Clarithromycin pills 250mg №14

Indications

Treatment of infectious and inflammatory diseases caused by susceptible microorganisms:

- infections of the lower respiratory tract (bronchitis, pneumonia);

- infections of the upper respiratory tract (laryngitis, pharyngitis, tonsillitis, sinusitis);

- infections of the skin and soft tissues (folliculitis, furunculosis, erysipelas, impetigo, wound infection);

- gastric ulcer and duodenal ulcer (in combination with drugs that reduce acidity): for the treatment of acute duodenal ulcer, Helicobacter pylori eradication and reduce the frequency of recurrence of peptic ulcer or in combination with Amoxicillin and Omeprazole / lansoprazole as a 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 infections in HIV-infected patients with CD4 count (T-helper lymphocytes) less than 100 / mm³.

Dosage and administration

The drug is taken orally, regardless of the meal.

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

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

For preventing the spread of infections caused by the mycobacterium avium complex, appoint 500 mg 2 times / day.

For Helicobacter pylori eradication prescribe a combination therapy with 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 the appointment of combination therapy with two drugs. The first scheme: clarithromycin - 500 mg 3 times / day in combination with omeprazole at a dose of 40 mg / day for 14 days, with the appointment over the next 14 days of omeprazole at a dose of 20-40 mg / day. The second scheme: clarithromycin - 500 mg 3 times / day in combination with lansoprazole at a dose of 60 mg / day for 14 days. For complete healing of ulcers may require an additional decrease in the acidity of gastric juice.

Have patients with chronic renal failure (CC <30 ml / min or serum creatinine concentration more than 3.3 mg / dL) reduce the dose by 2 times, or increase the interval between doses in 2 times. The maximum duration of the course of the drug in patients of this group should be no more than 14 days.

Adverse effects

Determination of the frequency of adverse reactions (according to the WHO classification): very often (≥10%); often (≥1% and <10%); infrequently (≥0.1% and <1%); rarely (≥0.01% and <0.1%); very rarely (0.01%).

Gastrointestinal: often - diarrhea, vomiting, abdominal pain and nausea, change in taste (dysgeusia); rarely - glossitis, stomatitis, candidiasis of the oral mucosa, discoloration of the tongue and teeth (tooth discoloration is reversible and usually restored by professional cleaning by a dentist), abnormal liver function, including a transient increase in liver transaminase activity and hepatocellular and / or cholestatic hepatitis, accompanied or not accompanied by jaundice (hepatic dysfunction can be severe and usually reversible), acute pancreatitis, pseudomembranous colitis (from moderate to threatening Life Span); in isolated cases, deaths from liver failure were recorded, which were usually observed in the presence of serious concomitant diseases and / or the simultaneous use of other drugs.

Nervous system: infrequently - transient headaches, dizziness, anxiety, insomnia, nightmares, tinnitus; rarely seizures; very rarely - myalgia, parasthesia, confusion, disorientation, hallucinations, psychosis and depersonalization.

Cardiovascular: rarely, ventricular tachycardia, ventricular arrhythmia of the "pirouette" type, fluttering and ventricular fibrillation, prolongation of the QT interval on an ECG (like in other macrolides).

Special senses: very rarely - noise, tinnitus, impaired smell, change in taste (dysgeusia); in rare cases - hearing loss, passing after discontinuation of the drug.

Urogenital: very rarely - the development of interstitial nephritis and renal failure.

Allergic reactions: infrequently - skin rash, itching, urticaria, skin flushing; rarely - Anaphylactic reactions, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis.

From the laboratory indicators: 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

- porphyria;

- simultaneous intake with the following drugs: astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, oral midazolam, alprazolam, triazolam;

- pregnancy;

- lactation period (breastfeeding);

- children's and teenage age up to 18 years;

- hypersensitivity to the drug;

- Hypersensitivity to macrolides in history.

WITH caution should use the drug for violations of the liver and kidneys.

Use during pregnancy and lactation

The safety of clarithromycin during pregnancy has not been 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 the liver

The drug is contraindicated in liver failure.

Application for violations of kidney function

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

Use in children

Contraindicated in children and adolescents under 18 years of age.

Special notes

Caution should be given to Clarithromycin Zentiva in patients with impaired liver function; it is necessary to conduct regular monitoring of serum enzymes.

Precautions should be prescribed Clarithromycin Zentiva on the background of drugs metabolized in the liver; It is recommended to control the concentration of these drugs in the serum.

