Nomides, 30 mg capsules 10 pcs

Indications

Treatment of influenza in adults and children over the age of 1 year.

Prevention of influenza in adults and adolescents over 12 years of age in groups at high risk of contracting the virus (in military units and large industrial teams, in weakened patients).

Influenza prevention in children over 1 year old.

Active ingredient

Composition

Active ingredient:

Oseltamivir 30 mg, (as oseltamivir phosphate) 39.4 mg.

Excipients: colloidal silica (aerosil), copovidone, pregelatinized starch, croscarmellose sodium, sodium stearyl fumarate, talc.

Capsule composition:

Capsule body: titanium dioxide – 2,0000%, gelatin – up to 100%;

Capsule cap: titanium dioxide – 2,0000%, gelatin – up to 100%.

How to take, the dosage

Oseltamivir is taken orally, with or without meals. Tolerability can be improved if the drug is taken with food.

When used by adults, adolescents, children who are unable to swallow the capsule or if there are signs of “aging” of the capsules (e.g., increased fragility or other physical impairment) open the capsule and pour its contents into a small amount (maximum 1 teaspoon) of a suitable sweetened food (chocolate syrup with normal or no sugar content, honey, light brown sugar or table sugar dissolved in water, sweet dessert, condensed milk with sugar, apple puree or yogurt) in order to mask the bitter taste. The mixture should be thoroughly mixed and given to the patient whole. The mixture should be swallowed immediately after preparation. Detailed recommendations are given in the subsection “Extemporaneous preparation of the suspension”.

The standard dosing regimen

The treatment

The drug must be started within 2 days of the onset of symptoms.

Adults and adolescents aged ≥12 years

The recommended daily dose is 150 mg. The drug is prescribed in a dose of 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) 2 times daily orally for 5 days. Increasing the dose over 150 mg/day does not increase the effect.

Children weighing more than 40 kg or aged 8 to 12 years

Children who are able to swallow capsules may also be treated by taking 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) 2 times daily for 5 days.

Children 1 to 8 years of age

The recommended dosing regimen is oseltamivir capsules 30 and 45 mg.

Body weight

Recommended dose over 5 days

≤15 kg

>15-23 kg

&gt23-40 kg

30 mg twice a day

45 mg twice a day

60 mg twice a day

Extemporally prepared suspension can be used (see “Extemporally prepared suspension”).

You can use the suspension prepared extemporaneously (see “Extemporaneous Suspension Preparation”).

Prevention

The drug should be started at least 2 days after exposure.

Adults and adolescents aged ≥12 years

Please 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) once daily orally for at least 10 days after exposure. During seasonal influenza epidemics, 75 mg once daily for 6 weeks. The prophylactic effect lasts as long as the drug intake lasts.

Children who weigh more than 40 kg or who are 8 to 12 years of age

Children who can swallow the capsules may also receive prophylactic therapy by taking 75 mg (one 75 mg capsule or one 30 mg capsule + one 45 mg capsule) once daily for 10 days.

Children 1 to 8 years of age

The recommended dosing regimen is oseltamivir capsules 30 and 45 mg.

Body weight

Recommended dose over 10 days

≤15 kg

>15-23 kg

gt;23-40 kg

30 mg once daily

45 mg once daily

60 mg once daily

Extemporally prepared suspension can be used (see “Extemporally prepared suspension”).

You can use the suspension prepared extemporaneously (see “Extemporaneous Suspension Preparation”).

Dosage in special cases

Patients with impaired renal function

Treatment

Patients with a creatinine clearance greater than 60 ml/min do not require dose adjustments. In patients with creatinine clearance between 30 and 60 mL/min, the dose of oseltamivir should be reduced to 30 mg twice daily for 5 days.

In patients with a creatinine clearance of 10 to 30 mL/min, the dose of oseltamivir should be reduced to 30 mg once daily for 5 days. In patients on permanent hemodialysis, oseltamivir at the initial dose of 30 mg can be taken before dialysis if influenza symptoms appear within 48 h between dialysis sessions. To maintain plasma concentrations at therapeutic levels, oseltamivir should be taken 30 mg after each dialysis session. Patients on peritoneal dialysis should take oseltamivir at 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 have not been studied. In this regard, there are no dosing recommendations for this group of patients.

