Klacid: the first and original clarithromycin. Varieties, names, composition and forms of release

Composition and form of release of the drug

Powder for the preparation of a suspension for oral administration white or almost white, granular, with a fruity aroma; when shaken with water, an opaque suspension of white or almost white color is formed, with a fruity aroma.

Excipients: carbomer (carbopol 974P) - 150 mg, povidone K90 - 35 mg, hypromellose phthalate - 304.2 mg, - 32.1 mg, silicon dioxide - 10 mg, maltodextrin - 238.7 mg, sucrose - 2276.2 mg, titanium dioxide - 35.7 mg, xanthan gum - 3.8 mg, fruit flavor - 35.7 mg, potassium sorbate - 20 mg, citric acid - 4.24 mg.

70.7 g - 100 ml plastic bottles (1) complete with dosing spoon or dosing syringe - packs of cardboard.

pharmachologic effect

Semi-synthetic macrolide antibiotic. Suppresses the synthesis of proteins in the microbial cell, interacting with the 50S ribosomal subunit of bacteria. It acts mainly bacteriostatically, as well as bactericidal.

Active against gram-positive bacteria: Streptococcus spp., Staphylococcus spp., Listeria monocytogenes, Corynebacterium spp.; gram-negative bacteria: Helicobacter pylori, Haemophilus influenzae, Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Borrelia burgdorferi; anaerobic bacteria: Eubacterium spp., Peptococcus spp., Propionibacterium spp., Clostridium perfringens, Bacteroides melaninogenicus; intracellular microorganisms: Legionella pneumophila, Chlamydia trachomatis, Chlamydophila pneumoniae, Ureaplasma urealyticum, Mycoplasma pneumoniae.

It is also active against Toxoplasma gondii, Mycobacterium spp. (except for Mycobacterium tuberculosis).

Pharmacokinetics

When administered orally, clarithromycin is well absorbed from the gastrointestinal tract. Eating slows down absorption, but does not affect the bioavailability of the active substance.

Clarithromycin penetrates well into biological fluids and tissues of the body, where it reaches a concentration 10 times greater than in.

Approximately 20% of clarithromycin is immediately metabolized to form the main metabolite 14-hydroclarithromycin.

At a dose of 250 mg T 1/2 is 3-4 hours, at a dose of 500 mg - 5-7 hours.

It is excreted in the urine unchanged and as metabolites.

Indications

Treatment of infectious and inflammatory diseases caused by pathogens sensitive to clarithromycin: infections upper divisions respiratory tract and ENT organs (tonsillopharyngitis, otitis media, acute sinusitis); infections lower divisions respiratory tract (acute bronchitis, exacerbation of chronic bronchitis, community-acquired bacterial and atypical pneumonia); odontogenic infections; skin and soft tissue infections; mycobacterial infections (M.avium complex, M.kansasii, M.marinum, M.leprae) and their prevention in AIDS patients; eradication of Helicobacter pylori in patients with duodenal ulcer or gastric ulcer (only as part of combination therapy).

Contraindications

History of QT prolongation, ventricular arrhythmia, or ventricular tachycardia type "pirouette"; hypokalemia (risk of prolongation of the QT interval); severe hepatic failure, occurring simultaneously with kidney failure; cholestatic jaundice/hepatitis in history, developed during the use of clarithromycin; porphyria; I trimester of pregnancy; lactation period (breastfeeding); simultaneous administration of clarithromycin with astemizole, cisapride, pimozide, terfenadine; with ergot alkaloids, eg ergotamine, dihydroergotamine; with midazolam for oral administration; with HMG-CoA reductase inhibitors (statins), which are largely metabolized by the CYP3A4 isoenzyme (, simvastatin), with colchicine; with ticagrelor or ranolazine; hypersensitivity to clarithromycin and other macrolides.

Dosage

Individual. When taken orally for adults and children over 12 years of age, a single dose is 0.25-1 g, the frequency of administration is 2 times / day.

For children under 12 years of age, the daily dose is 7.5-15 mg / kg / day in 2 divided doses.

In children, clarithromycin should be used in the appropriate dosage form intended for this category of patients.

The duration of treatment depends on the indications.

In patients with impaired renal function (CC less than 30 ml / min or serum creatinine more than 3.3 mg / dl), the dose should be reduced by 2 times or the interval between doses should be doubled.

Maximum daily doses: for adults - 2 g, for children - 1 g.

Side effects

From the digestive system: often - diarrhea, vomiting, dyspepsia, nausea, pain in the abdomen; infrequently - esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence, increased blood bilirubin concentration, increased activity of ALT, ACT, GGT, alkaline phosphatase, LDH, cholestasis, hepatitis , incl. cholestatic and hepatocellular; frequency unknown - acute pancreatitis, discoloration of the tongue and teeth, liver failure, cholestatic jaundice.

Allergic reactions: often - rash; infrequently - anaphylactoid reaction, hypersensitivity, bullous dermatitis, itching, urticaria, maculo-papular rash; frequency unknown - anaphylactic reaction, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

From the nervous system: often - headache, insomnia; infrequently - loss of consciousness, dyskinesia, dizziness, drowsiness, tremor, anxiety, irritability; frequency unknown - convulsions, psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, nightmares, paresthesia, mania.

From the side of the skin: often - intense sweating; frequency unknown - acne, hemorrhages.

From the sense organs: often - dysgeusia; infrequently - vertigo, hearing loss, ringing in the ears; frequency unknown - deafness, ageusia, parosmia, anosmia.

From the side of the cardiovascular system: often - vasodilation; infrequently - cardiac arrest, atrial fibrillation, prolongation of the QT interval on the ECG, extrasystole, atrial flutter; frequency unknown - ventricular tachycardia, incl. pirouette type.

From the urinary system: infrequently - an increase in the concentration of creatinine, a change in the color of urine; frequency unknown - renal failure, interstitial nephritis.

From the side of metabolism and nutrition: infrequently - anorexia, loss of appetite, increased urea concentration, changes in the albumin-globulin ratio.

From the musculoskeletal system: infrequently - muscle spasm, musculoskeletal stiffness, myalgia; frequency unknown - rhabdomyolysis, myopathy.

From the respiratory system: infrequently - asthma, epistaxis, pulmonary embolism.

From the hematopoietic system: infrequently - leukopenia, neutropenia, eosinophilia, thrombocythemia; frequency unknown - agranulocytosis, thrombocytopenia.

From the blood coagulation system: infrequently - an increase in the value of MHO, prolongation of prothrombin time.

Local reactions: very often - phlebitis at the injection site, often - pain at the injection site, inflammation at the injection site.

From the body as a whole: infrequently - malaise, hyperthermia, asthenia, chest pain, chills, fatigue.

drug interaction

Clarithromycin inhibits the activity of the CYP3A4 isoenzyme, which leads to a slowdown in the rate of metabolism of astemizole when they simultaneous application. As a result, there is an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the "pirouette" type.

Simultaneous administration of clarithromycin with lovastatin or simvastatin is contraindicated due to the fact that these statins are largely metabolized by the CYP3A4 isoenzyme, and combined use with clarithromycin increases their serum concentrations, which leads to an increased risk of myopathy, including rhabdomyolysis. Cases of rhabdomyolysis have been reported in patients taking clarithromycin concomitantly with these drugs. If clarithromycin is required, lovastatin or simvastatin should be discontinued for the duration of therapy.

Clarithromycin should be used with caution in combination therapy with other statins. It is recommended to use statins that do not depend on the metabolism of CYP3A isoenzymes (for example, fluvastatin). If co-administration is necessary, it is recommended to take the lowest dose of the statin. The development of signs and symptoms of myopathy should be monitored. With simultaneous use with atorvastatin, the concentration of atorvastatin in the blood plasma moderately increases, and the risk of developing myopathy increases.

