Claritrosin tablets 250 mg, 10 pcs. (clarithromycin)

Latin name

CLARITHROSIN

Release form

Tablets, film-coated yellow, round, biconvex in cross section - one layer of white or almost white.

Packaging



Pharmacological action

Clarithromycin is a semi-synthetic broad-spectrum antibiotic from the macrolide group. It has an antibacterial effect, interacting with the 50S ribosomal subunit of sensitive bacteria and inhibiting protein synthesis.

Sustained-release tablets are a uniform crystalline base, during the passage of which through the gastrointestinal tract provides a prolonged release of the active substance.

Clarithromycin showed high in vitro activity against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro clarithromycin is highly effective against Legionella pneumophila and Mycoplasma pneumoniae.

Enterobacteriaceae and Pseudomonas, as well as other lactose-free gram-negative bacteria, are resistant to clarithromycin.

Clarithromycin has been shown to have an antibacterial effect against the following pathogens: gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptocochemcus gheramelema hemofermelosa hemosaemeliomaemeriema gaefema gonorrhoeae, Legionella pneumophila, Pasteurella multocida, Helicobacter pylori, Campylobacter jejuni intracellular microorganisms: Mycoplasma pneumoniae, Chlamydophila (Chlamydia) pneumoniae (TWAR), Chlamydia trachomatis, Borrelia burgorferi anerobov: Clostridium perfringes, Peptococcus niger, Propionibacterium acnes, Bacteroides melaninogenicus Mycobacterium: Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC) - Mycobacterium avium, Mycobacterium intracellulare.

Production of -lactamase does not affect the activity of clarithromycin. Most strains of staphylococci resistant to methicillin and oxacillin are resistant to clarithromycin.

Clarithromycin has an effect in vitro against most strains of the following microorganisms (however, the safety and efficacy of clarithromycin in clinical practice has not been confirmed by clinical studies and the practical significance remains unclear): gram-positive aerobic microorganisms (Streptococcus agalactiae, Streptococci (groups C, F, G, Viridans) Gram-negative aerobic microorganisms - Bordetella pertussis, Pasteurella multocida Gram-positive anaerobic microorganisms - Clostridium perfringes, Peptococcus niger, Propionibacterium acnes Gram-negative erobnye microorganisms - Bacteroides melaninogenicus spirochete - Borrelia burgdorferi, Treponema pallidum and Campylobacter jejuni.

The main metabolite of clarithromycin in the human body is the microbiologically active metabolite 14-hydroxyclarithromycin. The microbiological activity of the metabolite is the same as that of the starting substance, or 1-2 times weaker against most microorganisms. The exception is Haemophilus influenzae, for which the metabolite is 2 times more effective. The starting material and its main metabolite have either an additive or synergistic effect against Haemophilus influenzae in vitro and in vivo, depending on the culture of the bacteria.

Indications

Treatment of infectious and inflammatory diseases, caused by clarithromycin sensitive pathogens:

- lower respiratory tract infections (bronchitis, community-acquired pneumonia)

- upper respiratory tract infections (pharyngitis, tonsillitis, sinusitis)

- skin and soft tissue infections (folliculitis, erysipelatous inflammation)

- to eradicate Helicobacter pylori and reduce the recurrence rate of duodenal ulcer

- common mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare

- prevention of spread infection of Mycobacterium avium complex (MAC).

Contraindications

- porphyria

- concomitant use of astemizole, cisapride, pimoside, terfenadine, ergotamine and other ergot alkaloids, midazolam for oral administration, alprazolam, triazolam srdlcp / isomaltases, fructose intolerance, glucose-galactose malabsorption

- lactation period

- children under 3 years old

- hypersensitivity to clarithromycin (including other macrolides) and other components of the drug a.

Precautions: renal or hepatic insufficiency, myasthenia gravis, concomitant use of drugs metabolized by the liver, concomitant use of colchicine, pregnancy.

Use during pregnancy and lactation

Use of the drug during pregnancy and lactation is only possible if the intended benefit to the mother outweighs the potential risk to the fetus.

Clarithromycin is excreted in breast milk, so if you need to prescribe the drug during lactation, you should stop breastfeeding.

Composition

1 tab. - clarithromycin 250 mg.

Excipients: povidone (polyvinylpyrrolidone) - 21 mg, sodium carboxymethyl starch - 40 mg, lactose monohydrate - 20 mg, potato starch - 60.5 mg, colloidal silicon dioxide (aerosil) - 5 mg, magnesium stearate - 5 mg, talc - 15 mg microcrystalline cellulose - up to 500 mg.

