What group of antibiotics does Josamycin belong to? Josamycin (Vilprafen) - macrolide antibiotic for special cases

Restoration of microflora

Probiotics

Macrolide antibiotics have high activity against many infectious agents. One of the representatives of this group of antibacterial agents is Vilprafen Solutab. Is this drug allowed for children, what microorganisms does it affect, how is it used correctly, and what side effects can it cause?

Release form

The drug is presented in dispersible white-yellow or white oblong tablets. They taste sweet and smell like strawberries. On one side of the tablet there is the number 1000, and the other side is marked with IOSA. The drug is packaged in blisters of 5 pieces, and one pack includes 10 tablets.

Compound

The main component of the anbiotic Vilprafen Solutab is represented by josamycin. Its dosage per tablet is 1000 mg. To make the medicine solid, keep its shape and dissolve in water, colloidal silicon dioxide, hyprolose and magnesium stearate, as well as sodium docusate and microcrystalline cellulose are added to it. For a pleasant taste, the preparation contains strawberry flavoring and aspartame.

Operating principle

Josamycin has a bacteriostatic effect due to the binding of this substance to the ribosomes of microbial cells, as a result of which the synthesis of protein molecules in bacteria is disrupted. This leads to a slowdown in the reproduction and growth of microorganisms.

The medication is active against:

• Streptococci (including pneumococci and pyogenic species).
• Causative agents of diphtheria.
• Meningococcus.
• Peptococci.
• Listeria.
• Staphylococci (including aureus).
• Gonococcus.
• Legionella
• Causative agents of anthrax.
• Bordetell.
• Clostridium.
• Borellium.
• Treponema pallidum.
• Propionibacterium.
• Peptostreptococci.
• Ureaplasma.
• Moraxell.
• Brucella.
• Gonococcus.
• Helicobacter.
• Haemophilus influenzae.
• Chlamydia.
• Bacteroides.
• Campylobacter.
• Mycoplasma.

However, the medicine is often inactive when infected with enterobacteriaceae. It has almost no effect on the normal intestinal microflora. We also note that the medication usually acts on strains of microbes that are resistant to erythromycin and other macrolides.

The tablet is absorbed very quickly in the digestive tract, and food intake does not affect this process in any way. The maximum level of josamycin in plasma is determined approximately one hour after taking the medication. The half-life of the drug is 1-2 hours, with only 10% of the drug excreted by the kidneys, and most of it is excreted in the bile after metabolic changes in the liver.

Indications

Treatment with the drug "Vilprafen Solutab" is prescribed:

• For tonsillitis, otitis media, paratonsillitis, scarlet fever, sore throat, diphtheria, laryngitis and other infections of the ENT organs.
• For bronchitis, whooping cough, community-acquired pneumonia and other bacterial infections of the lower respiratory tract.
• For alveolitis, gingivitis, periodontitis and other dental infections.
• When the eyes are damaged by bacteria - for example, with blepharitis.
• For erysipelas, phlegmon, felon, furunculosis, burn infection, lymphadenitis and other soft tissue lesions.
• For gonorrhea, chlamydial urethritis, syphilis and other infections of the genitourinary organs.
• For gastrointestinal diseases caused by Helicobacter.

From what age does it apply?

The limitation in prescribing Vilprafen Solutab is not the age of the child, but his weight. The medication is approved only for children weighing more than 10 kilograms. This means that one child can be prescribed the drug at 6 months, while another toddler can be given tablets only from 1 year. It all depends on body weight.

Contraindications

"Vilprafen Solutab" is not prescribed if the child has:

• There is an intolerance to josamycin or other ingredients of the tablets.
• An allergy to any macrolide antibiotic was detected.
• Liver function is severely impaired.

Side effects

A child’s body can react to “Vilprafen Solutab” with the appearance of:

• Nausea.
• Unpleasant sensations in the stomach.
• Vomiting.
• Stool liquefaction.

Rare side effects from taking this antibiotic: constipation, angioedema, decreased appetite, stomatitis, urticaria, jaundice, hearing loss or purpura.

