Nomides capsules 75mg, 10pcs

Composition

Active ingredient:

excipients: Silicon dioxide colloidal (Aerosil) at 6.00 mg/9,00 mg/15,00 mg;copovidon -3,60 mg/5,40 mg/9,00 mg;starch pregelatinization – 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.

Composition of solid gelatin capsules:

For a 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 a dosage of 45 mg:

capsule body:

purified water-14-15 mg, sodium lauryl sulfate-0.08 mg, titanium dioxide-0.97524 mg, diamond 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, diamond blue dye-0.2626 mg, gelatin-up to 100 mg.

For a dosage of 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; dye sunny sunset yellow E 110-1.2753 mg, dye crimson [Ponceau 4R] E 124-0.2401 mg, gelatin-up to 100 mg

Pharmacological action

Nomides is an antiviral drug that includes oseltamiviracarboxylate, which inhibits influenza A and B viruses. As a result, it suppresses: the release of newly formed viral particles from infected cells, their penetration into the epithelial cells of the respiratory tract and the further spread of the virus in the body. Nomides is an effective means of preventing and treating influenza in adults and children over the age of 1 year. When starting treatment no later than 40 hours after the first symptoms of influenza appear, Nomides significantly reduces the period of clinical manifestations of influenza infection, reduces their severity and reduces the frequency of complications of influenza that require the use of antibiotics (bronchitis, pneumonia, sinusitis, otitis media), shortens the time of virus isolation from the body. After oral use of oseltamivir, phosphate is readily absorbed in the gastrointestinal tract and is highly converted to an active metabolite by hepatic esterases. Plasma concentrations of the active metabolite are determined within 30 minutes and reach an almost maximum level 2-3 hours after use. At least 75% of the oral dose enters the systemic circulation as an active metabolite. Plasma concentrations are dose-proportional and independent of food intake.

Indications

• Treatment of influenza in adults and children over the age of 1 year.
• Prevention of influenza in adults and adolescents over the age of 12 years who are at high risk of infection with the virus (in large groups, in weakened patients).
• Prevention of influenza in children older than 1 year.

Contraindications

• Hypersensitivity to oseltamivir phosphate or any component of the drug,
• End-stage renal failure (creatinine clearance < 10 ml/min), severe hepatic insufficiency,
• Children under 1 year of age.

Side effects

In studies on the treatment of influenza in adults/adolescents, the most common adverse reactions (HP) were nausea, vomiting, and headache. Most HPV occurred on the first or second day of treatment and resolved independently within 1-2 days. In studies on flu prevention in adults and adolescents, the most common HPV symptoms were nausea, vomiting, headache, and pain. Vomiting was most common in children. The described changes in most cases did not require discontinuation of the drug. Treatment and prevention of influenza in adults and adolescents

Table 1 shows 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 for up to 6 weeks for prevention), and the frequency of which is at least 1% higher compared to placebo. Studies on the treatment of influenza included adults/adolescents without comorbidities and patients at risk, i. e. patients with a high risk of developing complications of influenza (elderly and senile patients, patients with chronic heart or respiratory diseases). In general, the safety profile in patients at risk was similar to that in adults/adolescents without concomitant pathology.

In influenza prevention studies, the safety profile of patients who received the recommended dose of the drug (75 mg once a day for up to 6 weeks) did not differ from that in studies on the treatment of influenza, despite the longer use of the drug.

Table 1. Percentage of adults/adolescents with HP who occurred with a frequency of >1% in the oseltamivir group in studies on the treatment and prevention of influenza infection (difference with placebo >>1%).

*The frequency category is presented only for the oseltamivir group. The following frequency categories were used to estimate the HP frequency: very often (>1/10); often (>1/100, >>The following are adverse events that occurred with a frequency of >1% in adults and adolescents treated with oseltamivir as therapy and prevention of influenza infection. These adverse events were either more common in patients treated with placebo, or the difference in frequency between the oseltamivir and placebo groups was less than 1%. Gastrointestinal disorders (oseltamivir vs. placebo): treatment – diarrhea (6% vs. 7%), abdominal pain (including upper abdominal pain,2% vs. 3%); prevention – diarrhea (3% vs. 4%), upper abdominal pain (2% vs. 2%), dyspepsia (1% vs. 1%). Infections and infestations (oseltamivir vs. placebo):  treatment – bronchitis (3% vs. 4%), sinusitis (1% vs. 1%), herpes simplex (1% vs. 1%); prevention – nasopharyngitis (4% vs. 4%), upper respiratory tract infections (3% vs. 3%), influenza infection (2% vs. 3%). General disorders (oseltamivir vs. placebo):

treatment – dizziness (including vertigo,2% vs 3%); prevention of fatigue (7% vs 7%), pyrexia (2% vs 2%), flu-like disease (1% vs. 2%), dizziness (1% vs 1%), pain in extremity (1% vs 1%).

