Clarithromycin Ecositrin® tablets 500 mg
Ecoantibiotics are antibacterial drugs manufactured in Russia, available in the most in-demand pharmacotherapeutic classes of antibiotics: aminopenicillins, protected aminopenicillins, macrolides, and fluoroquinolones. They are used for the treatment of infectious and inflammatory diseases of various organs and systems.
Description
This broad-spectrum bactericidal agent was created by the Japanese company Taisho Pharmaceutical in 1980 as an improved replacement for erythromycin. Compared to its pharmaceutical predecessor, Clarithromycin can be used at a lower dosage and causes fewer side effects. Since then, this updated antimicrobial agent has been used as a first- and second-line drug for the treatment of common and complicated infections in adults and children.
Dosage Form and Composition
The antimicrobial drug is available in the form of tablets and capsules. The oval, biconvex, yellow tablets are coated with a protective film. The package contains 7, 10, or 15 tablets. The hard capsules, white in color, are made of gelatin and titanium dioxide. They are filled with the drug's powder or a solid mass. The package also contains 7, 10, or 14 capsules. The excipients used include lactose monohydrate, povidone, corn starch, calcium stearate, croscarmellose, and polysorbate 80.
Indications for Use
The fast-acting antibiotic penetrates the bacterial cell, irreversibly disrupting the protein synthesis of various pathogenic organisms, which leads to the death of the infectious agents and, consequently, to the patient's recovery.
According to the instructions, Clarithromycin destroys a large number of species of Gram-positive and Gram-negative bacteria. The most sensitive to the main active substance are:
- Staphylococcus aureus (causing purulent inflammatory processes in almost any organ);
- Streptococcus pneumoniae (complicating pneumonia);
- Haemophilus influenzae (responsible for the development of respiratory tract and nervous system infections, which are especially dangerous for children under 5);
- Streptococcus pyogenes (known as the causative agent of glomerulonephritis, tonsillopharyngitis, and rheumatic fever in childhood);
- Moraxella catarrhalis (a cause of otitis media and sinusitis in children, as well as acute bronchitis in adults);
- Clostridium (causing botulism, tetanus, gas gangrene);
- Helicobacter pylori (the microorganism responsible for gastritis and stomach ulcers);
- Mycobacteria (causing tuberculosis, enlargement of the liver and spleen, as well as skin and wound infections and various abscesses);
- Bordetella (the bacillus that causes whooping cough and parapertussis);
- Legionella (the causative agent of severe pneumonia, extrapulmonary infections, and severe flu-like conditions);
- Pseudomonas aeruginosa (a common cause of nosocomial infections).
- All Indications for Use (Instructions)
When should this drug be used?
The most detailed source of information about the drug "Clarithromycin" is the specially developed pharmaceutical instructions. This effective third-generation antibiotic is used in different countries worldwide to treat a wide range of diseases. Thus, the instructions for use of Clarithromycin indicate that it is effective for the following problems:
- Diseases of the upper respiratory tract and ENT organs (otitis media, tonsillopharyngitis, acute sinusitis);
- Infections of the lower respiratory tract (community-acquired bacterial and atypical pneumonia, acute bronchitis, chronic bronchitis in the acute stage);
- Mycobacterial infections;
- Odontogenic infections;
- Infectious lesions of the skin and soft tissues;
- Gastric or intestinal ulcers caused by the bacterium Helicobacter pylori;
- Venereal diseases;
- Tuberculosis (as an auxiliary agent).
Clarithromycin is often prescribed to patients for whom penicillin antibiotics (e.g., amoxicillin) are contraindicated. In such cases, this drug becomes a real lifesaver.
Dosage and Administration
The instructions for use recommend taking Clarithromycin in the form of tablets or capsules according to the type of disease and depending on the characteristics of its course.
The usual therapeutic dose for adults and children over 12 years of age is 250 – 500 mg twice a day. The maximum daily dose should not exceed 1 g.
