Clarithromycin Ecositrin pills 500 mg, 14 pcs.

Composition

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of 1 tab. contains:

Active ingredient:

clarithromycin – 500 mg.

Auxiliary substances:

lactulose-600 mg,

povidone-K 25-18.2 mg,

magnesium stearate-13 mg,

colloidal silicon dioxide (aerosil) – 8.66 mg,

talc-26 mg,

potassium polacrylate-up to 1300 mg.

Shell composition:

hypromellose – 14.28 mg, talc-1.71 mg, titanium dioxide-7.756 mg, macrogol-4000-6.21 mg, dye azorubin-0.044 mg

. Pharmacological action

Broad-spectrum antibiotic.

Indications

For adults:

— pharyngitis

— – tonsillitis;

– acute sinusitis—

– exacerbation of chronic bronchitis

— – community-acquired pneumonia—

– uncomplicated skin and subcutaneous tissue infections;

— disseminated infection caused by Mycobacterium avium and Mycobacterium intracellulare.

— in combination with amoxicillin and omeprazole / lansoprazole as a triple therapy for infections caused by Helicobacter pylori, including duodenal ulcer.

For children:

— pharyngitis

— – tonsillitis;

– community-acquired pneumonia—

– acute sinusitis—

– acute otitis media;

– uncomplicated skin and subcutaneous tissue infections;

— disseminated infection caused by Mycobacterium avium and Mycobacterium intracellulare.

Contraindications

— hypersensitivity to clarithromycin, other macrolide antibiotics, other components of the drug;

— severe liver failure, occurring simultaneously with renal insufficiency;

— porphyria;

— hypokalemia;

— simultaneous administration of cisapride, astemizole, pimozide, of terfenadine, ergotamine and other ergot alkaloids;

— concurrent use of lovastatin and simvastatin, with midazolam for oral administration with colchicine in patients with impaired renal function or liver disease, receiving inhibitors of P-glycoprotein or strong inhibitors of CYP3A4 isoenzyme;

the patients with lengthening of the QT interval, a history of ventricular fibrillation or ventricular tachycardia type “pirouette”;

— cholestatic jaundice/hepatitis arising out of the use of clarithromycin (in the anamnesis);

— children’s age up to 12 years (for this dosage form);

— lactation period (breastfeeding);

— lactose intolerance or lactase deficiency and glucose-galactose malabsorption.

With caution:

— renal failure of moderate and severe;

— liver failure moderate and severe;

— myasthenia gravis;

— simultaneous use with drugs that induce and metabolized by CYP3A4, benzodiazepines (alprazolam, triazolam, midazolam for/in use), antiarrhythmic drugs of class IA and III, blockers of slow calcium channels, which are metabolized by CYP3A4;

— ischemic heart disease;

— severe heart failure;

— hypomagnesemia;

bradycardia.

Side effects

Nervous system disorders: headache, dizziness, restlessness, insomnia, nightmares, seizures, depression, disorientation, hallucinations, psychosis, depersonalization, confusion.

From the digestive system: nausea, vomiting, gastralgia, diarrhea, stomatitis, glossitis, candidiasis of the oral mucosa, discoloration of the tongue and teeth, acute pancreatitis, increased activity of hepatic transaminases, hepatocellular and cholestatic hepatitis, cholestatic jaundice, rarely-pseudomembranous colitis, hepatic insufficiency with a fatal outcome, mainly against the background of severe concomitant diseases and/or concomitant drug therapy.

Lactulose, which is part of the preparation Ecozitrin®, eliminates the risk of side effects associated with the negative effect of the antibiotic on the intestinal microbiocenosis.

From the cardiovascular system: ventricular tachycardia, including the “pirouette” type, fluttering and flickering of the ventricles, an increase in the QT interval on the ECG.

From the side of the senses: noise, ringing in the ears, changes in taste (dysgeusia), in some cases — hearing loss that passes after discontinuation of the drug, a violation of the sense of smell.

Musculoskeletal disorders: myalgia.

From the side of hematopoietic organs: rarely-thrombocytopenia, (unusual bleeding, hemorrhage).

