Clacid SR, 500 mg 7 pcs

Clacid SR is an antibiotic of macrolide group. Clarithromycin inhibits protein synthesis in microbial cell by interacting with 50S ribosomal subunit of bacteria. Highly active against a wide range of aerobic, anaerobic, Gram-positive and Gram-negative bacteria.

Clarithromycin has demonstrated high in vitro activity against standard and isolated cultures of bacteria. Highly effective against many aerobic and anaerobic gram-positive and gram-negative microorganisms. In vitro studies confirm high effectiveness of clarithromycin against Legionella pneumophila and Mycoplasma pneumoniae.

The drug is also active against aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae; other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis, Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacferium intracellulare.

The Enterobacteriaceae, Pseudomonas spp. and other non-lactose degrading Gram-negative bacteria are not sensitive to clarithromycin.
B-lactamase production has no effect on clarithromycin activity. Most staphylococcal strains that are resistant to methicillin and oxacillin are also resistant to clarithromycin.

Clarithromycin is also effective in vitro against most strains of the following microorganisms (but the safety and effectiveness of clarithromycin in clinical practice has not been confirmed by clinical studies, and the practical significance remains unclear): Aerobic Gram-positive microorganisms: Streptococcus agalactiae, Streptococci (groups C,F,G), Viridans group streptococci; aerobic gram-negative microorganisms: Bordeteila pertussis, Pasteurella multocida; anaerobic gram-positive microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes; anaerobic gram-negative microorganisms: Bacteroides melaninogenicus; Borrelia burgdorferi, Treponema pallidum, Campylobacter jejuni.

The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker against most microorganisms. The exception is Haemophilus influenzae against which the effectiveness of the metabolite is 2 times higher. The starting substance and its main metabolite have either additive or synergistic effect against Naemophilus influenzae under in vitro and in vivo conditions depending on the bacterial culture.

The sustained release tablets are a homogeneous crystalline base that allows prolonged release of the active ingredient as it travels through the gastrointestinal tract.

Indications

infectious and inflammatory diseases caused by microorganisms sensitive to clarithromycin: lower respiratory tract infections (such as bronchitis, pneumonia); upper respiratory tract infections (such as pharyngitis, sinusitis);
infections of the skin and soft tissues (such as folliculitis, inflammation of the subcutaneous tissue, erysipelas).

Pharmacological effect

Klacid SR is an antibiotic of the macrolide group. Clarithromycin inhibits protein synthesis in microbial cells by interacting with the 50S ribosomal subunit of bacteria. Highly active against a wide range of aerobic, anaerobic, gram-positive and gram-negative bacteria.

Clarithromycin has demonstrated 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 studies confirm the high effectiveness of clarithromycin against Legionella pneumophila and Mycoplasma pneumoniae.

The drug is also active against aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Neisseria gonorrhoeae; other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis, mycobacteria Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC): Mycobacterium avium, Mycobacferium intracellulare.

Enterobacteriaceae, Pseudomonas spp., as well as other gram-negative bacteria that do not degrade lactose are insensitive to clarithromycin.
The production of b-lactamase does not affect the activity of clarithromycin. Most strains of staphylococci resistant to methicillin and oxacillin are also resistant to clarithromycin.

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

The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker against most microorganisms. The exception is Haemophilus influenzae, for which the effectiveness of the metabolite is 2 times higher. The parent substance and its main metabolite have either an additive or synergistic effect against Haemophilus influenzae in vitro and in vivo, depending on the bacterial culture.

Extended-release tablets are a homogeneous crystalline base, which, when passed through the gastrointestinal tract, ensures a long-term release of the active substance.

Special instructions

The drug is prescribed with caution to patients with impaired liver function. In the presence of chronic liver diseases, it is necessary to regularly monitor serum enzymes.

The drug should also be prescribed with caution to patients with mild to moderate renal impairment. In case of severe renal impairment (creatinine clearance less than 30 ml/min), immediate-release clarithromycin (250 mg or 500 mg tablets) should be prescribed.

In case of co-administration with warfarin or other indirect anticoagulants, it is necessary to monitor the prothrombin time.

Active ingredient

Clarithromycin

Composition

1 tab. contains:

Active substances:

clarithromycin 500 mg;

Excipients:

anhydrous citric acid – 128 mg,

sodium alginate – 120 mg,

sodium calcium alginate – 15 mg,

lactose monohydrate – 115 mg,

povidone K30 – 30 mg,

talc – 30 mg,

stearic acid – 21 mg,

magnesium stearate – 10 mg.

Film shell composition: hypromellose – 9.81 mg, macrogol 400 – 3.27 mg, macrogol 8000 – 3.27 mg, titanium dioxide – 1.64 mg, yellow dye (quinoline yellow) – 1.23 mg, sorbic acid – 0.16 mg.

Pregnancy

The safety of clarithromycin during pregnancy and breastfeeding has not been established.

The use of clarithromycin during pregnancy (especially in the first trimester) is possible only when there is no alternative therapy and the potential benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to take it during lactation, breastfeeding should be stopped.