Drugs that are CYP3A inducers (eg, phenytoin, carbamazepine, phenobarbital, St. It is necessary to control the plasma concentration of the CYP3A inducer, which may increase due to inhibition of CYP3A by clarithromycin.

When combined with rifabutin, the concentration of rifabutin in the blood plasma increases, the risk of developing uveitis increases, and the concentration of clarithromycin in the blood plasma decreases.

When combined with clarithromycin, an increase in plasma concentrations of phenytoin, carbamazepine,.

Strong inducers of isoenzymes of the cytochrome P450 system, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentine are able to accelerate the metabolism of clarithromycin and, thus, reduce the concentration of clarithromycin in plasma and weaken it therapeutic effect, and at the same time increase the concentration of 14-OH-clarithromycin, a metabolite that is also microbiologically active. Since the microbiological activity of clarithromycin and 14-OH-clarithromycin differs in relation to different bacteria, the therapeutic effect may be reduced when clarithromycin and enzyme inducers are used together.

Plasma concentration of clarithromycin decreases with the use of etravirine, while the concentration of the active metabolite 14-OH-clarithromycin increases. Since 14-OH-clarithromycin has low activity against MAC infections, the overall activity against their pathogens may change, so an alternative treatment should be considered for the treatment of MAC.

A pharmacokinetic study showed that co-administration of ritonavir 200 mg every 8 hours and clarithromycin 500 mg every 12 hours resulted in a marked suppression of clarithromycin metabolism. When co-administered with ritonavir, C max of clarithromycin increased by 31%, C min increased by 182% and AUC increased by 77%, while the concentration of its metabolite 14-OH-clarithromycin was significantly reduced. Ritonavir should not be co-administered with clarithromycin at doses greater than 1 g/day.

Clarithromycin, atazanavir, saquinavir are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. When saquinavir is co-administered with ritonavir, the potential effect of ritonavir on clarithromycin should be considered.

With simultaneous use with zidovudine, the bioavailability of zidovudine is slightly reduced.

Colchicine is a substrate for both CYP3A and P-glycoprotein. Clarithromycin and other macrolides are known to be inhibitors of CYP3A and P-glycoprotein. When clarithromycin and colchicine are co-administered, inhibition of P-glycoprotein and/or CYP3A may lead to an increased effect of colchicine. The development of clinical symptoms of colchicine poisoning should be monitored. There have been post-marketing reports of cases of colchicine poisoning when taken concomitantly with clarithromycin, more often in elderly patients. Some of the reported cases have occurred in patients with renal insufficiency. Some cases have been reported to have resulted in death. The simultaneous use of clarithromycin and colchicine is contraindicated.

With the combined use of midazolam and clarithromycin (orally 500 mg 2 times / day), an increase in the AUC of midazolam was noted: 2.7 times after intravenous administration of midazolam and 7 times after oral intake. Co-administration of clarithromycin with oral midazolam is contraindicated. If intravenous midazolam is used with clarithromycin, the patient should be carefully monitored for possible dose adjustments. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A, including triazolam and alprazolam. For benzodiazepines whose excretion is independent of CYP3A (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.

With the combined use of clarithromycin and triazolam, effects on the central nervous system, such as drowsiness and confusion, are possible. With this combination, it is recommended to monitor the symptoms of CNS disorders.

With simultaneous use with warfarin, it is possible to increase the anticoagulant effect of warfarin and increase the risk of bleeding.

It is assumed that digoxin is a substrate for P-glycoprotein. Clarithromycin is known to inhibit P-glycoprotein. With simultaneous use with digoxin, a significant increase in the concentration of digoxin in the blood plasma and the risk of developing glycoside intoxication are possible.

Perhaps the occurrence of ventricular tachycardia type "pirouette" with the combined use of clarithromycin and quinidine or disopyramide. While taking clarithromycin with these drugs, regular ECG monitoring should be carried out for an increase in the QT interval, and serum concentrations of these drugs should also be monitored. In post-marketing use, cases of hypoglycemia have been reported with the co-administration of clarithromycin and disopyramide. It is necessary to control the concentration of glucose in the blood while using clarithromycin and disopyramide. It is believed that it is possible to increase the concentration of disopyramide in the blood plasma due to inhibition of its metabolism in the liver under the influence of clarithromycin.

Co-administration of fluconazole at a dose of 200 mg daily and clarithromycin at a dose of 500 mg 2 times / day caused an increase in the average value of the minimum equilibrium concentration of clarithromycin (C min) and AUC by 33% and 18%, respectively. At the same time, co-administration did not significantly affect the average equilibrium concentration of the active metabolite 14-OH-clarithromycin. Dose adjustment of clarithromycin is not required in case of concomitant use of fluconazole.

Clarithromycin and itraconazole are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. Clarithromycin may increase plasma concentrations of itraconazole, while itraconazole may increase plasma concentrations of clarithromycin.

With simultaneous use with methylprednisolone, the clearance of methylprednisolone decreases; with prednisone - cases of development of acute mania and psychosis are described.

With simultaneous use with omeprazole, the concentration of omeprazole increases significantly and the concentration of clarithromycin in the blood plasma slightly increases; with lansoprazole - glossitis, stomatitis and / or the appearance of a dark color of the tongue are possible.

With simultaneous use with sertraline, the development of serotonin syndrome cannot theoretically be excluded; with theophylline - it is possible to increase the concentration of theophylline in the blood plasma.

With simultaneous use with terfenadine, it is possible to slow down the rate of metabolism of terfenadine and increase its concentration in blood plasma, which can lead to an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the "pirouette" type.

Inhibition of the activity of the isoenzyme CYP3A4 under the influence of clarithromycin leads to a slowdown in the rate of metabolism of cisapride with their simultaneous use. As a result, the concentration of cisapride in the blood plasma increases and the risk of developing life-threatening cardiac arrhythmias, including ventricular arrhythmias of the "pirouette" type, increases.

The primary metabolism of tolterodine is carried out with the participation of CYP2D6. However, in the part of the population lacking CYP2D6, metabolism occurs with the participation of CYP3A. In this population, suppression of CYP3A results in significantly higher serum concentrations of tolterodine. Therefore, in patients with low levels of CYP2D6-mediated metabolism, a dose reduction of tolterodine may be required in the presence of CYP3A inhibitors such as clarithromycin.

With the combined use of clarithromycin and oral hypoglycemic agents (for example, sulfonylurea derivatives) and / or insulin, severe hypoglycemia may occur. Co-administration of clarithromycin with certain hypoglycemic agents (eg, nateglinide, pioglitazone, repaglinide, and rosiglitazone) may result in inhibition of CYP3A isoenzymes by clarithromycin, which may lead to hypoglycemia. It is believed that with simultaneous use with tolbutamide, there is a possibility of developing hypoglycemia.

With simultaneous use with fluoxetine, a case of the development of toxic effects caused by the action of fluoxetine is described.

While taking clarithromycin with other ototoxic drugs, especially aminoglycosides, care must be taken and the functions of the vestibular and hearing aids should be monitored both during and after therapy.

With simultaneous use with cyclosporine, the concentration of cyclosporine in the blood plasma increases, there is a risk of increased side effects.

With simultaneous use with ergotamine, dihydroergotamine, cases of increased side effects of ergotamine and dihydroergotamine are described. Post-marketing studies show that when clarithromycin is co-administered with ergotamine or dihydroergotamine, the following effects associated with acute poisoning with ergotamine group drugs are possible: vascular spasm, ischemia of the extremities and other tissues, including the central nervous system. The concomitant use of clarithromycin and ergot alkaloids is contraindicated.

Each of these PDE inhibitors is metabolized, at least in part, with the participation of CYP3A. At the same clarithromycin is able to inhibit CYP3A. Co-administration of clarithromycin with sildenafil, tadalafil, or vardenafil may result in an increased inhibitory effect on PDE. With these combinations, dose reduction of sildenafil, tadalafil and vardenafil should be considered.