Instructions for use and dosage

• "Vilprafen Solutab" can be taken in different ways - either swallow the tablet or part of it with water, or dissolve the drug in water, taking a liquid in a volume of 20 ml or more. If the medication dissolves, the suspension should be mixed well before swallowing.
• The daily dose of Vilprafen Solutab for a child is calculated by weight. For 1 kilogram of body weight you need from 40 to 50 mg of the active substance. For example, a 4-year-old child weighing 16 kg will receive 750 mg of josamycin per day, so he is given 1/4 tablet three times a day. If the baby is 6 years old and weighs 20 kg, then the daily dose will be 50x20 = 1000 mg. This amount corresponds to 1 tablet. For such a small patient, the medication is prescribed 1/2 tablet twice a day.
• For people over 14 years of age, 1-2 pieces per day are prescribed, dividing this dosage into 2 or 3 doses. If required, the dose can be increased to 3 tablets per day.
• How long to take the drug is determined by the doctor individually in each case. The duration of taking the antibiotic can be either 5 days or 3 weeks. For example, for streptococcal sore throat, Vilprafen Solutab is prescribed for at least 10 days.

Overdose

So far there have been no cases of overdose, but doctors suggest that exceeding the dose of soluble tablets will lead to a negative reaction of the digestive tract (in the form of vomiting, stomach discomfort or diarrhea). If problems arise, you should consult a doctor.

Interaction with other drugs

• "Vilprafen Solutab" is not prescribed together with any bactericidal antibiotics, as well as with representatives of the lincosamide group.
• If you take antihistamines (astemizole or terfenadine) at the same time, the risk of heart rhythm disturbances increases.
• It is not recommended to combine treatment with josamycin and xanthines, cyclosporine or ergot alkaloids.

Terms of sale

Purchasing Vilprafen Solutab requires a prescription from a doctor. The average cost of one package of medicine is 650 rubles.

Storage Features

To store the drug, you should find a place where the medication cannot be reached by a small child. The temperature during storage of the medicine should not exceed 25 degrees Celsius. The shelf life of dispersible tablets is 2 years.

Included in the preparations

Included in the list (Order of the Government of the Russian Federation No. 2782-r dated December 30, 2014):

VED

ONLS

ATX:

J.01.F.A.07 Josamycin

Pharmacodynamics:

The drug is an antibiotic of the macrolide group with a predominantly gram-positive spectrum of action. The bacteriostatic effect of the drug is due to inhibition of protein synthesis in bacteria at the translocation stage. At high local concentrations it exhibits a bactericidal effect.The drug is especially effective against intracellular microorganisms such as Chlamydia trachomatis,Chlamydia pneumonuae, Mycoplasma pneumoniae,Mycoplasma hominis,Ureaplasma urealyticum, Legionella pneumophila, and is also effective against Staphylococcus aureus,Streptococcus pyogenes,Streptococcus pneumoniae (pneumococcus),Corynebacterium diphtheria, Neisseria meningitidis,Neisseria gonorrhoeae,Haemophilus influenzae,Bordetella pertussis,Peptococcus,Peptostreptococcus,Clostridium perfringens, Treponema pallidum.

Pharmacokinetics:

Rapidly absorbed from the gastrointestinal tractregardless of food, binding to plasma proteins is no more than 15%, metabolized in the liver, excreted in bile and urine (20%).

Indications:

Skin and soft tissue infections; And infections of the genital organs and urinary tract; infectious and inflammatory diseases caused by microorganisms sensitive to josamycin; diphtheria; lower respiratory tract infections; oral infections; chlamydial, mycoplasma and mixed infections of the urinary tract and genital organs; scarlet fever.

I.A20-A28.A22 Anthrax

I.A30-A49.A31.0 Pulmonary infection caused by Mycobacterium

I.A30-A49.A36 Diphtheria

I.A30-A49.A37 Whooping cough

I.A30-A49.A38 Scarlet fever

I.A30-A49.A46 Erysipelas

I.A30-A49.A48.1 Legionnaires' disease

I.A50-A64.A50 Congenital syphilis

I.A50-A64.A51 Early syphilis

I.A50-A64.A52 Late syphilis

I.A50-A64.A54 Gonococcal infection

I.A50-A64.A55 Chlamydial lymphogranuloma (venereal)