The course of infectious therapy can last from 6 to 14 days.
Extended-release tablets containing 500 mg of the active ingredient are designed for a single daily dose.
If Clarithromycin is used to treat severe diseases and infections caused by Mycobacterium avium, it is permissible to take 0.5 – 1 g of the antimicrobial agent twice a day. In this case, the duration of treatment may increase to 6 months.
Patients with chronic renal failure are prescribed 250 mg of the drug once a day. The duration of therapy can be up to two weeks.
For mycobacterial infections and for the prevention of such diseases, 500 mg should be taken twice daily.
For the treatment of odontogenic infections, 250 mg of the antibiotic is prescribed twice a day. The treatment regimen is designed for 5 days.
The instructions for Clarithromycin indicate that the drug is absorbed regardless of food or fluid intake. The patient can take the tablet before, during, or after breakfast, lunch, or dinner. To achieve a stable result, it is not recommended to violate the treatment regimen proposed by the doctor. If a patient misses a dose, the next tablet should be taken as soon as possible, but a double dose is not permissible as it may cause intoxication.
Clarithromycin: Instructions for Use of Tablets for Adults
According to the instructions for use, Clarithromycin tablets are prescribed to adults for the treatment of a wide range of infectious and inflammatory diseases. The specific dosage and treatment regimen should definitely be discussed with a doctor. One should not rely solely on the instructions for use of Clarithromycin tablets for adults and self-medicate, as there is a possibility of side effects.
How effective is it in treating common diseases?
The use of clarithromycin for pneumonia is justified if the lung inflammation is caused by intracellular bacteria. This refers to atypical pneumonia, which occurs under the influence of chlamydia or mycoplasma. Atypical pneumonia, which often leads to cardiopulmonary failure, can also appear as a result of legionella multiplication. These microorganisms actively multiply in warm and moist environments; their colonies are found in public pools and showers.
If the cause of a gastric ulcer is the bacterium Helicobacter pylori, the instructions for use of Clarithromycin recommend using the drug for eradication therapy. This pathogen develops resistance to the macrolide antibiotic in only 13% of cases, which determines the effectiveness of the treatment.
Clarithromycin shows good results in the therapy of urogenital chlamydia and mycoplasmosis. The antimicrobial agent easily penetrates bacterial cells and eliminates pathogenic microflora.
How well is the drug absorbed?
The active antibiotic is rapidly absorbed from the gastrointestinal tract. The instructions for clarithromycin 500 state that food slows down the absorption of the drug, but its bioavailability does not decrease significantly. A stable therapeutic concentration of the drug substance in the blood plasma is noted 72 hours after the start of the course of administration. The drug accumulates in the skin, lungs, and soft tissues.
Extended-release tablets are absorbed more slowly. This is necessary to maintain a constant therapeutic concentration of the active substance while reducing the frequency of antibiotic intake.
What about contraindications?
Continuing the review of Clarithromycin, the instructions for use advise adults to take the tablets consciously and only as prescribed by a doctor.
The drug should not be used in case of hypersensitivity to the main component of the antibiotic.
This medication is also contraindicated during the first trimester of pregnancy.
The macrolide may be dangerous for patients with severe renal failure and porphyria.
Patients with certain types of arrhythmia and people with potassium and lactose deficiency should also be prescribed other antibacterial agents.
Clarithromycin is not intended for the therapy of tonsillitis and otitis media in children under the age of eighteen. For the treatment of other diseases, therapists and infectious disease specialists prescribe this drug to children who have reached 12 years of age.
Is this antibiotic appropriate during pregnancy and lactation?
After the first trimester of pregnancy, Clarithromycin is allowed only in exceptional cases. If it becomes necessary to treat with the antibiotic during lactation, breastfeeding should be discontinued.
How does it interact with other medicines?
The drug is prohibited to be combined with Cisapride, Astemizole, Lovastatin, Terfenadine, Simvastatin.
