Clarithromycin capsules 250 mg 14 pcs. (Clarithromycin)

Release form

Capsules.

Packing

14 pcs.

Pharmacological action

Macrolide bacteriostatic second-generation antibiotic from the macrolide group of a wide spectrum of action. It disrupts the synthesis of protein of microorganisms (binding the 50S subunit of the membrane of the ribosome of the microbial cell).

Active against: Streptococcus agalactiae (Staphylococcus pyogenes, Staphylococcus viridans, Staphylococcus pneumoniae) Haemophilus influenzae (parainfiuenzae), Haemophilus ducreyi, Neisseria gonorrhoeae, Neisseria meningitidis, Listeria monocytogenes, Legionella pneumophila, Mycoplasma pneumoniae, Helicobacter (Campylobacter) pylori, Campylobacter jejuni, Chlamidia pneumoniae (trachomatis), Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Propionibacterium acnes, Mycobacterium avium, Mycobacterium leprae , Staphylococcus aureus, Ureaplasma urealyticum, Toxoplasma gondii, Corynebacterium spp., Borrelia burgdorferi, Pasteurella multocida, some anaerobes (Eubacterium spp., Peptococcus spp., Besides M. clobridium, Cellulitis, M. tuberculosis, M. tuberculosis, Ibid.

Indications

Clarithromycin is indicated for the treatment of infectious diseases caused by susceptible microorganisms. These diseases include:

Lower respiratory tract infections (bronchitis, pneumonia).

Upper respiratory tract infections (pharyngitis, sinusitis), otitis media.

Infections of the skin and soft tissues (folliculitis, erysipelas).

Common or localized mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellular. Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii.

Clarithromycin is indicated for the elimination of H. pylori and reduce the recurrence rate of duodenal ulcers.

Contraindications

Clarithromycin is contraindicated in patients with hypersensitivity to macrolide antibiotics.

Do not prescribe ergot derivatives for clarithromycin.

When treating with clarithromycin, it is forbidden to take cisapride, pimozide, astemizole and terfenadine (see also section Interaction with other medicinal products). In patients taking these drugs simultaneously with clarithromycin, there is an increase in their concentration in the blood. At the same time, prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular paroxysmal tachycardia, ventricular fibrillation, and ventricular flutter or fibrillation, are possible.

Severe impairment of liver and / or kidney function.

Use during pregnancy and lactation

Safety of clarithromycin during pregnancy and lactation has not been established. Therefore, during pregnancy, clarithromycin is prescribed only in the absence of alternative therapy, if the intended benefit exceeds the possible risk to the fetus.

Clarithromycin passes into breast milk, so if you need to prescribe a drug during lactation, you should stop breast-feeding.

Special instructions

In the presence of chronic liver diseases, regular monitoring of serum enzymes is necessary.

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

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

With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.

It is necessary to pay attention to the possibility of cross-resistance between clarithromycin and other macrolide antibiotics, as well as lincomycin and clindamycin.

With prolonged or repeated use of the drug, superinfection (the growth of insensitive bacteria and fungi) is possible.

Composition

Active ingredient:

clarithromycin - 250 mg.

Excipients:

milk sugar,

corn starch,

polyvinylpyrrolidone,

sodium lauryl sulfate,

calcium octadecanoate.

Dosing and Administration

For adults, the average oral dose is 250 mg 2 times / day. If necessary, 500 mg 2 times / day can be prescribed. The duration of treatment is 6-14 days.

For children, the drug is prescribed at a dose of 7.5 mg / kg body weight / day. The maximum daily dose is 500 mg. The duration of treatment is 7-10 days.

For the treatment of infections caused by Mycobacterium avium, Clarithromycin is prescribed orally - 1 g 2 times / day. The duration of treatment may be 6 months or more.

In patients with renal failure, with creatinine clearance less than 30 ml / min, the dose should be reduced by 2 times. The maximum duration of the course in patients of this group should be no more than 14 days.

Drug interaction

When taken simultaneously, it increases the concentration in the blood of drugs metabolized in the liver by cytochrome P450 enzymes, indirect anticoagulants, carbamazepine, theophylline, astemizole, cisapride, terfenadine (2-3 times), triazolam, cyclazolam, disopyramide, phenytoin, rifabutin, lovastatin, digoxin, ergot alkaloids, etc.

Rare cases of acute skeletal muscle necrosis have been reported, coinciding in time with the simultaneous administration of clarithromycin and hydroxymethylglutaryl-CoA reductase inhibitors - lovastatin and simvastatin.

There are reports of an increase in the concentration of digoxin in the plasma of patients receiving both digoxin and clarithromycin tablets. In such patients, it is necessary to constantly monitor the content of digoxin in the serum in order to avoid digital intoxication.

Clarithromycin can reduce the clearance of triazolam and, thus, increase its pharmacological effects with the development of drowsiness and confusion.

The simultaneous use of clarithromycin and ergotamine (ergot derivatives) can lead to acute ergotomin intoxication, manifested by severe peripheral vasospasm and perverse sensitivity.

Co-administration of zidovudine orally with adult HIV-infected patients and clarithromycin tablets may decrease the equilibrium concentrations of zidovudine. Considering that clarithromycin probably alters the absorption of orally administered zidovudine, this interaction is largely avoided when taking clarithromycin and zidovudine at different hours of the day (with an interval of at least 4 hours).

With the simultaneous administration of clarithromycin and ritonavir, serum concentrations of clarithromycin increase. Dose adjustment of clarithromycin in these cases is not required for patients with normal renal function. However, in patients with creatinine clearance from 30 to 60 ml / min. the dose of clarithromycin should be reduced by 50%. With creatinine clearance less than 30 ml / min. the dose of clarithromycin should be reduced by 75%. With simultaneous treatment with ritonavir, clarithromycin should not be prescribed in doses above 1 g / day.

Overdose

Probably the development of symptoms from the gastrointestinal tract (nausea, vomiting, diarrhea) headache, confusion.

Immediate overdose with gastric lavage and symptomatic treatment. Hemodialysis and peritoneal dialysis do not lead to a significant change in serum clarithromycin levels.

Storage Conditions

In a dry, dark place, out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life

2 years.

Deystvuyushtee substance

Clarithromycin

Terms and conditions

prescription

Prescription

Prescription

Prescription

Pregnant women II and III trimester as prescribed by a doctor, Adults prescribed by a doctor, Children over 12 years of age as prescribed by the doctor

Vertex, Russia



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