Nervous system disorders (oseltamivir vs. placebo):  treatment – insomnia (1% vs. 1%); prevention-insomnia (1% vs. 1%). Respiratory, thoracic, and mediastinal disorders (oseltamivir vs. placebo):  treatment – cough (2% vs. 2%), nasal congestion (1% vs. 1%);

prevention – nasal congestion (7% vs. 7%), sore throat (5% vs. 5%), cough (5% vs. 6%), rhinorrhea (1% vs. 1%). Musculoskeletal and connective tissue disorders (oseltamivir vs. placebo):  prevention – back pain (2% vs. 3%), arthralgia (1% vs. 2%), myalgia (1% vs. 1%).

Genital and breast disorders (oseltamivir vs. placebo):  prevention-dysmenorrhea (3% vs. 3%).

Treatment and prevention of influenza infection in the elderly and senile age

The safety profile of 942 elderly and senile patients treated with oseltamivir or placebo did not differ clinically from that of younger patients (up to 65 years). Prevention of influenza infection in immunocompromised patients

In a 12-week influenza prevention study involving 475 immunocompromised patients (including 18 children aged 1-12 years), in patients treated with oseltamivir (n = 238), the safety profile was consistent with that previously described in influenza prevention studies.

Treatment and prevention of influenza infection in children without concomitant diseases aged 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 HP, oseltamivir (n=858) was observed with a frequency of >1% and at least 1% more often than placebo (n=622), vomiting occurred. Children who received the recommended dose of the drug once a day as a post-exposure prophylaxis at home had the most frequent vomiting (8% in the oseltamivir group versus 2% in the group that did not receive preventive treatment). Oseltamivir was well tolerated, and the reported adverse events were consistent with those 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, and the difference between the oseltamivir and placebo/no-prophylaxis groups was less than 1%.

Gastrointestinal disorders (oseltamivir vs. placebo):

treatment – diarrhea (9% vs. 9%), nausea (4% vs. 4%), abdominal pain (including upper abdominal pain,3% vs. 3%). Infections and infestations (oseltamivir vs. placebo):

treatment – otitis media (5% vs. 8%), bronchitis (2% vs. 3%), pneumonia (1% vs. 3%), sinusitis (1% vs. 2%). Respiratory, thoracic, and mediastinal disorders (oseltamivir vs. placebo):

treatment – asthma (including exacerbation,3% vs. 4%), nosebleeds (2% vs. 2%); prevention – cough (12% vs. 26%), nasal congestion (11% vs. 20%). Skin and subcutaneous tissue disorders (oseltamivir vs. placebo):

treatment – dermatitis (including allergic and atopic dermatitis,1% vs. 2%). Hearing disorders and labyrinth disorders (oseltamivir vs. placebo):

treatment – ear pain (1% vs. 1%). Visual disturbances (oseltamivir vs. placebo):

treatment-conjunctivitis (including redness of the eyes, discharge from the eye and pain in the eyes,1% vs Additional adverse events reported during the treatment of influenza in children that did not meet the criteria described above. Blood and lymphatic system disorders (oseltamivir vs. placebo):

treatment-lymphadenopathy ( Hearing disorders and labyrinth disorders (oseltamivir vs. placebo):

treatment – damage to the eardrum ( Postmarket ing monitoring

The following are some of the adverse events associated with oseltamivir that were observed during the post-marketing follow-up period. The frequency of these adverse events and / or a causal relationship with the use of the drug cannot be established, as the true population size is not known due to the voluntary nature of the reports.

Skin and subcutaneous tissue disorders: hypersensitivity reactions-dermatitis, skin rash, eczema, urticaria, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, allergies, anaphylactic and anaphylactoid reactions, angioedema. Liver and biliary tract disorders:

hepatitis, increased activity of “liver” enzymes in patients with flu-like symptoms treated with oseltamivir; fulminant hepatitis (including fatal outcome), liver failure, jaundice. Neuropsychiatric disorders

Flu infection can be associated with a variety of 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 (including symptoms such as impaired consciousness, disorientation in time and space, abnormal behavior, delusions, hallucinations, agitation, anxiety, and nightmares) have been reported in patients (mainly children and adolescents) taking oseltamivir for the treatment of influenza. 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 reported in patients with influenza who did not receive oseltamivir.