With the simultaneous use of clarithromycin and which are metabolized by the CYP3A4 isoenzyme (for example, verapamil, amlodipine, diltiazem), caution should be exercised, since there is a risk of arterial hypotension. Plasma concentrations of clarithromycin, as well as calcium channel blockers, may increase with simultaneous use. Arterial hypotension, bradyarrhythmia and lactic acidosis are possible while taking clarithromycin and verapamil.

special instructions

Clarithromycin should be used with caution in patients with moderate to severe renal impairment; liver failure of moderate and severe degree, with coronary artery disease, severe heart failure, hypomagnesemia, severe bradycardia (less than 50 bpm); simultaneously with benzodiazepines, such as alprazolam, triazolam, midazolam for intravenous administration; simultaneously with other ototoxic drugs, especially aminoglycosides; simultaneously with drugs that are metabolized by CYP3A isoenzymes (including carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, omeprazole, indirect anticoagulants, quinidine, rifabutin, sildenafil, tacrolimus, vinblastine; simultaneously with CYP3A4 inducers (including rifampicin , phenytoin, carbamazepine, phenobarbital, St. John's wort); simultaneously with statins, the metabolism of which does not depend on the CYP3A isoenzyme (including fluvastatin); simultaneously with blockers of slow calcium channels, which are metabolized by CYP3A4 isoenzymes (including verapamil, amlodipine, diltiazem); simultaneously with class I A antiarrhythmic drugs (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol).

There is cross-resistance between macrolide antibiotics.

Antibiotic treatment alters the normal intestinal flora, so superinfection caused by resistant microorganisms is possible.

It should be borne in mind that severe persistent diarrhea may be due to the development of pseudomembranous colitis.

Prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.

Pregnancy and lactation

Use in the first trimester of pregnancy is contraindicated.

Application in the II and III trimesters of pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Before buying an antibiotic Klacid, you must carefully read the instructions for use, methods of application and dosage, as well as other useful information on the drug Klacid. On the site "Encyclopedia of Diseases" you will find all the necessary information: instructions for proper use, recommended dosage, contraindications, as well as reviews of patients who have already used this drug.

Klacid - Composition and form of release

Currently, the antibiotic Klacid is available in two varieties: Klacid; Klacid SR.

The variety Klacid SR differs from Klacid in that it is a tablet of prolonged (long-term) action. There are no other differences between Klacid and Klacid SR, therefore, as a rule, both varieties of the drug are combined under the same name "Klacid". We will also use the name "Klacid" to refer to both varieties of the drug, specifying which one is in question only if necessary.

Klacid SR is available in a single dosage form - these are tablets of prolonged (long-term) action, and Klacid - in three dosage forms, such as:

- Lyophilisate for solution for infusion;

- Powder for suspension for oral administration;

- Tablets.

As an active substance, all dosage forms of both varieties contain clarithromycin in various dosages.

So, Klacid SR tablets contain 500 mg of the active substance.

Lyophilisate for solution for infusion contains 500 mg of clarithromycin per vial.

Tablets of the usual duration of action Klacid are available in two dosages - 250 mg and 500 mg of clarithromycin.

Powder for the preparation of the suspension is also available in two dosages - these are 125 mg / 5 ml and 250 mg / 5 ml. This means that the finished suspension may have an active substance concentration of 125 mg per 5 ml or 250 mg per 5 ml.

In everyday life, various dosage forms, varieties and dosages of Klacid are called short and capacious names, reflecting their main characteristics. So, tablets are often called Klacid 250 or Klacid 500, where the number next to the name reflects the dosage of the drug. Suspension, taking into account the same principle, is called Klacid 125 or Klacid 250, etc.

Tablets of both dosages Klacid and prolonged action Klacid SR have the same biconvex, oval shape and are covered with a yellow-colored shell. Tablets are available in packs of 7, 10, 14, 21 and 42 pieces. Powder for suspension for oral administration is a small granules, painted white or almost white in color and having a fruity odor. The powder is available in 42.3 g vials, complete with dosing spoon and syringe. When the powder is dissolved in water, an opaque suspension is formed, colored white and having a fruity aroma. Lyophilisate for solution for infusion is available in hermetically sealed vials and is a white powder with a slight aroma.

Pharmacological action: bacteriostatic, antibacterial.

Coated tablets 1 tab.

active ingredient: clarithromycin 250 mg

excipients: 0.5 g

tablet core 250 mg: croscarmellose sodium; MCC; pregelatinized starch; silicon dioxide; povidone; stearic acid; magnesium stearate; talc; quinoline yellow E104

tablet shell 250 mg: hypromellose; hyprolosis; propylene glycol; sorbitan monooleate; titanium dioxide; sorbic acid; vanillin; quinoline yellow (E104)

tablet core 0.5 g: croscarmellose; MCC; silicon dioxide; povidone; stearic acid; magnesium stearate; talc

tablet shell 0.5 g: hypromellose; hydroxypropyl cellulose; propylene glycol; sorbitan monooleate; titanium dioxide; sorbic acid; vanillin; quinoline yellow (E104)

Klacid - Pharmacological action

Pharmacodynamics

Klacid is a popular semi-synthetic antibiotic of the macrolide group, which has antibacterial action, interacting with the 50S ribosomal subunit of sensitive bacteria and inhibiting protein synthesis.

Klacid demonstrated high activity in vitro against standard and isolated bacterial cultures. Highly effective against many aerobic and anaerobic, gram-positive and gram-negative microorganisms.

Klacid in vitro is highly effective against Legionella pneumophila, Mycoplasma pneumoniae and Helicobacter (Campilobacter) pylori. Enterobacteriaceae and Pseudomonas as well as others that do not degrade lactose Gram-negative bacteria not sensitive to clarithromycin.

It has been shown that clarithromycin has an antibacterial effect against the following pathogens: aerobic gram-positive microorganisms - Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes; aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainftuenzae, Moraxella catarrhalis, Legionella pneumophila, Neisseria gonorrhoeae; other microorganisms - Mycoplasma pneumoniae, Chlamydia pneumoniae (TWAR), Chlamydia trachomatis; mycobacteria - Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum; Mycobacterium avium complex (MAC) — a complex including: Mycobacterium avium, Mycobacterium intracellulare.

The production of beta-lactamase does not affect the activity of clarithromycin.

Most strains of staphylococci resistant to methicillin and are also resistant to clarithromycin.

Helicobacter pylori. The sensitivity of H. pylori to clarithromycin was studied on H. pylori isolates isolated from 104 patients prior to drug therapy. Clarithromycin-resistant strains of H. pylori were isolated in 4 patients, strains with intermediate resistance were isolated in 2 patients, and H. pylori isolates were sensitive to clarithromycin in the remaining 98 patients. Clarithromycin is active in vitro and against most strains of the following microorganisms (however, the safety and efficacy of using clarithromycin in clinical practice not supported by clinical studies and practical value remains unclear):

- aerobic gram-positive microorganisms - Streptococcus agalactiae, Streptococci ( groups C,F,G), Viridans group streptococci;

- aerobic gram-negative microorganisms - Bordetella pertussis, Pasteurella multocida;

- anaerobic gram-positive microorganisms - Clostridium perfringens, Peptococcus niger, Propionibacterium acnes;

- anaerobic gram-negative microorganisms - Bacteroides melaninogenicus;

- spirochetes - Borrelia burgdorferi, Treponema pallidum;

- campylobacter - Campylobacter jejuni.

The main metabolite of clarithromycin in the human body is the microbiologically active metabolite, 14-hydroxyclarithromycin (14-OH-clarithromycin). The microbiological activity of the metabolite is the same as that of the parent substance, or 1-2 times weaker in relation to most microorganisms. The exception is H.influenzae, for which the efficiency of the metabolite is 2 times higher. The parent substance and its major metabolite have either an additive or synergistic effect against H. influenzae in vitro and in vivo, depending on the bacterial culture.

