Clarithromycin Zentiva 500mg 14 tablets

Product form, composition and packaging 

The tablets covered with a film cover of yellow color, oval, biconvex, with a risk on one of the sides, the view of the fracture – from white to almost white.

Excipients: croscarmellose sodium 70 mg, starch pregelatinization – 130 mg, microcrystalline cellulose – 170.6 mg, silicon dioxide colloidal – 14.4 mg povidone K30 40 mg, stearic acid – 25 mg, talc – 35 mg magnesium stearate 15 mg. film Composition shell: hyprolose 2 mg, hypromellose (viscosity 15 GPA) – 26 mg, propylene glycol – 17.2 mg, sorbitan oleate modified – 2 mg, vegetable oil – 1.1 mg titanium dioxide 6 mg quinoline yellow dye – 0.5 mg, sorbic acid 1.1 mg. of 7 PCs. – blisters (2) – packs of cardboard.

1 tab.

clarithromycin 500 mg

Clinical and pharmacological group: Antibiotic of macrolides group

Pharmaco-therapeutic group: Antibiotic, macrolide

Indications

Treatment of infectious and inflammatory diseases caused by sensitive microorganisms:

• infections of the lower respiratory tract (bronchitis, pneumonia),
• infections of the upper respiratory tract (laryngitis, pharyngitis, tonsillitis, sinusitis),
• infections of skin and soft tissues (folliculitis, furunculosis, erysipelas, impetigo, wound infection),
• gastric and duodenal ulcer (in combination with drugs that reduce acidity): for the treatment of acute duodenal ulcer, eradication Helicobacter pylori and reduce the frequency of recurrence of peptic ulcer or in combination with amoxicillin and omeprazole / lansoprazole as triple therapy),
• common or localized mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare,
• localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii,
• Prevention of Mycobacterium avium infection in HIV-infected patients with a CD4 count (T helper lymphocytes) less than 100 /mm3.

ICD-10 codes

Dosage regimen

The drug is taken orally, regardless of the meal.

For the treatment of infections of the respiratory tract, skin and soft tissues, the average dose is 250-500 mg 2 times / day. The duration of treatment is 6-14 days.

For the treatment of infections caused by Mycobacterium avium, the drug is prescribed for 500 mg 2 times / day. The maximum daily dose is 1000 mg.The duration of treatment can be 6 months or more.

To prevent the spread of infections caused by Mycobacterium avium complex, appoint 500 mg 2 times / day.

For eradication of Helicobacter pylori is prescribed combination therapy of three drugs. The first scheme: clarithromycin-500 mg 2 times/day, lansoprazole – 30 mg 2 times/day and amoxicillin – 1 g 2 times / day for 10 days. The second scheme: clarithromycin-500 mg 2 times/day, amoxicillin – 1 g 2 times/day and omeprazole – 20 mg 2 times / day for 7-10 days.

It is also possible to prescribe combination therapy with two drugs. The first scheme: clarithromycin-500 mg 3 times/day in combination with omeprazole dose 40 mg/day for 14 days, with the appointment for the next 14 days omeprazole dose 20-40 mg / day. Second line: clarithromycin – 500 mg 3 times/day in combination with lansoprazole at a dose of 60 mg/day for 14 days. For complete healing of the ulcer may require additional reduction of gastric juice acidity.

In patients with chronic renal insufficiency (CC<, 30 3= “b=” > dose reduced by 2 times, or increase the interval between doses by 2 times. The maximum duration of a course of the drug in patients of this group should be no more than 14 days.

Side effect

Determination of the frequency of adverse reactions (according to who classification): very often (?10%), often (?1% and <, 10%), 0=”” 1=”” 01=”” p=””>

From the digestive system: often – diarrhea, vomiting, abdominal pain and nausea, changes in taste (dysgeusia), rarely – glossitis, stomatitis, candidiasis of the mucous membrane of the mouth, change the color of the tongue and teeth (discoloration of teeth reversible and is usually restored by a professional cleaning at the dentist), violations of liver function, including a transient increase in liver enzymes and hepatocellular and/or cholestatic hepatitis, accompanied or not accompanied by jaundice (hepatic dysfunction may be severe and usually reversible), acute pancreatitis, pseudomembranous colitis (moderate to life-threatening), in a few cases, deaths from liver failure were recorded, which were usually observed in the presence of serious comorbidities and/or the simultaneous use of other drugs.

