Clarithromycin - description of the drug, instructions for use, reviews

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Manufacturers: Alembic Ltd

Active ingredients

• Clarithromycin

Disease class

• Purulent and unspecified otitis media
• Acute sinusitis
• Acute pharyngitis, unspecified
• Acute laryngitis and tracheitis
• Pneumonia without specifying the pathogen
• Chronic sinusitis
• Chronic tonsillitis
• Chronic laryngitis
• Bronchitis, not specified as acute or chronic
• Chronic bronchitis, unspecified
• Stomach ulcer
• Duodenal ulcer
• Skin abscess, boil and carbuncle
• Local infection of skin and subcutaneous tissue, unspecified
• Mycobacterium infection, unspecified
• Other chlamydial sexually transmitted diseases
• Chlamydial infection, unspecified
• Post-traumatic wound infection, not elsewhere classified
• Acute tonsillitis, unspecified

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Broad spectrum antibacterial action

Pharmacological group

• Macrolides and azalides

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Clarithromycin-DJ

The use of the following drugs with clarithromycin is contraindicated due to the potential for serious side effects

Cisapride and pimozide

When used together, it is possible to increase the concentration of cisapride/pimozide, increase the QT interval, and cause cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointes.

Terfenadine and astemizole

When used together, it is possible to increase the concentration of terfenadine/astemizole in the blood, the occurrence of cardiac arrhythmias, an increase in the QT interval, ventricular tachycardia, ventricular fibrillation and ventricular tachycardia of the pirouette type.

Ergotamine/dihydroergotamine

When used together, the following effects associated with acute poisoning with drugs of the ergotamine group are possible: vascular spasm, ischemia of the limbs and other tissues, including the central nervous system.

Effect of other drugs on clarithromycin

Drugs that are inducers of the CYP3A isoenzyme

(for example, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) may induce the metabolism of clarithromycin. This may result in subtherapeutic concentrations of clarithromycin, resulting in reduced effectiveness. In addition, it is necessary to monitor the concentration of the CYP3A inducer isoenzyme in the blood plasma, which may increase due to the inhibition of the CYP3A isoenzyme by clarithromycin. When rifabutin and clarithromycin were used together, an increase in plasma concentrations of rifabutin and a decrease in serum concentrations of clarithromycin were observed with an increased risk of developing uveitis. The following drugs have a proven or suspected effect on clarithromycin concentrations; if they are co-administered with clarithromycin, it may be necessary to adjust the vines or switch to an alternative treatment.

Efavirenz, nevirapine, rifampicin, rifabutin and rifapentine

Strong inducers of the cytochrome isoenzyme 1450 system, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentine, can accelerate the metabolism of clarithromycin and, thus, reduce the plasma concentration of clarithromycin and weaken the 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 is different for different bacteria, the therapeutic effect may be reduced when clarithromycin is used together with enzyme inducers.

Etravirine

The concentration of clarithromycin decreases with the use of etravirine, but the concentration of the active metabolite 14-OH-clarithromycin increases. Because 14-OH-clarithromycin has low activity against Mycobacterium avium complex (MAC), overall activity against this organism may be affected and alternative treatments should be considered for the treatment of MAC.

Fluconazole

Coadministration of fluconazole 200 mg daily and clarithromycin 500 mg twice daily in 21 healthy volunteers resulted in an increase in clarithromycin minimum steady-state concentration (Cmin) and AUC of 33% and 18%, respectively. However, co-administration did not significantly affect the average steady-state concentration of the active metabolite 14-OH-clarithromycin. No dose adjustment of clarithromycin is required in case of concomitant use of fluconazole.

Ritonavir

A pharmacokinetic study showed that co-administration of ritonavir 200 mg every eight hours and clarithromycin 500 mg every 12 hours resulted in a marked suppression of the metabolism of clarithromycin. When coadministered with ritonavir, clarithromycin Cmax increased by 31%, Cmax increased by 182%, and AUC increased by 77%. Complete suppression of the formation of 14-OH-clarithromycin was noted. Due to the wide therapeutic index, dosage reduction is not required in patients with normal renal function. In patients with renal failure, it is advisable to consider the following dose adjustment options: with creatinine clearance of 30-60 ml/min, the dose of clarithromycin should be reduced by 50%; if creatinine clearance is less than 30 ml/min, the dose of clarithromycin should be reduced by 75%. Ritonavir should not be co-administered with clarithromycin in doses exceeding 1 g/day.

