0.975 24 / 1.500 38 mg; sodium lauryl sulfate - 0.12 / 0.08 / 0.12 mg; purified water - 14-15 / 14-15 / 14-15 mg; additionally for capsules with a dosage of 45 mg: brilliant blue dye - 0.262 6 mg;
cap: gelatin - up to 100/100/100 mg; titanium dioxide - 2.05 / 0.975 24 / 1.500 38 mg; sodium lauryl sulfate - 0.12 / 0.08 / 0.12 mg; purified water - 14-15 / 14-15 / 14-15 mg; additionally for capsules with a dosage of 45 mg: brilliant blue dye - 0.262 6 mg; for capsules with a dosage of 75 mg: crimson dye [Ponso 4R] E124 - 0.240 1 mg; dye sunset sunset yellow E110 - 1.275 3 mg.

Pharmacological properties

Pharmacodynamics

Nomides is an antiviral drug, and its active ingredient, oseltamivir phosphate, is a prodrug. The active metabolite of oseltamivir phosphate, oseltamivir carboxylate, is an effective and selective inhibitor of neuraminidase of influenza A and B viruses, an enzyme that catalyzes 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 - suppresses the pathogenicity and replication of the virus, reduces the release of influenza A and B viruses from the body.

Studies of clinical isolates of the influenza virus have shown that the content of oseltamivir carboxylate required to inhibit neuraminidase by 50% (IC ₅₀) varies from 0.1 to 1.3 nM for influenza A virus and is 2.6 nM for the virus influenza B. The median IC ₅₀ value for influenza B virus, according to published studies, is slightly higher and amounts to 8.5 nM.

In clinical trials, the likelihood of the emergence of resistant influenza viruses or viruses with reduced drug sensitivity has been studied.

In all patients with a virus resistant to oseltamivir carboxylate, the carriage was temporary, it did not affect the elimination of the virus and did not cause a deterioration in the clinical state.

Depending on the patient population, phenotyping / geno- and phenotyping in patients with mutations leading to resistance was:

Children aged 1-12: 4.1% (19 out of 464) / 5.4% (25 out of 464)
adolescents 12+ and adults: 0.32% (4 in 1,245) / 0.4% (5 in 1,245)

None of the studies performed complete genotyping.

The development of resistance in persons with normal function of the immune system when using the drug for seasonal prophylaxis (within 42 days), prophylaxis of family contacts (within 10 days) and post-exposure prophylaxis (within 7 days) was not observed.

Resistance has also not been reported in the 3-month seasonal prophylaxis study in immunocompromised patients.

In patients who did not take oseltamivir, naturally occurring mutations of influenza A and B viruses with reduced sensitivity to the drug were found.

More than 99% of the 2008 H1N1 virus strains circulating in Europe were found to have a H275Y substitution mutation in 2008, which leads to the emergence of resistance. In most cases, swine flu (2009 H1N1 influenza virus) was susceptible to the substance. Strains resistant to it have been found both in individuals with normal immune function and in immunocompromised patients receiving Nomides. Depending on the region of residence and the season, the frequency of occurrence of such viruses and the degree of decrease in drug sensitivity may vary. Oseltamivir resistance was also noted when prescribing the drug both for therapy and for prophylaxis in patients with pandemic H1N1 influenza.

In patients with weakened immune systems and in younger patients, the incidence of resistance may be higher than in other individuals. Influenza viruses from oseltamivir-treated patients and laboratory strains of influenza viruses resistant to Nomides carry the N1 and N2 neuraminidase mutations. The mutations leading to resistance are often specific to the neuraminidase subtype.

The decision on the prescription of a medicinal product should be made taking into account the seasonal sensitivity of the influenza virus to it (the latest data are provided by the World Health Organization).

According to preclinical data, which were obtained in the course of standard studies for the study of chronic toxicity, genotoxicity and pharmacological safety, no particular danger to humans was identified.