From the nervous system: infrequently – transient headaches, dizziness, anxiety, insomnia, nightmares, tinnitus, rarely – convulsions, very rarely – myalgia, parasthesia, confusion, hallucinations, psychosis and depersonalization.

From the cardiovascular system: rarely-ventricular tachycardia, ventricular arrhythmia such as “pirouette”, trembling and flickering of the ventricles, lengthening THE Qt interval on the ECG (as in other macrolides).

From the sensory organs: very rarely – noise, ringing in the ears, impaired sense of smell, change in taste (dysgeusia), in isolated cases – loss of hearing, going after drug withdrawal.

From the side of urinary system: very rarely – interstitial nephritis and renal failure.

Allergic reactions: rare – skin rash, itching, urticaria, hyperemia of skin, rarely anaphylactic reactions, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis.

From laboratory parameters: very rarely-leukopenia, thrombocytopenia, hypercreatininemia, hypoglycemia (while taking hypoglycemic drugs).

Other: unusual bleeding, hemorrhage, myalgia, with prolonged or repeated use of the drug may develop superinfection (development of resistance of microorganisms).

Contraindications to use

• porphyria,
• simultaneous administration with the following drugs: astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, midazolam for oral administration, alprazolam, triazolam,
• pregnancy,
• lactation (breastfeeding) period),
• children and adolescents under 18 years of age,
• hypersensitivity to the components of the drug,
• hypersensitivity to macrolides in history.

With caution, the drug should be used for violations of liver and kidney function.

Application during pregnancy and breast-feeding

The safety of clarithromycin during pregnancy is not established. Therefore, during pregnancy clarithromycin is prescribed only in the absence of alternative therapy, if the intended use of the drug for the mother exceeds the possible risk to the fetus.

Clarithromycin is excreted in breast milk, so if necessary, the appointment of the drug during lactation should stop breastfeeding.

Application for violations of liver function

The drug is contraindicated in hepatic insufficiency.

Application for violations of renal function

The drug is contraindicated in severe renal failure. In patients with impaired renal function in CC less than 50 ml / min dose should be reduced by 2 times, with the course of treatment can not exceed 14 days.

Use in children

Contraindicated in children and adolescents under 18 years.

Special instruction:

With caution, clarithromycin Zentiva should be prescribed to patients with impaired liver function, it is necessary to conduct regular monitoring of serum enzymes.

With caution Should appoint clarithromycin Zentiva against drugs metabolized in the liver, it is recommended to monitor the concentration of these drugs in serum.

In case of joint administration Of clarithromycin Zentiva with warfarin or other indirect anticoagulants, prothrombin time should be controlled.

Caution should be exercised when prescribing the drug Clarithromycin Zentiva patients with moderate and severe renal insufficiency. In clinical practice, cases of colchicine toxicity when combined with clarithromycin, particularly in elderly people. Some of them were observed in patients with renal failure, there have been several reported cases of death in these patients.

In the event of during or after treatment of severe and prolonged diarrhea should be excluded diagnosis of pseudomembranous colitis, which requires immediate withdrawal of the drug Clarithromycin Zentiva and the appointment of appropriate treatment. With prolonged or repeated use of the drug Clarithromycin Zentiva may develop superinfection (growth of insensitive bacteria and fungi). With the development of a secondary infection, adequate therapy should be prescribed.

Cross-resistance between Clarithromycin Zentiva and other macrolide antibiotics, as well as lincomycin and clindamycin, should be considered.

Influence on the ability to drive vehicles and control mechanisms

There is no evidence of the impact of clarithromycin on the ability to drive vehicles and machinery. However, when applying the drug in patients who drive vehicles or work with machinery, it is necessary to take into account the presence of reports of dizziness and disorientation in patients receiving clarithromycin.

Overdose:

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

Treatment: immediate gastric lavage, if necessary, symptomatic therapy. Hemodialysis and peritoneal dialysis do not lead to a significant change in serum clarithromycin levels.

