Clarithromycin 500mg tablets 10

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Hips(cm) 87.5-89.5 91.5 94 99
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Active substance: clarithromycin 500 mg.

Excipients: lactulosa - 600 mg, povidone-K25 - 18.2 mg, magnesium stearate - 13 mg, silicon dioxide colloidal (aerosil) - 8.66 mg, talc - 26 mg, potassium polakrylin - up to 1300 mg.

Shell composition: hypromellose - 14.28 mg, talc - 1.71 mg, titanium dioxide - 7.756 mg, macrogol-4000 - 6.21 mg, dye azorubin - 0.044 mg.

Pharmacological properties

Semi-synthetic antibiotic of the group of macrolides of a wide spectrum of action. Disrupts the protein synthesis of microorganisms (binds to the 50S-subunic membrane of the ribosome membrane of the microbial cell). It acts on extra- and intracellular pathogens. Clarithromycin activity against most of the following microorganisms has been proven in vitro and in clinical practice - aerobic gram-positive microorganisms: Listeria monocytogenes, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes; aerobic gram-negative microorganisms: Neisseria gonorrhoeae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila, Mycobacterium leprae, Mycobacterium chelonae, Mycobacterium kansasii, Mycobacterium fortuitum; other microorganisms: Mycoplasma pneumonia, Chlamydia pneumoniae; Mycobacterium avium complex (MAC) - complex including: Mycobacterium avium and Mycobacterium intracellulare; Helicobacter pylori.

β-lactamases do not affect the activity of clarithromycin.

Activity of clarithromycin in vitro - aerobic gram-positive microorganisms: Streptococcus agalactiae, Streptococci groups C, F, G, Streptococci groups viridans; aerobic gram-negative microorganisms: Bordetella pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; spirochetes: Borrelia burgdorferi, Treponema pallidum; Campylobacter: Campylobacter jejuni.

The microbiologically active metabolite of clarithromycin, 14-hydroxyclarythromycin, is twice as active as the original compound against Haemophilus influenzae. Clarithromycin and its metabolite in combination can have both additive and synergistic effects on Haemophilus influenzae in vitro and in vivo, depending on the strain of the bacterium.

Most strains of staphylococci resistant to methicillin and oxacillin are resistant to clarithromycin.

It is possible to develop cross-resistance to clarithromycin and other antibiotics of the macrolide group, as well as lincomycin and clindamycin.

Indications for use


  • pharyngitis;
  • tonsillitis;
  • acute sinusitis;
  • exacerbation of chronic bronchitis;
  • community-acquired pneumonia;
  • uncomplicated infections of the skin and subcutaneous tissue;
  • disseminated infection caused by Mycobacterium avium and Mycobacterium intracellulare.
  • in combination with amoxicillin and omeprazole/ lansoprazole in the form of triple therapy for infections caused by Helicobacter pylori, including duodenal ulcer.


  • pharyngitis;
  • tonsillitis;
  • community-acquired pneumonia;
  • acute sinusitis;
  • acute otitis media;
  • uncomplicated infections of the skin and subcutaneous tissue;
  • disseminated infection caused by Mycobacterium avium and Mycobacterium intracellulare.

hypersensitivity to clarithromycin, other antibiotics of the macrolide group, others components of the drug; severe liver failure, occurring simultaneously with renal failure; porphyria; hypokalemia; simultaneous administration of cisapride, astemizole, pimozide, terfenadine, ergotamine and other ergot alkaloids; simultaneous use with lovastatin and simvastatin, with midazolam for oral administration, with colchicine in patients with impaired renal or hepatic function taking P-glycoprotein inhibitors or potent inhibitors of the isoenzyme CYP3A4; the presence in patients of a prolongation of the QT interval in the anamnesis, ventricular arrhythmia or ventricular tachycardia of the "pirouette" type; cholestatic jaundice / hepatitis, which arose with the use of clarithromycin (in the anamnesis); children's age up to 12 years (for this dosage form); lactation (breastfeeding); lactose intolerance or lactase deficiency, and see also glucose-galactose malabsorption.

