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* Based on theoretical activity of 951 IU/mg.

Antibacterial drug from the macrolide group. The mechanism of action is associated with disruption of protein synthesis in the microbial cell due to reversible binding to 5 0S -a subunit of the ribosome. In therapeutic concentrations, as a rule, it has a bacteriostatic effect, slowing down the growth and reproduction of bacteria. When high concentrations are created at the site of inflammation, a bactericidal effect is possible.

Josamycin is active against gram-positive bacteria (Staphylococcus spp., incl. methicillin-sensitive strainsStaphylococcus aureus, Streptococcus spp., incl. Streptococcus pyogenes And Streptococcus pneumoniae, Corynebacterium diphtheriae, Listeria monocytogenes, Propionibacterium acnes, Bacillus anthracis, Clostridium spp., Peptococcus spp., Peptostreptococcus spp.), gram negative bacteria( Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Bordetella spp., Brucella spp.. Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni), sensitivityBacteroides fragilismay be variableChlamydia spp., incl. C. trachomatis, Chlamydophila spp., incl. Chlamydophila pneumoniae(previously calledChlamydia pneumoniae), Mycoplasma spp., incl. Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma spp., Treponema pallidum, Borrelia burgdorferi. As a rule, it is not active against enterobacteria, therefore it has little effect on the microflora of the gastrointestinal tract. In some cases, it remains active in case of resistance to erythromycin and other 14- and 15-membered macrolides (streptococci, staphylococci). Resistance to josamycin is less common than to 14- and 15-membered macrolides.

After oral administration, it is quickly absorbed from the gastrointestinal tract; food intake does not affect bioavailability. The maximum plasma concentration of josamycin is achieved 1 hour after administration. When taken at a dose of 1 g, the maximum concentration in blood plasma is 2-3 mcg/ml. About 15% of josamycin is bound to plasma proteins. is well distributed in organs and tissues (with the exception of the brain), creating concentrations that exceed plasma concentrations and remain at a therapeutic level for a long time.

It creates especially high concentrations in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Crosses the placental barrier and is secreted into breast milk. metabolized in the liver to less active metabolites and excreted mainly in bile. The half-life of the drug is 1-2 hours, but may be prolonged in patients with impaired liver function. Excretion of the drug by the kidneys does not exceed 10%.

Infectious and inflammatory diseases caused by microorganisms sensitive to josamycin:

- Infections of the upper respiratory tract and ENT organs:

tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), scarlet fever (as an alternative to beta-lactam antibiotics, if their use is not possible).

- Lower respiratory tract infections:

acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, whooping cough, psittacosis.

- Skin and soft tissue infections:

folliculitis, boil, furunculosis, abscess, anthrax, erysipelas, acne, lymphangitis, lymphadenitis, phlegmon, panaritium, wound (including postoperative) and burn infections.

- Oral infections:

gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess.

Eye infections:

blepharitis, dacryocystitis.

- Infections of the genitourinary system:

non-gonococcal infections of the urogenital tract (including urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and/or mycoplasmas, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum).

- Gastrointestinal diseases associated with N. pylori:

peptic ulcer of the stomach and duodenum, chronic gastritis, etc.

- ebastine,

- dopamine receptor agonists: lisuride, pergolide,

- triazolam,

- halofantrine,

- disopyramide,

- tacrolimus,

- terfenadine and (see section "Interaction with other drugs").

Caution is required when using josamycin together with the following drugs: indirect anticoagulants.

Despite the fact that this dosage form is intended for children, information about the use of josamycin during pregnancy and lactation is provided below.

Pregnancy

The use of the drug during pregnancy is possible if the expected benefit to the mother outweighs the potential risk to the fetus. The need to use the drug during pregnancy should be assessed by a doctor. Limited clinical observations indicate that the use of josamycin during pregnancy does not lead to an increase in the incidence of adverse pregnancy outcomes and is not associated with the occurrence of any specific malformations in the child. In preclinical studies, no teratogenic or fetotoxic effects of josamycin were detected.

Lactation

It has been established that macrolides are secreted in mother's milk, and the concentration of the drug in milk is equal to or higher than its concentration in blood plasma. The main danger lies in the effect of the drug on the child’s intestinal microflora. Thus, taking the drug Vilprafen® according to indications during breastfeeding is allowed. The need to use the drug during lactation should be assessed by a doctor. If a child develops gastrointestinal disorders (diarrhea, candidiasis of the oral mucosa), breastfeeding should be suspended (or the drug should be stopped). When prescribing cisapride to newborns or breastfed infants, maternal use of macrolides is contraindicated due topotential risk of drug interaction, dangerous for the development of ventricular tachycardia of the “pirouette” type in a child.

