CLABAX - macrolide; antibacterial drug of systemic action.
Release form and composition
Klabuks is available in the form of coated tablets 250 and 500 mg (250 mg - 4 pieces in blisters, 1, 3 or 10 blisters in a cardboard box; 500 mg - 10 pieces in blisters, 1 blister in a cardboard box) .
The active ingredient of the drug is clarithromycin: in 1 tablet 250 or 500 mg.
Auxiliary components: magnesium stearate, microcrystalline cellulose, croscarmellose sodium (AC-DI-Sol), purified talc, stearic acid, povidone (PVP K-30), colloidal silicon dioxide, purified water (evaporates during production).
The composition of the film coating: hyprolosis, hypromellose, propylene glycol, titanium dioxide, sorbitan monooleate, vanillin, purified talc, quinoline yellow lacquer (CI N 47005), purified water (evaporates during production).
The label uses black ink Opacode S-1-27794 (isopropyl alcohol, glazed shellac, ferric oxide (E172) black Cl 77499, N-butyl alcohol, IMS 74 OP, propylene glycol, purified water) and isopropyl alcohol (evaporates during production) .
Indications for use
Klabuks is prescribed for the treatment of infectious and inflammatory diseases, the causative agents of which are microorganisms sensitive to clarithromycin, such as:
- Infections of the upper respiratory tract and upper respiratory tract: acute sinusitis, otitis media, tonsillopharyngitis;
- Lower respiratory tract infections: atypical and community-acquired bacterial pneumonia, exacerbation of chronic bronchitis, acute bronchitis;
- Infections of the skin and soft tissues;
- Odontogenic infections;
- Mycobacterial infections (M.leprae, M.kansasii, M.avium complex, M.marinum) and their prevention in AIDS patients;
- Eradication of Helicobacter pylori in patients with peptic ulcer and 12 duodenal ulcer (as part of combination therapy).
- Lengthened QT interval, ventricular arrhythmia, or ventricular tachycardia of the “pirouette” type in history;
- Severe hepatic impairment simultaneously with renal insufficiency;
- An indication of a history of hepatitis or cholestatic jaundice that developed with the use of clarithromycin;
- I trimester of pregnancy;
- Simultaneous intake of cisapride, astemizole, terfenadine, pimozide, ergot alkaloids (for example, anesthetics or dihydroergotamine), midazolam, colchicine, ranolazine, ticagrelor, HMG-CoA reductase inhibitors (statins), and they are completely exhausted, and they are quite a little exhausted. ;
- Hypersensitivity to clarithromycin or other macrolides.
Patients diagnosed with moderate to severe renal or hepatic failure, severe bradycardia (less than 50 beats / minute), coronary heart disease, severe heart failure, hypomagnesia should be under special observation during the treatment period.
Dosing and Administration
CLABAX should be taken orally.
The dose for each patient is selected individually. The average dose for adult patients is 250 mg 2 times a day. If necessary, it can be increased to 500-1000 mg 2 times a day.
The daily dose for children under 12 years old is 7.5-15 mg per kilogram of body weight in 2 doses.
Maximum daily doses: for adults - 2000 mg, for children - 1000 mg.
The duration of treatment depends on the evidence. The average course is from 6 to 14 days.
For the treatment of mycobacterial infections caused by Mycobacterium avium, the drug is prescribed in 1000 mg 2 times a day. In this case, the treatment can last 6 months or more.
For patients with impaired renal function (if creatinine clearance is less than 30 ml / minute or a serum level is more than 3.3 mg / deciliter), the dose is reduced by 2 times, or the intervals between doses are increased by 2 times. The course of treatment is not more than 14 days.
- The hematopoietic system: infrequently - eosinophilia, thrombocythemia, neutropenia, leukopenia; frequency not established - thrombocytopenia, agranulocytosis;
- Allergic reactions: often - rash; infrequently - hypersensitivity reactions, pruritus, urticaria, bullous dermatitis, maculopapular rash, anaphylactoid reaction; frequency not established - drug rash with systemic symptoms and eosinophilia (DRESS syndrome), angioedema, toxic epidermal necrolysis, anaphylactic reaction, Stevens-Johnson syndrome;
- Blood coagulation system: infrequently - prolongation of prothrombin time, increase in MHO value;
- Gastrointestinal tract: often - pain in the abdomen, nausea and / or vomiting, diarrhea; infrequently - stomatitis, glossitis, dry mouth, abdominal distention, flatulence, belching, constipation, gastritis, proctalgia, esophagitis, cholestasis, increased bilirubin concentration in the blood, hepatitis (including hepatocellular and cholestatic), increased activity of liver enzymes, gastroesophageal reflux disease; Frequency is not installed - change the color of the tongue and teeth, cholestatic jaundice, acute pancreatitis, liver failure;
- Urinary system: infrequently - change the color of urine, increasing the concentration of creatinine; frequency not established - interstitial nephritis, renal failure;
- Sense organs: often - taste disturbances (including dysgeusia); infrequently - ringing in the ears, hearing loss, vertigo; frequency not established - anosmia, parosmia, agevziya, deafness;
- Musculoskeletal system: infrequently - myalgia, musculoskeletal stiffness, muscle spasm; frequency not established - myopathy, incl. rhabdomyolysis;
- Cardiovascular system: often - vasodilation; infrequently - atrial flutter and atrial fibrillation, extrasystole, prolongation of QT interval on ECG, cardiac arrest; frequency not established - ventricular tachycardia (including the type of "pirouette");
- Infectious and parasitic diseases: infrequently - gastroenteritis, candidiasis, cellulitis, secondary infections (including vaginal); frequency not established - erysipelas, pseudomembranous colitis;
- Metabolism and nutrition: infrequently - loss of appetite, anorexia, changes in the ratio of albumin to globulin, increasing the concentration of urea;
- Respiratory system: infrequently - nosebleeds, asthma, pulmonary thromboembolism;
- Central nervous system (CNS): often - headache, insomnia; infrequently - anxiety, dizziness, dyskinesia, drowsiness, irritability, loss of consciousness, tremor; frequency not established - confusion, depression, depersonalization, disorientation, psychotic disorders, hallucinations, paresthesia, nightmarish dreams, mania, convulsions;
- Skin: often - intense sweating; frequency is not installed - hemorrhage, acne;
- On the part of the body as a whole: infrequently - chills, chest pain, asthenia, fatigue, fever, malaise.
