Nomides - instructions for use, reviews, analogs and formulations (capsules or tablets 30 mg, 45 mg, 75 mg) of a drug for the treatment and prevention of influenza in adults, children and pregnancy. Composition of the drug on the basis of oseltamivir from Pharmasynthesis

In this article, you can read the instructions for using the drug Nomides. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Nomidez in their practice. A big request is to actively add your feedback about the drug manufactured by Pharmasynthesis: the medicine helped or did not help to get rid of the disease, what complications and side effects were observed, possibly not stated by the manufacturer in the annotation. Analogues of Nomides in the presence of existing structural analogs.Use for the treatment and prevention of influenza in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Nomides - antiviral drug. Oseltamivir phosphate (active ingredient of Nomides) is a prodrug, its active metabolite (oseltamivir carboxylate, OK) is an effective and selective inhibitor of neuraminidase of influenza A and B viruses, which catalyzes the release of newly formed viral particles from infected cells, their penetration into cells epithelium of the respiratory tract and further spread of the virus in the body. It inhibits the growth of the influenza virus and suppresses the replication of the virus and its pathogenicity, reduces the allocation of influenza A and B viruses from the body. Studies of clinical isolates of the influenza virus have shown that the OC concentration necessary to inhibit neuraminidase by 50% (IC50) is 0.1-1.3 nM for influenza A virus and 2.6 nM for influenza B.

Composition

Oseltamivir phosphate + excipients.

Pharmacokinetics

Nomides is readily absorbed in the gastrointestinal tract and is highly converted into an active metabolite under the action of hepatic and intestinal esterases.The concentration of active metabolite in plasma is determined within 30 minutes, the time of reaching a maximum concentration of 2-3 hours, and more than 20 times the concentration of the pro-drug. At least 75% of the ingested dose falls into the systemic bloodstream as an active metabolite, less than 5% in the form of the starting drug. The plasma concentrations of both the prodrug and the active metabolite are proportional to the dose and do not depend on the intake of food. According to studies conducted in animals, after taking oseltamivir phosphate inside, its active metabolite was found in all major foci of infection (lungs, bronchial washings, nasal mucosa, middle ear and trachea) in concentrations providing antiviral effect. The association of the active metabolite with plasma proteins is 3%. The association of the prodrug with plasma proteins is 42%, which is not enough to cause significant drug interactions. Oseltamivir phosphate is highly converted into an active metabolite by the action of esterases, which are predominantly in the liver. Neither oseltamivir phosphate nor active metabolite are substrates or inhibitors of cytochrome P450 isoenzymes.It is excreted (more than 90%) in the form of active metabolite mainly by the kidneys. The active metabolite is not further transformed and is excreted by the kidneys (more than 99%) by glomerular filtration and tubular secretion. The half-life of the active metabolite is 6-10 hours.

In elderly and senile patients (65-78 years old), the metabolite exposure in the equilibrium state is 25-35% higher than in younger patients when similar doses of oseltamivir are administered. The half-life of the drug in elderly and senile patients did not differ significantly from that in younger patients. Taking into account the data on the exposure of the drug and its tolerability, patients of the elderly and senile age do not need dose adjustment for the treatment and prevention of influenza.

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

Indications

• treatment of influenza in adults and children over the age of 3;
• prevention of influenza in adults and adolescents over 12 years of age who are at high risk of infection with the virus (in large groups, in weakened patients);
• prevention of influenza in children older than 3 years.

Forms of release

Capsules 30 mg, 45 mg and 75 mg (sometimes mistakenly called tablets).

Instructions for use and dosage

Nomides is taken internally, regardless of food intake or during meals.

Treatment of influenza

The drug should be taken no later than 2 days after the onset of symptoms of the disease.

Adults and adolescents over the age of 12 years

The recommended daily dose is 150 mg. The drug is given 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 with a body weight of more than 40 kg or over the age of 8 years

Children who can swallow capsules can also receive treatment, taking 75 mg (one capsule of 75 mg or one capsule of 30 mg + one capsule of 45 mg) twice a day for 5 days.

Children over the age of 3 years

Recommended dosage regimen Nomides capsules 30 and 45 mg:

• body weight less than or equal to 15 kg - recommended dose for 5 days 30 mg twice daily;
• body weight more than 15-23 kg - recommended dose for 5 days 45 mg twice a day;
• body weight more than 23-40 kg - the recommended dose for 5 days is 60 mg twice a day.