With caution:

  • renal failure of moderate and severe degree;
  • moderate and severe liver failure;
  • myasthenina gravis;
  • simultaneous use with drugs inducing and metabolizing the isoenzyme CYP3A4, benzodiazepines (alprazolam, triazolam, midazolam for iv use), antiarrhythmic drugs of class IA and III, blockers of slow calcium channels, which are metabolized by the isoenzyme CYP3A4;
  • CHD;
  • severe heart failure;
  • hypomagnesemia;

pronounced bradycardia

Use in pregnancy and lactation

The safety of clarithromycin during pregnancy has not been established. During pregnancy, especially in the first trimester, it is recommended to prescribe clarithromycin, if the benefit is from its reception exceeds the potential risk to the fetus and / or there is no safer therapy with alternative drugs. If pregnancy occurred while taking the drug, the patient should be warned about the possible risk to the fetus.

If necessary, the appointment of the drug during lactation should resolve the issue of canceling breastfeeding.

Use in case of impaired liver function

With caution, prescribe for moderate and severe liver failure.

Contraindicated use of the drug in severe liver failure, occurring simultaneously with renal failure.

Use in renal dysfunction

With caution, prescribe for renal failure of moderate and severe degree.

Use in children

Contraindicated use of this dosage form in children under the age of 12 years.

Special instructions

In the presence of chronic liver disease should be regularly monitored for serum enzyme activity.

With caution, the drug is prescribed against the background of therapy with drugs metabolized by the liver (it is recommended to measure their concentration in the blood).

In the case of joint appointment with warfarin or other anticoagulants, it is necessary to monitor prothrombin time and INR.

With the development of a secondary infection, adequate therapy should be prescribed.

If severe diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

Before using the drug, it is necessary to conduct a sensitivity test for the development of resistance of Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes to antibiotics of the macrolide group. Possible development of cross-resistance to clarithromycin and others antibiotics of the macrolide group. With prolonged use of the drug, the development of superinfection is possible.

The drug should be used with caution in patients with a predisposition to prolonging the QT interval.

In patients with coronary artery disease, severe heart failure, hypomagnesemia, severe bradycardia, taking clarithromycin, as well as with simultaneous use with antiarrhythmic drugs of class IA (quinidine, procainamide) and III (dofetilide, amiodarone, sotalol), electrocardiogram should be regularly monitored for an increase in the QT interval.

Against the background of the use of the drug, the development of pseudomembranous colitis, aggravation of the symptoms of myasthenia gravis may be observed.

When using clarithromycin, impaired liver function was reported (increased activity of hepatic transaminases hepatocellular and / or cholestatic hepatitis with or without jaundice). Impaired liver function can be severe, but are usually reversible. There are reports of fatal cases of liver failure, mainly associated with the presence of serious comorbidities and / or the simultaneous use of other drugs. When signs and symptoms of hepatitis appear, such as anorexia, jaundice, darkening of urine, itching, abdominal soreness on palpation, clarithromycin therapy should be stopped immediately. In the presence of chronic liver disease, it is necessary to conduct regular monitoring of serum enzymes.

If hypersensitivity reactions occur, the drug must be discontinued.

Dosage and Administration

The drug is taken orally. Tablets should be swallowed without chewing, washed down with a small amount of liquid.

Adults and children over 12 years of age and weighing more than 33 kg:

with pharyngitis and tonsillitis caused by Streptococcus pyogenes - 250 mg every 12 hours for 10 days;

in acute sinusitis - 500 mg every 12 hours for 14 days;

with exacerbation of chronic bronchitis caused by Haemophilus influenzae - 500 mg every 12 hours for 7-14 days; caused by Haemophilus parainfluenzae - 500 mg every 12 hours for 7 days; caused by Moraxella catarrhalis, Streptococcus pneumoniae - 250 mg every 12 hours for 7-14 days;

with community-acquired pneumonia caused by Haemophilus influenzae - 250 mg every 12 hours for 7 days; caused by Streptococcus pneumoniae, Chlamydia pneumoniae, Mycoplasma pneumoniae - up to 250 mg every 12 hours for 7-14 days;

for uncomplicated infections of the skin and subcutaneous tissue caused by Staphylococcus aureus, Streptococcus pyogenes - 250 mg every 12 hours for 7-14 days.

