Active substanceClarithromycinClarithromycin
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: clarithromycin in terms of 100% anhydrous substance 250 mg or 500 mg;

    Excipients: potato starch 46.0 mg or 92.0 mg, microcrystalline cellulose 75.0 mg or 150.0 mg, povidone (low molecular weight polyvinylpyrrolidone) 40.0 mg or 80.0 mg, pregelatinized starch (starch-1500) 30.0 mg or 60.0 mg, silicon dioxide colloid (aerosil) 4.5 mg or 9.0 mg, magnesium stearate 4.5 mg or 9.0 mg;

    shell: opedrail II (polyvinyl alcohol, partially hydrolyzed 8.0 mg or 16.0 mg, macrogol (polyethylene glycol) 3350 4.040 mg or 8.080 mg, talc 2.960 mg or 5.920 mg, titanium dioxide E171 4.374 mg or 8.748 mg, aluminum varnish based on yellow quinoline E104 0.602 mg or 1.204 mg, an iron oxide dye (II) E172 0.006 mg or 0.012 mg, an aluminum lacquer based on a yellow sunset sunset E110 0.014 mg or 0.028 mg, an aluminum lacquer based on indigocarmine E132 0.004 mg or 0.008 mg).

    Description:

    The tablets covered with a film cover of yellow color, oval, biconcave form.

    Pharmacotherapeutic group:antibiotic-macrolide
    ATX: & nbsp

    J.01.F.A.09   Clarithromycin

    Pharmacodynamics:

    Semisynthetic macrolide antibiotic of the second generation from the group of macrolides of a wide spectrum of action. It breaks the synthesis of the protein of microorganisms (binds to the 50S subunit of the ribosome membrane of the microbial cell).

    It acts on extracorporeal and intracellular pathogens. The activity of clarithromycin against most strains of the following microorganisms is proved as 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) is a complex, including Mycobacterium avium, Mycobacterium intracellulare, Helicobacter pylori.

    Beta-lactamases do not affect the activity of clarithromycin.

    Activity of clarithromycin in vitro:

    - aerobic Gram-positive microorganisms: Listeria monocytogenes, Streptococcus agalactiae, Streptococci groups C, F, G, Streptococci of the viridans group;

    - 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 kansasii, Mycobacterium chelonae, Mycobacterium fortuitum;

    - Campylobacteria: Campylobacter jejuni.

    Microbiologically active metabolite of clarithromycin - 14- (R) -hydroxyclamirithromycin, is twice as active as the parent compound with respect to Haemophilus influenzae. Clarithromycin and its metabolite in combination can have both additive and synergistic effects on Haemophilus influenzae in vitro and in vivo, depending on the strain of the bacteria.

    Most strains of staphylococci, resistant to methicillin and oxacillin, are resistant to clarithromycin.

    It is possible to develop cross-resistance to clarithromycin and other antibiotics of the macrolide group, as well as to lincomycin and clindamycin.
    Pharmacokinetics:

    Absorption is fast. Food slows down absorption, without significantly affecting bioavailability. Bioavailability of tablets 250 mg - 50%. The connection with plasma proteins is 65-75%. After a single dose, 2 peaks of maximum concentration are recorded. The second peak is due to the ability of the drug to accumulate in the gallbladder, followed, a gradual or rapid intake into the intestine and absorption. The time required to reach the maximum concentration when taking 250 mg - 2-3 hours.

    After oral administration of 20-30% of the accepted dose of clarithromycin is rapidly hydroxylated in the liver by cytochrome CYP3A4, CYP3A5 and CYP3A7 isoenzymes with formation of the main metabolite - 14- (11) -hydraaboutxiclarithromycin, which has a pronounced antimicrobial activity against Haemophilus influenzae. With a regular intake of 250 mg / day, the equilibrium concentrations of the unchanged drug and its main metabolite are 1 and 0.6 μg / ml, respectively; the half-life is 3-4 and 5-6 hours, respectively. When the dose is increased to 500 mg / day, the equilibrium concentrations of the unchanged drug and its metabolite in plasma are 2.7-2.9 and 0.83-0.88 μg / ml, respectively; the half-life is 4.8-5.0 hours and 6.9-8.7 hours, respectively. In therapeutic concentrations, it accumulates in the lungs, skin and soft tissues (concentrations 10 times higher than serum levels).