Oral hypoglycemic agents/insulin

When clarithromycin is used concomitantly with oral hypoglycemic agents and/or insulin, severe hypoglycemia may occur. During the simultaneous use of clarithromycin and certain drugs that reduce glucose concentrations, such as nateglinide, pioglitazone, repaglinide and rosiglitazone, inhibition of the CYP3A isoenzyme by clarithromycin may occur, which may result in hypoglycemia. Careful monitoring of glucose concentrations is recommended.

Effect of clarithromycin on other drugs

Antiarrhythmics (quinidine and disopyramide)

Torsade de pointes-type ventricular tachycardia may occur when clarithromycin is co-administered with quinidine or disopyramide. When clarithromycin is used concomitantly with these drugs, the electrocardiogram should be regularly monitored for prolongation of the QT interval, and serum concentrations of these drugs should also be monitored.

During post-registration use, cases of hypoglycemia have been reported with the simultaneous use of clarithromycin and disopyramide. It is necessary to monitor the concentration of glucose in the blood while using clarithromycin and disopyramide.

Interactions caused by SURZA isoenzymes

Concomitant use of clarithromycin, which is known to inhibit CYP3A isoenzymes, and drugs primarily metabolized by CYP3A isoenzymes, may be associated with a mutual increase in their concentrations, which may enhance or prolong both therapeutic and side effects. Clarithromycin should be administered with caution to patients receiving drugs that are substrates of the CYP3A isoenzyme, especially if the CYP3A isoenzyme substrate has a narrow therapeutic index (for example, carbamazepine) and/or is extensively metabolized by this enzyme. If necessary, the dose of the drug taken together with clarithromycin should be adjusted. Also, if possible, serum concentrations of drugs primarily metabolized by the CYP3A isoenzyme should be monitored. The following drugs/classes are metabolized by the same CYP3A isoenzyme as clarithromycin: alprazolam, carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, midazolam, omeprazole, indirect anticoagulants (eg, warfarin), quinidine, rifabutin, sildenafil, tacrolimus, triazolam, and Vinbla steen . Drugs that interact in this manner through other isoenzymes within the cytochrome isoenzyme 1450 system include phenytoin, theophylline, and valproic acid.

The simultaneous use of drugs astemizole, cisapride, ergot alkaloids, lovastatin, simvastatin, pimozide, terfenadine with clarithromycin is contraindicated.

HMG-Co A-reductase inhibitors

Like other macrolides, clarithromycin increases concentrations of HMG-CoA reductase inhibitors (eg, lovastatin and simvastatin). Concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see section "Contraindications"). Patients should be examined to exclude signs and symptoms of myopathy. There are rare reports of the development of rhabdomyolysis in patients receiving therapy with atorvastatin or rosuvastatin in combination with clarithromycin. When combined with clarithromycin, atorvastatin or rosuvastatin should be used in the lowest possible doses or statins that do not depend on the metabolism of the CYP3A isoenzyme (for example, fluvastatin or pravastatin) should be used.

Indirect anticoagulants

When warfarin and clarithromycin are used together, bleeding and a marked increase in INR and prothrombin time are possible. INR and prothrombin time should be regularly monitored.

Omeprazole

Clarithromycin (500 mg every 8 hours) was studied in healthy adult volunteers in combination with omeprazole (40 mg daily). When clarithromycin and omeprazole were co-administered, steady-state plasma concentrations of omeprazole were increased (Cmax, AUC0-24 and T1/2 increased by 30%, 89% and 34%, respectively). The mean 24-hour gastric pH was 5.2 when omeprazole was used alone and 5.7 when omeprazole was used with clarithromycin.

Sildenafil, tadalafil and vardenafil

Each of these phosphodiesterase inhibitors is metabolized, at least in part, by the CYP3 A isoenzyme. However, the CYP3A isoenzyme may be inhibited in the presence of clarithromycin. Co-administration of clarithromycin with sildenafil, tadalafil or vardenafil may lead to increased phosphodiesterase inhibitory effects. When prescribing these drugs together with clarithromycin, consider reducing the dose of sildenafil, tadalafil and vardenafil.

