Clacid SR, Prolonged pills 500mg 5pcs

Composition

>of 1 tab. contains: Active ingredients: clarithromycin 500 mg; Excipients: citric acid anhydrous-128 mg, sodium alginate-120 mg, sodium calcium alginate-15 mg, lactose monohydrate-115 mg, povidone K 30-30 mg, talc-30 mg, stearic acid-21 mg, magnesium stearate-10 mg. The composition of the film shell: 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

Pharmacological action

Klacid SR is an antibiotic of the macrolide group. Clarithromycin inhibits protein synthesis in the microbial cell 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 showed high activity in vitro 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 efficacy 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.

They are insensitive to clarithromycin Enterobacteriaceae, Pseudomonas spp., as well as other gram-negative bacteria that do not decompose lactose.

The production of b-lactamase does not affect the activity of clarithromycin. Most strains of staphylococci that are resistant to methicillin and oxacillin are also resistant to clarithromycin.

Clarithromycin exerts its effects in vitro against most strains of the following microorganisms (however, the safety and effectiveness of using clarithromycin in clinical practice has not been confirmed in clinical studies, and 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 Hemophilus 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.

Tablets of prolonged action are a homogeneous crystalline base, during the passage of which through the gastrointestinal tract, a long-term release of the Active ingredient is ensured.

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);
• skin and soft tissue infections (such as folliculitis, inflammation of the subcutaneous tissue, erysipelas).

Use during pregnancy and lactation

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

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

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

Contraindications

• hypersensitivity to clarithromycin, macrolides and other components of the drug;
• simultaneous reception of clarithromycin with the following drugs: astemizole, cisapride, pimozide, terfenadine;
• concomitant use of clarithromycin with ergot alkaloids, for example, ergotamine, dihydroergotamine;
• concomitant use of clarithromycin with midazolam for oral use;
• concomitant use of clarithromycin with inhibitors of HMG-COA reductase (statins), which are largely metabolized by CYP3A4 (lovastatin or simvastatin), in connection with the increased risk of myopathy, including rhabdomyolysis;
• concomitant use of clarithromycin and colchicine;
• concomitant use of clarithromycin with ticagrelor or ranolazine;
• prolonged QT interval in history (was congenital or acquired QT prolongation) or ventricular arrhythmias, including ventricular tachycardia or ventricular tachycardia type “pirouette”;
• hypokalaemia (risk of QT interval prolongation);
• severe liver failure, occurring simultaneously with renal insufficiency;
• cholestatic jaundice/hepatitis in history, which developed in the application of clarithromycin;
• galactose intolerance, lactase deficiency, malabsorption syndrome of glucose-galactose;
• porphyria;
• breastfeeding; age up to 12 years (effectiveness and safety not 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 is usually repaired by professional brushing at the dentist. Rarely, liver function disorders were observed, including increased activity of liver enzymes, hepatic cell and / or cholestatic hepatitis with or without jaundice. These liver function disorders can be severe, but they are usually reversible. Very rare cases of liver failure and death were observed, mainly against the background of severe concomitant diseases and/or concomitant drug therapy.

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

Allergic reactions:  urticaria, hyperemia of the skin, pruritus, anaphylaxis, Stevens-Johnson syndrome.

From the hematopoietic system:  leukopenia, thrombocytopenia.

From the side of laboratory parameters:  increased blood creatinine; rarely-hypoglycemia (with simultaneous use of hypoglycemic drugs).

Other services:  development of microbial resistance.

Interaction

Concomitant use of clarithromycin with drugs that are metabolized with the participation of cytochrome P450 CYP3A isoenzyme may lead to an increase in plasma concentrations of such drugs as alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporine, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral medications. anticoagulants (e. g. 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 cytochrome P450 isoenzyme, such as phenytoin, theophylline, and valproate. When theophylline and carbamazepine were co-administered with clarithromycin, there was a moderate but significant increase in rhabdomyolysis (rare cases of rhabdomyolysis were reported when clarithromycin was co-administered with HMG-CoA reductase inhibitors (for example, lovastatin and simvastatin).

When clarithromycin was co-administered with cisapride, an increase in cisapride concentrations was observed. This can cause an increase in the QT interval, arrhythmia, ventricular tachycardia, fibrillation and flutter-flickering of the ventricles. Similar effects were observed in patients taking clarithromycin concomitantly with pimozide. Macrolide preparations 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 flutter-ventricular fibrillation. The content of acidic metabolites of terfenadine increases by 2-3 times, the QT interval increases, but this does not cause any clinical manifestations. The same pattern was observed when astemizole was administered concomitantly with macrolide preparations.

There have been reports of ventricular flutter-atrial fibrillation when clarithromycin is co-administered with quinidine and disopyramide. With the simultaneous use of these drugs, monitoring of their concentration in the blood is required.

When clarithromycin was co-administered with digoxin, an increase in serum digoxin levels was observed. In such patients, it is necessary to monitor the content of digoxin in the serum.

Concomitant oral use of clarithromycin and zidovudine resulted in a decrease in the steady-state zidovudine concentration in HIV-infected patients. Since clarithromycin affects the absorption of zidovudine, the two medications should be separated in time.

Ritonavir significantly slows down the metabolism of clarithromycin when taken concomitantly. The Cmax 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, patients without impaired renal function do not need to adjust the dose of clarithromycin. When creatinine clearance is 60-30 ml / min, the dose of clarithromycin should be reduced by 50% to a maximum dose of 500 mg (1 tablet of prolonged action) 1 time/day. When taking ritonavir, do not simultaneously prescribe a dose of clarithromycin greater than 1 g / day.

It is possible to develop cross-resistance between clarithromycin and other macrolide drugs, such as lincomycin and clindamycin

How to take, course of use and dosage

For adults Klacid SR is prescribed 500 mg (1 tab. ) 1 time/day. In severe infections, the dose is increased to 1 g (2 tablets) 1 time/day.

Tablets should be taken with a meal, swallowed whole, without breaking or chewing.

Overdose

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

Treatment: it is necessary to remove the unabsorbed drug from the gastrointestinal tract and conduct symptomatic therapy. Hemodialysis and peritoneal dialysis do not significantly affect the level of clarithromycin in serum.

Description

Tablets with a prolonged release, film-coated yellow color, oval.

Special instructions

Caution should be exercised when prescribing the drug to patients with impaired liver function. In the presence of chronic liver diseases, it is necessary to conduct regular monitoring of serum enzymes.

Caution should also be exercised when prescribing the drug to patients with mild to moderate renal impairment. For severe renal impairment (creatinine clearance less than 30 ml/min), fast-release clarithromycin (250 mg or 500 mg tablets) should be prescribed.

When co-administered with warfarin or other indirect anticoagulants, prothrombin time should be monitored.

Form of production

Long-acting coated tablets.

Storage conditions

In a dark place, at a temperature of 15-30 °C

Shelf life

1 year

Active ingredient

Clarithromycin

Conditions of release from pharmacies

By prescription

Dosage form

long-acting tablets

Purpose

Adults as prescribed by a doctor, Children as prescribed by a doctor, Children over 12 years of age

Indications

Bronchitis, Pharyngitis, Stomach and Duodenal Ulcers, Sinusitis, Otitis Media, Boils, Gastrointestinal Infections Caused by Helicobacter Pylori, Respiratory Tract Infections, Tonsillitis, Sore Throat, Colds, Skin Infections