    ATydIt is eaten by the kidneys and with fecal masses (20-30% - in unchanged form, the rest in the form of metabolites). With a single admission of 250 mg and 1200 mg, the kidney is excreted 37.9% and 46.0%, intestines - 40.2% and 29.1%, respectively.

    In chronic renal failure, the time to reach the maximum drug concentration, the maximum concentration, the area under the concentration-time curve (AUC) of clarithromycin and its metabolite increases.

    Indications:

    Infectious-inflammatory diseases caused by sensitive to clarithromycin microorganisms:

    - Lower respiratory tract infections (including pneumonia, bronchitis);

    - infections of the upper respiratory tract and ENT organs (including pharyngitis, sinusitis, mean otitis);

    - infections of the skin and soft tissues (including folliculitis, erysipelas);

    - mIcobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare;

    - localized infections caused by Mycobacterium fortuitum and Mycobacterium kansasii;

    - Pthe spread of infection caused by the complex Mycobacterium avium (MAS infection) in HIV-infected patients with a CD4 count of lymphocytes no more than 100 / μl;

    - in combination with amoxicillin and omeprazole / lansoprazole in the form of triple therapy for infections caused by Helicobacter pylori, including duodenal ulcer. In combination with omeprazole or ranitidine bismuth citrate in the form of dual therapy for the treatment of acute duodenal ulcer caused by Helicobacter pylori.

    Contraindications:

    - Hypersensitivity to clarithromycin (including other macrolides), other components of the drug;

    - porphyria;

    - simultaneous use with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids;

    - simultaneous use with lovastatin and simvastatin, with midazolam for oral administration, with colchicine in patients with impaired night or liver function, taking P-glycoprotein inhibitors or potent inhibitors of the proenzyme CYP3A4;

    - the presence in patients of prolongation of the QT interval in the history, ventricular arrhythmia or ventricular tachycardia of the "pirouette" type;

    - Cholestatic jaundice / hepatitis, caused by the use of clarithromycin (in the anamnesis);

    - severe hepatic insufficiency, which occurs simultaneously with renal insufficiency, hypokalemia;

    - Children under 12 years.

    Carefully:

    - Renal failure of moderate to severe severity;

    - hepatic insufficiency of moderate and severe degree;

    - ischemic heart disease, severe heart failure, hypomagnesemia, severe bradycardia;

    - Myasthenia gravis gravis;

    - simultaneous use with drugs, inducing and metabolizing isoenzyme CYP3A4, benzodiazepines (alprazolam, triazolam, midazolam for intravenous administration), antiarrhythmic drugs of Class 1A and III, blockers of "slow" calcium channels, which are metabolized by the isoenzyme CYP3A4.

    Pregnancy and lactation:

    In the first trimester of pregnancy, the use of the drug is contraindicated. Application in the II and III trimesters of pregnancy is possible only in cases where The estimated benefit to the mother exceeds the potential risk to the fetus.

    Clarithromycin excreted in breast milk, so during lactation should stop breastfeeding.

    Dosing and Administration:

    Inside, regardless of food intake.

    Adults and children over 12 years of age (with a body weight of more than 33 kg):

    - with pharyngitis and tonsillitis caused by Streptococcus pyogenes - 250 mg per each for 10 days every 12 hours;

    - with acute sinusitis - 500 mg for 14 days every 12 hours;

    - with exacerbation of chronic bronchitis caused by Haemophilus influenzae - by 500 mg for 7-14 days every 12 hours caused by Haemophilus parainfluenzae - 500 mg for 7 days every 12 hours caused by Moraxella catarrhalis, Streptococcus pneumoniae - 250 mg for 7-14 days every 12 hours;

    - with community-acquired pneumonia caused by Haemophilus influenzae - 250 mg for 7 days every 12 hours caused by Streptococcus pneumoniae, Chlamydia pneumoniae, Mycoplasma pneumoniae - by 250 mg for 7-14 days every 12 hours;

    - with uncomplicated infections of the skin and subcutaneous tissue caused by Staphylococcus aureus, Staphylococcus pyogenes 250 mg each for 7-14 days every 12 hours.