The described antibiotic loses its effectiveness when combined with Etravirine, Pimozide, Efavirenz, Nevirapine, Rifampicin.
It is also not allowed to combine the use of Clarithromycin and medications containing ergot alkaloids (Ergotamine, Ergonovine, and others).
Another unfortunate companion for the macrolide is Ticagrelor (a blood-thinning drug). Concurrent use with Tolbutamide is dangerous due to a decrease in blood sugar levels.
If the drug overlaps with Fluoxetine in the treatment regimen, the development of toxic complications is possible.
What are the side effects?
The nervous system may sometimes react to treatment with dizziness, headache, insomnia, and anxiety. In some cases, the patient has bad dreams.
Affecting the digestive organs, the antibiotic rarely causes nausea, urge to vomit, stomach pain, gastritis, stomatitis, glossitis, and diarrhea. Pseudomembranous enterocolitis occurs very rarely.
The patient may be bothered by tinnitus and a disturbance in the sense of taste. A rash may sometimes appear on the skin. It is possible that the allergy may take the form of an anaphylactoid reaction.
Other negative consequences, for example, abnormal blood test results or changes in heart rhythm, are observed in an extremely small number of patients and are reported with a probability of less than 0.1%.
Clarithromycin 500 mg: Instructions for Use
The instructions for Clarithromycin 500 contain all the necessary information for treatment, providing dosage regimens depending on the disease and the nature of its course. According to the instructions for use, Clarithromycin 500 mg should be taken for no more than 7-10 days. Since the drug's efficacy is high, an improvement in condition is observed as early as 2-3 days after its prescription.
Even if you notice relief and the symptoms of the disease have passed, you must continue taking Clarithromycin 500 according to the instructions for exactly as many days as prescribed by the doctor.
The price for Clarithromycin 500 mg and the instructions for use can be found at the pharmacy.
What can happen in case of an overdose?
With a sudden increase in the amount of the active substance, disturbances in the gastrointestinal tract may begin. Patients sometimes experience confusion and headaches. If symptoms of overdose are obvious, gastric lavage is recommended. In complex cases, symptomatic treatment may be required.
Are there any special recommendations?
If the patient has concomitant chronic diseases, during therapy with Clarithromycin, according to the instructions, it is necessary to monitor the quantitative indicators of serum enzymes.
Caution should be exercised when combining the macrolide antibiotic and medications whose metabolism occurs in the liver.
During the use of the antimicrobial agent, the composition of the intestinal microflora changes, so the possibility of a superinfection caused by bacteria resistant to the drug should not be ruled out.
When prescribing Clarithromycin 500 mg to children, the instructions recommend choosing the suspension dosage form.
How to store the drug?
The instructions for Clarithromycin state that, like other medicines, it should be protected from moisture and direct sunlight. The drug should be stored at a temperature not exceeding +25°C. The shelf life of the medication is limited to two years. The antibiotic should not be used after the expiration date.
This active third-generation antibiotic can be easily purchased at a pharmacy. The price of "Clarithromycin" 500 mg is low, and the instructions for use are included with the package. Before purchasing the drug, it is recommended to obtain a detailed consultation with a doctor.
Prescription Status
By prescription
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Instructions for use of Clarithromycin Ecositrin® tablets 500 mg
Brand name of the drug: Clarithromycin Ecositrin®
International Nonproprietary Name: clarithromycin.
Dosage form: film-coated tablets.