Shell composition: hypromellose - 10.53 mg, titanium dioxide - 3.85 mg, macrogol 4000 - 10.52 mg, dye tropeolin O - 0.1 mg.

Dosage and administration

The drug is taken orally, regardless of food intake.

Adults and children over 12 years old and / or weighing more than 33 kg are prescribed 250 mg every 12 hours. The course of treatment is 7-14 days.

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.

In case of exacerbation of chronic bronchitis caused by Naemorhilus influenzae, 500 mg every 12 hours for 7-14 days caused by Naemorhilus parainfluenzae 500 mg every 12 hours for 7 days caused by Moraxella catarrhalis, Streptococcus pneumoniae 250 mg every 12 hours within 7-14 days.

In community-acquired pneumonia caused by Naemorhilus influenzae, 250 mg every 12 hours for 7 days caused by Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydophila (Chlamydia) pneumoniae - 250 mg every 12 hours for 7-14 days.

In 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 prevention and treatment of infections caused by MAC, the recommended dose of clarithromycin is 500 mg 2 times / day. The duration of treatment is 6 months or more. The maximum daily dose is 1 g.

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

For the eradication of Helicobacter pylori

Combined treatment with three

preparations - clarithromycin 500 mg 2 times / day + lansoprazole 30 mg 2 times / day + amoxicillin 1000 mg 2 times / day for 10 days

- clarithromycin 500 mg 2 / day + omeprazole 20 mg / day 2 times / day + amoxicillin 1000 mg 2 times / day for 10 days.

Combined treatment with two

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

For children from 3 to 12 years of age, clarithromycin is prescribed in a daily dose of 15 mg / kg, divided into 2 doses for 10 days. The maximum daily dose is 1 g (1000 mg).

In patients with chronic renal failure with creatinine clearance less than 30 ml / min or with a serum creatinine content of more than 290 μmol / l (3.3 mg / 100 ml), the dose should be reduced by 2 times or the interval between doses should be doubled. The maximum duration of treatment in patients of this group is 14 days.

Side effects of the digestive system: dyspepsia, nausea, vomiting, gastralgia, diarrhea, stomatitis, glossitis, candidiasis of the oral mucosa, discoloration of the tongue and teeth, acute pancreatitis, increased activity of hepatic transaminases, hepatocellular and hepatic cholestate jaundice pseudomembranous colitis fatal liver failure, mainly against the background of severe concomitant diseases and / or concomitant drug therapy.

From the nervous system: headache, dizziness, anxiety, insomnia, confusion, disorientation, hallucinations, depersonalization, a sense of fear, psychosis, nightmares, depression, convulsions.

From the urinary system: interstitial nephritis, hypercreatininemia.

On the part of the sensory organs: noise, ringing in the ears, taste change, hearing loss that occurs after drug withdrawal, impaired smell.

From the hemopoietic system: thrombocytopenia (unusual bleeding, hemorrhage), leukopenia.

From the cardiovascular system: ventricular tachycardia, incl. such as pirouette, flutter and ventricular fibrillation, prolongation of the QT interval on the ECG.

Allergic reactions: skin rash, pruritus, urticaria, anaphylactic reactions, flushing of the skin, Stevens-Johnson syndrome, toxic epidermal necrolysis.

From the endocrine system: hypoglycemia (including while taking hypoglycemic agents).

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

Drug Interaction

Co-administration of clarithromycin and drugs primarily metabolised by CYP3A isoenzyme may increase their concentrations, which can enhance or prolong both therapeutic and side effects. Co-administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, alprazolam, midazolam, triazolam is contraindicated. srd srl is prescribed with carbamazepine, cilostazol, cyclosporin, disopyramine, methylprednisolone, omeprazole, indirect anticoagulants (incl. warfarin, rifabutin, sirol through other cytochrome P450 isoenzymes). It is necessary to adjust the dose of the drug and control the concentration in the blood.

When co-administered with cisapride, pimozide, terfenadine and astemizole, it is possible to increase the concentration of the latter in the blood, prolong the QT interval, arrhythmia, including ventricular tachycardia, including such as pirouette and ventricular fibrillation.

When combined with ergotamine and dihydroergotamine, acute poisoning with ergotamine (vascular spasm, ischemia of the extremities and other tissues, CNS) is possible.

Efavirenz, nevirapine, rifampicin, rifabutin and rifapentin (cytochrome P450 inducers) reduce plasma clarithromycin concentrations and attenuate its therapeutic effect and, at the same time, increase 14-hydroxyclarithromycin concentrations.

