Klabel 500 film-coated tablets 500 mg blister No. 14

Nobel

Composition of the medicinal product:

Pharmacological properties

Pharmacodynamics. Clarithromycin is a macrolide antibiotic for oral administration. It inhibits protein synthesis in the microbial cell, interacts with the 50S ribosomal subunit of bacteria. The drug is active against Streptococcus agalactiae, S. pyogenes, S. viridans, S. pneumoniae, Haemophilus influenzae, H. parainfluenzae, Neisseria gonorrhoeae, Listeria monocytogenes, Legionella pneumophilia, Mycoplasma pneumoniae, Helicobacter pylori, Campilobacter jejuni, Chlamydia pneumoniae, C. trachomatis, Moraxella catarrhalis, Bordetella pertussis, Propionibacterium acnes, Mycobacterium avium, Mycobacterium leprae, Staphylococcus aureus, Ureaplasma urealyticum, Toxoplasma gondii.
When taken orally, clarithromycin is metabolized to form the main metabolite 14-hydroxyclarithromycin, which has the same or 1-2 orders of magnitude less (depending on the type of microorganism) antibacterial activity than the unchanged substance.
Pharmacokinetics. Clarithromycin is acid-stable, and its absorption in the gastrointestinal tract after oral administration is about 55%. Food intake does not affect the bioavailability of clarithromycin. Clarithromycin is widely distributed in tissues and body fluids, with the exception of the nervous system. The concentration of the drug in the tissues significantly exceeds its concentration in the blood plasma. Almost 65-75% of clarithromycin is bound to blood plasma proteins, mainly the albumin fraction. Clarithromycin is extensively metabolized by liver enzymes, mainly cytochrome P450. It is excreted mainly in the urine. About 30% of the administered dose of the drug is excreted unchanged. T ½ of clarithromycin is approximately 4 hours.

Indication

Infections caused by microorganisms sensitive to clarithromycin:

disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare.
Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii.

Eradication of H. pylori in patients with duodenal ulcer with inhibition of hydrochloric acid secretion caused by omeprazole or lansoprazole (clarithromycin activity against H. pylori at neutral pH is higher than at acidic pH).

Method of application

Klabel 500 is taken orally, without chewing and with plenty of liquid. The use of the drug does not depend on food intake.
Adults and children over 12 years of age are prescribed 1 tablet per day with meals. In severe infections, the dose may be increased to 2 tablets. As a rule, the course of treatment is 7-14 days.
When treating mycobacterial infections, the recommended dose of the drug for adults is 500 mg 2 times a day.
Treatment of disseminated mycobacterial infections in AIDS patients should be continued until clinical and microbiological status improves. The drug is used in combination with other antimicrobial drugs.
The duration of treatment for other non-tuberculous mycobacterial infections is determined by the doctor individually.
For the prevention of mycobacterial infections, the recommended dose of the drug is 500 mg 2 times a day.
For the treatment of odontogenic infections, the recommended dose of the drug is 250 mg 2 times a day for 5 days.
The following treatment regimens are proposed for the eradication of H. pylori.
Treatment regimen with three drugs:
500 mg of the drug 2 times a day simultaneously with the appropriate dose of a proton pump inhibitor (e.g. lansoprazole, pantoprazole, omeprazole) and 1000 mg of amoxicillin or 400 mg of metronidazole 2 times a day. The duration of therapy is 10-14 days.
Treatment regimen with two drugs:
Usually the dose of Klabel is 500 mg 3 times a day, omeprazole - 40 mg once a day orally for 14 days.
Use in the elderly: as for adults.
The dosage for patients with impaired renal and hepatic function is determined by the doctor according to the degree of functional insufficiency.
In patients with severe renal impairment (creatinine clearance <30 ml/min), the dose of the drug must be adjusted, and the duration of treatment should not exceed 14 days.
If correction is necessary, the dose should be reduced by half, for example, 250 mg once a day or 250 mg twice a day for more severe infections.