Composition:
Each tablet contains:
Active substance: clarithromycin (calculated as the active substance) 250.0 mg; 500.0 mg
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Excipients: |
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250 mg |
500 mg |
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Calcium hydrogen phosphate dihydrate |
300.0 mg |
600.0 mg |
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Povidone-K25 |
9.1 mg |
18.2 mg |
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Magnesium stearate |
6.5 mg |
13.0 mg |
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Colloidal silicon dioxide (Aerosil) |
4.33 mg |
8.66 mg |
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Talc |
13.0 mg |
26.0 mg |
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Polacrilin potassium |
up to an uncoated tablet core weight of |
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650.0 mg |
1300.0 mg |
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Excipients of the coating: |
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Hypromellose |
9.52 mg |
14.28 mg |
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Talc |
1.14 mg |
1.71 mg |
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Titanium dioxide |
5.171 mg |
7.756 mg |
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Macrogol-4000 |
3.726 mg |
5.589 mg |
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Povidone-K17 |
0.414 mg |
0.621 mg |
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Azorubine dye |
0.029 mg |
0.044 mg |
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up to a coated tablet weight of |
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670.0 mg |
1330.0 mg |
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Description
Capsule-shaped, biconvex, pink, film-coated tablets. A cross-section shows two layers; the inner layer is white or almost white.
Pharmacotherapeutic group: antibiotic - macrolide.
ATC code: J01FA09.
Pharmacological properties:
Pharmacodynamics. A semisynthetic macrolide antibiotic with a broad spectrum of action. It disrupts the protein synthesis of microorganisms (binds to the 50S subunit of the microbial cell ribosome). It acts on extracellular and intracellular pathogens. The activity of clarithromycin against most of the following microorganisms has been proven in vitro and in clinical practice - Aerobic Gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes; Aerobic Gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Legionella pneumophila; Other microorganisms: Mycoplasma pneumoniae, Chlamydia pneumoniae; Mycobacteria: Mycobacterium avium complex (MAC) - a complex including: Mycobacterium avium and Mycobacterium intracellulare; Helicobacter pylori.
Beta-lactamases do not affect the activity of clarithromycin.
In vitro activity of clarithromycin - Aerobic Gram-positive microorganisms: Listeria monocytogenes, Streptococcus agalactiae, Streptococci groups C,F,G, Viridans group streptococci; Aerobic Gram-negative microorganisms: Neisseria gonorrhoeae, 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; Mycobacteria: Mycobacterium leprae, Mycobacterium chelonae; Campylobacters: Campylobacter jejuni.
The microbiologically active metabolite of clarithromycin, 14-hydroxyclarithromycin, is twice as active as the parent compound against Haemophilus influenzae. Clarithromycin and its metabolite in combination can have either additive or synergistic effects on Haemophilus influenzae in vitro and in vivo, depending on the bacterial strain.
Most strains of methicillin- and oxacillin-resistant staphylococci are resistant to clarithromycin.
Cross-resistance may develop between clarithromycin and other antibiotics of the macrolide group, as well as lincomycin and clindamycin.
Pharmacokinetics
Absorption is rapid. Food slows down absorption but does not significantly affect bioavailability. The bioavailability of 250 mg tablets is 50%. Plasma protein binding is 65-75%. After a single dose, two peaks of maximum concentration (Cmax) are recorded. The second peak is due to the drug's ability to accumulate in the gallbladder with subsequent gradual or rapid entry into the intestine and absorption. Time to reach maximum concentration (Tmax) after a 250 mg dose is 2-3 hours.
After oral administration, 20-30% of the administered dose is rapidly hydroxylated in the liver by cytochrome isoenzymes CYP3A4, CYP3A5, and CYP3A7 to form the primary metabolite, 14-hydroxyclarithromycin, which has significant antimicrobial activity against Haemophilus influenzae. It is an inhibitor of isoenzymes CYP3A4, CYP3A5, and CYP3A7.
With regular administration of 250 mg/day, the steady-state concentration (Css) of the unchanged drug and its primary metabolite is 1 and 0.6 mcg/ml, respectively; the half-life is 3-4 and 5-6 hours, respectively. When the dose is increased to 500 mg/day, the Css of the unchanged drug and its metabolite in plasma is 2.7-2.9 and 0.83-0.88 mcg/ml, respectively; the half-life is 4.8-5 and 6.9-8.7 hours, respectively. At therapeutic concentrations, it accumulates in the lungs, skin, and soft tissues (concentrations there are 10 times higher than the antibiotic level in blood plasma).
