Klacid SR - Instructions For The Use Of Tablets 500 Mg, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Klacid SR

Klacid SR: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15.and storage conditions
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Klacid SR

ATX code: J01FA09

Active ingredient: clarithromycin (Clarithromycin)

Manufacturer: Abbott Laboratories (Great Britain), Abbott Laboratories GmbH (Germany)

Description and photo update: 2018-22-10

Prices in pharmacies: from 415 rubles.

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Klacid SR is a drug with antibacterial action from the macrolide group.

Release form and composition

The dosage form of the release of Klacid SR is prolonged-release film-coated tablets: oval, yellow (5, 7, 10 or 14 pcs. In blisters, in a cardboard box 1 or 2 blisters).

Composition of 1 tablet:

• active substance: clarithromycin - 500 mg;
• additional components: stearic acid - 21 mg; anhydrous citric acid - 128 mg; magnesium stearate - 10 mg; sodium calcium alginate - 15 mg; sodium alginate - 120 mg; lactose - 115 mg; talc - 30 mg; povidone K30 - 30 mg;
• shell: sorbic acid - 0.16 mg; hypromellose - 9.81 mg; macrogol 8000 - 3.27 mg; macrogol 400 - 3.27 mg; yellow dye (yellow quinoline) - 1.23 mg; titanium dioxide - 1.64 mg.

Pharmacological properties

Pharmacodynamics

Clarithromycin is one of the semisynthetic antibiotics of the macrolide group. It has an antibacterial effect by interacting with the 50S ribosomal subunit and suppressing the protein synthesis of bacteria that are sensitive to it.

The drug is effective against standard laboratory and isolated during clinical practice in patients with bacterial strains.

Insensitive to the action of clarithromycin Enterobacteriaceae and Pseudomonas spp.

Klacid SR is effective against the following microorganisms / mycobacteria (proven in vitro and in clinical practice):

• aerobic gram-positive / gram-negative microorganisms: Haemophilus parainfluenzae, Legionella pneumophila, Neisseria gonorrhoeae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes, Haemophilus catarza, Moraxella;
• other microorganisms: Chlamydia pneumoniae (TWAR), Mycoplasma pneumonia;
• mycobacteria: Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium avium complex (MAC; a complex that includes Mycobacterium intracellulare and Mycobacterium avium).

Beta-lactamase production has no effect on the activity of clarithromycin. Most strains of staphylococci that are resistant to oxacillin and methicillin are resistant to the action of clarithromycin.

Klacid SR has a bactericidal effect against Helicobacter pylori; this activity is higher at neutral pH than at acidic.

Clarithromycin has an in vitro effect against most strains of the following microorganisms (the efficacy / safety of the drug has not been confirmed by clinical studies in clinical practice, its practical value is unclear):

• aerobic gram-positive / gram-negative microorganisms: Streptococcus agalactiae, Streptococci (groups C, F, G), Viridans group streptococci, Pasteurella multocida, Bordetella pertussis;
• anaerobic gram-positive / gram-negative microorganisms: Clostridium perfringens, Peptococcus niger, Propionibacterium acnes;
• anaerobic microorganisms: Bacteroides melaninogenicus;
• spirochetes: Treponema pallidum, Borrelia burgdorferi;
• campylobacter: Campylobacter jejuni.

The main metabolite of clarithromycin is the microbiologically active metabolite 14-hydroxy-clarithromycin (14-OH-clarithromycin). Its microbiological activity is the same as that of the original substance, or 1–2 times weaker in relation to most microorganisms. The exception is H. influenzae, in relation to which the efficiency of the metabolite is 2 times higher. Depending on the bacterial strain against H. influenzae, the active substance and its main metabolite have either an additive or a synergistic effect.

Pharmacokinetics

Absorption of clarithromycin in the form of sustained-release tablets does not differ from conventional-release tablets.

Metabolism occurs in the liver in the cytochrome P450 3A (CYP3A) system.

Absolute bioavailability is approximately 50%. When taking repeated doses of Klacid SR, cumulation is practically not detected, the nature of metabolism does not change.