I.A50-A64.A56.0 Chlamydial infections of the lower genitourinary tract

I.A50-A64.A56.1 Chlamydial infections of the pelvic organs and other genitourinary organs

I.A50-A64.A56.4 Chlamydial pharyngitis

I.A70-A74.A70 Chlamydia psittaci infection

I.B95-B97.B96.0 Mycoplasma pneumoniae as a cause of diseases classified elsewhere

VIII.H65-H75.H66 Purulent and unspecified otitis media

X.J00-J06.J01 Acute sinusitis

X.J00-J06.J02 Acute pharyngitis

X.J00-J06.J03 Acute tonsillitis

X.J00-J06.J04 Acute laryngitis and tracheitis

X.J10-J18.J15 Bacterial pneumonia, not elsewhere classified

X.J10-J18.J15.7 Pneumonia caused by Mycoplasma pneumoniae

X.J10-J18.J16.0 Pneumonia caused by chlamydia

X.J20-J22.J20 Acute bronchitis

X.J30-J39.J31 Chronic rhinitis, nasopharyngitis and pharyngitis

X.J30-J39.J32 Chronic sinusitis

X.J30-J39.J35.0 Chronic tonsillitis

X.J30-J39.J37 Chronic laryngitis and laryngotracheitis

X.J40-J47.J42 Chronic bronchitis, unspecified

XI.K00-K14.K05 Gingivitis and periodontal diseases

XI.K00-K14.K12 Stomatitis and related lesions

XII.L00-L08.L01 Impetigo

XII.L00-L08.L02 Skin abscess, boil and carbuncle

XII.L00-L08.L03 Cellulitis

XII.L00-L08.L08.0 Pyoderma

XIV.N10-N16.N10 Acute tubulointerstitial nephritis

XIV.N10-N16.N11 Chronic tubulointerstitial nephritis

XIV.N30-N39.N30 Cystitis

XIV.N30-N39.N34 Urethritis and urethral syndrome

XIV.N40-N51.N41 Inflammatory diseases of the prostate gland

XIV.N40-N51.N45 Orchitis and epididymitis

XIV.N70-N77.N70 Salpingitis and oophoritis

XIV.N70-N77.N71 Inflammatory diseases of the uterus, except the cervix

XIV.N70-N77.N72 Inflammatory disease of the cervix

XIV.N70-N77.N73.0 Acute parametritis and pelvic cellulitis

XIV.N70-N77.N74.2* Inflammatory diseases of the female pelvic organs caused by syphilis (A51.4+, A52.7+)

XIV.N70-N77.N74.3* Gonococcal inflammatory diseases of the female pelvic organs (A54.2+)

XIV.N70-N77.N74.4* Inflammatory diseases of the female pelvic organs caused by chlamydia (A56.1+)

Contraindications:

Liver dysfunction, hypersensitivity, prematurity.

Carefully:

Interval extension Q T , arrhythmias (history), renal failure, jaundice, porphyria, breastfeeding, myasthenia gravis.

Pregnancy and lactation:

Category Food and Drug Administration ( US Food and Drug Administration) not determined. Use during pregnancy and lactation is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.

When treating with macrolides and simultaneous use of hormonal contraceptives, non-hormonal contraceptives should be additionally used.

Directions for use and dosage:

Inside. Children under 14 years of age - 30-50 mg/kg per day in 3 doses.

Children over 14 years old and adults - 1-2 grams per day in 2-3 doses.

Side effects:

From the digestive system: rarely - lack of appetite, nausea, heartburn, vomiting, diarrhea, pseudomembranous colitis; in some cases - increased activity of liver transaminases, impaired bile outflow and jaundice.

Allergic reactions: rarely - urticaria.

Others: in some cases - dose-dependent transient hearing impairment.

Overdose:

Liver dysfunction, hearing loss, increased side effects. Treatment is symptomatic.

Interaction:

When taken simultaneously with lincomycin, the activity of both drugs decreases.

The drug enhances the nephrotoxicity of cephalosporin.

The drug may reduce the contraceptive effect of hormonal contraceptives.

Alcohol - an increase in the maximum concentration of alcohol in the blood by 40% when used simultaneously with josamycin for intravenous administration.