It is excreted by the kidneys and through the intestines (20-30% unchanged, the rest as metabolites). After a single dose of 250 mg and 1200 mg, 37.9% and 46% are excreted by the kidneys, and 40.2% and 29.1% through the intestines, respectively.
In case of renal impairment, an increase in Tmax, Cmax, and the area under the "concentration-time" curve (AUC) of clarithromycin and its metabolite is observed.
Indications for use
Adults: pharyngitis, tonsillitis, acute sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia, uncomplicated skin and subcutaneous tissue infections; disseminated infections caused by Mycobacterium avium and Mycobacterium intracellulare.
Adults in combination with amoxicillin and omeprazole/lansoprazole as triple therapy for infections caused by Helicobacter pylori, including duodenal ulcer.
Children: pharyngitis, tonsillitis, community-acquired pneumonia, acute sinusitis, acute otitis media, uncomplicated skin and subcutaneous tissue infections; disseminated infections caused by Mycobacterium avium and Mycobacterium intracellulare.
Contraindications:
Hypersensitivity, porphyria, lactation period, concurrent use of cisapride, astemizole, pimozide, terfenadine, ergotamine and other ergot alkaloids, oral forms of midazolam, alprazolam, triazolam.
Children under 12 years of age (for this dosage form).
Lactose intolerance or lactase deficiency, as well as glucose-galactose malabsorption.
Concomitant use with lovastatin and simvastatin, with oral midazolam, with colchicine in patients with impaired renal or hepatic function taking P-glycoprotein inhibitors or potent CYP3A4 isoenzyme inhibitors; history of QT interval prolongation in patients, ventricular arrhythmia or torsades de pointes ventricular tachycardia; cholestatic jaundice/hepatitis that occurred with previous use of clarithromycin; severe hepatic insufficiency occurring concurrently with renal failure, hypokalemia.
With caution:
Renal and/or hepatic insufficiency, myasthenia gravis, concurrent use of drugs metabolized by the liver, concurrent use of colchicine.
Concomitant use with drugs that induce and are metabolized by the CYP3A4 isoenzyme, benzodiazepines (alprazolam, triazolam, intravenous midazolam), Class IA and III antiarrhythmic drugs, "slow" calcium channel blockers that are metabolized by the CYP3A4 isoenzyme; in patients with coronary artery disease, severe heart failure, hypomagnesemia, significant bradycardia, myasthenia gravis.
Use during pregnancy and lactation:
The safety of clarithromycin use during pregnancy has not been established. During pregnancy, especially in the first trimester, clarithromycin should be prescribed only if the benefit to the mother outweighs the potential risk to the fetus and/or if there is no safer alternative therapy. If pregnancy occurs during drug use, the patient should be informed of the potential risks to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.
Dosage and administration:
For oral administration. Swallow the tablets whole without chewing, with a small amount of water.
Adults and children over 12 years of age and weighing more than 33 kg:
- for pharyngitis and tonsillitis caused by Streptococcus pyogenes – 250 mg every 12 hours for 10 days;
- for acute sinusitis – 500 mg every 12 hours for 14 days;
- for exacerbation of chronic bronchitis caused by Haemophilus influenzae – 500 mg every 12 hours for 7-14 days; caused by Haemophilus parainfluenzae – 500 mg every 12 hours for 7 days; caused by Moraxella catarrhalis, Streptococcus pneumoniae – 250 mg every 12 hours for 7-14 days;
- for community-acquired pneumonia caused by Haemophilus influenzae – 250 mg every 12 hours for 7 days; caused by Streptococcus pneumoniae, Chlamydia pneumoniae, Mycoplasma pneumoniae – 250 mg every 12 hours for 7-14 days;
- for uncomplicated skin and subcutaneous tissue infections caused by Staphylococcus aureus, Streptococcus pyogenes – 250 mg every 12 hours for 7-14 days.
