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One capsule of drug of Tamiflu contains 30, 45 or 75 mg of active ingredient of an oseltamivir (oseltamivir phosphate) + starch, croscarmellose sodium, the fumarating sodium of a stearil, gelatin, titanium dioxide, dyes iron oxide black, red and yellow, K30 povidone, talc.
Rolled into one drug 30 mg of active ingredient of an oseltamivir of phosphate + titanium dioxide, pitch xanthane contain, sodium saccharin, sorbitol, monosodium citrate, permasit Tutti-Frutti. After suspension preparation, the maintenance of an oseltamivir makes 12 mg on one milliliter.
Medicine release in the form of capsules from gelatin in blisters on 10 capsules, in a cardboard pack one blister. Capsules are firm, opaque. The capsule has the gray body with a text "ROCHE" and a pale yellow lid with a text of "30 mg", "45 mg" or "75 mg". Texts are executed by light blue ink. In each of tablets white and light yellow finely divided powder.
Means in the form of powder for preparation of suspension is let out in light-protective bottles with a capacity of 30 grams. In a set the plastic adapter and the dosing syringe with a measured glass is applied. The set is in cardboard packs with a partition. Powder of white or slightly yellowish color, has a specific pleasant fruit smell and taste. Powder large, granulated. After mixing with water opaque suspension of white or yellow color is formed.
Pharmacodynamics and pharmacokinetics
Oseltamivir – pro-medicine. One of its active metabolites – carboxyarmour of an oseltamivir is the selection inhibitor of a neuraminidase of flu A and B. It is enzyme which activates release of viruses from the cells infected with them, is responsible for reproduction and distribution of harmful agents on all organism, in particular in an epithelium of respiratory tracts.
There are processes of suppression of replication of viruses and decrease in their pathogenicity. Also activity of allocation and distribution of agents from a disease carrier organism decreases.
Drug facilitates disease, reduces time of course of a disease, reduces probability of emergence of such complications as bronchitis, sinusitis, otitis or pneumonia. According to clinical trials children till 12 flyings have a decrease in duration of an illness for 2 days.
At preventive reception at the persons contacting to the infected patients at members of the family of the patient the probability to ache with flu decreases by 92%.
It is remarkable that means does not exert impact on intensity of fight of an organism against a disease, antibodies are developed normal. Clinically significant cases of emergence of resistance to medicine were not noted.
Phosphate of an oseltamivir quickly and almost is completely soaked up in a digestive tract where turns into an active metabolite, waters influence of intestinal and hepatic esterases. To find an active metabolite in a blood plasma becomes possible already through half of hour after reception. The metabolite reaches the maximum concentration in 2-3 hours. A metabolite in plasma in 20 times more, than the accepted oseltamivir.
Pharmacokinetic indicators of means do not depend on meal.
Active ingredient can be found in mucous a nose and bronchial tubes, in lungs, tracheas and a middle ear.
Extent of linkng of a metabolite with proteins in a blood plasma — to 3%, pro-medicine communicates almost and a half proteins, however does not influence any farmakodinamichesky parameters in any way.
Drug (and its active metabolite) through kidneys and with a stake is removed (in insignificant degree). The elimination half-life makes about five - ten hours.
The persons having serious diseases of kidneys can have difficulties with removal of means from an organism, AUC will be in inverse proportion to extent of defeat of bodies. At hepatic pathology of such pattern it was not observed.
Correction of a dosage of drug is not required from elderly patients.
At the children who did not reach age of 12 years, the metabolism of means accelerates, medicine is almost twice quicker brought out of an organism. In this regard correction of a daily dosage is required.
Indications to use
Medicine is appointed for prevention and treatment of flu
For treatment of flu persons can use drug of one year. In case of a pandemic of flu use of means for children of 6-12 months is possible.
Medicine showed the greatest efficiency in case of reception within two days after infection and manifestation of the first symptoms.
Also Tamiflu can use as a prophylactic after contact with the infected persons at epidemics and pandemics at persons, is more senior than one year.
It should be noted that administration of drug does not replace vaccination against an influenza virus. Before use of means, especially children have from 6 to 12 months, it is necessary to consult with the attending physician.
Tamiflu is contraindicated:
- at an allergy on any of its components;
- to the children who did not reach age of 6 months;
- at a chronic renal failure, at creatinine Cl less than 10 ml a minute.
It is necessary to be careful to pregnant women and the feeding women, children are from 6 to 12 months old.
At administration of drug are most often shown: nausea, vomiting and a headache, especially in the first days.
At adult groups of patients and teenagers were observed:
- headaches, sleeplessness, spasms and hallucinations;
- cough, cold, nausea, pains in epigastric area, a diarrhea, indigestion;
- bronchitis, upper respiratory tract infections;
- enanthesis, eczema, dermatitis and urticaria;
- weakness, conjunctivitis, bleedings from a nose.
At children the following side reactions can be shown:
- otitis, pneumonia, sinusitis;
- nasal bleedings, cough, asthma;
- hearing disorder, pathologies of development of a tympanic membrane;
- nausea, abdominal pains, vomiting, conjunctivitis;
- dermatitis, urticaria.
During the post-registration period cases of emergence of the following side effects were revealed (were shown seldom, it is not established whether are connected with administration of drug):
- anaphylactic and anaphylactoid reactions;
- vision disorders;
- delirium, hallucinations, confusion of consciousness, alarm, nightmares at night;
- bleedings in a digestive tract;
- Quincke's edema, erythema, Stephens-Johnson's syndrome;
- hepatitis, increase of level of enzymes of a liver.
