Klabaks
Klabaks: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. With impaired renal function
- 10. Drug interactions
- 11. Analogs
- 12. Terms and conditions of storage
- 13. Terms of dispensing from pharmacies
- 14. Reviews
- 15. Price in pharmacies
Latin name: Klabax
ATX code: J01FA09
Active ingredient: clarithromycin (clarithromycin)
Manufacturer: Sun Pharmaceutical Industries Ltd., Ranbaxy Laboratories Ltd., India
Description and photo update: 2019-13-08
Prices in pharmacies: from 219 rubles.
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Klabax is a broad-spectrum antibacterial drug for systemic use, from the macrolide group.
Release form and composition
Klabaks is produced in the following dosage forms:
- Film-coated tablets: oval, biconvex, light yellow, black marking on one side, depending on the dose - "CXT 250" or "CXT 500" (250 mg: 4 pcs. In blisters, 1 or 3 blisters in a cardboard box; 500 mg: 10 pcs. in blisters, 1 blister in a cardboard box);
- Granules for preparation of suspension for oral administration: free-flowing granular powder, color from white to almost white, when mixed with water, forms a white or almost white suspension of sweetish taste with a fruity smell when mixed with water (42 g each (for dosage 125 mg / 5 ml) or 70 g (for a dosage of 250 mg / 5 ml) granules in high density polyethylene vials, equipped with a white screw cap with first opening control, childproof and filling volume label, complete with measuring spoon and measuring syringe with scale, 1 set each cardboard box).
Composition of 1 tablet:
- Active ingredient: clarithromycin - 250 mg or 500 mg;
- Auxiliary components: povidone, magnesium stearate, microcrystalline cellulose, purified talc, colloidal silicon dioxide, croscarmellose sodium;
- Film shell: hydroxypropyl cellulose, hydroxypropyl methylcellulose, propylene glycol, titanium dioxide, sorbitan monooleate, quinoline yellow varnish, purified talc, vanillin;
- Opacode Black printing ink (opacode S-1-17823 black): glazed (esterified) shellac in ethanol, iron oxide black (E172), isopropyl alcohol, butyl alcohol, ammonia solution, propylene glycol.
Composition of 5 ml of finished suspension:
- The active ingredient is clarithromycin 125 mg or 250 mg;
- Auxiliary components: hypromellose, croscarmellose sodium, microcrystalline cellulose, hydroxypropyl cellulose, alginic acid;
- Enteric coating of granules: methacrylic acid, purified talc, macrogol 1500, anhydrous colloidal silicon dioxide, carbomer (carbopol 974R);
- Auxiliary components for the suspension: aspartame, sucrose, xanth gum, sodium benzoate, sodium citrate, colloidal anhydrous silicon dioxide, titanium dioxide (E171), fruit flavor 051880, mint flavor (E517), sodium chloride.
Pharmacological properties
Pharmacodynamics
Clarithromycin is a broad-spectrum macrolide antibiotic of semi-synthetic origin. It disrupts the production of protein in microorganisms by binding to the 50S subunit of the ribosome membrane contained in the microbial cell. The substance acts on pathogens located both inside and outside the cell.
Clarithromycin is active in vitro (this is also proven by clinical practice) against strains of such microorganisms:
- Helicobacter pylori;
- aerobic gram-positive microorganisms: Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus;
- aerobic gram-negative microorganisms: Legionella pneumophila, Haemophilus parainfluenzae, Haemophilus influenzae, Moraxella catarrhalis;
- mycobacteria: Mycobacterium avium complex (MAC), including Mycobacterium intracellulare and Mycobacterium avium;
- other microorganisms: Chlamydia pneumoniae, Mycoplasma pneumoniae.
Beta-lactamases do not alter the activity of clarithromycin. Exclusively in vitro, the drug has a detrimental effect on the following bacteria:
- campylobacter: Campylobacter jejuni;
- aerobic gram-negative microorganisms: Pasteurella multocida, Bordetella pertussis, Neisseria gonorrhoeae;
- aerobic gram-positive microorganisms: Streptococci group viridans, Streptococci groups G, F, C, Streptococcus agalactiae, Listeria monocytogenes;
- anaerobic gram-negative microorganisms: Bacteroides melaninogenicus;
- anaerobic gram-positive microorganisms: Propionibacterium acnes, Peptococcus niger, Clostridium perfringens;
- mycobacteria: Mycobacterium chelonae, Mycobacterium leprae;
- spirochetes: Treponema pallidum, Borrelia burgdorferi.