Dosage regimen

The drug Vilprafen® is available in several dosage forms and dosages. The dosage form “granules for oral suspension” was created specifically for children in 3 dosages: 125 mg/5 ml, 250 mg/5 ml and 500 mg/5 ml.

Along with the drug, the kit contains a special syringe with divisions and marks corresponding to the child’s weight. This syringe is used for precise dosage and oral administration of the prepared suspension.

The recommended daily dose of josamycin 50 mg/kg body weight should be divided into 2 doses: 25 mg/kg in the morning and 25 mg/kg in the evening, not exceeding a dose of 1 g at each dose. The duration of treatment is determined by the doctor depending on the nature and severity of the infection and usually is at least 5-7 days.

If you miss the next dose, you should not take a double dose of the drug.

Preparation of the suspension

(1) shake the contents of the bottle well

(2) Add cooled boiled water to a circle

(3) Shake and let sit for a few minutes to get a good look at the liquid level.

(4) Add water (if necessary) to the circle mark on the bottle. The resulting foam should always be above this mark

(5) Shake the prepared suspension thoroughly before use.

Administration of the drug

(1) Place the supplied graduated syringe into the vial containing the prepared suspension.

(2) Draw the suspension into the syringe by pulling the syringe plunger to the mark corresponding to the child’s weight

(3) After use, rinse the syringe with water

(4) Glue the syringe holder included in the package to one side of the bottle, free from printed information (preferably)

(5) After use, place the syringe in the holder on the bottle

The dosage of the drug depends on the child’s body weight:

The drug Vilprafen® at a dose of 125 mg/5 ml is intended for children weighing 2-5 kg. The drug comes with a syringe marked with divisions from 2 to 5 kg. One division of this syringe corresponds to a weight of 0.5 kg and a dose of the drug Vilprafen* 12.5 mg per 1 kg of weight.

The drug Vilprafen® at a dose of 250 mg/5 ml is intended for children weighing 5-10 kg. The drug comes with a syringe marked with divisions from 2 to 10 kg. One division of this syringe corresponds to a weight of 1 kg and a dose of Vilprafen® 25 mg per 1 kg of weight.

The drug Vilprafen® at a dose of 500 mg/5 ml is intended for children weighing 10-40 kg. The drug comes with a syringe marked with divisions from 2 to 20 kg. One division of this syringe corresponds to a weight of 1 kg and a dose of the drug Vilprafen 50 mg per 1 kg of weight.

You must always strictly adhere to the dosage prescribed by your doctor. If you have any doubts about the correct use, you should consult your doctor.

The drug Vilprafen® is taken orally in the form of a suspension, which is prepared immediately before use.

The volume of suspension drawn up with a syringe, corresponding to the weight of the child, contains a dose of the drug for one dose.

Examples of suspension dosing:

For a child weighing 4 kg, Vilprafen® should be used at a dose of 125 mg/5 ml with the supplied “2-5 kg” syringe. For one dose, use this syringe to draw up the suspension up to the “4 kg” mark.

For a child weighing 6 kg, Vilprafen® should be used at a dose of 250 mg/5 ml with the supplied syringe “2-10 kg”. For one dose, use this syringe to draw up the suspension up to the “6 kg” mark.

For a child weighing 15 kg, Vilprafen® should be used at a dose of 500 mg/5 ml with the supplied syringe “2-20 kg”. For one dose, use this syringe to draw up the suspension up to the “15 kg” mark. If the child's weight exceeds the weight indicated on the syringe's graduations, draw up the required volume of suspension in two doses. For example, for a child weighing 30 kg, first fill the “2-20 kg” syringe with the suspension to the “20 kg” mark, then to the “10 kg” mark.

After opening the bottle and preparing the suspension, the shelf life of the suspension at room temperature is 7 days.

Be careful! The dosage syringe is used exclusively for oral administration of the Vilprafen® suspension and should not be used for dosing another medicinal product.

Do not use other devices for dosing and administering a suspension of the drug Vilprafen® (syringe, spoon, pipette from another drug), in addition to this special syringe corresponding to a specific dosage (i.e. supplied with the drug).

Gastrointestinal disorders:

Nausea, vomiting, abdominal pain, diarrhea, pseudomembranous colitis, gastralgia, stomatitis, constipation.