The results of three studies to identify the carcinogenic potential of the drug (one half-year study in transgenic Tg: AC mice for the active metabolite and a two-year study in mice and rats for oseltamivir) were negative.

Standard genotoxic tests for both the drug and its active metabolite were negative.

The reproductive function of female and male rats did not deteriorate when using the drug at a dose of 1.5 g per 1 kg of body weight per day.

When using oseltamivir, there was no effect on embryonic development in rats (dose 1.5 g per 1 kg of body weight per day) and rabbits (up to 0.5 g per 1 kg of body weight per day). The period of labor in rats with the introduction of the drug at a dose of 1.5 g per 1 kg of body weight per day increased. The safety limit between human exposure and the maximum dose that has no effect in rats (0.5 g per 1 kg of body weight per day) is 480 times higher for the drug and 44 times for its active metabolite. Fetal exposure ranged from 15 to 20% of that of the mother.

Oseltamivir and its active metabolite pass into the milk of lactating rats and, according to limited data, into human breast milk. Their amount in breast milk, according to the results of extrapolation of data obtained in animal studies, can be, respectively, 0.000 3 and 0.000 01 g per day.

With the introduction of the maximum doses of the active substance of the drug to guinea pigs, among about 50% of them, skin sensitization was noted, manifested in the form of erythema. Reversible eye irritation was also found in rabbits.

Oral administration of a single dose of ≥ 0.657 g of oseltamivir phosphate per 1 kg of body weight had no effect on adult rats, but in immature rat pups at the age of 7 days it was toxic and in some cases fatal. No side effects were observed with constant administration of the drug at a dose of 0.5 g per 1 kg of body weight per day from 7 to 21 days of the postnatal period.

Pharmacokinetics

absorption: under the action of intestinal and hepatic esterases of oseltamivir, phosphate is easily absorbed in the gastrointestinal tract (GIT) and is highly converted into an active metabolite (oseltamivir carboxylate). Within 30 minutes, the content of oseltamivir carboxylate in plasma is determined, which exceeds the concentration of the prodrug by more than 20 times. The time to reach the maximum concentration of the active metabolite is from 2 to 3 hours. In the form of oseltamivir carboxylate, 75% (minimum) of the taken orally dose of the drug enters the systemic circulation, in the form of the starting substance - no more than 5%. Plasma concentrations of the prodrug and active metabolite are dose proportional and do not depend on food intake;
distribution: the volume of distribution of oseltamivir carboxylate was 23 liters. According to animal studies, after oral administration, it was found in all the main foci of infection (in the trachea, middle ear, washing water of the bronchi, lungs, on the mucous membrane of the nasal cavity) at concentrations providing antiviral effect. The connection with plasma proteins of oseltamivir carboxylate is 3%, prodrugs - 42%, which is not enough to cause significant drug interactions;
metabolism: under the action of esterases, mainly in the liver, oseltamivir phosphate is highly converted to oseltamivir carboxylate. Neither the drug nor its active metabolite are inhibitors or substrates of isoenzymes of the cytochrome P _{450 system};
excretion: the drug is mainly excreted by the kidneys through tubular secretion and glomerular filtration in the form of oseltamivir carboxylate (more than 90%), which does not undergo further transformation. Renal clearance is 18.8 liters per hour and exceeds the glomerular filtration rate, which is 7.5 liters per hour. This indicates that the drug is also excreted by tubular secretion. Less than 20% of the dose taken is excreted by the intestines. The half-life of oseltamivir carboxylate varies from 6 to 10 hours.

The area under the curve "concentration of the active metabolite in plasma - time" when using oseltamivir at a dose of 0.1 g 2 times a day for 5 days in patients with varying degrees of kidney damage is inversely proportional to the decrease in renal function.

The pharmacokinetics of Nomides in end-stage renal disease [creatinine clearance (CC) <10 ml per minute] in non-dialysis patients has not been studied, which is why there are no dosage recommendations in this group of patients.

