active substance: clarithromycin ( clarithromycin )
1 tablet contains 250 mg or 500 mg of clarithromycin;
auxiliary substances: corn starch, microcrystalline cellulose, magnesium stearate, silicon colloidal dioxide, povidone, sodium croscarmellose;
shell: gipromelloza, titanium dioxide (E 171), talc, propylene glycol.
Antibacterial agents for systemic use. Macrolides. ATC code J01F A09.
Treatment of infections caused by susceptible to clarithromycin microorganisms:
Infections of the upper respiratory tract, i.e. nose and throat (tonsillitis, pharyngitis), and infection of the paranasal sinuses.
Infections of the lower respiratory tract (bronchitis, acute lobar pneumonia and primary atypical pneumonia).
Infections of skin and soft tissues (impetigo, folliculitis, erysipeloid, furunculosis, infected wounds).
Acute and chronic odontogenic infections.
Disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare. Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum or Mycobacterium kansasii.
H. pylori eradication in patients with duodenal ulcer during inhibition of hydrochloric acid secretion (clarithromycin activity in relation to H. pylori in neutral pH is higher than in acid pH).
Hypersensitivity to macrolide antibiotics and other components of the drug.
The simultaneous use of any of the following drugs: astemizole, cisapride, pimozide, terfenadine (this can lead to prolonged QT interval and development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and piruetas ventricular tachycardia ( torsades de pointes )), ergot alkaloids , for example ergotamine, dihydroergotamine (this can lead to ergotoxine), inhibitors of HMG-COA reductase inhibitors (statins), which are largely metabolized by CYP3A4 (lovastatin or simvastatin) (increased risk of myopathy, including rhabdomyolysis (see "Peculiarities of use" , "Interaction with other medicinal products and other forms of interaction").
The simultaneous use of clarithromycin and oral midazolam (see "Interaction with other medicinal products and other forms of interaction").
Prolonged QT interval or ventricular arrhythmia in anamnesis, including piruetas ventricular tachycardia ( torsades de pointes ) (see "peculiarities of use", "Interaction with other medicinal products and other forms of interaction").
Hypokalemia (risk of PROLONGATION of Qt interval).
Severe hepatic insufficiency and concomitant renal insufficiency.
Concomitant use of clarithromycin (and other strong CYP3A4 inhibitors) with colchicin in patients with renal or hepatic insufficiency (see "application Features", "Interaction with other drugs and other types of interactions").
CC less than 30 ml/min (because this form of drug does not reduce the dose below 500 mg per day).
Simultaneous use of clarithromycin with ticagrelor or ranolazine.
Method of application and doses
The recommended dose of clarithromycin for adults and children over 12 years is 250 mg (1 tablet) every 12:00, with more severe infections, the dose can be increased to 500 mg (2 tablets 250 mg) every 12:00. Usually, the duration of treatment depends on the severity of infection and ranges from 6 to 14 days.
Clarithromycin Grindeks you can apply with or without food since food does not affect the bioavailability of clarithromycin.
Treatment of odontogenic infections.
The recommended dose is 250 mg every 12: 00 for 5 days.
Application to patients with mycobacterial infection.
The initial dose for adults is 500 mg twice a day. If within 3-4 weeks of treatment is not observed improvement in clinical signs or biological indicators, the dose of clarithromycin can be increased up to 1000 mg twice a day.
Treatment of disseminated infections caused by POPPY in AIDS patients lasts as long as the clinical and microbiological efficacy of the drug, which has medical confirmation, lasts. Clarithromycin can be used in combination with other antimycobacterials means.
Eradication of H. pylori in patients with duodenal ulcer (adults).
Triple therapy (7-10 days).
Clarithromycin (500mg) twice a day should be used in conjunction with amoxicillin 1000 mg twice daily and omeprazole 20 mg per day for 7-10 days.
Triple therapy (10 days).
Clarithromycin (500mg) twice a day, lansoprazole 30 mg twice daily and amoxicillin 1000 mg twice a day for 10 days.
Double therapy (14 days).
Clarithromycin (500 mg) three times a day together with omeprazole 40 mg once a day inside for 14 days, further omeprazole 20 mg or 40 mg once a day inside for the next 14 days.
Double therapy (14 days).
Clarithromycin (500 mg) three times a day together with lansoprazole 60 mg once a day inside for 14 days. You may have to further inhibition of secretion of hydrochloric acid to reduce symptoms of an ulcer.
Clarithromycin is also used in such therapeutic regimens:
clarithromycin + tinidazole and omeprazole or lansoprazole;
clarithromycin + metronidazole and omeprazole or lansoprazole;
clarithromycin + tetracycline, bismuth bismuth and ranitidine;
clarithromycin + lansoprazole and amoxicillin;
clarithromycin + ranitidine, bismuth citrate.
Application in elderly patients: as for adults.
Use in patients with renal insufficiency in patients with severe renal insufficiency (creatinine clearance
Frequent and common adverse reactions in the treatment of clarithromycin adults and children is abdominal pain, diarrhea, nausea, vomiting and taste disorder. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics. No significant differences in the frequency of these adverse reactions were found between groups of patients who had or did not have mycobacterial infections during clinical trials.
The following are adverse reactions that have occurred during clinical trials and in the postmarketing application of various dosage forms and doses of clarithromycin, including immediate release. Adverse reactions, at least likely associated with clarithromycin, distributed among organ systems and frequency of occurrence: more than 10% - very often, 1-10% - often, 0.1-1% - infrequently, and with an unknown frequency * (adverse reactions in postmarketing study; frequency can not be determined from the available data). Within each group, adverse reactions are presented in descending order of severity if severity can be assessed.
Infections and infestations: infrequently - cellulite 1 , candidiasis of the oral cavity, gastroenteritis 2 , infection 3 , vaginal infection; with an unknown frequency - pseudomembranous colitis, erysipelas.
From the blood and lymphatic system: infrequently-leukopenia, neutropenia 4, thrombocytemia 3, eosinophilia 4; with an unknown frequency-agranulocytosis, thrombocytopenia.
From the immune system: infrequently-anaphylactoid reactions 1, hypersensitivity; with an unknown frequency-anaphylactic reactions, angioedema.
From the metabolic and nutritional: rarely - anorexia, loss of appetite with unknown frequency of hypoglycemia.
From the psyche: often-insomnia; infrequently-anxiety, nervousness 3 ; with an unknown frequency-psychosis, confusion, depression, depression, disorientation, hallucinations, nightmare, mania.
CNS: frequently - dysgeusia (violation of taste sensitivity), headache, taste disturbance; rarely, loss of consciousness 1 , 1 dyskinesia , dizziness, somnolence, tremor with unknown frequency - convulsion, ageusia (loss of taste sensitivity), parosmia, anosmia, paresthesia.
On the part of hearing and labyrinth: rare - dizziness, hearing loss, tinnitus with unknown frequency - hearing loss.
Heart: rarely, cardiac arrest 1 , atrial fibrillation 1 , prolonged QT interval, extrasystole 1 , heartbeat; unknown frequency - the type of pirouette ventricular tachycardia ( torsades de pointes ), ventricular tachycardia.
From the vascular system: often-vasodilation 1; with an unknown frequency-hemorrhage.
The respiratory system of the chest and mediastinum : rare - 1 asthma , epistaxis 2 , pulmonar