    In the treatment and prevention of infections caused by Mycobacterium avium prescribe inside by 500 mg-2 times a day. The maximum daily dose is 1000 mg. Duration of treatment - 6 months or more.

    For patients with chronic renal failure, with creatinine clearance less than 30 ml / min or a serum creatine concentration of more than 3.3 mg / 100 ml, the dose is reduced by a factor of 2,or 2 times increase the interval between receiving. The maximum duration of treatment in patients of this group is 14 days.

    Adults with a view to eradicating Helicobacter pylori in combination with other drugs

    Combination treatment with two drugs

    Clarithromycin, 500 mg 3 times a day, in combination with omeprazole at a dose of 40 mg / day within 14 days, from appointment for the next 14 days of omeprazole at a dose of 20 mg / day.

    Combined treatment with three drugs

    Clarithromycin, 500 mg, lansoprazole by 30 mg and amoxicillin on 1000 mg, all medicines on 2 times a day, within 10 days.

    Clarithromycin, 500 mg, amoxicillin 1000 mg and omeprazole 20 mg / day, all medicines twice a day, for 7-10 days.

    Side effects:

    Frequency: very often - more than 1/10 (in one patient out of 10), often - more than 1/100 and less than 1/10, infrequently - more than 1/1000 and less than 1/100, rarely - more than 1/10000 not less than 1 / 1000, very rarely - less than 1/10000, including isolated cases.

    Allergic reactions

    Often: skin rash.

    Infrequent: hypersensitivity, skin itching, hives.

    Very rarely: anaphylactic reaction, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), skin hyperemia.

    From the nervous system

    Often: headache, insomnia.

    Infrequent: dizziness, drowsiness, tremors, anxiety.

    Very rarely: convulsions, psychotic disorders, confusion, depersonalization, depression, disorientation, hallucinations, dream disturbances ("nightmarish" dreams), paresthesia, mania.

    From the skin

    Often: intense sweating.

    Infrequently: acne, purple Shenlaine-Henoch, hemorrhage.

    From the urinary system

    Very rarely: renal failure, interstitial nephritis.

    From the side of metabolism and nutrition

    Infrequent: anorexia, poor appetite.

    Very rarely: hypoglycemia.

    From the side of the musculoskeletal system

    Infrequently: arthralgia, myalgia.

    Very rare: myopathy, increased myasthenia gravis symptoms gravis.

    From the digestive system

    Often: diarrhea, vomiting, indigestion, nausea, pain in the abdomen.

    Infrequently: gastritis, stomatitis, glossitis, bloating, constipation, dryness of the oral mucosa, belching, flatulence, cholestasis, hepatitis, including cholestatic and hepatocellular.

    Very rarely: acute pancreatitis, discoloration of the tongue and teeth, hepatic insufficiency, cholestatic jaundice, gastralgia, candidiasis of the mucosa by the roton cavity.

    From the sense organs

    Often: dysgeusia, a taste perversion.

    Infrequently: twists, hearing impairment, ringing in the ears.

    Very rarely: deafness.

    From the side of the cardiovascular system

    Infrequent: atrial flutter, prolongation of the QT interval on an electrocardiogram.

    Very rarely: ventricular tachycardia, including the "pirouette" type.

    Laboratory indicators

    Often: deviation in the hepatic test.

    Infrequent: increasing the concentration of creatinine, leukopenia, neutropenia, eosinophilia, increased activity in the blood of alanine aminotransferase (ALT), aspartate aminotransferase (ACT), gamma glutamyl transferase (GGT), alkaline phosphatase (FA), lactate dehydrogenase (LDH).

    Very rarely: agranulocytosis, thrombocytopenia, increase in the value of the international normalized ratio (INR), prolongation of prothrombin time, change in urine color, hyperbilirubinemia.

    General disorders

    Infrequently: malaise, asthenia, pain in the chest, chills, fatigue.

    Infectious and parasitic diseases

    Very rarely: pseudomembranous colitis, erysipelas, erythrasma.

    Overdose:

    Symptoms: abdominal pain, nausea, vomiting, diarrhea, headache, confusion.