Contraindications

hypersensitivity to clarithromycin, macrolides and other components of the drug;
simultaneous use of clarithromycin with the following drugs: astemizole, cisapride, pimozide, terfenadine;
simultaneous use of clarithromycin with ergot alkaloids, for example, ergotamine, dihydroergotamine;
simultaneous use of clarithromycin with midazolam for oral administration;
simultaneous use of clarithromycin with HMG-CoA reductase inhibitors (statins), which are largely metabolized by the CYP3A4 isoenzyme (lovastatin or simvastatin), due to an increased risk of myopathy, including rhabdomyolysis;
simultaneous use of clarithromycin with colchicine;
simultaneous use of clarithromycin with ticagrelor or ranolazine;
history of QT prolongation (congenital or acquired recorded QT prolongation) or ventricular arrhythmia, including ventricular tachycardia or torsade de pointes;
hypokalemia (risk of QT interval prolongation);
severe liver failure occurring simultaneously with renal failure;
history of cholestatic jaundice/hepatitis that developed while using clarithromycin;
galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
porphyria;
breastfeeding period; age up to 12 years (efficacy and safety have not been established).

Side Effects

From the cardiovascular system: rarely – ventricular arrhythmia, including ventricular tachycardia (with an increase in the QT interval).

From the digestive system: nausea, abdominal pain, vomiting, diarrhea, gastralgia, pancreatitis, glossitis, stomatitis, oral candidiasis, discoloration of the tongue and teeth; rarely – pseudomembranous enterocolitis. Tooth discoloration is reversible and can usually be restored with professional cleaning by your dentist. Rarely observed liver dysfunction, incl. increased activity of liver enzymes, hepatic cell and/or cholestatic hepatitis with or without jaundice. These liver problems can be severe, but are usually reversible. Very rare cases of liver failure and death have been observed, mainly due to severe concomitant diseases and/or concomitant drug therapy.

From the side of the central nervous system: transient headaches, dizziness, anxiety, insomnia, nightmares, ringing in the ears, depersonalization, hallucinations, convulsions, feelings of fear; rarely – psychosis, confusion; in some cases – hearing loss (when clarithromycin was stopped, hearing was restored), a change in the sense of smell (usually accompanied by distortions in the sense of taste).

Allergic reactions: urticaria, skin hyperemia, itching, anaphylaxis, Stevens-Johnson syndrome.

From the hematopoietic system: leukopenia, thrombocytopenia.

From laboratory parameters: increase in creatinine content in the blood; rarely – hypoglycemia (while taking hypoglycemic drugs).

Other: development of resistance of microorganisms.

Interaction

Concomitant use of clarithromycin with drugs metabolized by the cytochrome P450 isoenzyme CYP3A may lead to increased plasma concentrations of drugs such as alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (eg warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam, vinblastine.

A similar mechanism of interaction is observed when using drugs that are metabolized by another isoenzyme of the cytochrome P450 system – phenytoin, theophylline and valproate. With the simultaneous use of theophylline and carbamazepine with clarithromycin, a moderate but significant (p) was observed. Rare cases of rhabdomyolysis have been described when taking clarithromycin with HMG-CoA reductase inhibitors (for example, lovastatin and simvastatin).

With simultaneous use of clarithromycin with cisapride, an increase in the concentration of cisapride was observed. This may cause QT prolongation, arrhythmia, ventricular tachycardia, fibrillation, and torsade de pointes. Similar effects have been observed in patients taking clarithromycin concomitantly with pimozide.

Macrolide drugs affect the metabolism of terfenadine. The level of terfenadine in the blood increases, which may be accompanied by an increase in the QT interval, the development of arrhythmia, ventricular tachycardia, fibrillation and ventricular fibrillation. The content of acid metabolites of terfenadine increases 2-3 times, the QT interval increases, but this does not cause any clinical manifestations. The same picture was observed when taking astemizole simultaneously with drugs from the macrolide group.

There are reports of the development of ventricular fibrillation with simultaneous use of clarithromycin with quinidine and disopyramide. When prescribing these drugs simultaneously, monitoring their concentrations in the blood is required.

With simultaneous use of clarithromycin with digoxin, an increase in serum digoxin levels was observed. Serum digoxin levels should be monitored in such patients.

With simultaneous oral administration of clarithromycin and zidovudine in HIV-infected patients, a decrease in the steady-state concentration of zidovudine was observed. Because clarithromycin interferes with the absorption of zidovudine, the two drugs should be taken separately.

Ritonavir significantly slows down the metabolism of clarithromycin when administered concomitantly. In this case, the Cmax value of clarithromycin increases by 31%, Cmin by 182%, AUC by 77%. There is a significant slowdown in the formation of 14-hydroxyclarithromycin. In this case, in patients without renal impairment, there is no need to adjust the dose of clarithromycin. With a CC of 60-30 ml/min, the dose of clarithromycin should be reduced by 50% to a maximum dose of 500 mg (1 tablet of extended release) 1 time/day. When taking ritonavir, do not simultaneously prescribe a dose of clarithromycin greater than 1 g/day.

Cross-resistance may develop between clarithromycin and other macrolide drugs, such as lincomycin and clindamycin.

Overdose

Symptoms: Taking a large dose of clarithromycin may cause gastrointestinal symptoms. In one patient with a history of bipolar disorder, changes in mental status, paranoid behavior, hypokalemia, and hypoxemia were described after taking 8 g of clarithromycin.

Treatment: the unabsorbed drug should be removed from the gastrointestinal tract and symptomatic therapy should be carried out. Hemodialysis and peritoneal dialysis do not have a significant effect on clarithromycin serum levels.

Storage conditions

In a place protected from light, at a temperature of 15–30 °C

Shelf life

1 year

Manufacturer

EbbVee S.r.L., Italy