The data obtained in animal and in vitro studies indicate that there is no significant increase in the area under the concentration-time curve of oseltamivir phosphate against the background of mild / moderate liver dysfunction. These data have been confirmed by clinical studies.

The safety and pharmacokinetics of oseltamivir phosphate in severe liver dysfunction have not been established.

The exposure of oseltamivir carboxylate in elderly patients and seniors (from 65 to 78 years) in the equilibrium state is 25–35% higher than that when using similar doses of Nomides in younger patients. The half-life of the drug in elderly and senile patients does not differ significantly from that in younger patients. Correction of the dosage regimen for the treatment and prevention of influenza in patients of these age groups, taking into account the data on the exposure of the substance and its tolerance, is not required.

The elimination of the prodrug and oseltamivir carboxylate in children is faster than in adults. This leads to the fact that the area under the concentration-time curve is lower in relation to a specific dose. Taking the drug at a dose of 0.002 g per 1 kg of body weight provides the same area under the concentration-time curve of the active metabolite, which is achieved after a single dose of capsules at a dose of 0.075 g (which is equivalent to about 0.001 g per 1 kg of body weight) in adults …

The pharmacokinetics of Nomides in children over the age of 12 is the same as in adults.

Indications for use

treatment and prevention of influenza in children over 3 years old;
treatment of influenza in adult patients;
prevention of influenza in adults and adolescents aged 12 years and older who are in groups at increased risk of infection with the virus (weakened patients, stay in large groups).

Contraindications

Absolute:

end-stage renal failure (CC ≤ 10 ml per 1 min);
severe liver failure;
children under 3 years old;
individual intolerance to the components of the drug.

Relative (Nomides is prescribed under medical supervision):

pregnancy;
period of breastfeeding.

Nomides, instructions for use: method and dosage

The capsules are taken orally, between meals, or with meals.

For the purpose of treatment, you should start taking Nomides no later than 2 days from the moment signs of pathology appear.

Recommended dosing regimen for influenza therapy:

adolescents over the age of 12 and adults: 75 mg 2 times a day (1 capsule of Nomides 75 mg or 1 capsule of 30 mg + 1 capsule of 45 mg) for 5 days. The daily dose is 150 mg;
children weighing> 40 kg or at the age of ≥ 8 years (provided that swallowing capsules does not cause them difficulty): 75 mg of the drug 2 times a day (1 capsule of 75 mg or 1 capsule of 30 mg + 1 capsule of 45 mg) for 5 days;
children aged ≥ 3 years: weighing ≤ 15 kg - 30 mg 2 times a day; from 15 to 23 kg - 45 mg 2 times a day; from 23 to 40 kg - 60 mg 2 times a day. The duration of treatment is 5 days.

In order to prevent the disease, it is necessary to start taking Nomides no later than 2 days after contact with patients.

Recommended dosing regimen for the prevention of influenza:

adolescents over the age of 12 and adults: 75 mg once a day (1 capsule of 75 mg or 1 capsule of 30 mg + 1 capsule of 45 mg) for 10 days (at least) after contact with the patient. During a seasonal flu epidemic - 75 mg 1 time per day for 42 days. The prophylactic effect continues during the entire period of taking the capsules;
children weighing> 40 kg or at the age of ≥ 8 years (provided that swallowing the capsules does not make them difficult): 75 mg of the drug once a day (1 capsule of Nomides 75 mg or 1 capsule of 30 mg + 1 capsule of 45 mg) for 10 days;
children aged ≥ 3 years: weighing ≤ 15 kg - 30 mg once a day; from 15 to 23 kg - 45 mg once a day; from 23 to 40 kg - 60 mg once a day. The duration of treatment is 10 days.

Correction of the dosage regimen for patients with CC> 60 ml per 1 min during the treatment of influenza is not performed. With QC from 30 to 60 ml in 1 min, the dose of Nomides is reduced to 30 mg 2 times a day for 5 days. With QC from 10 to 30 ml per minute, the dose of the drug is reduced to 30 mg once a day for 5 days.