From the urinary system: interstitial nephritis.

Laboratory parameters: leukopenia, hypercreatininemia, hypoglycemia (including when taking hypoglycemic drugs at the same time).

Allergic reactions: skin rash, pruritus, urticaria, hyperemia of the skin, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis, anaphylactic reactions.

Other services: secondary infections (development of microbial resistance).

Interaction

Concomitant administration of clarithromycin and drugs primarily metabolized by the CYP3A isoenzyme may result in a mutual increase in their concentrations, which may increase or prolong both therapeutic and side effects. Concomitant administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids is contraindicated; alprazolam, midazolam, triazolam.

Prescribe with caution with carbamazepine, cilostazol, cyclosporine, disopyramide, lovastatin, methylprednisolone, omeprazole, indirect anticoagulants (including warfarin), quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, vinblastine, as well as phenytoin, theophylline and valproic acid (metabolized through other isoenzymes cytochrome P 450).

When combined with cisapride, pimozide, terfenadine and astemizole, an increase in the concentration of the latter in the blood, an increase in the QT interval, the appearance of arrhythmias, including ventricular tachycardia, including the “pirouette” type, and ventricular fibrillation may occur. It is necessary to adjust the dose of drugs and control the concentration in the blood.

When combined 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 rifapentin (cytochrome P450 inducers) reduce the level of clarithromycin in plasma and weaken the therapeutic effect of the latter, and at the same time, increase the level of 14-hydroxyclarithromycin.

Concomitant administration of fluconazole at a dose of 200 mg daily and clarithromycin at a dose of 1 g / day may increase the CSS and AUC of clarithromycin by 33 and 18%, respectively. No dose adjustment of clarithromycin is required.

Concomitant administration of ritonavir 600 mg / day and clarithromycin 1 g / day may reduce the metabolism of clarithromycin (an increase in Cmax — by 31%, CSS-by 182% and AUC-by 77%), complete suppression of the formation of 14-hydroxyclarithromycin. In patients with chronic renal failure, dose adjustment is necessary: with a creatinine clearance of 30-60 ml / min, the dose of clarithromycin should be reduced by 50%, Ritonavir should not be co-administered with clarithromycin at a dose exceeding 1 g / day.

When taken together with quinidine and disopyramide, ventricular tachycardia of the “pirouette” type may occur. It is necessary to monitor the ECG (increase in the QT interval), serum concentrations of these drugs.

Clarithromycin increases the concentrations of HMG-CoA reductase inhibitors (lovastatin, simvastatin). It is possible to develop rhabdomyolysis in patients taking these drugs together.

Clarithromycin and omeprazole may increase the Cmax, AUC, and T1/2 of omeprazole by 30,89, and 34%, respectively. The average pH value in the stomach for 24 hours was 5.2 – when taking omeprazole alone and 5.7-when taking omeprazole together with clarithromycin.

When using clarithromycin and indirect anticoagulants, the effect of the latter may increase.

When clarithromycin is used with sildenafil, tadalafil or vardenafil (phosphodiesterase-5 inhibitors), the inhibitory effect on phosphodiesterase may increase. It may be necessary to reduce the dose of sildenafil, tadalafil and vardenafil.

With the combined use of clarithromycin with theophylline and carbamazepine, it is possible to increase the concentration of the latter in the systemic circulation.

When using clarithromycin with tolterodine in patients with a low level of metabolism via CYP2D6, it may be necessary to reduce the dose of tolterodine in the presence of clarithromycin (a CYP3A inhibitor).

Concomitant administration of clarithromycin (1 g / day) with midazolam (oral) may increase the AUC of midazolam by 7 times. Concomitant oral administration of clarithromycin with midazolam and other benzodiazepines that are metabolized by CYP3A (triazolam and alprazolam) should be avoided. When using midazolam (IV) and clarithromycin, dose adjustment may be required. The same precautions should be applied to other benzodiazepines that are metabolized by CYP3 A. For benzodiazepines whose elimination is independent of CYP3A(temazepam, nitrazepam, lorazepam), a clinically significant interaction with clarithromycin is unlikely.