Fluconazole 200 mg / day and clarithromycin 1 g / day may be co-administered with claritromycin CCs and AUC by 33% and 18%, respectively. No dose adjustment for clarithromycin is required.

Co-administration of ritonavir with 600 mg / day and clarithromycin 1 g / day may reduce clarithromycin metabolism (Cmax increase by 31%, CCS by 182% and AUC by 77%), complete suppression of 14-hydroxyclarithromycin formation. In patients with chronic renal insufficiency, dose adjustment is required: for QCs of 30-60 ml / min the clarithromycin dose should be reduced by 50%, for QCs less than 30 ml / min by 75%. Ritonavir should not be taken with clarithromycin at a dose greater than 1 g / day.

When combined with xnidine and disopyramide, ventricular tachycardia of the type pirouette may occur. ECG monitoring (QT interval increase), serum concentrations of these drugs are needed.

Clarithromycin increases the concentration of HMG-CoA reductase inhibitors (lovastatin, simvastatin), therefore, the risk of rhabdomyolysis increases.

Clarithromycin and omeprazole may increase Cmax, AUC and T1 / 2 of omeprazole by 30%, 89%, and 34%, respectively. The mean pH in the stomach for 24 h was 5.2 with omeprazole alone and 5.7 with omeprazole with clarithromycin.

When using clarithromycin and indirect anticoagulants, the latter may be enhanced.

When using clarithromycin with sildenafil, tadalafil or vardenafil (PDE5 inhibitors), an increase in PDE inhibitory effects is possible. Dose reduction of PDE5 inhibitors may be required.

Clarithromycin with theophylline and carbamazepine may be co-administered with systemic blood flow.

When using clarithromycin with tolterodine, patients with slow metabolism through the CYP2D6 isoenzyme may require a reduction in tolterodine dose.

Co-administration of clarithromycin (1 g / day) with midazolam (oral) may increase the AUC of milazolam 7-fold. Co-administration of clarithromycin and midazolam and other benzodiazepines metabolised by the CYP3A isoenzyme (triazolam and alprazolam) should be avoided. Dose adjustment may be required with midazolam (I / O) and clarithromycin. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A isoenzymes. For benzodiazepines whose elimination is independent of CYP3A isoenzymes (temazepam, nitrazepam, lorazepam), a clinically meaningful interaction with clarithromycin is unlikely.

When taking clarithromycin with colchicine, the effect of colchicine may be increased. Control of the possible development of clinical symptoms of colchicine intoxication is necessary, especially in the elderly and patients with CKD (fatal cases have been reported).

When co-administered with clarithromycin and digoxin, serum digoxin concentration should be carefully monitored (possibly increasing its concentration and developing potentially lethal arrhythmias).

Concurrent administration of zidovudine to HIV-infected adults orally and clarithromycin tablets may result in decreased zidovudine concentrations. Given that clarithromycin probably alters the absorption of oral zidovudine administered at the same time, this interaction is largely avoided when taking clarithromycin and zidovudine with an interval of at least 4 hours

When combined with clarithromycin (1 g / day) and atazanavir (40 mg / day), it is possible to increase the atazanavir AUC by 28%, clarithromycin 2 times , AUC reduction of 14-hydroxyclarithromycin by 70%. In patients with creatinine clearance of 30 to 60 ml / min, the clarithromycin dose should be reduced by 50%. Clarithromycin at doses in excess of 1 g / day should not be administered with protease inhibitors.

Co-administration of clarithromycin and itraconazole may increase the plasma concentrations of drugs. Patients receiving itraconazole and clarithromycin should be closely monitored for possible enhancement or prolongation of the pharmacological effects of these drugs.

When administered with clarithromycin (1 g / day) and saquinavir (in soft gelatin capsules, 1200 mg 3 times / day), AUC and CCssavinavir may be increased by 177% and 187%, respectively, and clarithromycin by 40%. If these drugs are co-administered for a limited time, no dose adjustment is required at the doses indicated above.

Co-administration with verapamil may reduce blood pressure, bradyarrhythmia and lactic acidosis.

Overdose

Symptoms: nausea, vomiting, diarrhea, abdominal pain, confusion.

Treatment: It is necessary to immediately wash the stomach and appoint symptomatic therapy. It is not removed during hemodialysis and peritoneal dialysis.

Storage conditions

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

Expiration

2 Year

Deystvuyuschee substances

clarithromycin

Synthesis, Russian



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