For patients on continuous hemodialysis, capsules at an initial dose of 30 mg can be prescribed before the start of the procedure if signs of pathology appear within 48 hours between dialysis sessions.

In order to maintain the plasma concentration at a therapeutic level, Nomides is recommended to be used in a dose of 30 mg after each dialysis session.

Patients who are on peritoneal hemodialysis should take capsules in the initial dose of 30 mg before the procedure, then 30 mg every 5 days.

The pharmacokinetics of oseltamivir in end-stage chronic renal failure (CC ≤ 10 ml per minute) in patients not on dialysis has not been studied, which is why there are no recommendations for dosing Nomides in this group of patients.

Correction of the dosage regimen for patients with CC> 60 ml per 1 min during the prevention of influenza is not carried out. With QC from 30 to 60 ml in 1 min, the dose of Nomides is reduced to 30 mg once a day. With QC from 10 to 30 ml in 1 min, the dose of the drug is reduced to 30 mg 1 time in 2 days.

For patients on continuous hemodialysis, capsules at an initial dose of 30 mg may be prescribed prior to the procedure. In order to maintain the plasma concentration at a therapeutic level, Nomides is recommended to be used in a dose of 30 mg after each subsequent odd dialysis session.

Patients who are on peritoneal dialysis should take capsules at an initial dose of 30 mg before the start of the procedure, then at 30 mg every 7 days.

The pharmacokinetics of oseltamivir and the safety of its use in the setting of mild to moderate liver dysfunction have not been studied.

Correction of the dosage regimen of Nomides in the treatment and prevention of pathology in elderly and senile patients, in persons with mild / moderate hepatic dysfunction, as well as in seasonal flu prophylaxis (for 84 days) in immunocompromised patients (after transplantation) in over 3 years of age is not required.

Side effects

In ongoing studies on the treatment of influenza in adolescents and adults, headache, nausea and vomiting were the most common adverse events. Most of them developed during the first 24–48 hours of treatment and passed on their own within 1–2 days.

In adolescent and adult prevention studies, the most common side effects were pain, headache, nausea and vomiting. The most common development in children was vomiting. In most cases, drug withdrawal was not required.

These side effects when taking Nomides at the recommended dose (for therapy - 75 mg 2 times a day for 5 days, for prophylaxis - 75 mg 1 time per day with a course of use up to 42 days) occurred most often (≥ 1%) and their incidence was at least 1% higher compared to the placebo group. The group of adolescents and adults who took part in the study included persons without concomitant diseases and patients from the risk group with a high probability of complications of influenza (patients with chronic pathologies of the respiratory and heart organs, elderly and senile patients). The safety profile in the risk group was generally similar to that of the adolescent / adult group without comorbidities.

Despite the longer course of taking Nomides, in studies on the prevention of influenza, the safety profile in patients who took capsules at the recommended dose (75 mg 1 time per day with a duration of up to 42 days) did not differ from that in the study on influenza therapy.

The percentage of adults and adolescents in the group with adverse reactions during oseltamivir / placebo therapy (among 2647/1977 subjects) and oseltamivir / placebo prophylaxis (among 1945/1588 subjects), respectively, was:

Gastrointestinal tract: nausea (very common) - 0/6% and 8/4%; vomiting (often) - 8/3% and 2/1%;
nervous system: headache (very common) - 2/1% and 17/16%;
general disorders: pain (often) - <1 / <1% and 4/3%.