The active metabolite of the active substance of Klabax - 14 (R) -hydroxyclarithromycin - is characterized by microbiological activity and affects Haemophilus influenzae twice as intensely as clarithromycin itself. The combination of clarithromycin and its metabolite can have both synergistic and additive effects on Haemophilus influenzae in vivo and in vitro, as determined by the bacterial strain.
Most strains of staphylococci that are resistant to oxacillin and methicillin are also characterized by resistance to clarithromycin. Cases of cross-resistance to clarithromycin and other macrolide antibiotics, as well as clindamycin and lincomycin, have been reported.
Pharmacokinetics
Clarithromycin is absorbed fairly quickly. Food intake reduces the rate of its absorption, while not altering its bioavailability. The bioavailability of the substance in the form of a suspension is similar or slightly higher than when taken in tablet form. Clarithromycin binds to plasma proteins by about 65-75%.
With a single dose of the drug, 2 peaks of maximum concentration are observed. The second of them is associated with the ability of clarithromycin to accumulate in the gallbladder with further gradual or rapid release. With oral administration of Klabax at a dose of 250 mg, the maximum concentration of clarithromycin is reached within 1-3 hours after administration.
After ingestion of the drug, 20% of the administered dose of clarithromycin is hydroxylated in the liver at a high rate through the cytochrome isoenzymes CYP3A7, CYP3A5 and CYP3A4. In this case, the main metabolite is formed - 14- (R) -hydroxyclarithromycin, characterized by pronounced antimicrobial activity against the bacterium Haemophilus influenzae.
Regular intake of Klabax in a daily dose of 250 mg allows reaching equilibrium concentrations of clarithromycin and its main metabolite of 1 and 0.6 μg / ml, respectively. The half-life in this case is 3-4 hours and 5-6 hours, respectively. An increase in the daily dose to 500 mg leads to an increase in the equilibrium concentrations of clarithromycin and its main metabolite to 2.7–2.9 and 0.83–0.88 μg / ml, respectively. The half-life is lengthened to 4.8–5 and 6.9–8.7 hours, respectively.
When Klabax is taken in therapeutic concentrations, it accumulates in soft tissues (the concentration is 10 times higher than the serum concentration), lungs and skin. Clarithromycin is excreted through the kidneys and intestines (approximately 20-30% - in unchanged form, the rest of the administered dose - in the form of metabolites). With a single dose of Klabax at a dose of 250 mg or 1200 mg, about 37.9 and 46% of the amount of clarithromycin are excreted through the kidneys, and 40.2 and 29.1% of the amount of clarithromycin, respectively, through the intestines.
Clarithromycin is an inhibitor of CYP3A7, CYP3A5 and CYP3A4 isoenzymes. In patients with chronic renal failure, the maximum concentration, the time required to reach it, and the area under the concentration-time curve for clarithromycin and its metabolite increase.
Indications for use
- Chronic and acute bronchitis, pneumonia;
- Pharyngitis, sinusitis, otitis media;
- Infections of soft tissues and skin.
Additionally for Klabax tablets:
- Eradication of Helicobacter pylori in gastric ulcer and duodenal ulcer (as part of complex treatment);
- Infections caused by Mycobacterium intracellulare or Mycobacterium avium;
- Toxoplasmosis, leprosy;
- Urea and mycoplasmosis, chlamydia.
Contraindications
- Severe liver failure, hepatitis (including a history);
- Simultaneous use with any of the following drugs: pimozide, terfenadine, astemizole, ergotamine, dihydroergotamine, simvastatin, lovastatin, cisapride;
- I trimester of pregnancy;
- Children under 6 years of age (for tablets);
- Hypokalemia, incl. surdocardial (cardio-auditory) syndrome (for granules);
- Hypersensitivity to clarithromycin, other macrolides and to any of the Klabax components.
In the II and III trimesters of pregnancy, the use of Klabax is possible only in case of a significant excess of the intended benefit to the mother over the potential risk to the fetus.
If it is necessary to take Klabax during lactation, breastfeeding should be discontinued for this period.
There are currently insufficient data on the safety and efficacy of clarithromycin use in children under 6 months of age.
Instructions for the use of Klabax: method and dosage
Film-coated tablets
Klabax tablets should be taken whole (do not grind, do not chew) with a liquid. Food intake practically does not affect the absorption of the drug, but it can slightly slow down this process.
The recommended dosing regimen for children from 12 years old and adults: 250 mg 2 times a day, if necessary, for severe infections, an increase in the dose to 500 mg 2 times a day is allowed, the course of therapy is from 5 to 14 days.