Alfentanil - increase the period of action of alfentanil with long-term use of macrolides (inhibition of liver enzymes).

Astemizole, terfenadine, cisapride - increased risk of toxic effects on the heart, ventricular fibrillation-flutter, paroxysmal tachycardia and death. Use is contraindicated!

Warfarin - increased risk of bleeding, especially in the elderly, due to an increase in prothrombin time, weakening of the metabolism and clearance of warfarin; use requires monitoring of prothrombin time.

Glucocorticoids - suppression of their biotransformation.

Digoxin - an increase in its content due to the obstruction of inactivation in the intestines (changes in intestinal flora under the influence of josamycin).

Other drugs that have ototoxic effects increase the risk of the latter, especially when using high doses and in cases of impaired renal function.

Carbamazepine - an increase in their concentration in the blood, the development of a toxic effect, simultaneous use is not recommended.

Xanthines: (aminophylline), - increasing the concentration in the blood and toxicity of xanthines due to a decrease in their clearance in the liver (after 6 days).

Penicillins and cephalosporins are an obstacle to the development of the bactericidal effect of penicillins due to their bacteriostatic effect.

Agents that have a hepatotoxic effect increase the risk of toxic effects on the liver.

Drugs that prolong the QT interval increase the risk of arrhythmias.

Statins - increased risk of acute rhabdomyolysis after completion of treatment with erythromycin.

Triazolam and - enhancing the pharmacological effects of these drugs by reducing their clearance.

Special instructions:

For patients with chronic kidney disease, special dosage selection is required.

When prescribing the drug to newborns, monitoring of liver function is necessary.

If pseudomembranous colitis develops, the drug should be discontinued and appropriate therapy prescribed. Drugs that reduce intestinal motility are contraindicated.

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

Instructions

Registration number:

Tradename: VILPRAFEN SOLUTAB

International Nonproprietary Name (INN): Josamycin

Dosage form: dispersible tablets

Composition for 1 tablet

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.

Description:

White or white with a yellowish tint, oblong-shaped tablets, sweet, with the smell of strawberries. With the inscription “JOSA” and a line mark on one side of the tablet and the inscription “1000” on the other.

Pharmacotherapeutic group: antibiotic, macrolide.

ATS code: J01FA07

Pharmacological properties

Pharmacodynamics.
The drug is used to treat bacterial infections; The bacteriostatic activity of josamycin, like other macrolides, is due to inhibition of bacterial protein synthesis. When high concentrations are created at the site of inflammation, it has a bactericidal effect.
Josamycin is highly active against intracellular microorganisms (Chlamydia trachomatis and Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Legionella pneumophila); gram-positive bacteria (Staphylococcus aureus, Streptococcus pyogenes and Streptococcus pneumoniae (pneumococcus), Corynebacterium diphteriae), gram-negative bacteria (Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis), as well as against some anaerobic bacteria (Peptococcus, Peptostreptococcus, Clo stridium perfringens). It has a slight effect on enterobacteria, and therefore little changes the natural bacterial flora of the gastrointestinal tract. Effective against resistance to erythromycin. Resistance to josamycin develops less frequently than to other macrolide antibiotics.

Pharmacokinetics.
After oral administration, josamycin is quickly and completely absorbed from the gastrointestinal tract; food intake does not affect bioavailability. The maximum serum concentration of josamycin is achieved 1-2 hours after administration. About 15% of josamycin is bound to plasma proteins. Particularly high concentrations of the substance are found in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in plasma by 8-9 times. Accumulates in bone tissue. Crosses the placental barrier and is secreted into breast milk. Josamycin is metabolized in the liver to less active metabolites and excreted mainly in bile. Excretion of the drug in urine is less than 20%.