Adverse events that occurred with a frequency of ≥ 1% in adolescents / adults taking Nomides for the treatment and prevention of influenza infection include (oseltamivir / placebo,%):

Gastrointestinal tract: therapy - abdominal pain, including in the upper abdomen (2/3%), diarrhea (6/7%); prevention - dyspepsia (1/1%), pain in the upper abdomen (2/2%), diarrhea (3/4%);
infections and invasions: therapy - herpes simplex (1/1%), sinusitis (1/1%), bronchitis (3/4%); prevention - influenza infection (2/3%), upper respiratory tract infections (3/3%), nasopharyngitis (4/4%);
general disorders: therapy - dizziness, including vertigo (2/3%); prevention - pain in the extremity (1/1%), dizziness (1/1%), flu-like illness (1/2%), pyrexia (2/2%), fatigue (7/7%);
nervous system: therapy - insomnia (1/1%); prevention - insomnia (1/1%);
respiratory system, chest and mediastinal organs: therapy - nasal congestion (1/1%), cough (2/2%); prevention - rhinorrhea (1/1%), cough (5/6%), tonsillitis (5/5%), nasal congestion (7/7%);
musculoskeletal and connective tissue: prevention - myalgia (1/1%), arthralgia (1/2%), back pain (2/3%);
genitals and mammary gland: prevention - dysmenorrhea (3/3%).

These side effects were either more common in the placebo group, or the difference in frequency between the oseltamivir and placebo groups did not exceed 1%.

There were no clinical differences in the safety profile in elderly and senile patients (942 subjects) who received oseltamivir / placebo from those in younger patients (up to 65 years).

In an ongoing 84-day influenza prevention study in immunocompromised individuals (475 patients, including 18 children 1–12 years old), the safety profile of the oseltamivir group (n = 238) was consistent with that of the disease prevention studies.

In studies on the treatment of natural influenza infection in children 1–12 years of age, side effects of the drug (n = 858), noted with a frequency exceeding 1%, and occurring at least 1% more often compared with placebo (n = 622), there was vomiting.

In children who took Nomides at home as post-exposure prophylaxis at the recommended dose once a day, the most common occurrence of vomiting was observed (8% when taking the drug and 2% in the group that did not receive preventive therapy). Oseltamivir was well tolerated and reported adverse reactions were consistent with those reported for influenza therapy in children.

Side effects that occurred with a frequency of ≥ 1% in children taking Nomides for treatment (n = 858) and a frequency of ≥ 5% when taking Nomides for the prevention of influenza infection (n = 148) include (oseltamivir / placebo,%):

Gastrointestinal tract: therapy - pain in the abdomen, including in its upper part (3/3%), nausea (4/4%), diarrhea (9/9%);
infections and invasions: therapy - sinusitis (1/2%), pneumonia (1/3%), bronchitis (2/3%), otitis media (5/8%);
respiratory system, chest and mediastinal organs: epistaxis (2/2%), asthma, including exacerbation (3/4%); prevention - nasal congestion (11/20%), cough (12/26%);
skin and subcutaneous tissues: therapy - dermatitis, including atopic and allergic (1/2%);
hearing organ and labyrinth disorders: therapy - ear pain (1/1%);
organ of vision: therapy - conjunctivitis, including pain in the eyes, discharge from the eyes and redness of the eyes (1 / <1%).

These adverse reactions were most common in the placebo / no prophylaxis group. The difference between placebo and drug / no prophylaxis groups was less than 1%.

Also, in children during treatment with influenza, the following adverse events (oseltamivir / placebo,%) developed:

blood and lymphatic system: lymphadenopathy (<1/1%);
organ of hearing and labyrinthine disorders: damage to the eardrum (<1/1%).