Clarithromycin binds to plasma proteins by 70% at a concentration in the range of 0.45-4.5 μg / ml. At a concentration of 45 μg / ml, the binding decreases to 41%, which is probably due to the saturation of the binding sites. This is observed only at concentrations that are many times higher than therapeutic ones.

The maximum concentration (C _max) of clarithromycin and 14-OH-clarithromycin in the blood plasma when taking 500/1000 mg once a day is 1.3 / 2.4 and 0.48 / 0.67 μg / ml, respectively. The half-lives (T1 / 2) of clarithromycin and the metabolite at the same doses are 5.3 / 5.8 and 7.7 / 8.9 hours, respectively.

The time of the onset of the maximum concentration (TC _max) when taking 500/1000 mg is 6 hours.

Clarithromycin has a non-linear metabolism that becomes more pronounced at high doses.

About 40% of the dose is excreted by the kidneys, 30% through the intestines.

The substance and its metabolite rapidly penetrate into body fluids and tissues. The concentration in the tissues, as a rule, is several times higher than the serum concentration.

In case of moderate and severe hepatic dysfunction without renal dysfunction, dose adjustment of Klacid SR is not required.

With impaired renal function, the maximum and minimum concentrations of clarithromycin in the blood plasma, the half-life, the area under the concentration-time pharmacokinetic curve (AUC) of clarithromycin and its metabolite increase. Excretion by the kidneys and the elimination constant decrease. The degree of changes in these indicators depends on the degree of impaired renal function.

Indications for use

Klacid SR 500 mg is prescribed for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the action of clarithromycin:

• infections of the upper and lower respiratory tract (pneumonia, bronchitis, pharyngitis, sinusitis);
• infections of soft tissues, skin (erysipelas, inflammation of the subcutaneous tissue, folliculitis).

Contraindications

Absolute:

• burdened history of prolongation of the QT interval, ventricular tachycardia such as pirouette, ventricular arrhythmia;
• severe renal failure with creatinine clearance (CC) less than 30 ml / min;
• severe hepatic impairment in combination with renal impairment;
• hypokalemia;
• porphyria;
• burdened history of cholestatic jaundice / hepatitis that developed during the use of drugs containing clarithromycin;
• lactase deficiency, galactose intolerance, impaired absorption of galactose and glucose;
• combination therapy with the following drugs / substances: astemizole, cisapride, terfenadine, pimozide, drugs containing ergot alkaloids (dihydroergotamine, ergotamine), midazolam (oral), HMG-CoA reductase inhibitors (statins), which are largely metabolized by CYP3YP4 (simvastatin, lovastatin), ticagrelor, ranolazine;
• lactation period;
• age up to 12 years;
• individual intolerance to the components of the drug, as well as other macrolides.

Relative (diseases / conditions in the presence of which the appointment of Klacid SR requires caution):

• hypomagnesemia;
• renal / hepatic failure, proceeding in moderate to severe;
• severe heart failure;
• ischemic heart disease (CHD);
• severe bradycardia (less than 50 beats / min);
• combination therapy with the following drugs / substances: benzodiazepines (including triazolam, alprazolam, midazolam for intravenous use), other ototoxic drugs, in particular aminoglycosides, drugs that are metabolized by the CYP3A isoenzyme (in particular, tacrolimus, omeprazole, sildenafil, diziralamazepine,, cyclosporine, methylprednisolone, indirect anticoagulants, rifabutin, quinidine, vinblastine), drugs that induce the isoenzyme CYP3A4 (in particular, phenytoin, rifampicin, phenobarbital, carbamazepine, St., blockers of slow calcium channels, which are metabolized by the isoenzyme CYP3A4 (in particular, amlodipine, verapamil, diltiazem), class IA and III antiarrhythmics (dofetilide,quinidine, amiodarone, procainamide, sotalol);
• pregnancy.

Instructions for use of Klacid SR: method and dosage

Klacid SR is taken orally, preferably with meals. The tablets should be swallowed whole without breaking or chewing.

The recommended daily dose is 1 tablet once a day. In severe cases of the disease, a single dose can be doubled.