Skin and subcutaneous tissue disorders:

Erythematous maculopapular rashes, erythema multiforme, bullous dermatitis, Stevens-Johnson syndrome, Lyell's syndrome.

Immune system disorders:

Hypersensitivity reactions in the form of severe itching, urticaria, facial swelling, Quincke's edema (angioedema), difficulty breathing, anaphylactoid reactions and anaphylactic shock;

Serum sickness.

Disorders of the liver and biliary tract:

Increased activity of transaminases and alkaline phosphatase, jaundice, cholestatic or cytolytic hepatitis.

Vascular system disorders:

Purpura, cutaneous vasculitis.

Metabolic and nutritional disorders:

Decreased appetite.

If the listed reactions occur, as well as a reaction not indicated in the instructions, you should consult a doctor.

To date, there is no data on specific symptoms of overdose. In case of overdose, the symptoms described in the “Side Effects” section should be expected, especially from the gastrointestinal tract (in particular, nausea, diarrhea).

Treatment: in case of overdose, the unabsorbed drug should be removed from the gastrointestinal tract (gastric lavage, activated charcoal, etc.) and symptomatic therapy should be carried out.

The use of the following drugs in combination with josamycin is contraindicated due to the potential for serious side effects:

- Ergotamine, dihydroergotamine

The result of the interaction is the risk of severe vasoconstriction (ergotism) with the possible development of limb necrosis (due to inhibition of hepatic metabolism and elimination of ergot alkaloids).

- Cisapride, pimozide

As a result of the interaction, the risk of developing life-threatening arrhythmias, including ventricular tachycardia of the “pirouette” type, increases.

- Ivabradin

As a result of the interaction, the plasma concentration of ivabradine and associated side effects increase (due to inhibition of the hepatic metabolism of ivabradine).

- Colchicine

The interaction results in an increased risk of colchicine side effects, including potentially fatal ones.

The use of the following drugs in combination with josamycin is not recommended:

- Ebastine

Increased risk of life-threatening arrhythmias in patients with congenital long interval syndrome QT.

- Dopamine receptor agonists (, lisuride, pergolide)

An increase in the concentration of dopamine receptor agonists in the blood plasma with a potential increase in their activity and the appearance of overdose symptoms.

- Triazolam

Several cases of increased side effects of triazolam (conduct disorder).

- Halofantrine

Increased risk of ventricular arrhythmias, including ventricular tachycardia of the "pirouette" type (" torsades de pointes "). If possible, you should discontinue taking josamycin. If it is impossible to cancel concomitant use of drugs, interval monitoring is necessary QT and ECG.

- Disopyramide

Increased risk of side effects of disopyramide: severe hypoglycemia,increasing the duration of the interval QT and life-threatening arrhythmias, including ventricular tachycardia of the “pirouette” type. Monitoring of clinical and laboratory data, as well as regular ECG monitoring, is necessary.

- Tacrolimus

Increased plasma concentrations of tacrolimus and creatinine as a result of inhibition of tacrolimus metabolism in the liver.

- Terfenadine and astemizole

During combined use of josamycin and antihistamines containing terfenadine or, the risk of developing life-threatening arrhythmias may be increased.

The use of the following drugs together with josamycin requires caution:

- Carbamazepine

It is possible to increase the concentration of carbamazepine in the blood plasma and develop overdose symptoms due to inhibition of its hepatic metabolism. It is recommended to monitor the patient's condition and the concentration of carbamazepine in the blood plasma. A dose reduction of carbamazepine may be required.

- Cyclosporine

Co-administration of josamycin and cyclosporine may cause an increase in plasma levels of cyclosporine and creatinine and increase the risk of nephrotoxicity. Plasma concentrations of cyclosporine and renal function should be regularly monitored. The dose of cyclosporine should be adjusted during co-administration with josamycin, as well as after discontinuation of josamycin.

- Indirect anticoagulants

It is possible to enhance the effect of indirect anticoagulants and increase the risk of bleeding.

Frequent monitoring of the international normalized ratio (INR) is necessary. It may be necessary to reduce the dose of indirect anticoagulants during co-administration with josamycin, and also in some cases after discontinuation of josamycin.

- Sildenafil

It is possible to increase the concentration of sildenafil in the blood plasma, increasing the risk of arterial hypotension. If co-administration is necessary, it is recommendedtake the smallest dose of sildenafil.

- Theophylline and aminophylline

Caution should be exercised when using josamycin together with theophylline or aminophylline, because there is a risk of increased plasma theophylline concentrations, especially in children.