In post-marketing observations, the following adverse reactions were recorded with the use of oseltamivir:

skin and subcutaneous tissues: Quincke's edema, anaphylactoid and anaphylactic reactions, allergies, toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, urticaria, eczema, skin rash, dermatitis (hypersensitivity reactions);
liver and biliary tract: jaundice, liver failure, fulminant hepatitis, including fatal hepatitis, increased activity of hepatic transaminases in patients with flu-like manifestations who received oseltamivir;
neuropsychic sphere: abnormal behavior, delirium, hallucinations. Sometimes these reactions were fatal. Their appearance is possible both with the development of encephalitis or encephalopathy, and without the occurrence of these pathologies. Patients (mostly children and adolescents) receiving Nomides for influenza therapy had convulsions and delirium, including nightmares, anxiety, agitation, hallucinations, delusions, abnormal behavior, disorientation in space and time, and impaired consciousness. In rare cases, they were accompanied by actions that endanger the patient's life. The role of oseltamivir in the occurrence of these effects is unknown, since similar neuropsychiatric disorders were also observed in patients with influenza who did not take the drug;
Gastrointestinal tract: gastrointestinal bleeding. The connection between the phenomena of hemorrhagic colitis and the use of Nomides cannot be ruled out, since these phenomena disappeared both after the patient recovered from the flu and after the drug was discontinued;
organ of vision: visual impairment;
heart: arrhythmia.

Overdose

In clinical trials and in the post-marketing use of Nomides, an overdose of oseltamivir in most cases was not accompanied by any adverse reactions. In other cases, the manifestations of overdose were consistent with the side effects of the drug.

special instructions

In patients (mostly in adolescents and children) who received Nomides for the treatment of influenza, convulsions and delirium-like psycho-neurological disorders were recorded. On rare occasions, they were accompanied by life-threatening actions. The role of the drug in the development of such reactions is unknown, since similar neuropsychiatric disorders were observed in patients with influenza who did not take oseltamivir. The likelihood of neuropsychiatric disorders in patients using the drug does not exceed that in people with influenza who do not take antiviral drugs.

To identify manifestations of abnormal behavior and assess the risk of continuing drug therapy when these disorders appear, careful monitoring of the condition and behavior of patients, especially children and adolescents, is recommended.

There are no data on the effectiveness of Nomides for any pathologies caused by pathogens other than influenza A and B viruses.

The drug is not a substitute for vaccination.

Prophylactic reception of Nomides is allowed for epidemiological indications.

Influence on the ability to drive vehicles and complex mechanisms

There have been no studies examining the effect of Nomides on the ability to drive vehicles and engage in potentially hazardous activities that require the speed of psychomotor reactions and high concentration of attention. According to the safety profile, the effect of oseltamivir on these activities is unlikely.

Application during pregnancy and lactation

During pregnancy / lactation, Nomides is used with caution and only in cases where the intended benefit to the mother outweighs the predicted risks to the fetus / child.

There have been no controlled studies of the use of Nomides during pregnancy. The results of post-marketing and observational studies have confirmed the benefits of the proposed standard dosing regimen for this group of patients. The results of pharmacokinetic analysis showed a lower exposure of oseltamivir carboxylate (by almost 30% throughout all trimesters of pregnancy) in pregnant women compared to non-pregnant women. However, the calculated exposure value was higher than inhibitory concentrations (IC value ₉₅) and therapeutic values for many strains of influenza virus.

When carrying out therapy or prophylaxis of a disease during pregnancy, changing the dosage regimen is not recommended. No direct or indirect adverse effect of the drug on pregnancy, embryofetal or postnatal development was found. The appointment of Nomides during pregnancy should be carried out taking into account the safety data, the course of pregnancy and the pathogenicity of the circulating strain of the influenza virus.

Preclinical studies conducted have confirmed that oseltamivir and oseltamivir carboxylate penetrate into the milk of lactating rats. Data on the excretion of the drug in breast milk in humans and its use during lactation are limited. Oseltamivir and oseltamivir carboxylate pass into breast milk in small amounts, creating subtherapeutic concentrations in the blood of an infant. When prescribing Nomides during breastfeeding, concomitant diseases and the pathogenicity of the circulating strain of influenza virus should also be taken into account.

Pediatric use

The appointment of Nomides is contraindicated for children under 3 years of age.

With impaired renal function

Nomides is contraindicated in patients with end-stage renal failure (CC ≤ 10 ml per minute).