For the treatment and prevention of infections caused by Mycobacterium avium – 500 mg twice daily. Maximum daily dose is 1000 mg. Duration of treatment is 6 months or more.
For the eradication of Helicobacter pylori:
Combination treatment with three drugs:
clarithromycin - 500 mg, lansoprazole - 30 mg and amoxicillin - 1000 mg twice daily for 10-14 days;
clarithromycin - 500 mg, omeprazole - 20 mg and amoxicillin - 1000 mg twice daily for 10 days.
Combination treatment with two drugs:
clarithromycin - 500 mg three times daily, omeprazole - 40 mg daily for 14 days, followed by omeprazole for the next 14 days at a dose of 20 mg daily.
For patients with chronic renal failure: (creatinine clearance less than 30 ml/min or serum creatinine concentration greater than 3.3 mg/100 ml), the dose should be reduced by half, or the interval should be doubled. The maximum duration of treatment in this group of patients is 14 days.
Side effects:
Nervous system: headache, dizziness, drowsiness, anxiety, insomnia, "nightmare" dreams, tremor, convulsions, depression; disorientation, hallucinations, psychosis, depersonalization, confusion, exacerbation of myasthenia gravis symptoms, psychotic disorders, paresthesia, mania, intense sweating, anorexia, malaise, asthenia, chills, fatigue.
Digestive system: nausea, belching, vomiting, flatulence, loss of appetite, gastritis, stomach pain, diarrhea, stomatitis, glossitis, oral mucosa candidiasis, discoloration of the tongue and teeth, dry mouth, acute pancreatitis, increased activity of "liver" transaminases, cholestasis, hepatocellular and cholestatic hepatitis, cholestatic jaundice, rarely - pseudomembranous colitis, liver failure with fatal outcome mainly against the background of severe concomitant diseases and/or concomitant drug therapy, dyspepsia, constipation.
Cardiovascular system: ventricular tachycardia, including torsades de pointes, ventricular flutter and fibrillation, increased QT interval on ECG.
Sensory organs: tinnitus, ringing in the ears, vertigo, taste disturbance (dysgeusia), ageusia, in isolated cases - hearing loss, reversible after drug discontinuation, smell disturbance, anosmia.
Skin and soft tissues: erythrasma, acne, erysipelas.
Musculoskeletal system: myalgia, myopathy, chest pain.
Hematopoietic organs: rarely - thrombocytopenia (unusual bleeding, hemorrhages), agranulocytosis, thrombocytosis, prolonged prothrombin time, increased INR.
Urinary system: interstitial nephritis, renal failure.
Laboratory parameters: leukopenia, neutropenia, eosinophilia, increased blood bilirubin concentration, hypercreatininemia, hypoglycemia (including with concurrent use of hypoglycemic drugs), change in urine color.
Allergic reactions - skin rash, itching, urticaria, skin hyperemia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis, anaphylactic reactions, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), Henoch-Schönlein purpura, hemorrhages.
Other: secondary infections (development of microorganism resistance).
Overdose
Symptoms: abdominal pain, nausea, vomiting, diarrhea. Treatment: gastric lavage, supportive therapy. Not removed by hemodialysis or peritoneal dialysis.
Drug interactions:
When clarithromycin is taken concomitantly with drugs primarily metabolized by the CYP3A isoenzyme, a mutual increase in their concentrations is possible, which may enhance or prolong both therapeutic and side effects. Concomitant use with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, as well as with lovastatin and simvastatin is contraindicated.
Drugs that are inducers of CYP3A (e.g., phenobarbital and St. John's wort) may induce the metabolism of clarithromycin. This may lead to subtherapeutic levels of clarithromycin, reducing its efficacy.