For the treatment and prevention of infections caused by Mycobacterium avium, prescribe 500 mg 2 times / day. The maximum daily dose is 1000 mg. Duration of treatment - 6 months or more.

For the purpose of eradication Helicobacter pylori

Combined treatment with three drugs:

  • clarithromycin - 500 mg, lansoprazole - 30 mg and amoxicillin - 1000 mg 2 times / day for 10-14 days;
  • clarithromycin - 500 mg, omeprazole - 20 mg and amoxicillin - 1000 mg 2 times / day for 10 days.

Combined treatment with two drugs:

  • clarithromycin - 500 mg 3 times / day, omeprazole - 40 mg / day for 14 days, with the appointment of omeprazole for the next 14 days at a dose of 20 mg / day.

For patients with chronic renal failure (QC less than 30 ml / min or serum creatinine concentrations of more than 3.3 mg / 100 ml), the dose is reduced by 2 times, or the interval is increased by 2 times. The maximum duration of treatment in patients in this group is 14 days.


Symptoms: abdominal pain, nausea, vomiting, diarrhea.

Treatment: gastric lavage, maintenance therapy. Not removed by hemo- or peritoneal dialysis.

Side effects

From the nervous system: headache, dizziness, drowsiness, anxiety, insomnia, nightmares, tremors, convulsions, depression, disorientation, hallucinations, psychosis, depersonalization, confusion, increased symptoms of myasthenia gravis, psychotic disorders, paresthesia, mania, intense sweating, anorexia, malaise, asthenia, chills, fatigue.

From the digestive system: deterioration of appetite, nausea, belching, vomiting, flatulence, gastritis, gastralgia, diarrhea, stomatitis, glossitis, candidiasis of the oral mucosa, discoloration of the tongue and teeth, dryness of the oral mucosa, acute pancreatitis, increased activity of hepatic transaminases, cholestasis, hepatocellular and cholestatic hepatitis, cholestatic jaundice; rarely - pseudomembranous colitis, liver failure with a fatal outcome, mainly against the background severe concomitant diseases and / or concomitant drug therapy, dyspepsia, constipation.

From the cardiovascular system: ventricular tachycardia, incl. type "pirouette", fluttering and flickering of the ventricles, an increase in the intreval QT on the ECG.

From the senses: noise, ringing in the ears, vertigo, change in taste (dysgeusia), ageusia; in isolated cases - hearing loss that passes after discontinuation of the drug, impaired sense of smell, anosmia.

From the skin and soft tissues: erythrasmus, acne, erysipelas.

From the musculoskeletal system: myalgia, myopathy, chest pain.

On the part of the hematopoietic organs: rarely - thrombocytopenia, (unusual bleeding, hemorrhages), agranulocytosis, thrombocytosis, prolongation of prothrombin time, increased in the level of INR.

From the urinary system: interstitial nephritis, renal failure.

Laboratory indicators: leukopenia, neutropenia, eosinophilia, increased concentration of bilirubin in the blood hypercreatininemia, hypoglycemia (including with simultaneous administration of hypoglycemic drugs), change in the color of urine.

Allergic reactions: skin rash, itching, urticaria, skin flushing, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis, anaphylactic reactions, drug rash with eosinophilia and systemic symptoms (DRESS-syndrome), Schönlein-Henoch purpura, hemorrhages.

Other: secondary infections (development of resistance of microorganisms).

Storage conditions

The drug should be stored in a dry, protected from light, out of the reach of children at a temperature not exceeding 25 ° C.

Shelf life - 3 years.

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Product Details

Data sheet

Dosage form
500 mg
Number of tablets
INN Russian
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