The average duration of therapy is 5-14 days, with community-acquired pneumonia and sinusitis - 6-14 days.

In case of moderate renal dysfunction (CC - 30-60 ml / min), the daily dose of Klacid SR should not be higher than 500 mg.

Side effects

Possible violations (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rarely; with an unknown frequency - in cases where the frequency the occurrence of side effects cannot be determined):

• allergic reactions: often - rash; infrequently - anaphylactoid reaction, hypersensitivity, bullous dermatitis, pruritus, urticaria, maculopapular rash; with an unknown frequency - angioedema, anaphylactic reaction, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash with systemic symptoms and eosinophilia (DRESS syndrome);
• nervous system: often - insomnia, headache; infrequently - loss of consciousness, dyskinesia, dizziness, drowsiness, tremors, anxiety, increased excitability; with an unspecified frequency - paresthesia, psychotic disorders, convulsions, hallucinations, confusion, depersonalization, disorientation, depression, dream disturbances (nightmares), mania;
• skin: often - intense sweating; with an unknown frequency - hemorrhage, acne;
• urinary system: with an unknown frequency - interstitial nephritis, renal failure;
• metabolism / nutrition: infrequently - decreased appetite, anorexia;
• musculoskeletal system: infrequently - myalgia, musculoskeletal stiffness, muscle spasm; with an unknown frequency - myopathy, rhabdomyolysis;
• digestive system: often - abdominal pain, diarrhea, dyspepsia, vomiting, nausea; infrequently - gastritis, esophagitis, bloating, gastroesophageal reflux disease, constipation, belching, dry mouth, flatulence, proctalgia, cholestasis, stomatitis, glossitis, hepatitis, including hepatocellular or cholestatic; with an unknown frequency - hepatic failure, acute pancreatitis, discoloration of the teeth and tongue, cholestatic jaundice;
• respiratory system: infrequently - nosebleeds, asthma, pulmonary embolism;
• sense organs: often - taste perversion, dysgeusia; infrequently - hearing impairment, vertigo, ringing in the ears; with an unknown frequency - ageusia, deafness, anosmia, parosmia;
• cardiovascular system: often - vasodilation; infrequently - cardiac arrest, atrial fibrillation, atrial flutter, extrasystole, prolongation of the QT interval on the electrocardiogram; with an unknown frequency - ventricular tachycardia, including pirouette type;
• laboratory parameters: often - deviation in liver function tests; infrequently - an increase in the concentration of urea, creatinine, a change in the albumin / globulin ratio, thrombocythemia, eosinophilia, leukopenia, neutropenia, an increase in the activity of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, lactate dehydrogenase; with an unknown frequency - thrombocytopenia, agranulocytosis, prolongation of prothrombin time, an increase in the international normalized ratio (INR), an increase in the concentration of bilirubin in the blood, a change in the color of urine;
• parasitic / infectious diseases: infrequently - secondary infections (including vaginal), cellulitis, gastroenteritis, candidiasis; with an unknown frequency - erysipelas, pseudomembranous colitis;
• general disorders: infrequently - chills, malaise, asthenia, hyperthermia, chest pain, fatigue.

In AIDS and other immunodeficiency conditions, on the background of long-term therapy at high doses, it is often difficult to determine the differences between the adverse reactions of Klacid SR from the symptoms of HIV infection or concomitant disease.

Most often, when taking a daily dose of 1000 mg, the following side effects were noted: hearing impairment, nausea, taste perversion, vomiting, abdominal pain, rash, diarrhea, flatulence, constipation, headache, increased activity of aspartate aminotransferase and alanine aminotransferase in the blood. In addition, there are reports of low incidence adverse events, including shortness of breath, dry mouth and insomnia.

Overdose

The main symptoms: disturbances from the digestive system. Against the background of a history of bipolar disorder after taking 8 g of Klacid SR, one patient developed changes in the mental state, paranoid behavior, hypokalemia and hypoxemia.

