clarithromycin | Clarithromycin tablets coated. prolonged 500 mg 14 pcs.

Release form

Long-acting film-coated tablets.

Pharmacological action

Farmgroup: antibiotic-macrolide.

Pharmaceutical Action: Clarithromycin is a broad-spectrum, semi-synthetic macrolide antibiotic. The antibacterial effect of clarithromycin is carried out by suppressing protein synthesis due to the binding of bacterial ribosomes to the 50s subunit. Clarithromycin has a pronounced activity against a wide range of aerobic and anaerobic gram-positive and gram-negative organisms. The minimum inhibitory concentration of clarithromycin (MPC) is half that of erythromycin for most microorganisms.

14-hydroxy metabolite of clarithromycin also has antimicrobial activity. The minimum inhibitory concentrations of this metabolite are equal to or greater than the MIC of clarithromycin against H. influenzae 14-hydroxymetabolite twice as active as clarithromycin.

Clarithromncin exhibits in vitro activity against the following organisms - gram-positive aerobic bacteria: Staphylococcus aureus (sensitive to methicillin), Streptococcus agalactiae, Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus viridans and Listeria monocytogenes Gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni preferably intracellular microorganisms: Mycoplasma pneumonia Ureapticma urealyticum In addition, the drug is active on Streptococcus viridans and Listeria monocytogenes Gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni preferably intracellular microorganisms: Mycoplasma pneumonia, Ureaplasma urealyticum, Chlamydia trachomatis, Chlamydia pneumonia , Mycobacterium avium, Mycobacterium leprae, M. kansaii, M. chelonae, M. marinum, M. fortitum anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species Peptostreptococcus species. In addition, the drug is active on Streptococcus viridans and Listeria monocytogenes Gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni preferably intracellular microorganisms: Mycoplasma pneumonia, Ureaplasma urealyticum, Chlamydia trachomatis, Chlamydia pneumonia , Mycobacterium avium, Mycobacterium leprae, M. kansaii, M. chelonae, M. marinum, M. fortitum anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species Peptostreptococcus species. In addition, the drug is active on Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni, predominantly intracellular microorganisms: Mycoplasma pneumonia, Chlamydiaerium officiomium miumecomia mium cereum, M. marinum, M. fortitum anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species Peptostreptococcus species. In addition, the drug is active on Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni, predominantly intracellular microorganisms: Mycoplasma pneumonia, Chlamydiaerium officiomium miumecomia mium cereum, M. marinum, M. fortitum anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species Peptostreptococcus species. In addition, the drug is active on kansaii, M. chelonae, M. marinum, M. fortitum anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species Peptostreptococcus species. In addition, the drug is active on kansaii, M. chelonae, M. marinum, M. fortitum anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species Peptostreptococcus species. In addition, the drug is active onin relation to Toxoplasma species.

Clarithromycin has bactericidal activity against certain bacterial strains: Haemophilus influenzae Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Moraxella (Branhamella) catarrhalis Neisseria gonorrhoeae Helicobacter pylorierppybloblopplob.

Pharmacokinetics: Clarithromycin is rapidly and well absorbed from the gastrointestinal tract after oral administration. The microbiologically active metabolite 14-hydroxyclarithromycin is formed after the first passage through the liver. Eating does not affect the bioavailability of clarithromycin, however, it somewhat slows down the onset of clarithromycin absorption and the formation of 14-hydroxymetabolite. The pharmacokinetics of clarithromycin is non-linear in nature with an equilibrium concentration achieved 2 days after the start of the drug.

Clarithromycin is excreted in the urine, as well as in feces, mainly through bile. When taking 250 mg of clarithromycin 2 times / day. 15-20% of the administered dose is excreted unchanged in the urine. When taking 500 mg 2 times / day. urinary excretion is about 36%. 14-hydroxyclarithromycin is the main metabolite found in urine, it accounts for about 10-15%.

When taking 500 mg of clarithromycin 3 times / day. the concentration of clarithromycin in plasma is higher than when taking this dose 2 times / day.

The content of clarithromycin in tissues, including glandular and lung tissue, is several times higher than in circulating blood. At therapeutic concentrations, clarithromycin binds to plasma proteins by 80%.