Indications for use

Acute and chronic infections caused by microorganisms sensitive to the drug, for example:
Infections of the upper respiratory tract and ENT organs:
Sore throat, pharyngitis, paratonsillitis, laryngitis, otitis media, sinusitis, diphtheria (in addition to treatment with diphtheria toxoid), as well as scarlet fever in case of hypersensitivity to penicillin.
Lower respiratory tract infections:
Acute bronchitis, exacerbation of chronic bronchitis, pneumonia (including those caused by atypical pathogens), whooping cough, psittacosis.
Dental infections
Gingivitis and periodontal diseases. Infections in ophthalmology Blepharitis, dacryocystitis.
Skin and soft tissue infections
Pyoderma, furunculosis, anthrax, erysipelas (with hypersensitivity to penicillin), acne, lymphangitis, lymphadenitis, lymphogranuloma venereum.
Infections of the genitourinary system
Prostatitis, urethritis, gonorrhea, syphilis (with hypersensitivity to penicillin), chlamydial, mycoplasma (including ureaplasma) and mixed infections.

Contraindications

hypersensitivity to macrolide antibiotics, severe liver dysfunction

Pregnancy and lactation

Use during pregnancy and breastfeeding is permitted after a medical assessment of the benefits/risks. WHO Europe recommends josamycin as the drug of choice for the treatment of chlamydial infection in pregnant women.

Directions for use and doses

The recommended daily dosage for adults and adolescents over 14 years of age is 1 to 2 g of josamycin. The daily dose should be divided into 2-3 doses. If necessary, the dose can be increased to 3 g per day.
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.
Usually the duration of treatment is determined by the doctor. In accordance with the recommendations of the World Health Organization on the use of antibiotics, the duration of treatment for streptococcal infections should be at least 10 days.

In anti-Helicobacter therapy regimens, josamycin 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 (famotidine 40 mg/day or ranitidine 150 mg 2 times a day + josamycin 1 g 2 times a day). day + metronidazole 500 mg twice a day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) twice a day + amoxicillin 1 g twice a day + josamycin 1 g twice a day; omeprazole 20 mg (or lansoprazole 30 mg, or pantoprazole 40 mg, or esomeprazole 20 mg, or rabeprazole 20 mg) twice a day + amoxicillin 1 g twice a day + josamycin 1 g twice a day + bismuth tripotassium dicitrate 240 mg twice a day: famotidine 40 mg/day + furazolidone 100 mg twice a day + josamycin 1 g twice a day + bismuth tripotassium dicitrate 240 mg twice a day).

In the presence of atrophy of the gastric mucosa with achlorhydria, confirmed by pH-metry: Amoxicillin 1 g 2 times a day + josamycin 1 g 2 times a day + tripotassium bismuth d and citrate 240 mg 2 times a day.

For acne vulgaris and acne globulus, it is recommended to prescribe josamycin 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.

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

Side effect

From the gastrointestinal tract
Rarely - loss of appetite, nausea, heartburn, vomiting, dysbacteriosis and diarrhea. In the case of persistent severe diarrhea, one should keep in mind the possibility of life-threatening pseudomembranous colitis developing against the background of antibiotics.
Hypersensitivity reactions:
In extremely rare cases, allergic skin reactions (for example, urticaria) are possible.
From the liver and biliary tract
In some cases, a transient increase in the activity of liver enzymes in the blood plasma was observed, in rare cases accompanied by a violation of the outflow of bile and jaundice.
From the hearing aid
In rare cases, dose-related transient hearing impairment has been reported.
Others: very rarely - candidiasis.

Overdose and other errors when taking

To date, there is no data on specific symptoms of poisoning. In case of overdose, the symptoms described in the “Side Effects” section should be expected, especially from the gastrointestinal tract. If one dose is missed, you must immediately take a dose of the drug. However, if it is time for the next dose, do not take the “forgotten” dose, but return to your normal treatment regimen. You should not take double the dose. A break in treatment or premature discontinuation of the drug will reduce the likelihood of treatment success.

