Clarithromycin CP 500 mg, 14 pcs.

1 tablet contains:

Active substance:

clarithromycin 500 mg.

Excipients:

 hypromellose 2208 (100 MPa • s) 200 mg,

hypromellose (hydroxypropyl methylcellulose) 2910 (50 MPa • s) 150 mg,

microcrystalline cellulose 137.5 mg,

silicon dioxide colloidal 2.5 mg,

magnesium stearate 10 mg.

The composition of the film shell:

hypromellose 2910 (6 MPa • s) 15 mg,

hyprolose 5.82 mg,

talc 5.778 mg

titanium dioxide 3.261 mg,

iron oxide yellow 0.141 mg

Slow release macrolide antibiotic. The mechanism of action is the suppression of protein synthesis in a microbial cell by interaction with the ribosomal 50S subunit of bacteria.

The minimum inhibitory concentration (MIC) of clarithromycin is 2 times lower than the MIC of erythromycin. The metabolite of clarithromycin 14-hydroxyclarithromycin, has antimicrobial activity. Clarithromycin has a wide spectrum of antimicrobial activity.

The drug is active against gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, alpha-hemolytic streptococci, Listeria monocytogenes; Gram-negative organisms: Haemophilus influenzae, Haemophilus parainfluenzae, Helicobacter pylori, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, Legionella pneumophila, Bordetella pertussis; intracellular microorganisms: Mycoplasma pneumoniae, Ureaplasma urealyticum, Chlamydia trachomatis, Chlamydia pneumoniae, Mycobacterium avium, Mycobacterium leprae, Mycobacterium kansasii, Mycobacterium chelonae, Mycobacterumium fortum anaerobic microorganisms: Clostridium perfringens, Peptococcus species, Peptostreptococcus species, Propionibacterium acnes, Bacteroides melaninogenicus;

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

- respiratory tract infections (sinusitis, pharyngitis, bronchitis, pneumonia);

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

- Helicobacter pylori-associated diseases of the stomach and duodenum.

- porphyria;

- renal failure (CC less than 30 ml / min);

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

- fructose intolerance, impaired glucose-galactose uptake or sucrase-isomaltase deficiency;

- I trimester of pregnancy;

- lactation (breastfeeding);

- children's age up to 18 years;

- Hypersensitivity to the components of the drug;

- Hypersensitivity to antibiotics from the macrolide group.

Often: headache, dizziness, anxiety, fear; nausea, vomiting, abdominal pain, diarrhea.

Sometimes: candidal stomatitis, glossitis, discoloration of the tongue and teeth; arthralgia, myalgia; skin rash, urticaria; paresthesia, taste perversion, visual disturbances; increased activity of hepatic transaminases, plasma creatinine.

Rarely: insomnia, tinnitus, uveitis; disorientation, hallucinations, psychosis, depersonalization, confusion; tachycardia, ventricular arrhythmia; pseudomembranous enterocolitis, hepatitis, cholestatic jaundice, pancreatitis; interstitial nephritis, renal failure; hypoglycemia, leukopenia, thrombocytopenia; Stevens-Johnson syndrome (malignant exudative erythema) and toxic epidermal necrolysis.

In isolated cases: hearing loss that occurs after discontinuation of the drug.

With simultaneous use with the drug Clarithromycin SR:

- drugs that are metabolized with the participation of isoenzymes of the cytochrome P450 system (cilostazol, methylprednisolone, quinidine, sildenafil, ergot alkaloids, alprazolam, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoinpinoinpinoinpinoinib, isinoproininpino, ibininolin concentration, possibly ichininipinopininb, cyclin plasma;

-theophylline, digoxin, carbamazepine, colchicine - an increase in their plasma concentrations is possible;

-warfarin - it is possible to enhance the effect of warfarin (prothrombin time control is necessary);

-quinidine or disopyramide - ventricular tachycardia is possible;

Ergotamine or dihydroergotamine - increased their effects with the development of vasospasm;

Ritonavira - an increase in the concentration of clarithromycin is possible (with this combination, the dose of clarithromycin SR-ratiopharm should be no more than 500 mg /);

-cisapride, pimozide - possibly an increase in the QT interval, arrhythmia, ventricular tachycardia, fibrillation, flutter-ventricular fibrillation;

- with the simultaneous administration of clarithromycin and zidovudine in HIV-infected patients, a decrease in the concentration of zidovudine in the blood plasma was observed, because clarithromycin affects the absorption of zidovudine (the interval between doses of these drugs should be at least 4 hours).

Perhaps the development of cross-resistance between clarithromycin, lincomycin and clindamycin.

Clarithromycin SR is administered orally to adults and children over 18 years of age at a dose of 500 mg (1 tablet) with meals. If necessary, it is possible to increase the dose to 1 g (2 tablets) per dose or in 2 doses with an interval of 12 hours. The average daily dose is 500 mg. The maximum daily dose is 1 g.

The duration of treatment, as a rule, is 7-14 days.

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

Treatment: gastric lavage, symptomatic therapy.

Caution is required when using Clarithromycin SR in patients with impaired liver and kidney function.

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

Influence on the ability to drive vehicles and control mechanisms

Does not affect.