Patients with creatinine clearance greater than 60 mL/min do not require dose adjustment. In patients with creatinine clearance from 30 to 60 ml/min the dose of oseltamivir should be reduced to 30 mg once daily. In patients with a creatinine clearance of 10 to 30 ml/min, it is recommended to reduce the dose of oseltamivir to 30 mg once daily. In patients on permanent hemodialysis, oseltamivir at an initial dose of 30 mg can be taken before dialysis. To maintain plasma concentrations at therapeutic levels, oseltamivir should be taken 30 mg after each subsequent odd-numbered dialysis session. In patients on peritoneal dialysis, oseltamivir should be taken at an initial dose of 30 mg before dialysis, then 30 mg every 7 days. 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. In this regard, there are no dosing recommendations for this group of patients.

Patients with hepatic impairment

Dose adjustment is not required during treatment and prophylaxis of influenza in patients with mild to moderate hepatic impairment. Safety and pharmacokinetics of oseltamivir in patients with severe hepatic impairment have not been studied.

Elderly and elderly patients

Dose adjustment for prophylaxis or treatment of influenza is not required.

In immunocompromised patients (after transplantation)

For seasonal influenza prophylaxis in immunocompromised patients aged ≥1 year – for 12 weeks, no dose adjustment is necessary.

Children

Oseltamivir in this dosage form should not be administered to children under 1 year of age.

Extemporaneous preparation of Nomides® suspension

In cases in which adults, adolescents and children have trouble swallowing the capsules, or if there are signs of “aging” of the capsules, the capsule should be opened and its contents poured into a small amount (maximum 1 teaspoon) of a suitable sweetened food (see above). (see above) in order to mask the bitter taste. The mixture should be thoroughly mixed and given to the patient whole. The mixture should be swallowed immediately after preparation.

PEPPULES 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, gently 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 (to mask the bitter taste) and mix well.

3. Stir the mixture thoroughly and drink it immediately after preparation. If a small amount of mixture remains in the container, you should rinse the container with a small amount of water and drink the remaining mixture.

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

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

2. add 5 ml of water to the powder with a syringe marked with the amount of liquid taken. Stir thoroughly for 2 minutes.

3. Draw the desired amount of mixture from the container into the syringe according to the chart below:

Body weight

Recommended dose

Amount of Nomides® mixture per meal

≤15 kg

30 mg

2 ml

>15-23 kg

45 mg

3 ml

>23-40 kg

60 mg

4 ml

There is no need to take the undissolved white powder as it is an inactive filler. Pressing the syringe plunger, inject all of its contents into the second reservoir. The unused mixture must be discarded.

4. Add a small amount (max 1 teaspoon) of a suitable sweetened food item to the second cup, to mask the bitter taste, and mix well.

5. Stir the mixture thoroughly and drink it immediately after preparation. If there is a small amount of mixture left in the container, you should rinse the container with a little water and drink the remaining mixture.

This procedure should be repeated before each dose.

30 mg and 45 mg capsules

For proper dosing, you must follow the following instructions:

1. Determine the number of Nomides® capsules required to prepare the mixture:

Body Mass*

Number of NOMIDES® CAPSULES FOR A RECOMMENDED DOSE WITH AIM FOR 5 DAYS

≤15kg

1 capsule 30 mg 2 times a day

1 capsule 30 mg once daily

>15-23 kg

1 capsule 45 mg 2 times/day

1 capsule 45 mg once daily

>23-40 kg

2 capsules 30 mg twice daily

2 capsules 30 mg once daily

Interaction

Clinically significant drug interactions are unlikely according to pharmacological and pharmacokinetic studies. Oseltamivir phosphate is highly converted to active metabolite under the action of esterases mainly located in the liver. Drug interactions due to competition for binding to active esterase centers are not widely reported in the literature. The low degree of binding of oseltamivir and the active metabolite with plasma proteins does not give reasons to assume the presence of interactions related to displacement of drugs from binding to proteins.

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 is no reason for interaction with oral contraceptives.

Cimetidine, a nonspecific inhibitor of cytochrome P450 system isoenzyme and competes with alkaline and cationic drugs during tubular secretion, does not affect plasma concentrations of oseltamivir and its active metabolite.

It is unlikely that there are clinically significant interdrug interactions involving competition for tubular secretion, given the safety margin for most such drugs, the excretion routes for the active metabolite of oseltamivir (glomerular filtration and anionic tubular secretion), and the excretion capacity of each route.