Cross-resistance is observed between different macrolide antibiotics.
Antibacterial drugs change the normal intestinal flora, so there is a possibility of the development of superinfection due to the resistance of microorganisms.
It should be borne in mind that severe persistent diarrhea may indicate pseudomembranous colitis.
In patients receiving clarithromycin simultaneously with warfarin or other oral anticoagulants, the whole period of treatment should be monitored prothrombin time.
With the simultaneous use of Clabax with drugs containing the following medicinal substances, the development of undesirable reactions is possible:
- Astemizol, terfenadine, cisapride - lengthening of the QT interval, increasing the risk of developing ventricular arrhythmias of the "pirouette" type;
- Lovastatin, simvastatin, atorvastin - myopathy, including rhabdomyolysis;
- Rifabutin - increasing its concentration in plasma, the development of uveitis, reducing clarithromycin in the blood plasma;
- Colchicine - enhancing its action and, as a result, intoxication (more often in the elderly), up to death;
- Triazolam - effects on the central nervous system (confusion, drowsiness);
- Warfarin - enhancing its anticoagulant action, increasing the risk of bleeding;
- Digoxin - an increase in its concentration in plasma, the likelihood of developing glycosidic intoxication;
- Quinidine, procainamide - ventricular tachycardia type "pirouette";
- Disopyramide - hypoglycemia and ventricular tachycardia of the "pirouette" type;
- Methylprednisolone - a decrease in its clearance;
- Zidovudine - a decrease in its bioavailability;
- Theophylline, omeprazole, cyclosporine, phenytoin, carbamazepine, valproic acid - an increase in their concentration in the blood plasma, the risk of increased side effects;
- Prednisone - acute mania and psychosis;
- Lansoprazole - the appearance of a dark color of the tongue, glossitis and / or stomatitis;
- Sertraline - serotonin syndrome;
- Oral hypoglycemic agents and / or insulin - severe hypoglycemia;
- Fluoxetine - toxic effects due to its action;
- Ergotamine, dihydroergotamine - increased side effects, ischemia of the limbs and other tissues, including the central nervous system, vascular spasm;
- Calcium channel blockers metabolized by CYP3A4 isoenzyme - arterial hypotension;
- Verapamil - lactacidosis, bradyarrhythmia, arterial hypotension.
Caution should be exercised when using clarithromycin with the following substances and preparations:
- Ototoxic drugs (especially aminoglycosides) - during and after treatment, the functions of the auditory and vestibular apparatus should be monitored;
- Other statins - it is necessary to monitor the patient’s condition in time to detect the signs and symptoms of myopathy. It is recommended to prescribe statins, which do not depend on the metabolism of CYP3A isoenzyme (for example, fluvastatin), in the smallest effective doses;
- CYP3A inducer drugs (for example, phenobarbital, phenytoin, rifampicin, carbamazepine, St. John's wort) is to control the plasma concentration of the inducer CYP3A;
- Strong inducers of isoenzymes of the cytochrome P450 system (for example, rifampicin, nevirapine, rifabutin, efavirenz, rifapentin) - plasma clarithromycin concentration should be monitored; may decrease its content and, as a consequence, the therapeutic effect;
- Disopyramide - control of glucose concentration in the blood is necessary.
If you need to take Klabaksa in a daily dose of more than 1000 mg, you can not prescribe additional preparations based on ritonavir, it significantly inhibits the metabolism of clarithromycin, as a result of which its concentration increases significantly.
With the combined use of Clabax with etrivirin, the concentration of clarithromycin in plasma decreases and the concentration of its active metabolite 14-OH clarithromycin increases. However, it has low activity against mycobacterial infections, therefore it is recommended to consider alternative treatment options.
Clarithromycin significantly increases the serum concentration of tolterodine, so a dose reduction may be necessary.
It is contraindicated at the same time as Klabaks to appoint midazolam in oral dosage form. If necessary, it is necessary to apply its intravenous form, and in the process of treatment to monitor the patient's condition and, as necessary, adjust the dose. The same precautions should be observed in the appointment of other benzodiazepines and drugs metabolized by CYP3A (including triazolam and alprazolam, cyclosporine, cilostazol, disopyramide, carbamazepine, methylprednisolone, quinidine, rifabutin, indirect anticoagulants, sildenafil, vinblastine omeprazole, tacrolimus), and antiarrhythmics Class I (quinidine, procainamide) and Class III (amiodarone, dofetilide, sotalol).
With simultaneous use of clarithromycin with itraconazole may increase the plasma concentration of both substances.
If necessary, the appointment of tadalafil, sildenafil or vardenafil should be borne in mind that you may need to reduce their dose.
Terms and conditions of storage
Store at temperatures up to 25 ºС in a dry place out of reach of children.
Shelf life - 3 years.