Prevention of influenza

The drug should be taken no later than 2 days after contact with patients.

Adults and adolescents over the age of 12 years

For 75 mg (one capsule 75 mg or one capsule 30 mg + one capsule 45 mg) once a day inside for at least 10 days after contact with the patient. During the seasonal flu epidemic - 75 mg once a day for 6 weeks. Prophylactic action lasts as long as the drug takes.

Children with a body weight of more than 40 kg or over the age of 8 years

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

Children over the age of 3 years

Recommended dosage regimen Nomides capsules 30 and 45 mg:

• body weight less than or equal to 15 kg - recommended dose for 10 days 30 mg once a day;
• body weight more than 15-23 kg - the recommended dose for 10 days 45 mg once a day;
• body weight more than 23-40 kg - the recommended dose for 10 days 60 mg once a day.

Patients of elderly and senile age

Dose adjustments for the prevention or treatment of influenza are not required.

Patients with weakened immunity (after transplantation)

For seasonal flu prophylaxis in patients with weakened immunity at the age of over 3 years - within 12 weeks, dose adjustment is not required.

Side effect

• nausea and vomiting;
• diarrhea;
• bronchitis;
• stomach ache;
• gastrointestinal bleeding;
• dizziness;
• headache;
• cough;
• sleep disorders;
• weakness;
• pain of different localization;
• rhinorrhea;
• upper respiratory tract infection;
• asthma (including exacerbation);
• acute otitis media;
• pneumonia;
• sinusitis;
• dermatitis;
• lymphadenopathy;
• dermatitis;
• skin rash;
• eczema;
• hives;
• erythema multiforme;
• Stevens-Johnson syndrome;
• anaphylactic and anaphylactoid reactions;
• angioedema;
• hepatitis;
• convulsions;
• delirium (including such symptoms as impairment of consciousness, disorientation in time and space, abnormal behavior, delirium, hallucinations, agitation, anxiety, nightmares).

Contraindications

• chronic renal failure (persistent hemodialysis, chronic peritoneal dialysis, CC less than 10 ml / min);
• severe hepatic impairment;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Controlled studies in pregnant women were not conducted. However, the results of postmarketing and observational studies have demonstrated the benefits of the proposed standard dosing regimen for this patient population. Results of pharmacokinetic analysis showed a lower exposure of the active metabolite (approximately 30% during all trimesters of pregnancy) in pregnant women compared with non-pregnant ones. Nevertheless, the value of the calculated exposure remains above inhibitory concentrations (IC95 value) and therapeutic values ​​for many strains of the influenza virus. Changing the dosing regimen in pregnant women during therapy or prevention is not recommended. There was no direct or indirect adverse effect of the drug on pregnancy, embryo-fetal or postnatal development.When prescribing oseltamivir, pregnant women should take into account both the safety data and the course of pregnancy and the pathogenicity of the circulating strain of the influenza virus.

During preclinical studies, Nomides and the active metabolite penetrated the milk of lactating rats. Data on the excretion of oseltamivir with human breast milk in humans and the use of oseltamivir in lactating women are limited. Nomides and its active metabolite penetrate into breast milk in small amounts, creating sub-therapeutic concentrations in the blood of the infant. When Nomides is prescribed, lactating women should also consider the concomitant disease and pathogenicity of the circulating strain of the influenza virus.

During pregnancy and during breastfeeding, Nomides is used only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

Use in children

Do not prescribe Nomides children under 1 year.

special instructions

In patients (mainly children and adolescents) who took Nomides for the treatment of influenza, convulsions and delirium-like neuropsychiatric disorders were recorded.These cases were rarely accompanied by life-threatening acts. The role of oseltamivir in the development of these phenomena is unknown. Similar psychoneurological disorders were also noted in patients with influenza who did not receive oseltamivir. The risk of developing neuropsychiatric disorders in patients receiving oseltamivir does not exceed that of patients with influenza who do not receive antiviral drugs.

It is recommended to closely 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 use of the drug in the development of these phenomena.

Data on the efficacy of Nomides in all diseases caused by other pathogens, except for influenza viruses A and B, there.

Nomides is not a substitute for vaccination.

Prophylactic administration of the drug is possible by epidemiological indications.

