Jozamycin - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Macrolides and Azalides

Included in the formulation

Wilprafen®

pills inwards

Astellas Farma Europe BV Netherlands

Wilprafen®

granules inwards

Astellas Farma Europe BV Netherlands

Wilprafen® solutab®

pills inwards

Astellas Farma Europe BV Netherlands

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

ONLS

АТХ:

J.01.F.A.07 Josamycin

Pharmacodynamics:

The drug is an antibiotic of the macrolide group with predominantly Gram-positive action spectrum. Bacteriostatic effect of the drug is due to inhibition of protein synthesis in bacteria at the stage of translocation. At high local concentrations, it exhibits bactericidal action. The drug is particularly 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:

Quickly absorbed in the gastrointestinal tract regardless of food, the connection with plasma proteins is not more than 15%, is metabolized in the liver, excreted with bile and urine (20%).

Indications:

Infections of the skin and soft tissues; andinfection of the genitals and urinary tract; Infectious and inflammatory diseases caused by microorganisms sensitive to dzhozamycin; diphtheria; infections of the lower respiratory tract; infection of the oral cavity; chlamydial,mycoplasmal and mixed infections of the urinary tract and genital organs; scarlet fever.

ICD-10

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 Erys

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 parts of the genito-urinary tract

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

I.A50-A64.A56.4 Chlamydial pharyngitis

I.A70-A74.A70 Infection caused by Chlamydia psittaci

I.B95-B97.B96.0 Mycoplasma pneumoniae [M.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 disease

XI.K00-K14.K12 Stomatitis and related lesions

XII.L00-L08.L01 Impetigo

XII.L00-L08.L02 Abscess of skin, boil and carbuncle

XII.L00-L08.L03 Phlegmon

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

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 cellulite

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

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

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

Contraindications:

Dysfunction of the liver, hypersensitivity, prematurity of children.

Carefully:

Interval lengthening QT, arrhythmias (in the anamnesis), renal failure, jaundice, porphyria, breast-feeding, myasthenia gravis.

Pregnancy and lactation:

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

In the treatment of macrolides and the simultaneous use of hormonal contraceptives should additionally use non-hormonal contraceptives.

Dosing and Administration:

Inside. Children under the age of 14 years - 30-50 mg / kg per day for 3 admission.

Children over 14 years and adults - 1-2 grams per day for 2-3 hours.

Side effects:

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

Allergic reactions: rarely - hives.

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

Overdose:

Violations of liver function, loss of hearing, increased side effects. Treatment is symptomatic.

Interaction:

With simultaneous administration with lincomycin, the activity of both drugs decreases.

The drug enhances the nephrotoxicity of cephalosporin.

The drug can reduce the contraceptive effect of hormonal contraceptives.

Alcohol - increasing the maximum concentration of alcohol in the blood by 40% with simultaneous application with jozamycin for intravenous administration.

Alfentanil - an increase in the period of action of alfentanil with prolonged use of macrolides (inhibition of liver enzymes).

Astemizole, terfenadine, cisapride - increased risk of toxic effects on the heart, fibrillation-fluttering of the ventricles, paroxysmal tachycardia and death. The use is contraindicated!

Warfarin - increased risk of bleeding, especially in the elderly, by increasing prothrombin time, weakening metabolism and clearance of warfarin, the use requires monitoring of prothrombin time.

Glucocorticoids - suppression of their biotransformation.

Digoxin - an increase in its content, due to an obstacle inactivation in the intestine (alteration of the intestinal flora under the influence of josamycin).

Other drugs that have ototoxic effect are an increased risk of the latter, especially when using high doses and in violation of kidney function.

Carbamazepine, valproic acid - an increase in their concentration in the blood, the development of toxic effects, simultaneous use is not recommended.

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

Penicillins and cephalosporins - an obstacle to the development of the bactericidal effect of penicillins due to bacteriostatic action.

Means that have a hepatotoxic effect are an increased risk of toxic effects on the liver.

Means that extend the QT interval, is an increased risk of arrhythmias.

Statins - increased risk of acute rhabdomyolysis after the end of erythromycin treatment.

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

Special instructions:

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

When prescribing the drug, the newborn needs control of the liver function.

In the case of pseudomembranous colitis josamycin should be abolished and appropriate therapy prescribed. Drugs that reduce intestinal motility are contraindicated.

Consideration should be given to the possibility of cross-resistance to various antibiotics of the macrolide group (eg, microorganisms resistant to treatment with antibiotic-related chemical structures,may also be resistant to dzhozamycin).

Instructions

Josamycin (Josamycinum)