Theophylline, carbamazepine

When clarithromycin and theophylline or carbamazepine are used together, the concentration of these drugs in the systemic circulation may increase.

Tolterodine

The primary metabolism of tolterodine occurs through the 2D6 isoform of the cytochrome P450 isoenzyme (CYP2D6). However, in part of the population lacking the CYP2D6 isoenzyme, metabolism occurs through the CYP3A isoenzyme. In this population, inhibition of CYP3A results in significantly higher serum tolterodine concentrations. In populations with low levels of CYP2D6 metabolism, a dose reduction of tolterodine may be required in the presence of CYP3A inhibitors such as clarithromycin.

Benzodiazepines (eg, alprazolam, midazolam, tritonam)

When midazolam was co-administered with clarithromycin tablets (500 mg twice daily), midazolam AUC increased by 2.7 times after intravenous midazolam and 7 times after oral administration. Concomitant oral use of midazolam and clarithromycin should be avoided. If clarithromycin is coadministered during intravenous midazolam administration, the patient's condition should be carefully monitored for possible dose adjustment. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A, including triazolam and alprazolam. For benzodiazepines whose elimination is not dependent on the CYP3A isoenzyme (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.

When clarithromycin and triazolam are used together, effects on the central nervous system (CNS), such as drowsiness and confusion, are possible. Therefore, if coadministration occurs, it is recommended to monitor for symptoms of CNS impairment.

Interaction with other drugs

Colchicine

Colchicine is a substrate of both the CYP3A isoenzyme and the transport protein P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are used together, inhibition of Pgp and/or CYP3A may result in increased effects of colchicine.

Concomitant use with colchicine is contraindicated.

There have been post-marketing reports of cases of colchicine poisoning when used concomitantly with clarithromycin, most often in elderly patients. Some of the reported cases occurred in patients suffering from kidney failure. Some cases were reported to be fatal.

When using clarithromycin concomitantly with other ototoxic drugs, especially aminoglycosides, caution should be exercised and the functions of the vestibular and auditory systems should be monitored both during and after therapy.

Digoxin

Digoxin is suspected to be a Pgp substrate. Clarithromycin is known to inhibit Pgp. When clarithromycin and digoxin are used together, inhibition of Pgp by clarithromycin may lead to increased effects of digoxin. Concomitant use of digoxin and clarithromycin may also result in increased serum concentrations of digoxin. Some patients experienced significant clinical symptoms of digoxin toxicity, including potentially fatal arrhythmias. When clarithromycin and digoxin are used together, serum digoxin concentrations should be carefully monitored.

Zidovudine

Concomitant use of oral clarithromycin tablets and zidovudine in adult HIV-infected patients may result in a decrease in the steady-state concentration of zidovudine.

Because clarithromycin interferes with the absorption of oral zidovudine, interactions can be largely avoided by taking clarithromycin and zidovudine 4 hours apart.

This interaction was not observed in HIV-infected children taking clarithromycin pediatric suspension with zidovudine or dideoxyinosine. Since clarithromycin may interfere with the absorption of zidovudine when administered concomitantly orally in adult patients, such an interaction is unlikely to occur when clarithromycin is used intravenously.

Phenytoin and valproic acid

There is evidence of interactions between CYP3A inhibitors (including clarithromycin) and drugs that are not metabolized by CYP3A (phenytoin and valproic acid). For these drugs, when used together with clarithromycin, it is recommended to determine their serum concentration. There are reports of increased serum concentrations of phenytoin and valproic acid.

Bidirectional drug interactions

Atazanavir

Clarithromycin and atazanavir are substrates and inhibitors of the CYP3A isoenzyme. There is evidence of a bidirectional interaction between these drugs. Coadministration of clarithromycin (500 mg twice daily) and atazanavir (400 mg once daily) may result in a twofold increase in clarithromycin exposure and a 70% decrease in 14-OH-clarithromycin exposure, with a 28% increase in atazanavir AUC. Due to the wide therapeutic range of clarithromycin, no dose reduction is required in patients with normal renal function. In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), the dose of clarithromycin should be reduced by 50%. In patients with creatinine clearance less than 30 ml/min, the dose of clarithromycin should be reduced by 75% using the appropriate clarithromycin dosage form. Clarithromycin in doses exceeding 1000 mg per day should not be used before taking the CYP3A4 isoenzyme, the CYP2D6 isoenzyme together with protease inhibitors.