Contraindication:

hypersensitivity to clarithromycin, macrolide antibiotics and other components of the drug.
Concomitant use with any of the following drugs: astemizole, cisapride, pimozide, terfenadine (as this may lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and torsades de pointes), ergotamine, dihydroergotamine (as this may lead to ergotoxicity), lovastatin or simvastatin (due to the risk of rhabdomyolysis; treatment with these drugs should be discontinued during treatment with clarithromycin) (see Precautions, Interactions).
Patients with a history of QT prolongation or ventricular cardiac arrhythmias, including torsades de pointes.
In patients with renal or hepatic impairment who are taking P-glycoprotein or a strong CYP 3A4 inhibitor (e.g. clarithromycin), concomitant use of colchicine is contraindicated.
Patients with creatinine clearance <30 ml/min (since this form of the drug does not allow the dose to be reduced below 500 mg/day).

SIDE EFFECTS:

Clarithromycin is usually well tolerated.
The most common and common adverse reactions in adults and children treated with clarithromycin are abdominal pain, diarrhea, nausea, vomiting, and taste perversion. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics.
Infections and infestations: cellulitis, oral candidiasis, gastroenteritis, infection, vaginal infection, pseudomembranous colitis, erysipelas, erythrasma.
From the blood and lymphatic system: leukopenia, neutropenia, thrombocythemia, eosinophilia, agranulocytosis, thrombocytopenia.
Immune system disorders: anaphylactoid reactions, hypersensitivity, anaphylactic reactions.
Metabolism and nutrition disorders: anorexia, decreased appetite, hypoglycemia.
Psychiatric: insomnia; anxiety, nervousness, screaming; psychosis, confusion, depersonalization, depression, disorientation, hallucinations, nightmares.
From the side of the central nervous system: dysgeusia (taste disturbance), headache, taste distortion; loss of consciousness, dyskinesia, dizziness, drowsiness, tremor; convulsions, ageusia (loss of taste), parosmia, anosmia.
Hearing and labyrinth disorders: dizziness, hearing impairment, tinnitus; hearing loss.
Cardiac disorders: cardiac arrest, atrial fibrillation, QT prolongation, extrasystoles, palpitations; torsades de pointes, ventricular tachycardia.
Vascular disorders: vasodilation; hemorrhage.
From the respiratory system, chest organs and mediastinum: asthma, nosebleeds, pulmonary embolism.
From the digestive system: diarrhea, vomiting, dyspepsia, nausea, abdominal pain; esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence; acute pancreatitis, tongue discoloration, tooth discoloration.
Hepatobiliary system: abnormal liver function tests; cholestasis, hepatitis, increased ALT, AST, gamma-glutamyltransferase; hepatic failure, cholestatic jaundice, hepatocellular jaundice.
Skin and subcutaneous tissue disorders: rash, skin redness, hyperhidrosis; bullous dermatitis, pruritus, urticaria, maculopapular rash; Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acne, Henoch-Schonlein syndrome.
Musculoskeletal and connective tissue disorders: muscle spasms, musculoskeletal rigidity, myalgia; rhabdomyolysis (in some reports of rhabdomyolysis, clarithromycin was used concomitantly with statins, fibrates, colchicine or allopurinol), myopathy.
Renal and urinary disorders: increased blood creatinine, increased blood urea; renal failure, interstitial nephritis.
General disorders and administration site conditions: malaise, fever, asthenia, weakness, chest pain, chills, fatigue.
Laboratory tests: change in albumin-globulin ratio, increase in alkaline phosphatase level in the blood, increase in LDH level in the blood; increase in international normalized ratio, increase in prothrombin time, change in urine color.
Paresthesia, arthralgia, and angioedema have been reported.
There have been very rare reports of uveitis, mainly in patients receiving concomitant rifabutin. Most cases were reversible.
Colchicine toxicity (including fatal outcomes) has been reported with concomitant use of clarithromycin and colchicine, particularly in elderly patients, including those with renal impairment.

hypersensitivity to clarithromycin, macrolide antibiotics and other components of the drug.
Concomitant use with any of the following drugs: astemizole, cisapride, pimozide, terfenadine (as this may lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and torsades de pointes), ergotamine, dihydroergotamine (as this may lead to ergotoxicity), lovastatin or simvastatin (due to the risk of rhabdomyolysis; treatment with these drugs should be discontinued during treatment with clarithromycin) (see Precautions, Interactions).
Patients with a history of QT prolongation or ventricular cardiac arrhythmias, including torsades de pointes.
In patients with renal or hepatic impairment who are taking P-glycoprotein or a strong CYP 3A4 inhibitor (e.g. clarithromycin), concomitant use of colchicine is contraindicated.
Patients with creatinine clearance <30 ml/min (since this form of the drug does not allow the dose to be reduced below 500 mg/day).