- Digoxin

When administered together, josamycin and digoxin may increase the level of the latter in the blood plasma.

- Other antibacterial drugs

Since bacteriostatic antibioticsin vitromay reduce the antimicrobial effect of bactericidal antibiotics; their simultaneous use should be avoided. should not be used simultaneously with lincosamides due to a possible mutual decrease in effectiveness.

When using almost all antibacterial agents, including, cases of the development of pseudomembranous colitis, which can be life-threatening, have been described. The possibility of this adverse event should be borne in mind in patients with diarrhea during or after taking josamycin. A careful history must be taken because diarrhea caused byClostridium difficile, can develop within 2 months after finishing a course of antibiotic therapy. If pseudomembranous colitis occurs, the drug is discontinued and the necessary treatment is prescribed. Medicines that inhibit intestinal motility are contraindicated in this situation.

In patients with renal failure, therapy with josamycin should be carried out taking into account the results of appropriate laboratory tests (determination of endogenous creatinine clearance).

The possibility of cross-resistance to various macrolide antibiotics should be taken into account: microorganisms that are resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin. This medicinal product contains sodium in an amount of less than 1 mmol per 5 ml suspension (or dose per 5 kg).

Particular issues of violation of the international normalized ratio (INR)

There have been numerous cases of increased activity of indirect anticoagulants in patients taking antibiotics. Risk factors are the presence of an infectious disease (and concomitant inflammatory process), age and general condition of the patient. In this regard, it is quite difficult to determine the significance of individual factors - an infectious disease or an antibiotic used for its treatment - in changing the INR value. However, the possible influence of a number of antimicrobial agents should be taken into account: fluoroquinolones, macrolides,tetracyclines, co-trimoxazole and some cephalosporins.

This drug contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (most likely delayed).

There was no effect of the drug on the ability to drive vehicles or operate machinery.

Granules for the preparation of oral suspension 125 mg/5 ml, 250 mg/5 ml and 500 mg/5 ml.

Dosages 125 mg/5 ml and 250 mg/5 ml:

15 g of granules in a 100 ml clear glass bottle with a 60 ml circular line with a screw-on plastic cap with a tamper evident ring and a polyethylene stop valve.

Dosage 500 mg/5 ml:

20 g of granules in a 100 ml clear glass bottle with a 60 ml circular line with a screw-on plastic cap with a tamper evident ring and a polyethylene stop valve.

1 bottle along with instructions for use and a plastic dosing syringe with a syringe holder are placed in a cardboard box.

Store at a temperature not exceeding 25 °C.

Store the suspension at room temperature.

Keep out of the reach of children.

3 years. Should not be used after the expiration date stated on the package. The shelf life of the suspension is 7 days from the date of preparation.

dispersible tablets

Active substance:

Josamycin-1000 mg

(equivalent to josamycin propionate) - 1067.66 mg.

Excipients:

Microcrystalline cellulose - 564.53 mg, hyprolose - 199.82 mg, sodium docusate - 10.02 mg, aspartame - 10.09 mg, colloidal silicon dioxide - 2.91 mg, strawberry flavor - 50.05 mg, magnesium stearate - 34.92 mg.

Antibacterial drug from the macrolide group. The mechanism of action is associated with disruption of protein synthesis in the microbial cell due to reversible binding to the 508 ribosomal subunit. In therapeutic concentrations, as a rule, it has a bacteriostatic effect, slowing down the growth and reproduction of bacteria. When high concentrations are created at the site of inflammation, a bactericidal effect is possible.

Josamycin is active against gram-positive bacteria ( Staphylococcus spp., incl. h. methicillin-sensitive strains Staphylococcus aureus), Streptococcus spp., incl. h. Streptococcus pyogenes And Streptococcus pneumoniae, Corynebacterium diphtheriae, Listeria monocytogenes, Propionibacterium acnes, Bacillus anthracis, Clostridium spp. Peptococcus spp., Peptostreptococcus spp.),gram-negative bacteria ( Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Bordetella spp. Brucella spp., Legionella spp., Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Campylobacter jejuni ), sensitivity Bacteroides fragilis may be variable), Chlamydia spp., incl. h. WITH . trachomatis, Chlamydophila spp., incl. h. Chlamydophila pneumoniae(previously called Chlamydia pneumoniae), Mycoplasma spp., incl. h. Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma spp. Treponema pallidum, Borrelia burgdorferi.

As a rule, it is not active against enterobacteria, therefore it has little effect on the microflora of the gastrointestinal tract. In some cases, it remains active in case of resistance to erythromycin and other 14- and 15-membered macrolides (streptococci, staphylococci). Resistance to josamycin is less common than to 14- and 15-membered macrolides.