Itraconazole

Clarithromycin and itraconazole are substrates and inhibitors of the CYP3A isoenzyme, which determines the bidirectional interaction of the drugs. Clarithromycin may increase plasma concentrations of itraconazole, while itraconazole may increase plasma concentrations of clarithromycin. Patients taking itraconazole and clarithromycin concomitantly. should be closely monitored for symptoms of increased or prolonged pharmacological effects of these drugs.

Saquinavir

Clarithromycin and saquinavir are substrates and inhibitors of the CYP3A isoenzyme, which determines the bidirectional interaction of the drugs. Coadministration of clarithromycin (500 mg twice daily) and saquinavir (soft gelatin capsules, 1200 mg three times daily) in 12 healthy volunteers increased the AUC and Cmax of saquinavir by 177% and 187%, respectively, compared with saquinavir administration in separately. The AUC and Cmax values ​​of clarithromycin were approximately 40% higher than with clarithromycin monotherapy. When these two drugs are co-administered for a limited time at the doses/formulations indicated above, no dose adjustment is required. The results of drug interaction studies using saquinavir soft gelatin capsules may not be consistent with the effects observed with saquinavir hard gelatin capsules. The results of drug interaction studies with saquinavir monotherapy may not be consistent with the effects observed with saquinavir/ritonavir therapy. When using saquinavir with ritonavir, the potential effect of ritonavir on clarithromycin should be considered.

Blockers of "slow" calcium channels

When using clarithromycin simultaneously with blockers of “slow” calcium channels that are metabolized by the CYP3A4 isoenzyme (for example, verapamil, amlodipine, diltiazem), caution should be exercised, as there is a risk of arterial hypotension. Plasma concentrations of clarithromycin, as well as blockers of “slow” calcium channels, may increase with simultaneous use. Arterial hypotension, bradyarrhythmia and lactic acidosis are possible when taking clarithromycin and verapamil simultaneously.

Indications for use of Clarithromycin

The spectrum of action of the drug is very wide: it is active against chelonae mycobacterium and other mycobacteria, most types of the microorganism streptococcus. Clarithromycin differs from other antibiotics in that it can destroy bacilli and viruses at a deeper level, in tissue cells. Indications for the use of Clarithromycin are the following diseases:

• respiratory infections of the upper respiratory tract (nasopharynx, paranasal sinuses);
• lower respiratory tract infections: bronchitis, pneumonia, pneumonia;
• infectious lesions of the skin and soft tissues (impetigo, furunculosis, erysipelas, wound infection);
• mycobacterial infections, staphylococci, streptococci, chlamydia, legionella;
• as an adjuvant for tuberculosis;
• odontogenic infections (acute or chronic);
• for HIV infection;
• for stomach or intestinal ulcers to combat the bacterium Helicobacter pylori.

Clarithromycin price

The drug is inexpensive: 220-400 rubles, depending on the number of tablets. A course of therapy requires 2-3 packs of 7 or 10 capsules (see instructions). The price of Clarithromycin depends on the volume: 250 mg is cheaper than 500 and on the manufacturer: domestic companies are more profitable than European ones. The antibiotic is new, so price jumps may be extremely rare. The drug is widely available in pharmacies; it can be ordered and purchased in an online store with delivery to a point of sale or to your home. Let's look at how much Clarithromycin 500 mg costs in online pharmacy catalogs:

Contraindications

In later stages of pregnancy, during lactation and breastfeeding, you should consult a doctor, but it is better to stop taking it, since safety for the development of the fetus and child has not been established. Contraindications for Clarithromycin are allergic reactions to the components of the drug: they need to be diagnosed in advance using special tests. Children under 12 years of age and pregnant women during the first trimester are prohibited from taking tablets.

It may be dangerous to take the drug if the patient has pathologies on the ECG, arrhythmia has occurred, there is liver disease and kidney dysfunction, porphyria. For some diseases, doses may be reduced or the time between doses may be increased. For young children (up to 6 months), the use of injections is not recommended, since their effect on an unformed body has not been studied.