Clarithromycin penetrates into the gastric mucus. Clarithromycin levels in the mucus and tissues of the stomach increase with combination therapy with omeprazole. Clarithromycin passes into breast milk.

Indications

Infections caused by microorganisms sensitive to clarithromycin: - lower respiratory tract infections (including acute and chronic bronchitis, pneumonia)

- upper respiratory tract infections (including sinusitis and pharyngitis)

- skin and soft infections - duodenal ulcer for eradication of Helicobacter pylori (as part of complex therapy with proton pump inhibitors).

Contraindications

- simultaneous administration with ergot derivatives

- simultaneous administration of the following drugs: cisapride, pimozide, terfenadine

- children under 12 years of age

- pregnancy and lactation.

- hypersensitivity to the antibiotics of the macrolide group.

Caution: for patients with impaired liver and kidney function.

Use during pregnancy and lactation

Safety of Clarithromycin-Teva during pregnancy and lactation has not been studied.

The drug passes into breast milk. If necessary, use during lactation should stop breastfeeding.

Special instructions

Taking clarithromycin tablets in children under 12 years of age is not recommended.

With the simultaneous administration of clarithromycin and warfarin, prothrombin time should be regularly monitored.

With the simultaneous administration of clarithromycin and digoxin, serum digoxin concentration should be monitored.

Composition

1 tablet: - clarithromycin 500 mg

Excipients: povidone, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.

Shell composition: Opadry II 31F58914 white (hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000, sodium citrate).

Dosage and administration

Inside, regardless of food intake.

Adults and children over 12 years of age (with a body weight of more than 40 kg): the standard dose is 250 mg 2 times a day, with an interval of 12 hours. With sinusitis, severe infections, including those caused by Haemophilus influenzae, the dose can be increased to 500 mg 2 times a day, with an interval of 12 hours.

The average duration of a course of treatment is 7-14 days.

For patients with liver failure, the recommended dose is 250 mg every 24 hours.

For patients with renal failure (creatinine clearance less than 30 ml / min. ) the recommended dose is 250 mg every 24 hours or, in more severe infections, 250 mg 2 times a day, with an interval of 12 hours.

With mycobacterial infections, 500 mg of the drug is prescribed 2 times a day, with an interval of 12 hours.

For common MAC infections in AIDS patients:

The recommended dose of clarithromycin for adults and children over 12 years old (with a body weight of more than 40 kg) is 500 mg 2 times a day, with an interval of 12 hours.

Treatment should be continued until there is clinical and microbiological evidence of its benefits. Clarithromycin should be prescribed in combination with other antimicrobial agents.

For the prevention of infections caused by MAC:

The recommended dose of clarithromycin for adults and children over 12 years of age (with a body weight of more than 40 kg) is 500 mg 2 times a day, with an interval of 12 hours.

With odontogenic infections, the dose of clarithromycin is 250 mg 2 times a day for 5 days.

To eradicate H. pylori

Combined treatment with three drugs:

Clarithromycin, 500 mg 2 times a day, in combination with lansoprazole, 30 mg 2 times a day, and amoxicillin 1000 mg 2 times a day, for 10 days.

Clarithromycin, 500 mg 2 times a day, in combination with amoxicillin, 1000 mg 2 times a day, and omeprazole, 20 mg / day, for 7-10 days.

Combined treatment with two drugs

Clarithromycin, 500 mg 3 times a day, in combination with omeprazole at a dose of 40 mg / day, for 14 days, with an appointment for the next 14 days, omeprazole at a dose of 20-40 mg / day.

Clarithromycin, 500 mg 3 times a day, in combination with lansoprazole at a dose of 60 mg / day, for 14 days. For complete healing of the ulcer, an additional decrease in the acidity of the gastric juice may be required.