Sensitivity studies

Quantitative methods that require measuring the diameter of the zone of inhibition of growth of microorganisms provide the most accurate estimates of the sensitivity of bacteria to antimicrobial agents.

One recommended susceptibility test uses discs impregnated with 15 µg of clarithromycin (Kirby-Bauer diffusion test); the results of the test are interpreted depending on the diameter of the zone of growth inhibition of the microorganism and the MIC value of clarithromycin. The MIC value is determined by the method of dilution of the medium or diffusion into agar.

Laboratory tests give one of 3 results:

- moderately sensitive - the therapeutic effect is ambiguous, and it is possible that increasing the dosage can lead to sensitivity;

Pharmacokinetics

The drug is rapidly absorbed in the gastrointestinal tract. Absolute bioavailability is about 50%. With multiple doses of the drug, cumulation was not detected, and the nature of metabolism in the human body did not change. Eating immediately before taking the drug increased the bioavailability of the drug by an average of 25%.

Clarithromycin can be taken before or during meals.

In vitro

In in vitro studies, the binding of clarithromycin to plasma proteins is 70% at a concentration of 0.45 to 4.5 μg / ml. At a concentration of 45 μg/ml, binding is reduced to 41%, probably as a result of saturation of the binding sites. This is observed only at concentrations many times higher than therapeutic.

Healthy

When prescribing clarithromycin at a dose of 250 mg 2 times a day, the maximum Css of clarithromycin and 14-hydroxyclarithromycin in plasma were achieved after 2-3 days and amounted to 1 and 0.6 μg / ml, respectively. T1 / 2 of the parent drug and its main metabolite were 3-4 and 5-6 hours, respectively. When prescribing clarithromycin at a dose of 500 mg 2 times a day, the maximum Css of clarithromycin and 14-hydroxyclarithromycin in plasma were achieved after taking the 5th dose and amounted to on average 2.7-2.9 and 0.88-0.83 µg/ml, respectively. T1 / 2 of the parent drug and its main metabolite were 4.5-4.8 hours and 6.9-8.7 hours, respectively.

At equilibrium state the level of 14-hydroxyclarithromycin does not increase in proportion to the doses of clarithromycin, and T1 / 2 of clarithromycin and its main metabolite increase with increasing dose. The non-linear nature of the pharmacokinetics of clarithromycin is associated with a decrease in the formation of 14-OH- and N-demethylated metabolites with higher doses, which indicates the non-linearity of the metabolism of clarithromycin when taking high doses. About 37.9% is excreted in the urine after taking 250 mg and 46% after taking 1200 mg of clarithromycin, through the intestine - about 40.2 and 29.1%, respectively.

Clarithromycin and its 14-OH metabolite are well distributed in tissues and body fluids. After oral administration of clarithromycin, its content in cerebrospinal fluid remains low (with normal BBB permeability of 1-2% of the serum level). The content in tissues is usually several times more content in blood serum.

Liver dysfunction

In patients with moderate and severe violation functional state liver, but with preserved renal function, dose adjustment of Klacid is not required. Css in blood plasma and systemic clearance of clarithromycin do not differ in patients of this group and healthy patients. Css 14-hydroxyclarithromycin in people with impaired liver function is lower than in healthy people.

Impaired kidney function

In case of impaired renal function, the minimum and maximum content clarithromycin in plasma, T1 / 2, AUC of clarithromycin and 14-OH metabolite. Elimination rate and urinary excretion decrease. The degree of change in these parameters depends on the degree of impaired renal function.

Elderly patients

In elderly patients, the level of clarithromycin and its 14-OH metabolite in the blood was higher, and the excretion was slower than in the group of young people. It is believed that changes in pharmacokinetics in elderly patients are associated primarily with changes in creatinine clearance and renal function, and not with the age of patients.

Patients with mycobacterial infections

Css of clarithromycin and 14-OH-clarithromycin in patients with who received Klacid in usual doses(500 mg 2 times a day), were similar to those in healthy people. However, when using Klacid in more high doses, which may be required to treat mycobacterial infections, antibiotic concentrations may be significantly higher than usual.

In patients with HIV infection who took Klacid at a dose of 1000 and 2000 mg / day in 2 doses, Css was usually 2-4 and 5-10 μg / ml, respectively. When using the drug in higher doses, there was an increase in T1 / 2 compared to that in healthy people who received Klacid in normal doses. The increase in plasma concentrations and duration of T1 / 2 with the appointment of clarithromycin at higher doses is consistent with the known non-linearity of the pharmacokinetics of the drug.

Combination treatment with omeprazole

Klacid 500 mg 3 times a day in combination with omeprazole at a dose of 40 mg / day increases T1 / 2 and AUC0-24 of omeprazole. All patients receiving combination therapy, in comparison with those receiving omeprazole alone, there was an increase of 89% in AUC0-24 and 34% in T1 / 2 of omeprazole. In Klacid, Cmax, Cmin and AUC0-8 increased by 10%, 27% and 15%, respectively, compared with the data when only Klacid was used without Omeprazole. At steady state, gastric mucosal concentrations of clarithromycin 6 hours post-dose were 25-fold higher in the combination group than in those treated with clarithromycin alone. Concentrations of clarithromycin in the tissues of the stomach 6 hours after taking 2 drugs were 2 times higher than the data obtained in the group of patients who received only clarithromycin.

Klacid - Indications for use

It is necessary to know that Klacid SR is recommended for the treatment of infections of the upper and lower parts of the respiratory system, as well as skin and soft tissues. In principle, for all other infections listed above, Klacid SR can also be used, but this should be done only if it is not possible to use the usual Klacid, which in these cases is preferable.

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

- infections of the upper respiratory tract (pharyngitis, tonsillitis and sinusitis);

- infections of the lower respiratory tract (bronchitis,);

- otitis media;

- infections of the skin and soft tissues (, cellulitis, abscesses);

- disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare;

- localized infections caused by Mycobacterium fortuitum, Mycobacterium kansasii, Mycobacterium chelonae.

Klacid - Instructions for use of the suspension

Suspension Klacid is not sold ready-made, it must be prepared independently from the powder. Powders for the preparation of a suspension are currently sold in two dosages - 125 mg / 5 ml and 250 mg / 5 ml. Suspension 125 mg is sold in 60 ml bottles, and 250 mg - 100 ml. Accordingly, if a powder with a concentration of 125 mg / 5 ml is purchased, then approximately 30 ml of water will be needed to prepare a suspension from it, and about 50 ml for 250 mg / 5 ml.

From the powder in the vial, a suspension should be prepared immediately at the moment when it is planned to be used. This is due to the fact that the finished suspension can be stored for only 2 weeks, after which the drug should be discarded, even if it was not completely used. If treatment continues for more than two weeks, then every 14 days the remains of the old suspension should be discarded and a new one should be prepared. The suspension should be stored only at room temperature from 15° to 30°C, and shake well before each use.

To prepare the suspension, carefully open the vial. After that, add pure non-carbonated water to the mark and shake the vial vigorously to form a homogeneous, opaque white solution. If a powder with an active substance concentration of 125 mg / 5 ml was used, then after adding water, 60 ml of suspension will be obtained. If a powder of 250 mg/5 ml was used, then 100 ml of a ready-to-use suspension will be obtained.

Suspension Klacid is recommended for use in children, as it is easy to dose in the required amount. However, if necessary, adults can also take Klacid in the form of a suspension, measuring the appropriate dosage. But for adults it is more expedient to take Klacid tablets, because. the suspension will be used very quickly and several vials will be needed for the course of treatment, which, in the end, will lead to rather high unnecessary costs.