Use with caution with carbamazepine, cilostazol, cyclosporine, disopyramide, methylprednisolone, omeprazole, indirect anticoagulants (including warfarin), quinidine, rifabutin, sildenafil, tacrolimus, vinblastine, as well as phenytoin, theophylline, and valproic acid (metabolized via other cytochrome P450 isoenzymes). Use with caution with alprazolam, triazolam, intravenous midazolam. Dose adjustment of the drug and blood concentration monitoring are necessary.
When used concomitantly with cisapride, pimozide, terfenadine, and astemizole, an increase in the concentration of the latter in the blood, an increase in the QT interval, and the occurrence of arrhythmias, including ventricular tachycardia including torsades de pointes and ventricular fibrillation, are possible.
When used concomitantly with ergotamine and dihydroergotamine, acute poisoning with drugs of the ergotamine group (vascular spasm, ischemia of the extremities and other tissues, including the central nervous system) is possible.
Efavirenz, nevirapine, rifampicin, rifabutin, and rifapentine (cytochrome P450 inducers) reduce the plasma level of clarithromycin and weaken its therapeutic effect, while simultaneously increasing the level of 14-hydroxyclarithromycin.
With concomitant use of fluconazole 200 mg daily and clarithromycin 1 g/day, an increase in the Css and AUC of clarithromycin by 33% and 18%, respectively, is possible. No dose adjustment of clarithromycin is required.
With concomitant use of ritonavir 600 mg/day and clarithromycin 1 g/day, a decrease in the metabolism of clarithromycin is possible (increase in Cmax by 31%, Css by 182%, and AUC by 77%), with complete suppression of the formation of 14-hydroxyclarithromycin. In patients with chronic renal failure, dose adjustment is necessary: with creatinine clearance (CrCl) of 30-60 ml/min, the dose of clarithromycin should be reduced by 50%; with CrCl less than 30 ml/min, by 75%. Ritonavir should not be taken concomitantly with clarithromycin at a dose exceeding 1 g/day.
When used concomitantly with quinidine and disopyramide, torsades de pointes ventricular tachycardia may occur. ECG monitoring (QT interval prolongation), serum concentrations of these drugs is necessary.
Clarithromycin increases the concentrations of HMG-CoA reductase inhibitors (lovastatin, simvastatin). The development of rhabdomyolysis is possible in patients taking these drugs concomitantly.
When using clarithromycin and omeprazole, an increase in Cmax, AUC, and half-life of omeprazole by 30%, 89%, and 34%, respectively, is possible. The mean 24-hour gastric pH was 5.2 when taking omeprazole alone and 5.7 when taking omeprazole concomitantly with clarithromycin.
When using clarithromycin and indirect anticoagulants, the effect of the latter may be enhanced. When used concomitantly with warfarin and other indirect anticoagulants, the International Normalized Ratio (INR) and prothrombin time should be monitored.
When using clarithromycin with sildenafil, tadalafil, or vardenafil (phosphodiesterase-5 inhibitors), an increase in the inhibitory effect on phosphodiesterase may occur. A reduction in the dose of sildenafil, tadalafil, and vardenafil may be required.
Concomitant use of clarithromycin with theophylline and carbamazepine may increase the concentration of the latter in the systemic circulation.
When using clarithromycin with tolterodine in patients with low CYP2D6 metabolism, a dose reduction of tolterodine may be required in the presence of clarithromycin (a CYP3A inhibitor).
With concomitant use of clarithromycin (1 g/day) with midazolam (orally), a 7-fold increase in the AUC of midazolam is possible. When using midazolam (intravenously) and clarithromycin, dose adjustment may be required. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3A. For benzodiazepines whose elimination is not dependent on CYP3A (temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.
With concomitant use of clarithromycin with colchicine, the effect of colchicine may be enhanced. Monitoring for possible clinical symptoms of colchicine intoxication is necessary, especially in elderly patients and patients with chronic renal failure (fatal cases have been reported).