Side effects

Usually, clarithromycin is well tolerated by

patients from the gastrointestinal tract: nausea, vomiting, dyspepsia, diarrhea, abdominal pain, stomatitis, glossitis, pancreatitis, candidiasis of the oral cavity, discoloration of the tongue and teeth rarely - pseudocolembrosis. Tooth discoloration is reversible and is usually restored by special treatment in a dental clinic. As with other antibiotics from the macrolide group, there may be impaired liver function, including increased activity of hepatic enzymes, hepatocellular and / or cholestatic hepatitis with or without jaundice. These liver dysfunctions can be severe, but they are usually reversible. Cases of liver failure and death have been very rare, mainly due to severe concomitant diseases and / or concomitant drug therapy.

On the part of the blood system: in exceptional cases - leukopenia and thrombocytopenia increase in serum creatinine.

From the central and peripheral nervous system: paresthesia, headache, olfaction disorders, change in taste sensations dizziness, agitation, insomnia, nightmares, fear, ringing in the ears, confusion, disorientation, hallucinations, psychosis, depersonalization reversible hearing loss cramps.

From the cardiovascular system: as with other macrolides, prolongation of the QT interval, ventricular tachycardia, polymorphic ventricular tachyarrhythmia (torsades de pointes).

From the musculoskeletal system: arthralgia, myalgia.

From the urinary system: isolated cases of increased creatinine in blood plasma, interstitial nephritis, renal failure.

Allergic reactions: urticaria, angioedema, anaphylactic shock, in rare cases, Stevens-Johnson syndrome, toxic elidermal necrolysis.

Other: rarely - hypoglycemia in patients, taking oral hypoglycemic drugs or insulin.

Drug interaction

With simultaneous administration of clarithromycin with cisapride, pimozide and terfenadine in plasmaIf there are increased concentrations of these drugs, which can cause an increase in the QT interval and heart rhythm disturbances, including ventricular tachycardia, ventricular fibrillation, arrhythmias, and torsade de pointes, similar effects are observed while taking astemizole and other macrolides.

Clarithromycin does not interact with oral contraceptives.

As with other macrolide antibiotics, the concomitant use of clarithromycin and other drugs metabolized with the participation of cytochrome P450 (warfarin, ergot alkaloids, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, tacroliminum concentration may increase) blood serum.

With the simultaneous use of clarithromycin and HMG-KoA reductase inhibitors (lovastatin, simvastatin) may develop rhabdomyolysis.

With the simultaneous administration of clarithromycin and theophylline, the concentration of theophylline in the blood serum and its toxicity increase.

The simultaneous administration of clarithromycin and warfarin or digoxin may be accompanied by an increase in the severity of their effects.

With the simultaneous administration of clarithromycin and carbamazepine, the effect of carbamazepine may be enhanced due to a decrease in the rate of excretion of carbamazepine.

With the simultaneous administration of clarithromycin and zidovudine (by mouth) for HIV-infected adult patients, it is possible to reduce the equilibrium concentration of zidovudine, this can be largely avoided by increasing the interval between doses of clarithromycin and zidovudine to 1-2 hours. For children, this interaction was not observed.

While taking ritonavir and clarithromycin for the latter, the pharmacokinetic parameters increase: AUC, Cmax, Cmin. For patients with normal renal function, dose adjustment is usually not required due to the wide therapeutic range of clarithromycin doses.

With the simultaneous use of clarithromycin and omeprazole, clarithromycin and lansoprazole, as well as clarithromycin and ranitidine, an increase in the concentration of drugs in blood plasma is possible, but usually dose adjustment is not required.

With the simultaneous use of clarithromycin and hypoglycemic agents, including insulin, in rare cases, the development of hypoglycemia is possible.

Overdose

Symptoms: gastrointestinal symptoms in one of the patients taking 8 g of clarithromycin there was a case of mental disorders, paranoid behavior, hypoglycemia, hypoxemia.

Treatment: gastric lavage, supportive care. Hemodialysis or peritoneal dialysis is ineffective, as for other macrolides.

Active ingredient

Clarithromycin

Terms and conditions

prescription

Dosage form

tablets prolong.

Indications

Injuries, Radiculitis, Rheumatoid arthritis, Hematomas58 Nephralgia31 zania

Chlamydia, Sinusitis, Pharyngitis, Otitis, Bronchitis, GI infections, Skin infections, Pneumonia

Pharmstandard-Tomsk, Russia