Klacid in the form of a suspension can be used for children from the age of 6 months. From the age of 12, provided that the body weight of a teenager is 40 kg or more, it is recommended to give Klacid tablets already. The suspension can be taken regardless of food, at any convenient time. The required amount of suspension should be measured with the supplied dosing spoon or syringe. The suspension is given to children in its pure form, but if they do not like the taste, then you can drink it with water, juice, tea, milk or another drink. For infants, the suspension can be mixed into milk, formula or water.

The dosage of Klacid suspension for children depends on the type of microorganism that caused the infectious disease, as well as on body weight. So, for the treatment of infections in children caused by mycobacteria, there are one dosages of Klacid, and for diseases provoked by any other microbes, other doses of the antibiotic are taken.

So, for the treatment of infections caused by non-mycobacteria, a single dosage of Klacid for children is calculated individually, based on the ratio of 7.5 mg per 1 kg of weight. The drug in the calculated dosage is given to the child 2 times a day. It must be remembered that the dosage is individually calculated only for children weighing less than 40 kg. If a child weighs more than 40 kg, then he is given Klacid in dosages for adults.

Consider, for example, the calculation of the dose of the drug for a child weighing 20 kg. A single dosage of Klacid for a child weighing 20 kg is 20 kg * 7.5 mg = 150 mg. This means that the child must be given 150 mg of Klacid 2 times a day. Now it is necessary to calculate how many milliliters of the suspension should be given to the child so that he receives the necessary 150 mg of the active substance. We will calculate for a suspension with a concentration of 125 mg / 5 ml. To do this, we make a proportion as follows:

125 mg - 5 ml

150 mg - X ml,

where the top line indicates the concentration of the suspension (125 mg of the active substance is contained in 5 ml). Further, in the bottom line, under the number indicating the content of the active substance in a certain volume of suspension (in our example, this is 125 mg), we write how much of this substance should be given to the child (in the example, this is 150 mg). And under the indication of the volume in the first line (in the example it is 5 ml), in the second we write X, since we need to calculate how many milliliters of the suspension contains the required 150 mg of the active substance. Next, we write an equation for calculating the value of X, which looks like this:

X = 150 mg * 5 ml / 125 mg = 6 ml.

This means that a child weighing 20 kg should be given 6 ml of suspension at a concentration of 125 mg / 5 ml 2 times a day.

Similarly, the amount of suspension and the required dosage for children with any body weight are calculated. This algorithm can be used as a sample by simply substituting your own data into it. In proportion, if we are talking about a suspension with a concentration of 250 mg / 5 ml, in the first line they write not “125 mg - 5 ml”, but “250 mg - 5 ml”.

Dosage of Klacid for children, suffering from diseases caused by mycoplasmas, is also calculated individually, based on the ratio of 7.5 - 15 mg per 1 kg of body weight, 2 per day. The calculated daily dose is also given 2 times a day. In principle, dosages for the treatment of mycoplasmal diseases can not be calculated, but you can use the table above, which indicates the amount of suspension needed by a child with a particular body weight, based on the calculation of 7.5 mg per 1 kg of weight. You just need to remember that this table indicates the minimum dosage for the treatment of mycoplasmal infections, and they can be increased by a maximum of two times. For example, a child weighing 20 kg for the treatment of non-mycoplasmal infection should be given 150 ml of a suspension with a concentration of 125 mg / 5 ml 2 times a day. This means that a child weighing also 20 kg, but for the treatment of mycoplasma infection, you need to give 150-300 ml of a suspension with a concentration of 125 mg / 5 ml 2 times a day.

The maximum allowable daily dosage of Klacid for children weighing less than 40 kg for the treatment of any infections is 500 mg per day.

For children suffering from renal insufficiency, in which the creatinine clearance according to the Rehberg test is less than 30 ml / min, the standard dosage of Klacid should be halved.

The duration of therapy with Klacid for non-mycoplasmal infections should be 5-10 days. It is allowed to increase the course of treatment up to 14-21 days in case of severe infection. Usually tonsillitis or pharyngitis requires taking Klacid for 10 days, otitis media - 7 - 10 days, chronic bronchitis - 7 days, sinusitis - 14 days, typical pneumonia - 7 - 10 days, and atypical pneumonia - 14 - 21 days, etc. d. It is impossible to take the drug for less than 5 days, since in this case there is a very high risk of forming a microbe variety that is resistant to the action of this antibiotic.

With mycoplasmal infections, the duration of Klacid therapy is variable and is determined by the preservation of its effect. That is, the drug is taken as long as it is effective. It must be remembered that the treatment of mycoplasmal infections is long, so taking antibiotics can last several weeks or even months.

Klacid (tablets 250, 500) - Instructions for use

Klacid 250 and Klacid 500 mg tablets are intended for use by adults and adolescents over 12 years of age, provided that their body weight is at least 40 kg. If a teenager has already reached the age of 12 years, but his body weight is below 40 kg, then he should be given Klacid in the form of a suspension. Tablets are taken orally, regardless of food, at any convenient time, swallowing them whole, without biting, chewing or crushing in other ways, but drinking clean non-carbonated water.

The dosage and duration of therapy are the same for adults and adolescents over 12 years of age, and are determined by the severity of the disease, as well as the localization of the infectious and inflammatory process. So, in general, for infections of mild or moderate severity, it is recommended to take Klacid 250 mg 2 times a day, and in severe cases of the disease, it is optimal to increase the dosage to 500 mg 2 times a day. The usual duration of Klacid therapy is 5-14 days and is determined by the rate of recovery. You should not take pills for less than 5 days, since in this case there is a high risk of under-curing the infection and provoking its chronicity due to the formation of microbe strains that are resistant to the action of the antibiotic.

For the treatment of infections caused by mycobacteria (with the exception of tuberculosis), Klacid is recommended to take 500-1000 mg 2 times a day for a long period of time (from 10 days to 6 months). HIV-infected and AIDS patients with mycobacterial infections should take Klacid 500 mg 2 times a day for a long time - as long as the effectiveness of the antibiotic remains.

To prevent infections caused by the MAC complex, it is recommended to take Klacid 500 mg 2 times a day for the entire period of time during which the risk of infection remains.

For the treatment of odontogenic infections (for example, tooth granuloma, "flux", etc.), Klacid should be taken 250 mg 2 times a day for 5 days.

- lactation period;

- children's age up to 3 years (see "Special Instructions").

With caution: violations of the liver and kidneys.

Klacid is excreted mainly by the liver. In this regard, care should be taken when prescribing an antibiotic to patients with impaired liver function. Caution should be observed in the treatment of Klacid patients with moderate and severe renal insufficiency. Cases of toxicity of colchicine in combination with clarithromycin have been described in clinical practice, especially in the elderly. Some of them were observed at patients with a renal failure; Several deaths have been reported in these patients. The possibility of cross-resistance between clarithromycin and other macrolide drugs, as well as between lincomycin and clindamycin, must be considered.

Klacid side effects

The most common adverse events from the gastrointestinal tract, incl. diarrhea, vomiting, abdominal pain and nausea. Other adverse reactions included headache, taste disturbance, and transient elevations in liver enzymes.

Post-marketing experience

In the treatment of Klacid, abnormal liver function, including increased activity of liver enzymes, and hepatocellular and / or cholestatic hepatitis with or without jaundice. Hepatic dysfunction can be severe and is usually reversible. In very rare cases, deaths have been reported from, which are usually observed in the presence of serious concomitant diseases and / or the simultaneous use of other drugs.

Isolated cases of increased serum creatinine levels have been described, but their relationship with the drug has not been established.

At oral administration Klacida described allergic reactions, which ranged from small rashes to anaphylaxis and/toxic epidermal necrolysis.

There are reports of transient CNS effects including anxiety, insomnia, nightmares, tinnitus, disorientation, hallucinations, and depersonalization; their causal relationship with the drug has not been established.

In the treatment of Klacid, cases of hearing loss are described; hearing was usually restored after treatment was discontinued. There are also known cases of violations of smell, which are usually combined with a perversion of taste.