When clarithromycin is co-administered with colchicine, the effect of colchicine may be enhanced. It is necessary to monitor the possible development of clinical symptoms of colchicine intoxication, especially in elderly patients and patients with chronic renal failure (fatal cases have been reported).

When taking clarithromycin and digoxin together, the concentration of digoxin in the serum should be carefully monitored (its concentration may increase and potentially fatal arrhythmias may develop).

Concomitant administration of clarithromycin and zidovudine in adult HIV-infected patients may lead to a decrease in zidovudine CSS. The dosage of clarithromycin and zidovudine should be selected. This type of interaction does not occur in HIV-infected children receiving clarithromycin suspension together with zidovudine.

Concomitant administration of clarithromycin (l g / day) and atazanavir (400 mg / day) may increase the AUC of atazanavir by 28%, clarithromycin by 2 times, and decrease the AUC of 14-hydroxyclarithromycin by 70%. In patients with creatinine clearance 30-60 ml/min, the dose of clarithromycin should be reduced by 50%. Clarithromycin in doses exceeding 1 g / day should not be administered together with protease inhibitors.

When clarithromycin and intraconazole are co-administered, a mutual increase in the concentration of drugs in plasma is possible. Patients taking itraconazole and clarithromycin at the same time should be carefully monitored for possible increase or prolongation of the pharmacological effects of these drugs.

Concomitant administration of clarithromycin (l g / day) and saquinavir (in soft gelatin capsules,1200 mg 3 times a day) may increase the AUC and CSS of saquinavir by 177 and 187%, respectively, and clarithromycin — by 40%. When these two drugs are co-administered for a limited time in the doses/dosage forms indicated above, no dose adjustment is required.

When taken together with verapamil, a decrease in the risk of Blood pressure, bradyarrhythmia, and lactic acidosis.

How to take, course of administration and dosage

Inside, swallowing whole, without chewing, with a small amount of liquid.

Adults and children over 12 years weighing more than 33 kg:

– pharyngitis and tonsillitis caused by Streptococcus pyogenes,250 mg every 12 hours for 10 days;

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

– exacerbation of chronic bronchitis caused by Haemophilus influenzae,500 mg every 12 hours for 7-14 days; 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;

– with community-acquired pneumonia caused by Haemophilus influenzae 250 mg every 12 h 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 2 times a day. The maximum daily dose is 1000 mg. The duration of treatment is 6 months or more.

For the purpose of eradication of Helicobacter pylori:

Combined treatment with three drugs: clarithromycin-500 mg 2 times a day, lansoprazole-30 mg 2 times a day and amoxicillin-1000 mg 2 times a day for 10-14 days;

clarithromycin-500 mg 2 times a day, omeprazole-20 mg 2 times a day and amoxicillin-1000 mg 2 times a day for 10 days.

Combined treatment with two drugs: clarithromycin-500 mg 3 times a day, omeprazole-40 mg / day for 14 days, with the appointment of omeprazole for the next 14 days at a dose of 20 mg / day.

For patients with chronic renal failure: (creatinine clearance less than 30 ml/min or serum creatinine concentrations greater than 3.3 mg/100 ml), the dose is reduced 2-fold, or the interval between doses is increased 2-fold. The maximum duration of treatment in patients of this group is 14 days.

Overdose

Symptoms: abdominal pain, nausea, vomiting, diarrhea.

Treatment: gastric lavage, maintenance therapy. It is not removed during peritoneal or hemodialysis.

Special instructions

In the presence of chronic liver diseases, it is necessary to regularly monitor the activity of enzymes in the blood serum.

With caution, it is prescribed against the background of drugs that are metabolized in the liver (it is recommended to measure their concentration in the blood).

In the case of co-administration with warfarin or other anticoagulants, PV should be monitored.

If a secondary infection develops, adequate therapy should be prescribed.

If severe diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment.

Form of production

Film-coated tablets, pink in color, capsule-shaped, biconvex.

The cross-section shows two layers, the inner layer is white or almost white in color.

Active ingredient

Clarithromycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 150 gr.