Probenecid results in an AUC increase of the active metabolite of oseltamivir by approximately 2-fold (due to reduced active renal tubular secretion). However, no dose adjustment is required when concomitant use with probenecid, given the safety margin of the active metabolite.

Concomitant administration with amoxicillin does not affect plasma concentrations of oseltamivir and its components, showing little competition for excretion by anionic tubular secretion.

Concomitant administration with paracetamol has no effect on plasma concentrations of oseltamivir and its active metabolite or paracetamol.

Pharmacokinetic interactions between oseltamivir, its main metabolite were not found when concomitantly taken with paracetamol, acetylsalicylic acid, cimetidine or antacids (magnesium and aluminum hydroxide, calcium carbonate),warfarin, rimantadine or amantadine.

. When using oseltamivir with commonly used drugs such as angiotensin-converting enzyme inhibitors (enalapril, captopril), thiazide diuretics (bendroflumethiazide), antibiotics (penicillin, cephalosporins, azithromycin, erythromycin and doxycycline), H2-histamine receptor blockers (ranitidine, cimetidine), beta-adrenoblockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opiates (codeine), glucocorticosteroids, inhaled bronchodilators and non-narcotic analgesics (acetylsalicylic acid, ibuprofen and paracetamol), no changes in the nature or frequency of adverse events were observed.

The use of oseltamivir in combination with drugs with a narrow therapeutic scope (e.g., chlorpropamide, methotrexate, butadione) should be used with caution.

Special Instructions

Extemporaneous preparation of Nomides® suspension from capsules

. In cases where adults, adolescents and children have trouble swallowing the capsules or where there are signs of “aging” of the capsules, you should open the capsule and pour its contents into a small amount (maximum 1 teaspoon) of a suitable sweetened food (chocolate syrup with normal or no sugar content honey, light brown sugar or table sugar dissolved in water, sweet dessert, condensed milk with sugar, apple puree or yogurt) to mask the bitter taste. The mixture should be thoroughly mixed and given to the patient whole. The mixture should be swallowed immediately after preparation.

Capsules 75 mg

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

1. Holding one 75 mg capsule of Nomides® over a small container, gently 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 (to mask the bitter taste) and mix well.

3. Stir the mixture thoroughly and drink it immediately after preparation. If a small amount of mixture remains in the container, you should rinse the container with a small amount of water and drink the remaining mixture.

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

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

2. add 5 ml of water to the powder, using a syringe marked with the amount of liquid taken. Stir thoroughly for 2 minutes.

3. Draw the desired amount of mixture from the container into the syringe according to the following table.

Body weight

Recommended dose

/p>

30 mg

2 ml

>15-23 kg

45 mg

3 mL

>23-40 kg

60 mg

4 ml

There is no need to take the undissolved white powder because it is an inactive filler. Pressing the syringe plunger, inject all of its contents into the second reservoir. The unused mixture must be discarded.

4. Add a small amount (max 1 teaspoon) of a suitable sweetened food item to the second cup, to mask the bitter taste, and mix well.

5. Stir the mixture thoroughly and drink it immediately after preparation. If there is a small amount of mixture left in the container, you should rinse the container with a little water and drink the remaining mixture.

This process needs to be repeated before each dose.

Contraindications

Hypersensitivity to oseltamivir phosphate or any component of the drug;

End-stage renal failure (creatinine clearance ≤10 mL/min);

Severe hepatic failure;

Children under 1 year.

Pregnancy, period of breastfeeding.

Side effects

In studies of influenza treatment in adult/adolescent patients, the most common adverse reactions (HP) were nausea, vomiting, and headache. Most HP occurred on the first or second day of treatment and resolved on their own within 1-2 days. In studies of flu prevention in adults and adolescents, the most frequent HP were nausea, vomiting, headache, and pain. In children, vomiting was most common. The HPs described did not require drug withdrawal in most cases.

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 influenza prevention and treatment studies in adults and adolescents (75 mg 2 times daily for 5 days for treatment and 75 mg once daily up to 6 weeks for prevention) and that had at least a 1% higher incidence compared with placebo. The influenza treatment studies included adults/adolescents without concomitant pathology and patients in risk groups, i.e., patients at high risk of developing influenza complications (elderly and elderly patients, patients with chronic heart or respiratory diseases). In general, the safety profile of at-risk patients was consistent with that of adult/adolescent patients without concomitant pathology.