In the treatment of Klacid, stomatitis, oral thrush and discoloration of the tongue are described. Cases of tooth discoloration have been reported in patients treated with clarithromycin. These changes are usually reversible and can be corrected by a dentist.

In the treatment of Klacid, as well as other macrolides, in rare cases, prolongation of the QT interval and ventricular tachycardia of the "pirouette" type were noted.

Described rare cases pancreatitis and seizures.

There are development reports interstitial nephritis in the treatment of Klacid.

Cases of toxicity of colchicine in combination with clarithromycin have been described in clinical practice, especially in the elderly. Some of them were observed at patients with a renal failure; Several deaths have been reported in these patients.

Children with suppressed immunity

In patients with AIDS and other immunodeficiencies receiving higher doses of Klacid for a long time for the treatment of mycobacterial infections, it is often difficult to differentiate unwanted effects drug for symptoms of HIV infection or intercurrent illness.

Main adverse events patients taking Klacid orally at a dose of 1 g had nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, bloating, headache, hearing loss, constipation, increased levels of AST and ALT. Dyspnea, insomnia, and dry mouth have also been reported less frequently.

In this group of patients with suppressed immunity, significant deviations of laboratory parameters from the normative values were recorded in specific tests ( sharp rise or decrease). Based on this, approximately 2-3% of patients taking Klacid orally at a dose of 1 g / day had significant laboratory abnormalities, such as an increase in the level of AST, ALT and a decrease in the number of leukocytes and platelets. In a smaller number of patients, an increase in the level of blood urea nitrogen was also observed.

Overdose of Klacid

Symptoms: Taking a large dose of Klacid may cause symptoms of gastrointestinal disorders. One patient with a history of 8 g clarithromycin described mental status changes, paranoid behavior, and hypoxemia.

Treatment: in case of overdose, 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 the level of clarithromycin in serum, which is typical for other drugs of the macrolide group.

Klacid - Drug Interactions

Klacid inhibits the activity of the CYP3A4 isoenzyme, which leads to a slowdown in the rate of metabolism of astemizole with their simultaneous use. As a result, there is an increase in the QT interval and an increased risk of developing ventricular arrhythmia of the "pirouette" type.

Co-administration of Klacid with lovastatin or simvastatin is contraindicated due to the fact that these statins are largely metabolized by the CYP3A4 isoenzyme, and combined use with clarithromycin increases their serum concentrations, which leads to an increased risk of myopathy, including rhabdomyolysis. Cases of rhabdomyolysis have been reported in patients taking clarithromycin concomitantly with these drugs. If clarithromycin is required, lovastatin or simvastatin should be discontinued for the duration of therapy.

Klacid should be used with caution in combination therapy with other statins. It is recommended to use statins that do not depend on the metabolism of CYP3A isoenzymes (for example, fluvastatin). If co-administration is necessary, it is recommended to take the lowest dose of the statin. The development of signs and symptoms of myopathy should be monitored. With simultaneous use with atorvastatin, the concentration of atorvastatin in the blood plasma moderately increases, and the risk of developing myopathy increases.

Drugs that are CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarbital, St. It is necessary to control the plasma concentration of the CYP3A inducer, which may increase due to inhibition of CYP3A by clarithromycin.

When combined with clarithromycin, an increase in plasma concentrations of phenytoin, carbamazepine, valproic acid is possible.

Strong inducers of isoenzymes of the cytochrome P450 system, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentine, can accelerate the metabolism of clarithromycin and, thus, lower the plasma concentration of Clacid and weaken its therapeutic effect, and at the same time increase the concentration of 14-OH-clarithromycin - metabolite, which is also microbiologically active. Since the microbiological activity of clarithromycin and 14-OH-clarithromycin differs in relation to different bacteria, the therapeutic effect may be reduced when clarithromycin and enzyme inducers are used together.

The plasma concentration of Klacid decreases with the use of etravirine, while the concentration of the active metabolite 14-OH-clarithromycin increases. Since 14-OH-clarithromycin has low activity against MAC infections, the overall activity against their pathogens may change, so an alternative treatment should be considered for the treatment of MAC.

A pharmacokinetic study showed that co-administration of ritonavir 200 mg every 8 hours and clarithromycin 500 mg every 12 hours resulted in a marked suppression of clarithromycin metabolism. When co-administered with ritonavir, clarithromycin Cmax increased by 31%, Cmin increased by 182%, and AUC increased by 77%, while the concentration of its metabolite 14-OH-clarithromycin was significantly reduced. Ritonavir should not be co-administered with clarithromycin at doses greater than 1 g/day.

Klacid, atazanavir, saquinavir are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. When saquinavir is co-administered with ritonavir, the potential effect of ritonavir on clarithromycin should be considered.

With simultaneous use with zidovudine, the bioavailability of zidovudine is slightly reduced.

With the combined use of midazolam and clarithromycin (500 mg orally 2 times / day), an increase in the AUC of midazolam was noted: 2.7 times after intravenous administration of midazolam and 7 times after oral administration. Co-administration of clarithromycin with oral midazolam is contraindicated. If intravenous midazolam is used with clarithromycin, the patient should be carefully monitored for possible dose adjustments. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A, including triazolam and alprazolam. For benzodiazepines whose excretion is independent of CYP3A (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.

With the combined use of Klacid and triazolam, effects on the central nervous system, such as drowsiness and confusion, are possible. With this combination, it is recommended to monitor the symptoms of CNS disorders.

With simultaneous use with warfarin, it is possible to increase the anticoagulant effect of warfarin and increase the risk of bleeding.

Perhaps the occurrence of ventricular tachycardia of the "pirouette" type with the combined use of Klacid and quinidine or disopyramide. While taking clarithromycin with these drugs, regular ECG monitoring should be carried out for an increase in the QT interval, and serum concentrations of these drugs should also be monitored. In post-marketing use, cases of hypoglycemia have been reported with the co-administration of clarithromycin and disopyramide. It is necessary to control the concentration of glucose in the blood while using clarithromycin and disopyramide. It is believed that it is possible to increase the concentration of disopyramide in the blood plasma due to inhibition of its metabolism in the liver under the influence of clarithromycin.

Co-administration of fluconazole at a dose of 200 mg daily and clarithromycin at a dose of 500 mg 2 times / day caused an increase in the average value of the minimum equilibrium concentration of clarithromycin (Cmin) and AUC by 33% and 18%, respectively. At the same time, co-administration did not significantly affect the average equilibrium concentration of the active metabolite 14-OH-clarithromycin. Dose adjustment of clarithromycin is not required in case of concomitant use of fluconazole.

Klacid and itraconazole are substrates and inhibitors of CYP3A, which determines their bidirectional interaction. Clarithromycin may increase plasma concentrations of itraconazole, while itraconazole may increase plasma concentrations of clarithromycin.

With simultaneous use with methylprednisolone, the clearance of methylprednisolone decreases; with prednisone - cases of acute mania and psychosis are described.

The primary metabolism of tolterodine is carried out with the participation of CYP2D6. However, in the part of the population lacking CYP2D6, metabolism occurs with the participation of CYP3A.

Klacid - Special Instructions

With caution, Klacid should be used in patients with moderate to severe renal insufficiency; hepatic insufficiency of moderate and severe degree, with severe, severe hypomagnesemia, severe (less than 50 bpm); simultaneously with benzodiazepines, such as alprazolam, triazolam, midazolam for intravenous administration; simultaneously with other ototoxic drugs, especially aminoglycosides; simultaneously with drugs that are metabolized by CYP3A isoenzymes (including carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, omeprazole, indirect anticoagulants, quinidine, rifabutin, sildenafil, tacrolimus, vinblastine; simultaneously with CYP3A4 inducers (including rifampicin , phenytoin, carbamazepine, phenobarbital, St. John's wort); simultaneously with statins, the metabolism of which does not depend on the CYP3A isoenzyme (including fluvastatin); simultaneously with blockers of slow calcium channels, which are metabolized by CYP3A4 isoenzymes (including verapamil, amlodipine, diltiazem); simultaneously with class I A antiarrhythmic drugs (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol).