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Upper respiratory tract infections and OP-organs:

tonsillitis, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), scarlet fever (in case of hypersensitivity to penicillin).

Lower respiratory tract infections:

acute bronchitis, exacerbation of chronic bronchitis, community-acquired pneumonia, including those caused by atypical pathogens, whooping cough, psittacosis.

Infections in dentistry:

gingivitis, pericoronitis, periodontitis, alveolitis, alveolar abscess.

Infections in ophthalmology:

blepharitis, dacryocystitis

Skin and soft tissue infections:

folliculitis, boil, furunculosis, abscess, anthrax, erysipelas, acne, lymphangitis, lymphadenitis, phlegmon, panaritium, wound (including postoperative) and burn infections.

Infections of the genitourinary system:

urethritis, cervicitis, epididymitis, prostatitis caused by chlamydia and/or mycoplasma, gonorrhea, syphilis (with hypersensitivity to penicillin), lymphogranuloma venereum.

Gastrointestinal diseases associated with H. pylori

Peptic ulcer of the stomach and duodenum, chronic gastritis, etc.

Hypersensitivity to josamycin and other components of the drug;

Hypersensitivity to other macrolides;

Severe liver dysfunction;

Children weighing less than 10 kg.

Children aged 1 year have an average body weight of 10 kg.

The daily dosage for children weighing at least 10 kg is prescribed based on the calculation of 40-50 mg/kg body weight daily, divided into 2-3 doses: for children weighing 10-20 kg, the drug is prescribed at 250-500 mg ( 1/4-1/2 tablet dissolved in water) 2 times a day, for children weighing 20-40 kg the drug is prescribed at 500 mg-1000 mg (1/2 tablet -1 tablet dissolved in water) 2 times per day, more than 40 kg - 1000 mg (1 tablet) 2 times a day. Typically, the duration of treatment is determined by the doctor, ranging from 5 to 21 days, depending on the nature and severity of the infection. In accordance with WHO recommendations, the duration of treatment for streptococcal tonsillitis should be at least 10 days.

In anti-Helicobacter therapy regimens, it is prescribed in a dose of 1 g 2 times a day for 7-14 days in combination with other drugs in their standard dosages (40 mg/day or 150 mg 2 times a day + 1 g 2 times a day + 500 mg2 r/day; 20 mg (or 30 mg, or 40 mg, or 20 mg, or 20 mg) 2 times/day + 1 g 2 times/day + 1 g 2 times/day; 20 mg (or 30 mg, or 40 mg, or 20 mg, or 20 mg) 2 times / day + 1 g 2 times / day + 1 g 2 times / day + 240 mg 2 times / day: 40 mg / day + 100 mg 2 times / day + 1 g 2 r/day + 240 mg 2 r/day).

In the case of acne vulgaris and globular acne, it is recommended to prescribe a dose of 500 mg twice daily for the first 2-4 weeks, followed by 500 mg josamycin once daily as maintenance treatment for 8 weeks.

Vilprafen® Solutab® dispersible tablets can be taken in various ways: the tablet can be swallowed whole with water or dissolved in water before use. The tablets should be dissolved in at least 20 ml of water. Before administration, the resulting suspension should be thoroughly mixed.

From the gastrointestinal tract

Often - stomach discomfort, nausea

Uncommon: abdominal discomfort, vomiting, diarrhea

Rarely - stomatitis, constipation, loss of appetite

Very rarely - pseudomembranous colitis

Hypersensitivity reactions:

Rarely - urticaria, angioedema and anaphylactoid reaction.

Very rarely - bullous dermatitis, exudative erythema multiforme, incl. Steven-Johnson syndrome.

From the liver and biliary tract:

Very rarely - liver dysfunction, jaundice

From the senses:

In rare cases, dose-related transient hearing loss has been reported

Others: very rarely - purpura

In the case of persistent severe diarrhea, one should keep in mind the possibility of life-threatening pseudomembranous colitis developing against the background of josamycin.

In patients with renal failure, treatment should be carried out taking into account the results of appropriate laboratory tests (determination of endogenous creatinine clearance).

The possibility of cross-resistance to various macrolide antibiotics should be taken into account (microorganisms resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin).

Dispersible tablets 1000 mg.

5 tablets per blister made of PVC/PVDC/aluminum foil.

2 blisters along with instructions for medical use are placed in a cardboard box.

Store in a dry place, protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.