In influenza prevention trials, the safety profile in patients receiving the recommended dose of the drug (75 mg once daily up to 6 weeks) did not differ from that in influenza treatment trials, despite longer administration of the drug.

Table 1. Percentage of adults/adolescents with HP occurring at ≥1% in the oseltamivir group in influenza infection treatment and prevention trials (difference from placebo ≥1%).

System-organ class

Unintended reaction

Treatment

Prevention

Frequency Categorya

Placebo N=1977

Oseltamivir (75 mg once daily) N=1945

Placebo N=1588

Gastrointestinal disorders

Nausea

0%

6%

6%

4%

very often

Vomiting

8%

3%

2%

/p>

1%

often

Nervous system disorders

Headache

/td>

2%

1%

17%

16 %

very often

General disorders

Pain

˂1 %

˂1 %

4 %

3%

often

a Frequency category is provided for the oseltamivir group only. The following frequency categories are used to estimate the frequency of HP: very frequent (≥1/10); frequent (≥1/100, < 1/10).

The following are adverse events that occurred with a frequency of ≥1% in adults and adolescents who received oseltamivir as therapy and prophylaxis for influenza infection. These adverse events either occurred more frequently in patients receiving placebo, or the difference in frequency between the oseltamivir and placebo groups was less than 1%.

Gastrointestinal disorders (oseltamivir versus 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 invasions (oseltamivir vs placebo):

Treatment – bronchitis (3% vs. 4%), sinusitis (1% vs. 1%), herpes simplex (1% vs. 1%);

Prevention – nasopharyngitis (4% vs. 4%), upper respiratory infections (3% vs. 3%), influenza infection (2% vs. 3%).

General disorders (oseltamivir vs placebo):

Treatment – dizziness (including vertigo, 2% vs. 3%);

Prevention – fatigue (7% vs. 7%), pyrexia (2% vs. 2%), flu-like illness (1% vs. 2%), dizziness (1% vs. 1%), limb pain (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%).

Muscular and connective tissue disorders (oseltamivir vs placebo):

Preventive – back pain (2% vs. 3%), arthralgia (1% vs. 2%), myalgia (1% vs. 1%).

Renital and breast disorders (oseltamivir vs placebo):

Preventive dysmenorrhea (3% vs. 3%).

The treatment and prevention of influenza infection in the elderly and elderly

The safety profile in 942 elderly and elderly patients who received oseltamivir or placebo was not clinically different from that in younger individuals (under 65 years).

The prevention of influenza infection in immunocompromised patients

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

The treatment and prevention of influenza infection in children without comorbidities aged 1 to 12 years and patients with bronchial asthma

In studies of the treatment of natural influenza infection in children aged 1 to 12 years, HP vomiting was noted at ≥1% and at least 1% more frequently when using oseltamivir (n = 858) compared with placebo (n = 622). Vomiting was most common in children who received the recommended dose of the drug once daily as post-exposure prophylaxis at home (8% in the oseltamivir group versus 2% in the non-preventive treatment group). Oseltamivir was well tolerated, the reported adverse events were consistent with those previously described in the treatment of influenza in children. Adverse events reported in children with an incidence of ≥1% in influenza treatment trials (n = 858) or with an incidence of ≥5% in influenza prevention trials (n = 148) are presented below. These adverse events were more frequent in the placebo/no prophylaxis group; the difference between the oseltamivir and placebo/no prophylaxis groups was less than 1%.

Gastrointestinal disorders (oseltamivir versus placebo):

Treatment – diarrhea (9% vs. 9%), nausea (4% vs. 4%), abdominal pain (including upper abdominal pain, 3% vs. 3%).

Infections and invasions (oseltamivir vs placebo):

The treatments were otitis media (5% vs. 8%), bronchitis (2% vs. 3%), pneumonia (1% vs. 3%), and sinusitis (1% vs. 2%).

Respiratory, thoracic, and mediastinal disorders (oseltamivir vs. placebo):

Treatment – asthma (including exacerbation, 3% vs. 4%), nasal bleeding (2% vs. 2%);

Prevention – cough (12% vs. 26%), nasal congestion (11% vs. 20%).

Skin and subcutaneous tissue disorders (oseltamivir vs placebo):

The treatment was dermatitis (including allergic and atopic dermatitis, 1% vs. 2%).