Interaction with other drugs

Vilprafen Solutab / other antibiotics
Since bacteriostatic antibiotics can reduce the bactericidal effect of other antibiotics, such as penicillins and cephalosporins, co-administration of josamycin with these types of antibiotics should be avoided. Josamycin should not be prescribed together with lincomycin, as a mutual decrease in their effectiveness is possible.
Vilprafen Solutab / xanthines
Some representatives of macrolide antibiotics slow down the elimination of xanthines (theophylline), which can lead to possible intoxication. Clinical experimental studies indicate that josamycin has less effect on theophylline release than other macrolide antibiotics.
Vilprafen Solutab / antihistamines
After co-administration of josamycin and antihistamines containing terfenadine or astemizole, there may be a slowdown in the elimination of terfenadine and astemizole, which in turn can lead to the development of life-threatening cardiac arrhythmias.
Vilprafen Solutab / ergot alkaloids
There are individual reports of increased vasoconstriction following co-administration of ergot alkaloids and macrolide antibiotics. There was one case of patient's lack of tolerance to ergotamine while taking josamycin. Therefore, the concomitant use of josamycin and ergotamine should be accompanied by appropriate monitoring of patients.
Vilprafen Solutab / cyclosporine
Co-administration of josamycin and cyclosporine may cause an increase in the level of cyclosporine in the blood plasma and the creation of nephrotoxic concentrations of cyclosporine in the blood. Plasma concentrations of cyclosporine should be regularly monitored.
Vilprafen Solutab / digoxin
When administered together, josamycin and digoxin may increase the level of the latter in the blood plasma.
Vilprafen Solutab / hormonal contraceptives
In rare cases, the contraceptive effect of hormonal contraceptives may be insufficient during treatment with macrolides. In this case, it is recommended to additionally use non-hormonal contraception.

special instructions

In patients with renal failure, treatment should be carried out taking into account the results of appropriate laboratory tests.
The possibility of cross-resistance to different macrolide antibiotics should be considered (for example, microorganisms that are resistant to treatment with antibiotics related in chemical structure may also be resistant to josamycin).

Release form: dispersible tablets 1000 mg.
Standard Packing:
5 or 6 tablets dispersible in a blister made of polyvinyl chloride film and aluminum foil. 2 blisters along with instructions for use in a cardboard box.

Best before date: 2 years

Vilprafen Solutab should not be used after the expiration date indicated on the package.

Storage conditions

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

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription

Registration applicant (RU owner)

Astllas Pharma Europe B.V., Elisabethof 19, 2353 EB Leiderdorp,
Netherlands / Astellas Pharma Europe B.V.,
Elisabethhof 19,2353 EW Leiderdorp, The Netherlands.

Manufacturer:
Montefarmaco S.
Italy/Montefarmaco S.p.A.
Via Galilei, n.7,20016 Pero (MI), Italy

Packer (primary packaging)
Montefarmaco S.p.A., Italy

Packer (secondary/tertiary packaging)
Montefarmaco S.p.A., Italy or Temmler Italia S.r.L., Italy
Issue quality control
Temmler Italia S.r.L., Italy
Subject to packaging at ORTAT CJSC
Manufacturer Montefarmaco S.
Italy/Montefarmaco S.p.A. Via Galilei, n.7,20016 Pero (MG), Italia

Packer and release control
ZAO ORTAT, Russia
157092, Kostroma region, Susaninsky
district, village Severnoe, Mr. Kharitonovo.

Send claims to the Moscow Representative Office of Astellas
Pharma Yuroy B.V. by the address:
109147 Moscow, Marksistskaya st. 16,
"Mosalarco Plaza-1" business center,

| Josamycin

Analogs (generics, synonyms)

Azivok, Azitral, Azitrox, Azithromycin, AzitRus, Azicide, Arvicin, Arvicin retard, Benzamicin, Binoclair, Vilprafen, Vilprafen solutab, Grunamycin syrup, Dinabak, Zetamax retard, Zimbaktar, Zinerit, Zitrolide, Zitrocin, Ilozon, Klabaks, Klarbakt, Clarithromycin, Claricin, Klasine, Klatsid, Kriksan, Xitrocin, Lecoclar, Macropen, Oleandomycin phosphate, Oletetrin, Pilobact, Rovamycin, Roxide, Roxilor, Roxithromycin, Romiclar, Rulide, Safocid, Spiramycin, Sumaklid, Sumamed, Sumamecin, Sumamox, Sumatrolide sol YouTube, Fromilid, Fromilid Uno, Hemomycin, Ecomed, Elrox, Erythromycin, Ermitsed, Esparoxi

Recipe (international)

Rp.: Tab. Josamycini 0.5.
D.S.: Take 2 tablets 2 times a day.