In case of duodenal ulcer, Klabaks is taken as part of an anti-Helicobacter course of therapy, 500 mg 2 or 3 times a day for 7-10 days.
In patients with severe renal insufficiency, dose adjustment should be made depending on creatinine clearance (CC). With CC up to 30 ml / min: moderately severe infections - 250 mg once a day; more severe - 250 mg 2 times a day.
For the treatment of infections caused by Mycobacterium avium, take Klabax 500 mg 2 times a day.
For children 6-12 years old, a daily dose of 15 mg / kg / day is recommended, divided into 2 doses, every 12 hours for 5-10 days.
Granules for preparation of oral suspension
According to the instructions, Klabax in the form of a suspension is intended for oral administration, mainly in children (due to the possibility of careful dosing).
The recommended duration of the course of therapy depends on the severity of the patient's condition and the type of pathogenic microflora, and ranges from 5 to 10 days.
The recommended daily dose of Klabax in suspension at doses of 125 mg / 5 ml and 250 mg / 5 ml for children, at the rate of 7.5 mg / kg twice a day:
- From 1 to 2 years (weight 8-11 kg): 125 mg / 5 ml - 2.5 ml; 250 mg / 5 ml - 1.25 ml (62.5 mg);
- From 3 to 6 years old (weight 12-19 kg): 125 mg / 5 ml - 5.0 ml; 250 mg / 5 ml - 2.5 ml (125 mg);
- From 7 to 9 years old (weight 20-29 kg): 125 mg / 5 ml - 7.5 ml; 250 mg / 5ml - 3.75 ml (187.5 mg);
- From 10 to 12 years old (weight 30-40 kg): 125 mg / 5 ml - 10 ml; 250 mg / 5 ml - 5 ml (250 mg).
Above 500 mg twice daily, clarithromycin should be taken only for the treatment of serious infections.
Children under 1 year old and weighing less than 8 kg Klabax are taken twice a day at a dose of 7.5 mg / kg.
Before preparing the suspension, the bottle with granules should be gently shaken until the granules begin to move freely.
To prepare a suspension for oral administration, it is necessary to add boiled chilled water to the mark on the vial and shake it until a homogeneous yellowish-white suspension is obtained.
Side effects
- Central nervous system (CNS): confusion, dizziness, fear, nightmares, insomnia;
- Digestive system: abdominal pain, diarrhea, nausea, vomiting, glossitis, stomatitis; rarely - pseudomembranous colitis; in some cases - cholestatic jaundice, increased activity of liver enzymes;
- Allergic reactions: anaphylactic responses, urticaria; in some cases - Stevens-Johnson syndrome;
- Other: a temporary change in taste.
Overdose symptoms are diarrhea, nausea, vomiting. Treatment of the condition: gastric lavage, supportive symptomatic therapy.
Overdose
In case of an overdose of Klabax, there may be unwanted symptoms from the gastrointestinal tract (diarrhea, nausea, vomiting), as well as headache and impaired consciousness. In this case, it is recommended to immediately perform gastric lavage and prescribe symptomatic therapy. Peritoneal dialysis and hemodialysis do not significantly affect the elimination of clarithromycin from the blood.
special instructions
Antibiotic therapy alters the normal intestinal microflora, so there is a possibility of developing superinfection caused by microorganisms resistant to clarithromycin.
Macrolide antibiotics are cross-resistant.
Severe persistent diarrhea may be a sign of pseudomembranous colitis.
In the case of the simultaneous use of clarithromycin with theophylline, digoxin, lovastatin, carbamazepine, simvastatin, midazolam, phenytoin, triazolam, cyclosporine and ergot alkaloids, it is necessary to control the concentration of these substances in the blood plasma.
Periodically, it is recommended to monitor the prothrombin time in patients receiving warfarin or other oral anticoagulants concomitantly with clarithromycin.
Influence on the ability to drive vehicles and complex mechanisms
The influence of Klabax on the ability to drive vehicles, work with moving machinery, or perform potentially hazardous types of work that require increased concentration and concentration of attention is not well understood.
With impaired renal function
For patients with renal dysfunction (CC does not exceed 30 ml / min or serum creatinine is more than 3.3 mg / dl), it is recommended to reduce the dose of Klabax by 2 times, or double the time interval between doses.