SIDE EFFECTS:

Clarithromycin is usually well tolerated.
The most common and common adverse reactions in adults and children treated with clarithromycin are abdominal pain, diarrhea, nausea, vomiting, and taste perversion. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics.
Infections and infestations: cellulitis, oral candidiasis, gastroenteritis, infection, vaginal infection, pseudomembranous colitis, erysipelas, erythrasma.
From the blood and lymphatic system: leukopenia, neutropenia, thrombocythemia, eosinophilia, agranulocytosis, thrombocytopenia.
Immune system disorders: anaphylactoid reactions, hypersensitivity, anaphylactic reactions.
Metabolism and nutrition disorders: anorexia, decreased appetite, hypoglycemia.
On the part of the psyche: insomnia; anxiety, nervousness, screaming; psychosis, confusion, depersonalization, depression, disorientation, hallucinations, nightmares.
From the side of the central nervous system: dysgeusia (taste disturbance), headache, taste distortion; loss of consciousness, dyskinesia, dizziness, drowsiness, tremor; convulsions, ageusia (loss of taste), parosmia, anosmia.
Hearing and labyrinth disorders: dizziness, hearing impairment, tinnitus; hearing loss.
Cardiac disorders: cardiac arrest, atrial fibrillation, QT prolongation, extrasystoles, palpitations; torsades de pointes, ventricular tachycardia.
Vascular disorders: vasodilation; hemorrhage.
From the respiratory system, chest organs and mediastinum: asthma, nosebleeds, pulmonary embolism.
From the digestive system: diarrhea, vomiting, dyspepsia, nausea, abdominal pain; esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence; acute pancreatitis, tongue discoloration, tooth discoloration.
Hepatobiliary system: abnormal liver function tests; cholestasis, hepatitis, increased ALT, AST, gamma-glutamyltransferase; hepatic failure, cholestatic jaundice, hepatocellular jaundice.
Skin and subcutaneous tissue disorders: rash, skin redness, hyperhidrosis; bullous dermatitis, pruritus, urticaria, maculopapular rash; Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acne, Henoch-Schonlein syndrome.
Musculoskeletal and connective tissue disorders: muscle spasms, musculoskeletal rigidity, myalgia; rhabdomyolysis (in some reports of rhabdomyolysis, clarithromycin was used concomitantly with statins, fibrates, colchicine or allopurinol), myopathy.
Renal and urinary disorders: increased blood creatinine, increased blood urea; renal failure, interstitial nephritis.
General disorders and administration site conditions: malaise, fever, asthenia, weakness, chest pain, chills, fatigue.
Laboratory tests: change in albumin-globulin ratio, increase in alkaline phosphatase level in the blood, increase in LDH level in the blood; increase in international normalized ratio, increase in prothrombin time, change in urine color.
Paresthesia, arthralgia, and angioedema have been reported.
There have been very rare reports of uveitis, mainly in patients receiving concomitant rifabutin. Most cases were reversible.
Colchicine toxicity (including fatal outcomes) has been reported with concomitant use of clarithromycin and colchicine, particularly in elderly patients, including those with renal impairment.

hypersensitivity to clarithromycin, macrolide antibiotics and other components of the drug.
Concomitant use with any of the following drugs: astemizole, cisapride, pimozide, terfenadine (as this may lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and torsades de pointes), ergotamine, dihydroergotamine (as this may lead to ergotoxicity), lovastatin or simvastatin (due to the risk of rhabdomyolysis; treatment with these drugs should be discontinued during treatment with clarithromycin) (see Precautions, Interactions).
Patients with a history of QT prolongation or ventricular cardiac arrhythmias, including torsades de pointes.
In patients with renal or hepatic impairment who are taking P-glycoprotein or a strong CYP 3A4 inhibitor (e.g. clarithromycin), concomitant use of colchicine is contraindicated.
Patients with creatinine clearance <30 ml/min (since this form of the drug does not allow the dose to be reduced below 500 mg/day).