Disorders of the gastrointestinal tract: gastrointestinal bleeding after taking oseltamivir (in particular, a link between the phenomena of hemorrhagic colitis and taking oseltamivir cannot be excluded, since these phenomena disappeared both after the patient recovered from the flu and after discontinuation of the drug).

Visual disorders: visual impairment.

Cardiac disorders: arrhythmia.

Interaction

Clinically significant drug interactions are unlikely according to pharmacological and pharmacokinetic studies. Oseltamivir phosphate is highly converted to the active metabolite by esterases mainly located in the liver. Drug interactions caused by competition for binding to the active sites of esterases are not widely represented in the literature.

The low degree of binding of oseltamivir and the active metabolite to plasma proteins does not suggest the presence of interactions associated with the displacement of drugs from protein binding. In vitro studies show that neither oseltamivir phosphate nor its active metabolite is a preferred substrate for polyfunctional cytochrome P450 oxidases or for glucuronyltransferases.

There are no grounds for interaction with oral contraceptives. Cimetidine, a non-specific inhibitor of the cytochrome P450 isoenzyme and competing in the process of tubular secretion with alkaline-type drugs and cations, does not affect the plasma concentrations of oseltamivir and its active metabolite. Clinically significant drug-drug interactions associated with competition for tubular secretion are unlikely, given the safety reserve for most of these drugs, the elimination pathways of the active metabolite of oseltamivir (glomerular filtration and anionic tubular secretion), as well as the excretory capacity of each of the pathways.

Probenecid leads to an increase in the AUC of the active metabolite of oseltamivir by approximately 2 times (due to a decrease in active tubular secretion in the kidneys). However, no dose adjustment is required when used concomitantly with probenecid, given the safety reserve of the active metabolite.

Concomitant use with amoxicillin does not affect the plasma concentrations of oseltamivir and its components, demonstrating weak competition for elimination by anionic tubular secretion.

Concomitant use with paracetamol does not affect the plasma concentrations of oseltamivir and its active metabolite or paracetamol. No pharmacokinetic interactions were observed between oseltamivir, its main metabolite, when co-administered with paracetamol, acetylsalicylic acid, cimetidine or antacids (magnesium and aluminum hydroxide, calcium carbonate), warfarin, rimantadine or amantadine.

When using osaltemivir with commonly used medications, such as angiotensin-converting enzyme inhibitors (enalapril, captopril), thiazide diuretics (bendroflumetiazid), antibiotics (penicillin, cephalosporins, azithromycin, erythromycin, and doxycycline), H%^%2-histamine receptor blockers (ranitidine, cimetidine), beta-blockers, etc. adrenoblockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opiates (codeine), corticosteroids, inhaled bronchodilators and non-narcotic analgesics (acetylsalicylic acid, ibuprofen and paracetamol), changes in the nature or frequency of adverse events were not observed.

Oseltamivir should be used with caution in combination with drugs that have a narrow therapeutic range (for example, chlorpropamide, methotrexate, butadione).