Drug interactions
Interaction of the following substances / drugs and clarithromycin with simultaneous use:
- Astemizole, cisapride: clarithromycin, inhibiting the activity of the isoenzyme CYP3A4, slows down their metabolic rate, thereby increasing the QT interval and increasing the risk of developing ventricular arrhythmias of the "pirouette" type;
- Atorvastatin: its concentration in blood plasma increases moderately, increasing the risk of myopathy;
- Warfarin: it is possible to increase its anticoagulant effect and, as a result, increase the risk of bleeding;
- Digoxin: probably a significant increase in its concentration in blood plasma with the development of glycosidic intoxication;
- Disopyramide: there is a possibility of an increase in its concentration in the blood plasma as a result of inhibition of the metabolism of disopyramide in the liver under the influence of clarithromycin, as a result of which it is possible to prolong the QT interval, develop pirouette-type cardiac arrhythmias, increase insulin secretion and hypokalemia;
- Zidovudine: its bioavailability decreases slightly;
- Itraconazole, carbamazepine, cyclosporine: their concentration in blood plasma increases, side effects may increase;
- Colchicine: there is evidence of life-threatening severe toxic reactions resulting from its action;
- Lansoprazole: possible stomatitis, glossitis, dark staining of the tongue;
- Methylprednisolone: decrease in its clearance;
- Midazolam: increasing its concentration in blood plasma, enhancing the effects;
- Omeprazole: its concentration increases significantly and the concentration of clarithromycin in blood plasma increases slightly;
- Pimozide: its concentration in blood plasma increases, there is a risk of developing a severe cardiotoxic effect;
- Prednisone: there is reliable data on the development of psychosis and acute mania;
- Ritonavir: a significant increase in the concentration of clarithromycin is likely, while the concentration of its metabolite, 14-hydroxyclarithromycin, is significantly reduced;
- Rifabutin: its concentration in blood plasma increases, increasing the risk of developing uveitis; the concentration of clarithromycin in the blood plasma decreases;
- Rifampicin: the concentration of clarithromycin in the blood plasma is significantly reduced;
- Sertraline: there is a possibility of developing serotonin syndrome;
- Theophylline: an increase in its concentration in blood plasma is possible;
- Terfenadine: probably a decrease in the metabolic rate of terfenadine and an increase in its concentration in blood plasma (may cause an increase in the QT interval and an increased risk of developing ventricular arrhythmias of the "pirouette" type);
- Tolbutamide: hypoglycemia may develop;
- Phenytoin: it is possible to increase its concentration in blood plasma, increase the risk of developing a toxic effect;
- Fluoxetine: there is reliable data on the development of toxic effects;
- Ergotamine, dihydroergotamine: there is evidence of increased side effects.
Analogs
Klabaks analogs are: Klabaks OD, Clarithromycin, Clarosip, Klacid, Clarbact, Seidon-Sanovel, Ecositrin, Fromilid, Fromilid Uno.
Terms and conditions of storage
Store in a dark, dry place out of reach of children at a temperature not exceeding 25 ° C.
Shelf life is 2 years.
The finished suspension should be kept in a tightly closed container, do not freeze, do not refrigerate, do not use for more than 2 weeks.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Clubax
There are often mixed reviews about Clubax. Despite the high efficacy of the drug, the incidence of adverse reactions is quite high. They are observed already on the second day of therapy and are expressed in nausea, vomiting, dizziness, and a bitter taste in the mouth. Sometimes they are so pronounced that patients have to interrupt treatment before receiving the first successful results.
Price for Clubaks in pharmacies
The approximate price for Klabaks in film-coated tablets with a dosage of 250 mg is 251–260 rubles, and Klabaks 500 mg is 388–401 rubles (the package includes 14 pcs.). Suspension granules are currently not commercially available.
Klabax: prices in online pharmacies
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Drug name Price Pharmacy |
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Klabaks OD 500 mg film-coated tablets of prolonged action 7 pcs. 219 r Buy |
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Klabaks 250 mg film-coated tablets 14 pcs. 273 r Buy |
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Klabaks OD tablets p.o. 500mg 7 pcs. 280 RUB Buy |
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Klabaks tablets p.p. 500mg 14 pcs. RUB 380 Buy |
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Klabaks 500 mg film-coated tablets 14 pcs. RUB 380 Buy |
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Klabaks OD 500 mg film-coated tablets of prolonged action 14 pcs. 399 RUB Buy |
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Klabaks OD tablets p.o. 500mg 14 pcs. 486 r Buy |
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Klabaks 250 mg film-coated tablets 4 pcs. 543 r Buy |
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Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