    Treatment: gastric lavage, maintenance therapy, symptomatic therapy. Not removed with hemo- or peritoneal dialysis

    Interaction:

    The use of the following drugs together with clarithromycin is contraindicated in connection with the possibility of developing serious side effects

    Cisapride, pimozide, terfenadine, astemizole

    With the simultaneous use of clarithromycin with cisapride / pimozide / terfenadine / astemizole, it is possible to increase the concentration of the latter and the blood plasma, which may lead to an increase in the QT interval and the appearance of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, ventricular pirouette tachycardia (see " Contraindications ").

    Alkaloids of ergot

    With the combined use of clarithromycin with ergotamine or dihydroergotamine, acute poisoning with a group of ergotamines is possible: vascular spasm, ischemia of limbs and other tissues, including the central nervous system. Simultaneous use of clarithromycin and ergot alkaloids is contraindicated (see the section "Contraindications"),

    The effect of other drugs on clarithromycin

    The following drugs have a proven or suspected effect on the concentration of clarithromycin. In the case of their combined use with clarithromycin, dosage adjustment and the transition to alternative treatment may be required.

    Preparations that are inducers of the isoenzyme CYP3A (for example, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort), can induce the metabolism of clarithromycin. This can lead to a subtherapeutic concentration of clarithromycin, which leads to a decrease in its effectiveness. In addition, it is necessary to monitor the concentration of the CYP3A inductor in the blood plasma, which may increase due to inhibition of the CYP3A isoenzyme by clarithromycin.

    Efavirenz, nevirapine, rifampicin, rifabutin, rifapentin

    Strong inductors of the cytochrome P430 system, such as efavirenz, nevirapine, rifampicin, rifabutin and rifapentin can accelerate the metabolism of clarithromycin and thus, reduce the concentration of clarithromycin in the blood and weaken the therapeutic effect, and at the same time increase the concentration of 14- (R) -hydroxyclarithromycin.

    Etravirine

    The concentration of clarithromycin decreases with the use of etravirine, but the concentration of the active metabolite 14- (R) -hydroxyclarithromycin increases.

    Fluconazole

    The simultaneous administration of fluconazole at a dose of 200 mg daily and clarithromycin at a dose of 1 g / day increases the minimum average value of the equilibrium concentration of clarithromycin (Cmin) and the area under the "concentration-time" curve of clarithromycin by 33% and 18%, respectively. Correction of the dose of clarithromycin in the case of concurrent administration of fluconazole is not required.

    Ritonavir

    Joint intake of ritonavir at a dose of 600 mg / day and clarithromycin 1 g / day leads to a decrease in the metabolism of clarithromycin. With the joint administration of ritonavir, the maximum equilibrium concentration (Cmax) clarithromycin increased by 31%, Cmin increased by 182% and the area under the concentration-time curve increased by 77%. A complete inhibition of the formation of 14- (R) -hydroxyclamirithromycin. In patients with chronic renal failure, dose adjustment is necessary: ​​with creatinine clearance of 30-60 ml / min, the dose of clarithromycin should be reduced by 50%, with a creatinine clearance of less than 30 ml / min by 75%. Doses of clarithromycin exceeding 1 g / day should not be used together with ritonavir.

    Oral hypoglycemic drugs / insulin

    With the combined use of clarithromycin and oral hypoglycemic agents and / or insulin, pronounced hypoglycemia can be observed.Careful monitoring of glucose level is recommended.

    Action of clarithromycin on other drugs

    Antiarrhythmic drugs

    Possible occurrence of ventricular tachycardia of the "pirouette" type in the joint application of clarithromycin and antiarrhythmic drugs (quinidine, procainamide). With the simultaneous use of clarithromycin with these drugs, the electrocardiogram should be monitored regularly to increase the QT interval, and the serum concentrations of these drugs should be monitored.

    Interactions caused by isoenzymes CYP3A

    Joint reception of clarithromycin and drugs, primarily metabolized by isoenzymes CYP3A, can enhance or prolong both therapeutic and side effects. Clarithromycin should be used with caution in patients receiving drugs that are substrates of the isoenzyme CYP3A, especially if these drugs have a narrow therapeutic range (for example, carbamazepine), and / or intensively metabolized by this enzyme, if necessary, dose adjustment of the drug taken with clarithromycin should be performed.Also, if possible, monitoring of serum concentrations of drugs that are primarily metabolized by the CYP3A isoenzyme should be conducted.

    Inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A-reductase (HMG-CoA reductase) (statins)

    Clarithromycin increases the concentration of HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin). The combined use of clarithromycin with lovastatin or simvastatin is contraindicated (see "Contraindications") because these statins are heavily metabolized by the CYP3A4 isoenzyme and co-administration with clarithromycin increases their serum concentrations, which leads to an increased risk of myopathy. If it is necessary to use clarithromycin, you should stop taking lovastatin or simvastatin for the duration of therapy.

    Indirect anticoagulants

    With the joint administration of warfarin and clarithromycin, bleeding is possible, expressed by an increase in INR and prothrombin time. In the case of combined use with warfarin or other indirect anticoagulants, it is necessary to monitor INR and prothrombin time.

    Omeprazole

    With simultaneous reception of clarithromycin and omeprazole plasma levels of clarithromycin and its metabolite increase. The concentration of clarithromycin in tissues and gastric mucosa with simultaneous reception is also increased.

    Sildenafil, tadalafil, vardenafil

    The combined use of clarithromycin with sildenafil, tadalafil or vardenafil (phosphodiesterase 5 inhibitors) may increase the inhibitory effect on phosphodiesterase. You may need to reduce the dose of sildenafil, tadalafil and vardenafil.

    Theophylline, carbamazepine

    With the combined use of clarithromycin and theophylline or carbamazepine, an increase in the concentration of these drugs in the systemic circulation is possible.

    Tolterodin

    With the combined use of clarithromycin with tolterodine in patients with a low activity of the CYP2D6 isoenzyme, a dose reduction of tolterodine in the presence of clarithromycin (an inhibitor of the CYP3A isoenzyme) may be required.

    Benzodiazepines (e.g., alprazolam, midazolam, triazolam)

    With the simultaneous administration of clarithromycin (1 g / day) with midazolam (orally), an increase in the area under the concentration-time curve of midazolam was observed 7-fold.It is necessary to avoid the combined oral administration of clarithromycin and midazolam. When using midazolam (intravenous) and clarithromycin, a dose adjustment may be required.

    The same precautions should also be applied to other benzodiazepines that are metabolized by CYP3A isoenzymes, including triazolam, alprazolam. For benzodiazepines, the excretion of which does not depend on the isoenzyme CYP3A (temazepam, nitrazepam, lorazepam), clinically significant interaction with clarithromycin is unlikely.

    With the combined use of clarithromycin and triazolam, the central nervous system (CNS) may be affected, for example, drowsiness and confusion. In this regard, in the case of joint application, it is recommended to follow the symptoms of the CNS disorder.

    Interaction with other drugs

    Colchicine

    With the joint administration of clarithromycin with colchicine, the effect of colchicine may be enhanced. It is necessary to monitor the possible development of clinical symptoms of colchicine poisoning, especially in elderly patients and patients with chronic kidney failure (as reported, some cases ended in a fatal outcome).

    In patients with normal renal and hepatic function, a dose of colchicine should be lowered with simultaneous use with clarithromycin.

    Simultaneous use of clarithromycin and colchicine is contraindicated in patients with impaired liver and kidney function (see section "Contraindications").

    Digoxin

    Joint reception of digoxin and clarithromycin may lead to an increase in serum digoxin concentration in patients. With the joint administration of clarithromycin and digoxin, the concentration of digoxin in the blood serum should be carefully monitored (possibly increasing its concentration and the development of potentially detailed arrhythmias).

    Zidovudine

    Simultaneous reception of clarithromycin and zidovudine by adult HIV-infected patients can lead to a decrease in the equilibrium concentration of zidovudine. Because the clarithromycin affects the absorption of zidovudine when ingested, interactions can be largely avoided by taking clarithromycin and zidovudine with an interval of 4 hours.

    Phenytoin and valproic acid

    When joint application of phenytoin or valproic acid with clarithromycin is recommended to determine their serum concentrations,as there are reports of their increase.