SIDE EFFECTS:

Clarithromycin is usually well tolerated.
The most common and common adverse reactions in adults and children treated with clarithromycin are abdominal pain, diarrhea, nausea, vomiting, and taste perversion. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics.
Infections and infestations: cellulitis, oral candidiasis, gastroenteritis, infection, vaginal infection, pseudomembranous colitis, erysipelas, erythrasma.
From the blood and lymphatic system: leukopenia, neutropenia, thrombocythemia, eosinophilia, agranulocytosis, thrombocytopenia.
Immune system disorders: anaphylactoid reactions, hypersensitivity, anaphylactic reactions.
Metabolism and nutrition disorders: anorexia, decreased appetite, hypoglycemia.
Psychiatric: insomnia; anxiety, nervousness, screaming; psychosis, confusion, depersonalization, depression, disorientation, hallucinations, nightmares.
From the side of the central nervous system: dysgeusia (taste disturbance), headache, taste distortion; loss of consciousness, dyskinesia, dizziness, drowsiness, tremor; convulsions, ageusia (loss of taste), parosmia, anosmia.
Hearing and labyrinth disorders: dizziness, hearing impairment, tinnitus; hearing loss.
Cardiac disorders: cardiac arrest, atrial fibrillation, QT prolongation, extrasystoles, palpitations; torsades de pointes, ventricular tachycardia.
Vascular disorders: vasodilation; hemorrhage.
From the respiratory system, chest organs and mediastinum: asthma, nosebleeds, pulmonary embolism.
From the digestive system: diarrhea, vomiting, dyspepsia, nausea, abdominal pain; esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence; acute pancreatitis, tongue discoloration, tooth discoloration.
Hepatobiliary system: abnormal liver function tests; cholestasis, hepatitis, increased ALT, AST, gamma-glutamyltransferase; hepatic failure, cholestatic jaundice, hepatocellular jaundice.
Skin and subcutaneous tissue disorders: rash, skin redness, hyperhidrosis; bullous dermatitis, pruritus, urticaria, maculopapular rash; Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acne, Henoch-Schonlein syndrome.
Musculoskeletal and connective tissue disorders: muscle spasms, musculoskeletal rigidity, myalgia; rhabdomyolysis (in some reports of rhabdomyolysis, clarithromycin was used concomitantly with statins, fibrates, colchicine or allopurinol), myopathy.
Renal and urinary disorders: increased blood creatinine, increased blood urea; renal failure, interstitial nephritis.
General disorders and administration site conditions: malaise, fever, asthenia, weakness, chest pain, chills, fatigue.
Laboratory tests: change in albumin-globulin ratio, increase in alkaline phosphatase level in the blood, increase in LDH level in the blood; increase in international normalized ratio, increase in prothrombin time, change in urine color.
Paresthesia, arthralgia, and angioedema have been reported.
There have been very rare reports of uveitis, mainly in patients receiving concomitant rifabutin. Most cases were reversible.
Colchicine toxicity (including fatal outcomes) has been reported with concomitant use of clarithromycin and colchicine, particularly in elderly patients, including those with renal impairment.

hypersensitivity to clarithromycin, macrolide antibiotics and other components of the drug.
Concomitant use with any of the following drugs: astemizole, cisapride, pimozide, terfenadine (as this may lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and torsades de pointes), ergotamine, dihydroergotamine (as this may lead to ergotoxicity), lovastatin or simvastatin (due to the risk of rhabdomyolysis; treatment with these drugs should be discontinued during treatment with clarithromycin) (see Precautions, Interactions).
Patients with a history of QT prolongation or ventricular cardiac arrhythmias, including torsades de pointes.
In patients with renal or hepatic impairment who are taking P-glycoprotein or a strong CYP 3A4 inhibitor (e.g. clarithromycin), concomitant use of colchicine is contraindicated.
Patients with creatinine clearance <30 ml/min (since this form of the drug does not allow the dose to be reduced below 500 mg/day).

