Oseltamyvyr | Nomides capsules 30 mg 10 pcs.

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BID532858
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Pharmacological action

Nomides is an effective means of preventing and treating influenza in adults and children over the age of 1 year. At the beginning of treatment no later than 40 hours after the onset of the first symptoms of influenza, Nomides significantly shortens the period of clinical manifestations of influenza infection, reduces their severity and reduces the incidence of influenza complications requiring antibiotics (bronchitis, pneumonia, sinusitis, otitis media), shortens the time of virus isolation out of the body.

After oral administration of oseltamivir, phosphate is readily absorbed in the gastrointestinal tract and is highly converted into an active metabolite by hepatic esterases. Plasma concentrations of the active metabolite are determined within 30 minutes and reach almost maximum levels 2-3 hours after administration. At least 75% of the ingested dose enters the systemic circulation as an active metabolite. Plasma concentrations are dose-proportional and independent of food intake.
Pharmacological action

Nomides is an effective means of preventing and treating influenza in adults and children over the age of 1 year. At the beginning of treatment no later than 40 hours after the onset of the first symptoms of influenza, Nomides significantly shortens the period of clinical manifestations of influenza infection, reduces their severity and reduces the incidence of influenza complications requiring antibiotics (bronchitis, pneumonia, sinusitis, otitis media), shortens the time of virus isolation out of the body.

After oral administration of oseltamivir, phosphate is readily absorbed in the gastrointestinal tract and is highly converted into an active metabolite by hepatic esterases. Plasma concentrations of the active metabolite are determined within 30 minutes and reach almost maximum levels 2-3 hours after administration. At least 75% of the ingested 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.

Influenza prophylaxis in adults and adolescents over the age of 12 who are at increased risk of contracting the virus (in large groups, in debilitated 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 liver failure,

Children under 1 year of age.

Special instructions

Extemporaneous preparation of Nomides® suspension from

capsules In cases where adults, adolescents and children have difficulty swallowing the capsules or if there are signs of aging of the capsules, you must open the capsule and pour its contents in a small amount (maximum 1 teaspoon) of a suitable sweetened food product (chocolate syrup with normal sugar content or sugar free, 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. Swallow the mixture immediately after preparation.

Capsules 75 mg

If a dose of 75 mg is required for patients, the following instructions must be followed:

1. While 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 (not more than 1 teaspoon) of a suitable sweetened food (to hide the bitter taste) and mix well.

3. Stir the mixture thoroughly and drink it immediately after preparation. If a small amount of the mixture remains in the container, 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 must be followed for proper dosing:

1. While 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 fluid collected. Stir thoroughly for 2 minutes.

3. Pour the required amount of mixture from the container into the syringe according to the following table.

Body weight

Recommended dose

Amount of mixture Nomides® per dose

15 kg

30 mg

2 ml

> 15-23 kg

45 mg

3 ml

> 23-40 kg

60 mg 4 mg

the need for the collection of undissolved white powder, since it is an inactive filler. Having pressed the syringe plunger, enter all its contents into the second container. The remaining unused mixture must be discarded.

4. In a second container, add a small amount (not more than 1 teaspoon) of a suitable sweetened food to hide the bitter taste, and mix well.

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

This procedure should be repeated before each dose.

Composition

Active ingredient:

Oseltamivir phosphate: 39.40 mg 59.10 mg 98.50 mg

which corresponds to the content of

Oseltamivir:

30.00 mg

45.00 mg

75.00 mg

excipients Colloidal silicon dioxide (aerosil) - 6.00 mg / 9.00 mg / 15.00 mg of copovidone-3.60 mg / 5, 40 mg / 9.00 mg pregelatinized starch - 65.60 mg / 98.40 mg / 164.00 mg of croscarmellose sodium - 1.840 mg / 2.760 mg / 4.60 mg sodium stearyl fumarate - 0.920 mg / 1.388 mg / 2.30 mg talc - 2.640 mg / 3.960 mg / 6.60 mg.