For violations of liver function

Nomides is not indicated for patients with severe hepatic impairment.

Drug interactions

Clinically significant drug interactions, according to pharmacological and pharmacokinetic studies, are unlikely.

Oseltamivir phosphate is highly converted to oseltamivir carboxylate by esterases, which are mainly located in the liver. Drug interactions due to competition for binding to active centers of esterases have not been described. The low degree of binding to plasma proteins of the drug and oseltamivir carboxylate is not a basis for the assumption of the presence of interactions that are associated with the displacement of drugs from the bond with proteins.

In vitro studies show that neither oseltamivir phosphate nor oseltamivir carboxylate is the preferred substrate for glucuronyl transferases or polyfunctional oxidases of the cytochrome P _{450 system}. There is no reason to interact with oral contraceptives.

The nonspecific inhibitor of the isoenzyme of the cytochrome P _{450 system,} cimetidine, which also competes with cations and alkaline-type drugs in the process of tubular secretion, does not affect plasma concentrations of oseltamivir and its active metabolite.

Clinically significant drug-drug interactions associated with competition for tubular secretion are unlikely due to the safety margin for most such drugs, the routes of excretion of oseltamivir carboxylate (anionic tubular secretion and glomerular filtration), as well as the excretory capacity of each of the routes.

Probenecid leads to an approximately 2-fold increase in the area under the concentration-time curve of oseltamivir carboxylate through a decrease in active tubular secretion in the kidney. At the same time, dose adjustment for combined use with probenecid is not required, given the safety margin of the active metabolite.

Combined use with amoxicillin does not affect the plasma concentrations of both oseltamivir and its components, since the competition for excretion by anionic tubular secretion is weak.

Plasma concentrations of oseltamivir, oseltamivir carboxylate and paracetamol do not change when taken simultaneously.

No pharmacokinetic interactions were found between the drug / its active metabolite and amantadine, remantadine, warfarin, antacids (calcium carbonate, aluminum and magnesium hydroxide), cimetidine, acetylsalicylic acid or paracetamol.

When prescribing oseltamivir with commonly used drugs, such as non-narcotic analgesics (paracetamol, ibuprofen, acetylsalicylic acid), inhaled bronchodilators, glucocorticosteroids, opiates (codeine), sympathomimetics (pseudoephedrine), xanthines), betaophyllin blockers (theophyllin) H ₂ -histamine receptors (cimetidine, ranitidine), antibacterial agents (doxycycline, erythromycin, azithromycin, cephalosporins, penicillin), thiazide diuretics (bendroflumethiazide) and inhibitors of angiotensin-converting effects.

It is important to use Nomides with caution in combination with drugs that have a narrow breadth of therapeutic action (for example, butadione, methotrexate, chlorpropamide).

Analogs

Nomides analogs are Flustop, Oseltamivir-native, Tamiflu, Oseltamivir Avexim, Tamiflu, Influcein, Oseltamivir-Akrikhin, etc.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Nomides

According to reviews, Nomides is a safe and effective drug used to treat and prevent influenza in children aged 3 years and older and adults.

Among the disadvantages of Nomides are the presence of a wide list of side effects, the bitter taste of the capsules and the cost of the drug.

Price for Nomides in pharmacies

The approximate price for Nomides for a pack of 10 capsules is: with a dosage of 30 mg - from 285 to 407 rubles; a dosage of 45 mg - from 425 to 605 rubles; dosage of 75 mg - from 626 to 887 rubles.

Nomides: prices in online pharmacies

Drug name

Price

Pharmacy

Nomides 30 mg capsule 10 pcs.

RUB 290

Buy

Nomides capsules 30mg 10 pcs.

RUB 298

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Nomides 45 mg capsule 10 pcs.

414 RUB

Buy

Nomides capsules 45mg 10 pcs.

431 r

Buy

Nomides 75 mg capsule 10 pcs.

646 r

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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!