Therapy: removal of unabsorbed substances from the gastrointestinal tract (gastric lavage, intake of activated charcoal, etc.) and symptomatic treatment. Peritoneal dialysis and hemodialysis do not significantly affect serum clarithromycin concentration.

special instructions

Long-term use of Klacid SR can cause the formation of colonies with an increased number of insensitive fungi and bacteria. With superinfection, appropriate therapy is required.

There are reports of hepatic dysfunction, which can be severe, but in most cases reversible, in some cases fatal, which is mainly associated with the presence of serious concomitant diseases and / or combination therapy. When itching, anorexia, jaundice, darkening of urine, abdominal pain on palpation and other symptoms of hepatitis appear, Klacid SR is immediately canceled.

Patients with chronic liver disease require regular monitoring of serum blood enzymes.

During therapy, pseudomembranous colitis may develop from mild to life-threatening severity. Klacid SR can cause changes in the normal intestinal microflora and, as a consequence, the growth of Clostridium difficile. C. difflcile-induced pseudomembranous colitis should be suspected in all cases of diarrhea following antibiotic use. After the end of the course, careful medical monitoring of the patient's condition is shown. There is evidence of the development of pseudomembranous colitis 2 months after the end of the drug intake.

The development of cross-resistance to clarithromycin and other antibiotics of the macrolide group, as well as clindamycin and lincomycin, is possible.

Mild to moderate soft tissue / skin infections are in most cases caused by Staphylococcus aureus and Streptococcus pyogenes. At the same time, they can show resistance to macrolides, and therefore it is necessary to carry out a sensitivity test.

When acute hypersensitivity reactions appear, treatment with Klacid SR is immediately canceled and appropriate therapy is started.

Influence on the ability to drive vehicles and complex mechanisms

Care must be taken when driving because there is a risk of side effects including dizziness, vertigo, disorientation and confusion.

Application during pregnancy and lactation

• pregnancy - the appointment of the drug, especially during the first trimester, is possible only in the absence of alternative therapy in cases where the potential benefit exceeds the harm;
• lactation period - taking Klacid SR is contraindicated.

Pediatric use

According to the instructions, Klacid SR is not prescribed for children under 12 years of age.

With impaired renal function

• severe renal failure with creatinine clearance (CC) less than 30 ml / min - the use of Klacid SR is contraindicated;
• moderate / severe renal failure - the appointment of therapy requires caution.

For violations of liver function

• severe hepatic impairment in combination with renal impairment - the use of Klacid SR is contraindicated;
• moderate / severe hepatic impairment - the appointment of therapy requires caution.

Drug interactions

Contraindicated combinations:

• pimozide, cisapride, astemizole and terfenadine: an increase in their concentration in blood plasma, which can, in turn, lead to a prolongation of the QT interval and the development of cardiac arrhythmias;
• HMG-CoA reductase inhibitors (statins): an increase in their serum concentrations, which increases the likelihood of myopathy, including rhabdomyolysis; when combined with other statins, caution is required; in cases of the need for combined therapy, it is recommended to use drugs that do not depend on the metabolism of the CYP3A isoenzyme (in particular, fluvastatin);
• ergot alkaloids: development of vascular spasm, ischemia of extremities and other tissues, including damage to the central nervous system.

Drugs that are inducers of the CYP3A isoenzyme (for example, St. John's wort, rifampicin, carbamazepine, phenytoin, phenobarbital) can induce the metabolism of clarithromycin, which may reduce the effectiveness of Clacid SR. In addition, it is necessary to monitor the plasma concentration of the inducer of the isoenzyme CYP3A in the blood, which may increase due to inhibition of this isoenzyme by clarithromycin.

Substances / medicines that affect the plasma concentration of clarithromycin in the blood (it may be necessary to adjust the dose or switch to alternative therapy):

• etravirine: decrease in clarithromycin concentration, it is recommended to consider alternative therapy in the treatment of Mycobacterium avium complex (MAC) infections;
• rifapentine, efavirenz, rifampicin, nevirapine, rifabutin: acceleration of the metabolism of clarithromycin and, thus, a decrease in its concentration in plasma and a weakening of the therapeutic effect;
• ritonavir: significant inhibition of clarithromycin metabolism; dose adjustment is usually done in patients with renal impairment;
• fluconazole: an increase in the plasma concentration of clarithromycin (no dose adjustment of Clacid SR is required).