Composition of hard 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, brilliant blue dye - 0.2626 mg, gelatin - up to 100 mg

cap capsules: purified water - 14-15 mg, sodium lauryl sulfate - 0.08 mg, titanium dioxide - 0, 97524 mg, brilliant blue dye - 0.2626 mg, gelatin - up to 100 mg.

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, sunset yellow dye E 110 - 1.2753 mg, crimson dye [Ponceau 4R] E 124 - 0.2401 mg, gelatin - up to 100 mg.

Dosage and administration of

The drug oseltamivir is taken orally, regardless of food intake or with food.

Treatment

Acceptance of the drug should be started no later than 2 days after the development of symptoms of the disease. Adults and adolescents aged 12 years of age

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

Children weighing more than 40 kg or aged 8 years old

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

Children aged 1 year Recommended dosage of oseltamivir capsules 30 and 45 mg.

Body weight Recommended dose for 5 days

15 kg: 30 mg twice daily

> 15-23 kg: 45 mg twice daily

> 23-40 kg: 60 mg twice daily



prophylaxis the drug must be started no later than 2 days after contact with patients.

Adults and teenagers aged 12 years

75 mg (one capsule 75 mg or one capsule 30 mg + one capsule 45 mg) once a day by mouth for at least 10 days after contact with the patient. During a seasonal influenza epidemic - 75 mg once a day for 6 weeks. The preventive effect lasts as long as taking the drug.

Children weighing more than 40 kg or aged 8 years old

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

Children aged 1 year Recommended dosage of oseltamivir capsules 30 and 45 mg.

Recommended dosage of oseltamivir capsules 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 day

Dosage in special cases

Patients with impaired renal function: Treatment with

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 twice a day for 5 days.

In patients with creatinine clearance of 10 to 30 ml / min, the dose of oseltamivir should be reduced to 30 mg once a day for 5 days. For patients on permanent hemodialysis, oseltamivir in an initial dose of 30 mg can be taken before dialysis, if flu symptoms appear within 48 hours between dialysis sessions. To maintain a plasma concentration at the therapeutic level, oseltamivir should be taken 30 mg after each dialysis session. Patients undergoing peritoneal dialysis, oseltamivir should be taken in an initial dose of 30 mg before dialysis, then 30 mg every 5 days.

The pharmacokinetics of oseltamivir in patients with end-stage chronic renal failure (with creatinine clearance 10 ml / min) who are not on dialysis have not been studied. In this regard, there are no dosage recommendations for this group of patients.



prophylaxis Patients with creatinine clearance greater than 60 ml / min dose adjustment is not required. In patients with creatinine clearance from 30 to 60 ml / min, the dose of oseltamivir should be reduced to 30 mg once a day. In patients with creatinine clearance from 10 to 30 ml / min, it is recommended to reduce the dose of oseltamivir to 30 mg every other day. Patients undergoing permanent hemodialysis, oseltamivir in an initial dose of 30 mg can be taken before dialysis. To maintain a plasma concentration at the therapeutic level, oseltamivir should be taken 30 mg after each subsequent odd dialysis session. For patients on peritoneal dialysis, oseltamivir should be taken in an initial dose of 30 mg before dialysis, then 30 mg every 7 days. The pharmacokinetics of oseltamivir in patients with end-stage chronic renal failure (with creatinine clearance less than 10 ml / min) who are not on dialysis have not been studied. In this regard, there are no dosage recommendations for this group of patients.

Patients with impaired liver function

Dose adjustment in the treatment and prevention of influenza in patients with impaired liver function of mild to moderate severity is not required. The safety and pharmacokinetics of oseltamivir in patients with severe hepatic impairment have not been studied.

Elderly and senile patients

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

Immunocompromised patients (after transplantation).

For seasonal influenza prophylaxis in immunocompromised patients 1 year of age — within 12 weeks, dose adjustment is not required.

active substance

Oseltamivir

Terms of delivery from

pharmacies Prescription

dosage form

capsules

Indications

Hrypp

Pharmasyntez JSC, Russia

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