Drug interaction

During simultaneous administration of clarithromycin and drugs which are primarily metabolized by CYP3A isoenzymes may reciprocal increase in their concentration, which could increase or prolong both therapeutic and adverse effects. Contraindicated co-administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, alprazolamum, midazolam, triazolam.

With caution is prescribed with carbamazepine, Cilostazol, cyclosporine, disopyramide, lovastatin, methylprednisolone, omeprazole, indirect anticoagulants (including warfarin), quinidine, rifabutin, sildenafilum, simvastatin, tacrolimus, vinblastine, phenytoin, theophylline and valproic acid (metabolized by other cytochrome P450 isoenzymes). Require dose adjustment of medicinal products and control the concentration in the blood serum.

In a joint application with cisaprid, pimozid, terfenadine and astemizole may increase the concentration of these drugs in the blood, lengthening the QT interval and the development of cardiac arrhythmias, including ventricular paroxysmal tachycardia, fibrillation, fluttering or ventricular flicker, multiform ventricular tachycardia “pirouette”. Such a mechanism of interaction is noted in the application of drugs, metabolized by other isoenzyme cytochrome P450 – phenytoin, theophylline and valproic acid. At simultaneous appointment of the above preparations monitoring of their concentrations in blood serum and ECG is required.

Clarithromycin can reduce the clearance of triazolam and thus increase its pharmacological effects with the development of drowsiness and confusion of consciousness. For benzodiazepines, the removal of which does not depend on the isoenzyme CYP3A (temazepam, nitrazepam, lorazepam), a clinically important interaction with clarithromycin is unlikely.

There are reports of an increase in the concentration of digoxin in plasma in patients receiving both digoxin and clarithromycin. It is necessary to constantly monitor the content of digoxin in serum to avoid digitalis intoxication and the development of potentially lethal arrhythmias.

Concomitant use with ergotamine and dihydroergotamine (ergot derivatives) can lead to acute ergotamine intoxication, manifested by severe peripheral vasospasm, ischemia of extremities and other tissues including the Central nervous system, and perverted sensibility.

While taking clarithromycin with inhibitors of HMG-COA reductase-lovastatin and simvastatin, rare cases of rhabdomyolysis are described.

Efavirenz, nevirapine, rifampicin, rifabutin and rifapentin (inducers of cytochrome P450 isozyme) reduce the concentration of clarithromycin in plasma and weaken its therapeutic effect and at the same time increase the concentration of 14-hydroxyclarithromycin.

When co-administration of 200 mg daily and clarithromycin at a dose of 1 g/day may increase Css and AUC clarithromycin 33% and 18% respectively. Dose adjustment of clarithromycin is required.

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

Concomitant intake of clarithromycin (normal release pill) and zidovudine in adult HIV-infected patients may result in lower CSS of zidovudine. Selection of clarithromycin and zidovudine doses is necessary.

When concomitant administration of clarithromycin and ritonavir, atazanavir or other protease inhibitors, increased values of serum concentrations of clarithromycin as that in this case, it should not be administered at doses over 1 g/day, and protease inhibitor.

When co-administration clarithromycin and Itraconazole may increase the concentration of drugs in plasma. For patients concurrently receiving clarithromycin and Itraconazole, should be carefully monitored due to the possible increase or prolongation of the pharmacological effects of these drugs.

The simultaneous administration of clarithromycin (1 g/day) and saquinavir (soft gelatin capsules, 1200 mg 3 times/day) may increase the AUC and SNR by 177% and 187%, respectively, and clarithromycin by 40%. The joint appointment of these two drugs for a limited time at the doses/dosage forms listed above, dose adjustment is not required.

Since the co-administration of colchicine, which is a substrate for CYP3A and P-glycoprotein, and clarithromycin, as well as other macrolides – inhibitors of CYP3A and P-glycoprotein, inhibition can lead to increased action of colchicin, patients should be carefully monitored to identify the symptoms of toxic effects of colchicin.

When using clarithromycin with tolterodine in patients with low activity isozyme CYP2D6 may require lower doses of tolterodine in the presence of clarithromycin (inhibitor of CYP3A isoenzymes).

During simultaneous administration of clarithromycin with verapamil may reduce blood pressure, bradiaritmia and lactic acidosis.

Storage conditions and terms:

The drug should be stored out of reach of children at a temperature not exceeding 25°C. shelf life – 2 years.