Other interactions:

• oral hypoglycemic agents / insulin: development of severe hypoglycemia (requires careful monitoring of glucose concentration);
• antiarrhythmics (disopyramide, quinidine): development of pirouette-type ventricular tachycardia (with combined use, regular monitoring of the electrocardiogram is required for prolongation of the QT interval, monitoring of serum concentrations of these drugs and blood glucose concentration is also shown);
• indirect anticoagulants: the development of bleeding, a pronounced increase in INR and prothrombin time (control of these indicators is required);
• drugs that are primarily metabolized by the CYP3A isoenzyme: a mutual increase in their concentrations, which can lead to an increase / prolongation of therapeutic and side effects (caution is especially required in cases of combined use with drugs that have a narrow therapeutic range or are intensively metabolized by this enzyme; if necessary, the combination is corrected doses, if possible, control serum concentrations of these drugs);
• sildenafil, vardenafil, tadalafil: an increase in the inhibitory effect on phosphodiesterase (a decrease in their dose may be required);
• omeprazole: an increase in its equilibrium plasma concentrations;
• tolterodine: an increase in its concentration in serum (a decrease in its dose may be required);
• carbamazepine, theophylline: an increase in their concentration in the systemic circulation;
• aminoglycosides and other ototoxic drugs: the combination requires caution and control of the function of the auditory and vestibular apparatus, including the period after the end of use;
• benzodiazepines (midazolam, alprazolam, triazolam): condition monitoring is required; the combination with oral midazolam is contraindicated; Triazolam can affect the central nervous system (manifests itself as drowsiness and confusion), which requires control of symptoms;
• colchicine: enhancing its action; the combination is contraindicated (if combined use is necessary, control of the development of clinical symptoms of colchicine poisoning is required, especially in elderly patients);
• zidovudine (in HIV-infected adult patients): decrease in its equilibrium concentration; a significant decrease in interaction is possible if an interval of 4 hours is observed between their use;
• digoxin: an increase in its action, which can lead to the appearance of clinical symptoms of poisoning, including potentially lethal arrhythmias (it is necessary to carefully monitor its serum concentration);
• atazanavir: drug interactions; with CC below 60 ml / min, the dose of Klacid SR is reduced;
• valproic acid, phenytoin: an increase in their serum concentrations (it is necessary to determine this indicator);
• itraconazole: a mutual increase in their plasma concentrations, a careful examination of patients is required for an increase in the duration / enhancement of their pharmacological effects;
• blockers of slow calcium channels: a mutual increase in their plasma concentrations and the risk of developing arterial hypotension, bradyarrhythmia and lactic acidosis.

Analogs

Analogues of Klacid SR are Romiklar, Klaricin, Kispar, Zimbaktar, Klabaks, Bacticap, Clarithromycin, Ecositrin, Klasine, Seidon-Sanovel, Clerimed, Biotericin, Klacid, etc.

Terms and conditions of storage

Store in a place protected from light at a temperature of 15-30 ° C. Keep out of the reach of children.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Klacid SR

Reviews of Klacide SR vary. Many people note its effectiveness, fast action and relief of symptoms. However, in other cases, the lack of effect is indicated and the development of pronounced side effects, including disorders of the digestive system, headache, panic attacks. Also from the disadvantages is the high cost of the drug.

Price for Klacid SR in pharmacies

The approximate price for Klacid SR 500 mg (5, 7 or 14 pieces per package) is 425-475, 500-560 or 840-940 rubles.

Klacid SR: prices in online pharmacies

Drug name Price Pharmacy

Klacid SR 500 mg film-coated tablets with prolonged release 5 pcs. 415 RUB Buy

Klacid SR tablets p.o. with prolonged release. 500mg 5 pcs. RUB 471 Buy

Klacid SR 500 mg film-coated tablets with prolonged release 7 pcs. 493 r Buy

Klacid SR tablets p.o. with prolonged release. 500mg 7 pcs. 507 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!