In the case of co-administration of the drug Clarithromycin Zentiva with Warfarin or other indirect anticoagulants, it is necessary to control the prothrombin time.

Caution should be exercised in the appointment of the drug Clarithromycin Zentiva in patients with moderate and severe renal failure.In clinical practice, described cases of colchicine toxicity in combination with clarithromycin, especially in the elderly. Some of these were observed in patients with renal insufficiency; several deaths have been reported in such patients.

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

Consideration should be given to the possibility of cross-resistance between Clarithromycin Zentiva and other macrolide antibiotics, as well as Lincomycin and Clindamycin .

Influence on ability to drive motor transport and control mechanisms

There is no data on the effect of clarithromycin on the ability to drive vehicles and mechanisms. However, when using the drug in patients who are engaged in driving vehicles or working with mechanisms, it is necessary to take into account the presence of reports about the occurrence of dizziness and disorientation in patients while taking clarithromycin.

Overdose

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

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

Drug interaction

When co-administered with clarithromycin and drugs that are primarily metabolized by CYP3A isoenzymes, a mutual increase in their concentrations is possible, which can enhance or prolong both therapeutic and side effects. Concomitant use with astemizol, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, alprazolam, midazolam, triazolam is contraindicated.

With caution prescribed with Carbamazepine, cilostazol, cyclosporine, disopyramide, lovastatin, methylprednisolone, omeprazole, indirect anticoagulants (includingwarfarin), quinidine, rifabutin, Sildenafil, Simvastatin, tacrolimus, vinblastine, phenytoin, theophylline and valproic acid (metabolized by other cytochrome P450 isoenzymes). Correction of the dose of drugs and control of serum concentration is necessary.

When combined with cisapride, pimozide, terfenadine and astemizole, it is possible to increase the concentration of these drugs in the blood, prolong the QT interval and develop cardiac arrhythmias, including ventricular paroxysmal tachycardia, fibrillation, atrial flutter or ventricular fibrillation, multiforme ventricular tachycardia of the type of ventricular tachycardia of the type of ventricular tachycardia; A similar mechanism of interaction is observed when using drugs that are metabolized by another isoenzyme of the cytochrome P450 system - phenytoin, theophylline, and valproic acid. With the simultaneous appointment of the above drugs requires monitoring of their concentrations in serum and ECG.

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

There are reports of increased concentrations of Digoxin in the plasma of patients who received both digoxin and clarithromycin. The content of digoxin in serum should be constantly monitored in order to avoid digitalis intoxication and the development of potentially lethal arrhythmias.

Combined use with ergotamine and dihydroergotamine (ergot derivatives) can lead to acute ergotamine intoxication, manifested by severe peripheral vasospasm, ischemia of the extremities and other tissues, including the CNS, and perverse sensitivity.

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

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

When co-administration of Fluconazole at a dose of 200 mg daily and clarithromycin at a dose of 1 g / day may increase C_ss and clarithromycin AUC by 33% and 18%, respectively. Correction dose of clarithromycin is not required.

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

Simultaneous administration of clarithromycin (normal release tablets) and zidovudine in adult HIV-infected patients may result in decreased C_ss zidovudine. Selection of clarithromycin and zidovudine is necessary.

With the simultaneous appointment of clarithromycin and ritonavir, atazanavir or other protease inhibitors, the serum concentration of both clarithromycin, which in this case should not be administered in doses above 1 g / day, and the protease inhibitor increase.

When co-administration of clarithromycin and itraconazole, a mutual increase in plasma concentrations of the drugs is possible. Patients at the same time taking itraconazole and clarithromycin, should be carefully monitored due to the possible enhancement or lengthening of the pharmacological effects of these drugs.

With simultaneous administration of clarithromycin (1 g / day) and saquinavir (in soft gelatin capsules, 1200 mg 3 times / day) an increase in AUC and C is possible._ss saquinavir by 177% and 187%, respectively, and clarithromycin by 40%. When these two medicines are given together for a limited time in the doses / dosage forms indicated above, no dose adjustment is required.

Since 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 may lead to an increase in the action of colchicine, patients should be carefully monitored to identify the toxic effects of colchicine .

When using clarithromycin with tolterodine in patients with low CYP2D6 isoenzyme, it may be necessary to reduce the dose of tolterodine in the presence of clarithromycin (an inhibitor of isoenzymes CYP3A).

When co-administered with clarithromycin and Verapamil, a decrease in blood pressure, bradyarrhythmia, and lactic acidosis may be possible.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.