Prescription form - 107-1/у (Russia)

pharmachologic effect

Reversibly binds to the 50S ribosomal subunit, inhibits protein synthesis and the reproduction of microbial cells (bacteriostatic effect). When high concentrations are created at the site of inflammation, it has a bactericidal effect. It has a wide spectrum of action, including gram-positive (Staphylococcus spp., producing and not producing penicillinase, Streptococcus spp., including Streptococcus pyogenes and Streptococcus pneumoniae, Bacillus anthracis, Corynebacterium diphtheriae) and gram-negative (Neisseria gonorrhoeae, Neisseria meningitidis, some species Shigella, Haemophilus influenzae, Bordetella pertussis) bacteria, intracellular microorganisms (Mycoplasma spp., including Mycoplasma hominis, Mycoplasma pneumoniae, Chlamydia spp., including Chlamydia trachomatis, Chlamydia pneumoniae, Ureaplasma urealyticum, Legionella pneumophila) and some anaerobes (Peptococcus, Peptostreptococcus, Clostridium perfringens, Bacteroides fragillis). It has a slight effect on enterobacteria, and therefore little changes the natural bacterial flora of the gastrointestinal tract. Effective against resistance to erythromycin. Resistance to josamycin develops less frequently than to other macrolide antibiotics.

When administered to pregnant female mice and rats during the period of organogenesis at a high dose (3 g/kg), it increased mortality rates and caused fetal growth retardation without signs of teratogenic effects.

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract; food intake does not affect bioavailability. Cmax in serum is achieved after 1-2 hours and is at a single dose of 400 mg - 0.33 mg/l, 500 mg - 0.67-0.71 mg/l, 1000 mg - 2.4 mg/l, 1250 mg - (2.08±1.13) mg/l, 2000 mg - (5.79±2.47) mg/l. Plasma protein binding is about 15%. It is well soluble in fats and ionizes little at normal pH values ​​of blood and tissue fluids, and penetrates well through histohematic barriers into various organs and tissues. Distribution volume - 300.56 l. Particularly high concentrations are found in the lungs, tonsils, saliva, sweat and tear fluid. The concentration in sputum exceeds the concentration in blood plasma by 8-9 times.

Accumulates in bone tissue. It can penetrate and accumulate in adenoids, middle ear exudate, paranasal sinus secretions, gums, and prostate gland. It practically does not penetrate into the cerebrospinal fluid, passes through the placenta and is secreted into breast milk. Biotransforms in the liver to form less active metabolites. At least three metabolites have been detected: 14-hydroxyjosamycin, hydroxyjosamycin and deisovaleryljosamycin. T1/2 - 4 hours.

Excreted mainly in bile, less than 20% in urine.

Mode of application

For adults: When taken orally by adults and children over 14 years of age - 1-2 g per day in 2-3 divided doses. Children under 14 years of age - 30-50 mg/kg per day in 3 divided doses. The duration of treatment depends on the indications for use.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to josamycin:

infections of the upper respiratory tract and ENT organs (including pharyngitis, tonsillitis, paratonsillitis, otitis media, sinusitis, laryngitis);
diphtheria (in addition to treatment with diphtheria antitoxin);
scarlet fever (with hypersensitivity to penicillin);
lower respiratory tract infections (including acute bronchitis, bronchopneumonia, pneumonia, including atypical form, whooping cough, psittacosis);
oral infections (including gingivitis and periodontal disease);
infections of the skin and soft tissues (including pyoderma, boils, anthrax, erysipelas (with hypersensitivity to penicillin), acne, lymphangitis, lymphadenitis);
infections of the urinary tract and genital organs (including urethritis, prostatitis, gonorrhea;
with hypersensitivity to penicillin - syphilis, lymphogranuloma venereum);
chlamydial, mycoplasma (including ureaplasma) and mixed infections of the urinary tract and genital organs.

Contraindications

Hypersensitivity (including to other macrolides), severe liver dysfunction, prematurity of children

Side effects

lack of appetite;
nausea,
vomit;
heartburn;
diarrhea;
pseudomembranous colitis;
increased activity of liver transaminases; violation of the outflow of bile and jaundice;
hives;
dose-dependent transient hearing impairment.

Release form

Film-coated tablets 500 mg and 1000 mg.

ATTENTION!

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