With concomitant use of clarithromycin and digoxin, the serum concentration of digoxin should be carefully monitored (an increase in its concentration and the development of potentially fatal arrhythmias are possible).
Concomitant use of clarithromycin and zidovudine in adult HIV-infected patients may lead to a decrease in the Css of zidovudine. Dose adjustment of clarithromycin and zidovudine is necessary. This type of interaction is not observed in HIV-infected children receiving clarithromycin suspension concomitantly with zidovudine.
With concomitant use of clarithromycin (1 g/day) and atazanavir (400 mg/day), an increase in the AUC of atazanavir by 28%, clarithromycin by 2 times, and a decrease in the AUC of 14-hydroxyclarithromycin by 70% are possible. In patients with CrCl 30-60 ml/min, the dose of clarithromycin should be reduced by 50%. Clarithromycin in doses exceeding 1 g/day should not be prescribed concomitantly with protease inhibitors.
With concomitant use of clarithromycin and itraconazole, a mutual increase in the plasma concentrations of the drugs is possible. Patients simultaneously taking itraconazole and clarithromycin should be closely monitored due to the possible enhancement or prolongation of the pharmacological effects of these drugs.
With concomitant use of clarithromycin (1 g/day) and saquinavir (in soft gelatin capsules, 1200 mg three times a day), an increase in the AUC and Css of saquinavir by 177% and 187%, respectively, and of clarithromycin by 40% is possible. When prescribing these two drugs concomitantly for a limited time in the doses/forms indicated above, no dose adjustment is required.
With concomitant use with verapamil, a decrease in blood pressure, bradyarrhythmia, and lactic acidosis are possible.
With concomitant use of clarithromycin and oral hypoglycemic agents, including insulin, hypoglycemia may rarely develop. Careful monitoring of blood glucose levels is recommended.
With concomitant use with clarithromycin (500 mg twice daily), etravirine reduces the plasma concentration of clarithromycin by 53% and increases the concentration of the active metabolite, 14-hydroxyclarithromycin, by 46%. Since 14-hydroxyclarithromycin has reduced activity against Mycobacterium avium complex (MAC), the overall activity of clarithromycin and its metabolite against this pathogen may be altered.
Special instructions:
In the presence of chronic liver diseases, regular monitoring of serum enzyme activity is necessary.
Use with caution against the background of drugs metabolized by the liver (it is recommended to measure their blood concentration).
In case of concomitant use with warfarin or other anticoagulants, prothrombin time should be monitored.
If a secondary infection develops, appropriate therapy should be prescribed.
If severe diarrhea occurs during or after treatment, pseudomembranous colitis should be considered, which requires immediate drug discontinuation and appropriate treatment.
Dosage form:
Film-coated tablets 250 mg and 500 mg.
4, 5, 7, 10 tablets in a blister pack made of polyvinyl chloride film or multilayer polyvinyl chloride film and printed lacquered aluminum foil.
4, 5, 7, 10, 14 tablets in a plastic vial with a screw cap or a polymer jar with a screw cap.
Self-adhesive labels are affixed to the vial or jar.
1 or 2 blister packs or 1 vial or 1 jar, together with the instructions for use, are placed in a cardboard carton.
Shelf life:
3 years. Do not use after the expiration date.
Storage conditions:
Store in a dry, dark place at a temperature not exceeding 25°C. Keep out of reach of children.
Prescription status:
By prescription.
Name and address of the legal entity in whose name the registration certificate is issued / Organization accepting claims:
JSC "AVVA RUS", Russia, 121614,
Moscow, Krylatskie Kholmy St., 30, building 9.
Tel/Fax: +7 (495) 956-75-54.
ecoantibiotic.ru
Production site address:
JSC "AVVA RUS", Russia, 610044, Kirov Region, Kirov, Luganskaya St., 53a.
Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.