    Bi-directional drug interactions

    Atazanavir

    With the combined use of clarithromycin (1 g / day) and atazanavir (400 mg / day) may lead to a twofold increase in the effect of clarithromycin and a decrease in the effect of 14- (R) -hydroxyclamirithromycin by 70%, with an increase in the area under the concentration-time curve of atazanavir by 28%.

    In patients with normal renal function, a decrease in the dose of clarithromycin is not required.

    In patients with moderate renal insufficiency (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%. Clarithromycin in doses exceeding 1 g / day, can not be used in conjunction with protease inhibitors.

    Blocks of "slow" calcium channels

    With simultaneous use of clarithromycin and blockers of "slow" calcium channels that are metabolized by the CYP3A isoenzyme (for example, verapamil, amlodipine, diltiazem), you should be careful, since there is a risk of arterial hypotension.Plasma concentrations of clarithromycin as well as blockers of "slow" calcium channels can increase with simultaneous application. Arterial hypotension, bradyarrhythmia and lactic acidosis are possible with concurrent administration of clarithromycin and verapamil.

    Itraconazole

    With the joint administration of clarithromycin and itraconazole, a mutual increase in the concentration of drugs in the plasma is possible. Patients simultaneously taking itraconazole and clarithromycin, should be carefully examined for signs of increased or prolonged pharmacological effects of these drugs.

    Saquinavir

    With concurrent administration of clarithromycin (1 g / day) and saquinavir (in soft gelatin capsules, 1200 mg 3 times a day), an increase in the area under the concentration-time curve and Cmax saquinavir by 177% and 187%, respectively, and clarithromycin by 40%. If these two drugs are used together for a limited time in the doses indicated above, dose adjustment is not required.

    Special instructions:

    If signs and symptoms of hepatitis such as anorexia, jaundice, darkening of the urine, itching, tenderness of the abdomen during palpation, it is necessary to immediately stop therapy clarithromycin. In the presence of chronic liver diseases it is necessary to conduct regular monitoring of the activity of serum enzymes.

    Since resistance of Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes to macrolides is possible, it is important to carry out a sensitivity test for the administration of clarithromycin.

    Because of the risk of prolonging the QT interval, caution should be exercised clarithromycin in patients with coronary heart disease, severe heart failure, hypomagnesemia, bradycardia (<50 beats / min), and also with caution at the same time apply clarithromycin with other drugs that are able to increase the QT interval. Clarithromycin should not be prescribed to patients with congenital or acquired documented elongation of the QT interval or ventricular arrhythmia.

    Attention should be paid to the possibility of cross-resistance between clarithromycin and other macrolides, as well as lincomycin and clindamycin.

    Prolonged or repeated use of antibiotics can cause excessive growth of insensitive bacteria and fungi. If superinfection occurs, the use of clarithromycin should be discontinued and appropriate therapy initiated.

    When clarithromycin is used, cases of pseudomembranous colitis are described, the severity of which varies from mild to life-threatening. Clarithromycin can change the normal flora of the intestines, which leads to the growth of Clostridium difficile, causing the appearance of severe, prolonged diarrhea, in this regard, immediate withdrawal of the drug and the appointment of appropriate treatment. Careful observation of the patient is necessary 2 months after taking the drug.

    In patients receiving clarithromycin, reported on worsening of myasthenia gravis symptoms.

    In case of acute hypersensitivity reactions, such as anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptomatology (DRESS syndrome), purpura Shenlaine-Genoh, immediately stop taking clarithromycin and begin appropriate therapy.

    Effect on the ability to drive transp. cf. and fur:

    Given the side effect of the drug during the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Film coated tablets, 250 mg and 500 mg.

    Packaging:

    For 5 or 10 tablets, coated with a film sheath, into a contour cell package.

    For 5, 10, 15 or 20 tablets, coated with a film coating, in a can of light-protective glass or in a can of polymer or a polymer bottle.

    Each jar or bottle, or 1 or 2 contiguous packaged packs of 10 film-coated tablets, or 1, 2, 3 or 4 out-of-round packs of 5 tablets coated with a film coating, together with the instructions for use, are placed in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001064
    Date of registration:27.10.2011
    The owner of the registration certificate:DALHIMFARM, OJSC DALHIMFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspDALHIMFARM, OJSCDALHIMFARM, OJSC
    Information update date: & nbsp13.03.2015
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