Tamiflu, application instruction (Way and dosage)
Drug can be accepted during food or regardless of meal. At some patients medicine is better acquired if to drink it together with food.
The standard dosage on 75 mg a day can be divided into 2 parts, one capsule of 30 mg and one 45 mg.
It is better to begin treatment in the first days of an illness, at once after manifestation of the first symptoms.
The application instruction of Tamiflu in the form of capsules for treatment of flu
Adults and children of 13 flyings accept 75 mg 2 times a day. The course of treatment makes 5 days.
Tamiflu for children is recommended to appoint from 1 to 12 flyings in number from 60 to 150 mg a day divided into 2 receptions. Course of treatment of 5 days.
The dosage considerably depends on the child's weight:
- weighing up to 15 kg – 60 mg a day;
- weighing from 15 to 23 kg – 90 mg;
- to children weighing from 23 to 40 – 120 mg a day;
- weighing over 40 mg – 150 mg.
For children aged from half a year about one year appoint 3 mg to weight kg, 2 times a day. A course of treatment same, as well as for other age categories.
The instruction on capsules for prevention
It is recommended to take medicine as a prophylactic within 2 days after contact with the patient.
As a rule, accept on one capsule 75 mg within 10 days once a day.
During epidemic it is possible to drink 75 mg, within 1,5 months once a day.
Tamiflu for children till 12 flyings as prevention is appointed depending on weight:
- to 15 kg – 30 mg a day;
- from 15 to 23 kg – 45 mg a day;
- from 23 to 40 kg – 60 mg;
- more than 40 mg – 75 mg a day.
Duration of reception of means makes 10 days.
If the patient had problems with a capsule proglatyvaniye, or it looks unsuitable for the use, contents of a tablet can be poured out in a teaspoon. Then to add to capacity chocolate syrup, sugar, honey, condensed milk or other product capable to hide unpleasant taste of powder. The prepared product needs to be used at once after mixing.
Instruction for suspension preparation:
- It is necessary to shake up carefully bottle contents evenly to distribute powder at the bottom.
- Then to pour 52 ml of water in a measured glass (to the corresponding mark).
- To add the measured amount of water to a bottle, to close it and it is good to stir up within at least 15 seconds.
- To take off a cap from a bottle and to insert the adapter into a neck.
- It is good to close a bottle. To be convinced that the adapter correctly was located.
On a label it is necessary to specify a deadline of use of the prepared drug. Before accepting suspension, the bottle should be stirred up well. It is possible to measure necessary quantity of medicine by means of the measured syringe.
For patients with damage of kidneys at Cl of creatinine of 10-30 ml a minute the dosage is reduced to 75 mg once a day. The maximum duration of reception – 5 days. At preventive reception the dosage is reduced to 75 mg every other day or on 30 mg of suspension every day.
Safety of use of drug for children to 6 months and the persons having liver diseases is not established.
If you have a capsule with a capacity of 75 mg, and you need to give to the patient smaller quantity of an oseltamivir:
- To pour out contents of one capsule in small dry capacity.
- Measure the syringe with divisions 5 ml of water and add to powder. Well mix.
- If the dosage is required: 30 mg it is necessary to withdraw 2 ml of mix if 45 – 3 ml if 60 – 4 ml.
- To enter syringe contents into other capacity.
- To mix contents of the second capacity with sweetener (sugar, honey, juice, yogurt), to mix and give to the patient.
- If for once it was succeeded to accept not all contents of the second capacity, it is possible to add water and to give to drink the patient the turned-out solution.
Cases of overdose were not registered.
Nausea, dizziness and vomiting can be shown. At overdose it is necessary to stop reception of means and to make a symptomatic treatment.
Medicine has no specific antidote.
At reception to gram of means only nausea and vomiting was observed.
Medicinal interaction, as a rule, does not happen.
At a drug combination with probenetsidy (or other means blocking canalicular secretion) AUC of an active metabolite increases approximately twice, but at the same time it is not necessary to adjust a dosage of antiviral means.
Terms of sale
The recipe is required.
Drug should be stored in the place, unavailable to children.
To store capsules at normal humidity, at a temperature not higher than 25 degrees.
Powder for preparation of suspension is stored at a temperature from 15 to 25 degrees.
Already prepared suspension can be stored in the dark place at a temperature from 2 to 8 degrees (17 days) or from 15 to 25 degrees (10 days).
Period of validity
5 years for capsules, 2 years — for powder, from 10 to 17 days — for the prepared suspension.
At the children and teenagers sick with flu and accepting Tamiflu, cases of developing of spasms and a delirium were observed. However direct interrelation between psychoneurotic disturbances and administration of drug it was revealed not (results of three independent large-scale epidemiological researches). These symptoms were shown also at the children who were not taking this medicine.
At the patients having a heavy renal failure it is recommended to make adjustment daily a dosage, after consultation with the specialist.
Efficiency and safety of use of means for persons, with the weakened immunity is not established.
Reception of Tamiflu does not replace annual vaccination against flu. Medicine protects from a disease only for the period of its reception.
It is unknown, drug against other diseases is how effective (except an influenza virus And yes In).
Analogs of Tamiflu
Coincidence on the ATH code of the 4th level:
Structural analogs for drug at the moment do not exist. The close, but a little conceding analogs by efficiency Relentsa, Flustol, Ozeltamivir and Arbidol are insufficiently investigated.
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