SIDE EFFECTS:

Clarithromycin is usually well tolerated.
The most common and common adverse reactions in adults and children treated with clarithromycin are abdominal pain, diarrhea, nausea, vomiting, and taste perversion. These adverse reactions are usually mild and consistent with the known safety profile of macrolide antibiotics.
Infections and infestations: cellulitis, oral candidiasis, gastroenteritis, infection, vaginal infection, pseudomembranous colitis, erysipelas, erythrasma.
From the blood and lymphatic system: leukopenia, neutropenia, thrombocythemia, eosinophilia, agranulocytosis, thrombocytopenia.
Immune system disorders: anaphylactoid reactions, hypersensitivity, anaphylactic reactions.
Metabolism and nutrition disorders: anorexia, decreased appetite, hypoglycemia.
Psychiatric: insomnia; anxiety, nervousness, screaming; psychosis, confusion, depersonalization, depression, disorientation, hallucinations, nightmares.
From the side of the central nervous system: dysgeusia (taste disturbance), headache, taste distortion; loss of consciousness, dyskinesia, dizziness, drowsiness, tremor; convulsions, ageusia (loss of taste), parosmia, anosmia.
Hearing and labyrinth disorders: dizziness, hearing impairment, tinnitus; hearing loss.
Cardiac disorders: cardiac arrest, atrial fibrillation, QT prolongation, extrasystoles, palpitations; torsades de pointes, ventricular tachycardia.
Vascular disorders: vasodilation; hemorrhage.
From the respiratory system, chest organs and mediastinum: asthma, nosebleeds, pulmonary embolism.
From the digestive system: diarrhea, vomiting, dyspepsia, nausea, abdominal pain; esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, stomatitis, glossitis, bloating, constipation, dry mouth, belching, flatulence; acute pancreatitis, tongue discoloration, tooth discoloration.
Hepatobiliary system: abnormal liver function tests; cholestasis, hepatitis, increased ALT, AST, gamma-glutamyltransferase; hepatic failure, cholestatic jaundice, hepatocellular jaundice.
Skin and subcutaneous tissue disorders: rash, skin redness, hyperhidrosis; bullous dermatitis, pruritus, urticaria, maculopapular rash; Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acne, Henoch-Schonlein syndrome.
Musculoskeletal and connective tissue disorders: muscle spasms, musculoskeletal rigidity, myalgia; rhabdomyolysis (in some reports of rhabdomyolysis, clarithromycin was used concomitantly with statins, fibrates, colchicine or allopurinol), myopathy.
Renal and urinary disorders: increased blood creatinine, increased blood urea; renal failure, interstitial nephritis.
General disorders and administration site conditions: malaise, fever, asthenia, weakness, chest pain, chills, fatigue.
Laboratory tests: change in albumin-globulin ratio, increase in alkaline phosphatase level in the blood, increase in LDH level in the blood; increase in international normalized ratio, increase in prothrombin time, change in urine color.
Paresthesia, arthralgia, and angioedema have been reported.
There have been very rare reports of uveitis, mainly in patients receiving concomitant rifabutin. Most cases were reversible.
Colchicine toxicity (including fatal outcomes) has been reported with concomitant use of clarithromycin and colchicine, particularly in elderly patients, including those with renal impairment.

Conditions and shelf life

Existing reports indicate that clarithromycin overdose may cause gastrointestinal symptoms such as nausea, vomiting, diarrhea, or exacerbation of other adverse reactions. One patient with a history of bipolar psychosis who took 8 g of clarithromycin developed altered mental status, paranoid behavior, hypokalemia, and hypoxemia.
Treatment: Gastric lavage and symptomatic therapy. As with other macrolides, hemodialysis or peritoneal dialysis is unlikely to significantly alter the plasma levels of clarithromycin.

STORAGE CONDITIONS:

in a dry, dark place at a temperature not exceeding 25 °C.