How to take it, course of use and dosage

The drug oseltamivir is taken orally, regardless of food intake or during meals. Treatment with the drug should be started no later than 2 days after the development of symptoms of the disease. Adults and adolescents aged ≥ 12 years, the recommended daily dose is 150 mg. The drug is prescribed in a dose of 75 mg (one capsule of 75 mg or one capsule of 30 mg + one capsule of 45 mg) 2 times a day inside for 5 days. Children weighing more than 40 kg or aged ≥ 8 years who can swallow capsules can also receive treatment by taking 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) 2 times a day for 5 days. Children aged ≥ 1 year The recommended dosage regimen of oseltamivir capsules is 30 and 45 mg.Body weight Recommended dose for 5 days≤15 kg: 30 mg twice a day>15-23 kg: 45 mg twice a day>>23-40 kg: 60 mg twice a dayprophylaxis Taking the drug should be started no later than 2 days after contact with patients. Adults and adolescents aged ≥ 12 years: 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) once daily orally for at least 10 days after contact with the patient. During a seasonal flu epidemic-75 mg once a day for 6 weeks. The preventive effect lasts as long as the drug is taken. Children weighing more than 40 kg or aged ≥ 8 years of children who may swallow capsules can also receive preventive therapy by taking 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) once a day for 10 days. Children aged ≥ 1 year The recommended dosage regimen of oseltamivir capsules is 30 and 45 mg. The recommended dosage regimen of oseltamivir capsules is 30 and 45 mg. Body weight Recommended dose for 10 days≤15 kg: 30 mg 1 time per day>15-23 kg: 45 mg 1 time per day>>23-40 kg: 60 mg 1 time per daydosing in special cases Patients with impaired renal function:Treatment of patients with creatinine clearance greater than 60 ml / min, no dose adjustment is required. In patients with a creatinine clearance of 30 to 60 ml/min, the dose of oseltamivir should be reduced to 30 mg twice daily 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. In patients on continuous hemodialysis, oseltamivir at an initial dose of 30 mg can be taken before dialysis if flu symptoms appear within 48 hours between dialysis sessions. To maintain plasma concentrations at therapeutic levels, oseltamivir should be taken 30 mg after each dialysis session. In patients undergoing peritoneal dialysis, oseltamivir should be taken at an initial dose of 30 mg prior to dialysis, followed by 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 have not been studied. Therefore, there are no recommendations on dosage in this group of patients. Prophylaxis In patients with creatinine clearance greater than 60 ml / min, no dose adjustment is 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. In patients on continuous hemodialysis, oseltamivir at an initial dose of 30 mg can be taken before starting dialysis. To maintain plasma concentrations at therapeutic levels, oseltamivir should be taken 30 mg after each subsequent odd dialysis session. In patients undergoing peritoneal dialysis, oseltamivir should be taken at an initial dose of 30 mg prior to 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 have not been studied. Therefore, there are no recommendations on dosage in this group of patients. Patients with hepatic impairment No dose adjustment is required in the treatment and prevention of influenza in patients with mild to moderate hepatic impairment. The safety and pharmacokinetics of oseltamivir in patients with severe hepatic impairment have not been studied. Elderly and senile patients No dose adjustment is required for the prevention or treatment of influenza. Patients with weakened immune systems (after transplantation). For seasonal prevention of influenza in immunocompromised patients aged ≥1 year – for 12 weeks, no dose adjustment is required.

Overdose

In most cases, overdose during clinical trials and post-marketing use of oseltamivir was not accompanied by any adverse events.

In all other cases, the symptoms of overdose corresponded to the adverse events presented in the “Side effect” section.

Special instructions

Extemporal preparation of Nomides® suspension from capsules

In cases where adults, adolescents and children have problems swallowing capsules or if there are signs of “aging” of the capsules, it is necessary to open the capsule and pour its contents into a small amount (maximum 1 teaspoon) of a suitable sweetened food product (chocolate syrup with normal sugar content or without sugar content, honey, light brown sugar or table sugar dissolved in water, sweet dessert, condensed milk with sugar, applesauce or yogurt) in order to hide the bitter taste. The mixture must be thoroughly mixed and given to the patient as a whole. You should swallow the mixture immediately after cooking.

Capsules 75 mg

If patients require a dose of 75 mg, the following instructions should be followed::

1. Holding one 75 mg Nomides ® capsule over a small container, carefully open the capsule and pour the powder into the container.

2. Add a small amount (no more than 1 teaspoon) of a suitable sweetened food product (to hide the bitter taste) and mix well.

3. Mix the mixture thoroughly and drink it immediately after cooking. If there is a small amount of the mixture left in the container, then rinse the container with a small amount of water and drink the remaining mixture.

If patients require doses of 30-60 mg, then the following instructions should be followed for proper dosing:

1. Holding one 75 mg Nomides ® capsule over a small container, carefully open the capsule and pour the powder into the container.

2. Add 5 ml of water to the powder using a syringe with labels indicating the amount of liquid collected. Mix thoroughly for 2 minutes.

3. Fill the syringe with the required amount of mixture from the container according to the following table.

There is no need to collect undissolved white powder, since it is an inactive filler. By pressing the plunger of the syringe, insert all its contents into the second container. The remaining unused mixture must be discarded.

4. In the second container, add a small amount (no more than 1 teaspoon) of a suitable sweetened food product to hide the bitter taste, and mix well.

5. Mix the mixture thoroughly and drink it immediately after cooking. If there is a small amount of the mixture left in the container, then rinse the container with a small amount of water and drink the remaining mixture.

This procedure should be repeated before each dose of the drug.

Form of production

For a dosage of 75 mg: solid gelatin capsules No. “1”, white body, orange cap.

The contents of the capsules are white or white with a yellowish tinge powder.

Active ingredient

Oseltamivir

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor, Children over 3 years old, Adults as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Flu, Flu and cold prevention