There is cross-resistance between macrolide antibiotics.

Antibiotic treatment alters the normal intestinal flora, so superinfection caused by resistant microorganisms is possible.

It should be borne in mind that severe persistent diarrhea may be due to the development of pseudomembranous colitis.

Prothrombin time should be monitored periodically in patients receiving clarithromycin concomitantly with warfarin or other oral anticoagulants.

Pregnancy and lactation

Use in the first trimester of pregnancy is contraindicated.

Application in the II and III trimesters of pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If necessary, use during lactation should stop breastfeeding.

Application in childhood

Currently, there is insufficient data on the efficacy and safety of clarithromycin in children under 6 months of age.

For impaired renal function

In patients with impaired renal function (CC less than 30 ml / min or serum creatinine more than 3.3 mg / dl), the dose should be reduced by 2 times or the interval between doses should be doubled.

For impaired liver function

Contraindicated in severe liver failure, hepatitis (history).

Klacid - Analogues

Klacid can affect a large number of bacteria, but its only drawback compared to the benefits it brings is the cost. In pharmacies, the price of a broad-spectrum antibiotic "Klacid" reaches eight hundred rubles. However, a competent treating doctor will never prescribe a drug without being convinced of the diagnosis itself. After all, this medicine acts only on the bacteria of infectious infections indicated in the instructions. With a correctly diagnosed diagnosis, an analogue can also be used.

Klacid with bacterial angina can be replaced with an antibiotic, as well as its improved forms - powder for diluting Amoxicla suspension, Amoxicillin capsules, Solutab and Flemoxin tablets, Augmentin syrup. The reception of the described medicine takes place in severe cases of diseases and in cases where the above analogues do not give any effect.

If you are not satisfied with the price of the antibiotic Klacid, it is always possible to pick up analogues. But now they will have the same positive effect as from the drug discussed in this article, only a doctor can argue.

An analogue (Klacid has several of them) is selected according to the pharmacological properties of drugs. So, very often, instead of this drug, antibiotics based on clarithromycin are used, such as Klabax or Klarbakt tablets, Ecozitrin, and Clerimed.

There is also an analogue of this medicine on sale in pharmacies, which is called, that is, the Klacid antibiotic, which is identical in active substance, its cost does not exceed two hundred rubles. Many people have a question about why doctors do not attribute it to him, and the emphasis is on an expensive drug. The answer has one explanation. The antibiotic Klacid is a high-quality foreign-made medicine, while the medicine Clarithromycin is often a fake, containing less active ingredient than the original. Therefore, in order to achieve a 100% therapeutic effect, doctors focus on the Klacid remedy, although they do not exclude the use of similar, cheaper drugs.

So, having considered all the properties of the new antibiotic, you understand why today it has won the trust of many doctors and is so often found in their prescriptions. Despite the many positive properties, they take it strictly as prescribed by the doctor during infectious complications that cannot be treated with standard medicines. Frequent "friendship" with antibiotics can play a cruel joke with the formation of immunity as such. So be careful about the medicines that are prescribed to you and your children, regardless of age. And in no case do not buy them at your own discretion without visiting a doctor.

The most common analogues of Klacid for the active substance are as follows:

Arvicin retard

Binocular

Vero-Clarithromycin

clarbact

Clarithromycin

Clarithromycin Protech

Clarithromycin-Werte

Clarithrosin

Claricin

Claricite

Claromin

ClaroSip

clerimed

Lecoclar

Seidon-Sanovel

Fromilid

Fromilid Uno

Ecositrin

Klacid - Reviews of doctors

Maria Alexandrovna, pharmacist

Klacid is a modern antibiotic and one of the most powerful new macrolides. It has an antibacterial and anti-inflammatory effect. The drug showed high activity against gram-positive and gram-negative bacteria, chlamydia and mycoplasmas, as well as a number of microbacteria. All this indicates the breadth of the spectrum of action of this drug. Klacid is often used in the treatment of respiratory tract infections such as pharyngitis, bronchitis and pneumonia, as well as acute otitis media and skin and soft tissue infections. The drug helps in the treatment of a number of infectious and inflammatory diseases that are caused by microorganisms sensitive to clarithromycin (the active substance of the drug). It is available in the form of a powder for the preparation of a suspension with a fruity aroma, which makes it pleasant to use for children. Klacid is generally well and easily tolerated by children.

Smirnova E.A., pharmacy pharmacist

Excellent, high-quality broad-spectrum antibacterial agent. It is used to treat ENT organs, soft tissue infections, and many other diseases. The drug must be prescribed by a doctor to avoid incorrect and useless treatment. Be healthy!

Marina Sh. pharmacist

Klacid SR is a semi-synthetic antibiotic of the macrolipid group. The drug inhibits protein synthesis of bacteria that are sensitive to it, causing its antibacterial activity by this action. It is important to remember that it is contraindicated in people with severe renal insufficiency, and in patients with moderate renal impairment, the dose should be halved. The drug has shown its work well in the treatment of infections of the lower and upper respiratory tract, among which bronchitis, pharyngitis and pneumonia can be distinguished. Klacid SR will also be useful in the presence of folliculitis, inflammation subcutaneous tissue and . Against the background of pregnancy, it is better to look for alternative therapy in order to avoid the possibility of complications. The drug is able to penetrate into the mother's milk, so it is important to know that you can not continue breastfeeding while treating them. Klacid SR is available in the form of tablets, which is convenient both for its use and for storage.

Valentina Romanovna, pharmacist

Klacid is a semi-synthetic macrolide broad-spectrum antibiotic. It is widely used in the treatment of bacterial infections caused by susceptible microorganisms. The active substance of the drug disrupts the protein synthesis of microorganisms, which entails their incapacity. The choice of this remedy is fully justified in the treatment of respiratory tract infections, otitis media, as well as peptic ulcer of the stomach and duodenum. The drug assists in the treatment of odontogenic inflammatory diseases (infectious and inflammatory diseases that affect the bones of the jaws, adjacent soft tissues and regional lymph nodes). Klacid is available in tablet form to be taken before or with meals for maximum effectiveness.

Antipova T. M., pharmacy pharmacist

Klacid is a semi-synthetic macrolide antibiotic. It has an antibacterial effect. Klacid was prescribed by a doctor for sinusitis to my colleague, when the disease worsened so much that she was already advised to make a puncture, but she insisted on treatment with pills. Despite the high price, she drank a weekly course and felt relieved, she really didn’t need a puncture after klacid.

Klacid - Patient reviews

Natalia

The doctor prescribed Klacid for treatment of mycoplasma and ureplasma. After 1 use of the drug, it became just terrible. I had a wild weakness, dry mouth, apathy, lethargy. After 2 tablets, terrible pain in the liver and bitterness in the mouth, the condition was terrible .. Take care of yourself!

Valeria

Efficient, did an excellent job with the tension. I took both the suspension and the tablets, the suspension leaves a bitter taste in the mouth, then nothing can be interrupted, and it also weakens rather robustly - it carried me through a couple of times, but this was not the case with tablets, my body absorbed them better.

Olesya

ENT prescribed it to me, a good antibiotic, as for me. With it, even all sorts of bacteria for the intestines are not necessary to drink, and so there will be no disorder. And it doesn’t make me sick (it used to make some people throw up on me). Its price is not the smallest, but it works strongly.

Sima

Klacid Wed drank when she caught pneumonia. It was also not normal with the bronchi, so it was treated for a long time, seriously. They prescribed two pills at once, I began to sleep badly, could not fall asleep for a long time, I was nervous, I became irritable. Reduced to drink to 1 tablet, it began to pass. And the pneumonia passed without complications.