Impact on the ability to drive vehicles and mechanisms

Studies to study the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions,not conducted. Based on the safety profile, the effect of oseltamivir on these activities is unlikely.

Drug Interactions

Clinically significant drug interactions are unlikely according to pharmacological and pharmacokinetic data. Oseltamivir phosphate is highly converted to an active metabolite by the action of esterases, mainly located in the liver. Drug interactions caused by competition for binding to active centers of esterases are not widely reported in the literature. The low degree of binding of oseltamivir and the active metabolite to plasma proteins does not give grounds for assuming the presence of interactions associated with the displacement of drugs from binding to proteins.

Studies show that neither oseltamivir phosphate nor its active metabolite is the preferred substrate for polyfunctional oxidases of the cytochrome P450 system or for glucuronyl transferases. There are no grounds for interaction with oral contraceptives.

Cimetidine, a nonspecific inhibitor of the isoenzyme of the cytochrome P450 system and competing in tubular secretion with alkaline preparations and cations,does not affect the plasma concentrations of oseltamivir and its active metabolite.

Clinically significant inter-drug interactions associated with competition for tubular secretion are unlikely, taking into account the safety margin for most such drugs, the ways of excretion of the active metabolite of oseltamivir (glomerular filtration and anionic tubular secretion), and the yielding capacity of each pathway.

Probenecid results in an increase in the AUC of the active metabolite of oseltamivir by approximately 2-fold (due to a decrease in active tubular secretion in the kidneys). However, dose adjustment when used simultaneously with probenecid is not required, given the safety reserve of the active metabolite.

Simultaneous reception with Amoxicillin does not affect the plasma concentrations of oseltamivir and its components, demonstrating weak competition for excretion by anionic tubular secretion.

Simultaneous reception with Paracetamol does not affect the plasma concentrations of oseltamivir and its active metabolite or paracetamol.

Pharmacokinetic interactions between oseltamivir, its main metabolite was not detected with concurrent administration with paracetamol,acetylsalicylic acid, cimetidine or antacid agents (magnesium and aluminum hydroxide, calcium carbonate), warfarin, rimantadine, or amantadine.

When using Nomidesa with commonly used drugs such as ACE inhibitors (enalapril, captopril), thiazide diuretics (bendroflumethiazide), antibiotics (penicillin, cephalosporins, azithromycin, erythromycin, and doxycycline), blockers of H2-histamine receptors (ranitidine, cimetidine), beta - adrenoblockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opiates (codeine), glucocorticosteroids, inhaled bronchodilators and non-narcotic analgesics (acetylsalicylic acid, and uprofen and paracetamol), the nature of change or frequency of adverse events was observed.

Use Nomides in combination with drugs that have a narrow breadth of therapeutic effect (for example, chlorpropamide, methotrexate, butadione), should be taken with caution.

Analogues of Nomides

Structural analogs for the active substance:

• Oseltamivir Canon;
• Oseltamivir phosphate;
• Tamiflu;
• Floucestop.

Analogues on the curative effect (means for treating influenza and its symptoms):

• Alfaron;
• Amizon;
• Amiksin;
• Anaferon;
• Anaferon child;
• Antigrippin;
• Arbidol;
• Aflubin;
• Aeros;
• Baxin;
• Bronchicum;
• Bronchicum cough syrup;
• Vaxigrip;
• Vaccine influenza inactivated eluate-centrifuge liquid;
• Viferon;
• Hexapneumine;
• Genferon Light;
• Hydrel;
• Homeoantigrippin;
• Homeopathy;
• Grippferon;
• Ibuprofen;
• Ibufen;
• Isoprinosine;
• Immunal;
• Immunoglobulin;
• Immunorm;
• Ingavirin;
• Inflexal;
• Influbene;
• Influenza;
• Influcid;
• IRS 19;
• Kagocel;
• Carinate;
• Codipron;
• Coldrex;
• Lavomax;
• Levopron;
• Libexin;
• Linkas;
• Neovir;
• Nurofen;
• Nurofen for children;
• Orvire;
• Oscillococcinum;
• Paxelidine;
• Pliwalgin;
• Polyoxidonium;
• Reaferon EU Lipint;
• Remantadine;
• Rimantadine;
• Stopgripan forte;
• Tamiflu;
• Fervex;
• Fluuarix;
• Cycloferon;
• Cigapan;
• Ergoferon;
• Echinacea.

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