Hearing and labyrinth disorders (oseltamivir vs placebo):

The treatment was ear pain (1% vs. 1%).

Visual organ disorders (oseltamivir vs placebo):

treatment – conjunctivitis (including eye redness, ocular discharge, and eye pain, 1% vs < 1%).

Additional adverse events noted with flu treatment in children that did not meet the criteria described above.

Disorders of the blood and lymphatic system (oseltamivir vs. placebo):

The treatment was lymphoadenopathy (< 1% vs.)

Hearing and labyrinth disorders (oseltamivir vs placebo):

Treatment – Damage to the eardrum (< 1% vs.)

Post-marketing follow-up

The following are the adverse events with oseltamivir that were observed during the post-marketing follow-up period. The frequency of these adverse events and/or the causal relationship to the use of the drug cannot be determined because 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, allergy, anaphylactic and anaphylactoid reactions, Quincke’s edema.

Hepatic and biliary tract disorders: hepatitis, increased “liver” enzyme activity in patients with flu-like symptoms receiving oseltamivir; fulminant hepatitis (including fatal), liver failure, jaundice.

Nervous mental disorders

Influenza 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. These phenomena may occur against the background of encephalopathy or encephalitis, or without the manifestation of these diseases.

Convulsions and delirium (including symptoms such as impaired consciousness, disorientation in time and space, abnormal behavior, delirium, hallucinations, agitation, anxiety, nightmares) have been reported in patients (mostly children and adolescents) who took oseltamivir for flu treatment. These cases were rarely accompanied by life-threatening acts. The role of oseltamivir in the development of these phenomena is unknown. Similar neuropsychiatric disorders have also been reported in influenza patients who did not receive oseltamivir.

Gastrointestinal disorders: gastrointestinal bleeding after taking oseltamivir (in particular, the connection between 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.

Overdose

Pregnancy use

There have been no controlled studies in pregnant women. However, results of post-marketing and observational studies have demonstrated the benefit of the proposed standard dosing regimen for this patient population. Results of the pharmacokinetic analysis showed lower exposure of the active metabolite (approximately 30% across all trimesters of pregnancy) in pregnant women compared to nonpregnant women. Nevertheless, the estimated exposure value remains above inhibitory concentrations (IC95 value) and therapeutic values for many strains of influenza virus. Changing the dosing regimen in pregnant women during therapy or prophylaxis is not recommended. No direct or indirect adverse effects of the drug on pregnancy, embryo-fetal or postnatal development have been found (see “Preclinical data”). When prescribing oseltamivir to pregnant women, both safety data and the course of pregnancy and pathogenicity of the circulating strain of influenza virus should be considered.

In preclinical studies, oseltamivir and the active metabolite penetrated the milk of lactating rats. There are limited data on the excretion of oseltamivir with breast milk in humans and the use of oseltamivir in lactating women. Oseltamivir and its active metabolite penetrate into breast milk in small amounts (see “Preclinical data”), producing subtherapeutic concentrations in the blood of the infant. When prescribing oseltamivir to breastfeeding women, the concomitant disease and pathogenicity of the circulating strain of influenza virus should also be considered.

In pregnancy and during breastfeeding, oseltamivir is used only if the estimated benefit to the mother outweighs the potential risk to the fetus and child.

Psychiatric disorders

Convulsions and delirium-like neuropsychiatric disorders have been reported in patients (mostly children and adolescents) who have taken oseltamivir for influenza treatment. These cases were rarely accompanied by life-threatening actions. The role of oseltamivir in the development of these phenomena is unknown. Similar neuropsychiatric disorders have also been reported in influenza patients who did not receive oseltamivir. The risk of neuropsychiatric disorders in patients treated with oseltamivir is not greater than in influenza patients who do not receive antiviral medications.

Careful monitoring of the condition and behavior of patients, especially children and adolescents, is recommended to detect signs of abnormal behavior and to assess the risk of continuing the drug if these phenomena develop.

There are no data on the effectiveness of oseltamivir in any disease caused by pathogens other than influenza A and B viruses.

Oseltamivir is not a substitute for vaccination.

The prophylactic administration of the drug is possible under epidemiological indications. For recommendations on dose adjustment in patients with kidney disease, see Dosing in Special Cases.

Similarities