Miroslava

They took clacid with their son when both fell ill with sinusitis. The symptoms were terrible - it was almost impossible to breathe, a constant runny nose. The doctor prescribed this drug for both of us. Healed within a week. The instructions say a lot of side effects, but we did not have any of the above.

Oksana

He was prescribed when I got sick with sinusitis. I usually don’t tolerate antibiotics well, so I tried at first to be treated with folk remedies and warming up, but in the end I ran to the pharmacy for Klacid because the pain in the bridge of my nose became hellish and pounded with every inclination so that I thought I would die. He let me go almost immediately after the first appointment. Thank God it got out. There were no side effects because I drank Bifidumbacterin in parallel.

Valery Giryaev

A reliable antibiotic, the truth immediately hits my stomach hard - I had diarrhea from it, but it worked well for sinusitis, it just tortured me already and I practically did not breathe through my nose. You need to chew the tablets, but sometimes I swallowed them just like that and nothing, they worked anyway, now I breathe through my nose at last.

Terms and conditions of storage

Store in a place protected from light, at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf life: 5 years.

Do not use after the expiry date stated on the packaging.

Conditions for dispensing from pharmacies: By prescription.

We want to pay special attention to the fact that the description of the antibiotic Klacid is presented for informational purposes only! For more accurate and detailed information about the drug Klacid, please refer exclusively to the manufacturer's annotation! In no case do not self-medicate! You should definitely consult a doctor before using the drug!

An antibiotic prescribed to children of any age must meet several requirements at once. It must be effective enough to obtain the desired result without waiting for the results of bacteriological culture; safe for all tissues and organs of a growing organism, as well as convenient to use, that is, have various forms of release. All these requirements are perfectly met by the antibiotic "Klacid" - the active substance clarithromycin, a modern representative of the macrolide group.

When the drug is prescribed and its mechanism of action

Clarithromycin has a fairly wide spectrum of action, destroys gram-positive microorganisms (listeria, moraxella, diphtheroids), gram-negative (campylobacter, helicobacter, a number of clostridia), almost all mycobacteria (except for the classic Koch bacillus) and intracellular microorganisms (legionella, mycoplasma, chlamydia).

This antibacterial agent has a wide range of benefits. Among them, the most significant should be emphasized:

relatively high bioavailability, that is, the active substance and metabolite penetrate well into all tissues and organs;
antimicrobial activity is possessed not only by its main active substance, but also by all metabolites;
the drug is excreted approximately equally with urine and feces, which makes it possible to use it in patients with chronic kidney disease;
gastric juice does not adversely affect absorption, but rather promotes this process and potentiates the action of active metabolites.

All of the above properties of the drug "Klacid" allow you to use it as a first-line remedy for many infectious diseases of the respiratory and digestive tract

Indications

The drug "Klacid" is often used by pediatricians and family doctors. Its use is justified in the following situations:

infectious processes of the lower and upper parts of the respiratory system (from sinusitis to bronchitis and pneumonia);
inflammatory changes in the skin and subcutaneous fat (staphylo- and streptoderma, phlegmon, abscess, erysipelas);
complex treatment of inflammatory processes of the digestive canal (for example, a modern scheme for the treatment of peptic ulcer).

An important feature of clarithromycin is the lack of experience with the use and, accordingly, safety data in children under 12 years of age. The instruction of the drug allows its use only in adolescent children. Another important nuance is the caution and validity of the use in patients with impaired liver function, since the active substance is metabolized in the liver with the help of cytochrome P450. It becomes clear that the independent appointment of this remedy can end sadly.

The well-known pediatrician Evgeny Olegovich Komarovsky emphasizes the need for reasonable use of antibiotics with the active ingredient clarithromycin, since complications from the kidneys and liver are possible.

Contraindications

All macrolides, including Klacid, are contraindicated for use in the following cases:

a history of episodes of allergic reactions or hypersensitivity to any macrolide;
age up to 12 years;
severe kidney and / or liver disease;
hereditary pathology, manifested by insufficient production of lactose, absorption of galactose and glucose;
taking drugs based on ergot.

Only a specialist can assess the potential risk and the desired benefits. Only a doctor can suspect the occurrence of side effects in time and prevent their progression.

Dosages

The traditional dosage of the drug "Klacid" is 125-500 mg (depending on the severity of the condition) once a day, if necessary, the maximum dose can be divided into 2 doses. The average duration of the course of treatment should be at least 1-2 weeks.

The basis of the original drug "Klacid" is a semi-synthetic representative of macrolides, clarithromycin. The antibiotic exhibits antimicrobial activity against a number of different bacteria: groups of streptococcus and staphylococcus (in particular, producing β-lactamase), mycoplasma, mycobacteria (with the exception of tuberculosis), Haemophilus influenzae, the causative agent of gonorrhea, campylobacteriosis and Helicobacter pylori.

Is it possible to give to children

The drug is used according to age dosages and calculation on the body weight of the baby. Depending on the general condition and age category to which the patient belongs, the preferred form of the drug is chosen.

Indications for use

The drug is used:

With infections of the nasal cavity and oropharynx (, pharyngitis, etc.) and their complications (sinusitis, otitis media) caused by sensitive microflora.
With infectious lesions of the lungs and bronchi of streptococcal, staphylococcal etiology and other bacterial diseases with marked sensitivity to clarithromycin.
In the complex treatment of Hp-associated gastritis.
For skin infections.
In the presence of mycobacterial inflammation (except tuberculosis).

Forms of release of the drug

Klacid is available as:

Coated tablets of 0.25 and 0.5 g.
Lyophilisate 500 mg, from which a solution for parenteral infusions is made.
Vials with a suspension of 125 and 250 mg in 5 ml.

Instructions for use

For children, in accordance with body weight, oral administration of the Klacida suspension is prescribed from 6 months of age usually 2 times a day. For children, in accordance with body weight, oral administration of the Klacida suspension is usually prescribed 2 times a day. If the child weighs less than 8 kg, then a single dosage is calculated as 7.5 mg per kilogram of body weight. With a weight of more than 8 kg, the prepared suspension is used according to the instructions.

According to the proposed calculations, in accordance with the weight category of the child, a single dose is:

8 - 11 kg: 2.5 ml is prescribed as a suspension of 125 mg in 5 ml or 1.25 ml if the suspension contains 250 mg / 5 ml.
12 - 19 kg: 5 ml if the 125 mg/5 ml form is chosen, or 2.5 ml of suspension with a substance content of 250 mg in a standard volume.
20 - 29 kg: 7.5 or 3.75 ml at 125 mg or 250 mg per 5 ml, respectively.
30 - 40 kg: 10 ml (125 mg / 5 ml) or 5 ml (250 mg / 5 ml).

If a mycobacterial infection is detected, then a single dose can be doubled.

Adults and adolescents are prescribed 250-500 mg 2 (sometimes 3) times a day for a period of 1-2 weeks.

Compound

The main component that causes the bacteriostatic effect is macrolide - clarithromycin. Suspensions contain additional flavors, maltodextrin, sucrose, etc. Tablets are coated with an acid-resistant coating.

Side effects

Perhaps the development of allergic reactions, the impact on the mental state (deterioration of mood, psychosis), destruction of striated muscles, cholestasis, discoloration of urine, there is a risk of bleeding.

Contraindications

The presence of individual intolerance to the group of macrolides, incl. due to sensitization of the body to them. Simultaneous administration of colchicine, astemizole, pizopride, simvastatin and other statins.

Analogues

Clarithromycin is the active ingredient in substances for suspensions "Fromilid" 125 mg in 5 ml and "Seydon-Sanovel" 125 and 250 mg in 5 ml. The tablet form is presented the following drugs: "Ekozitrin", "Lekoklar", "Arvicin", "Coater", "Zimbaktar" and the most budgetary "Clarithromycin".