Clarbact 500mg N10 coated pills
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Active ingredients
Clarithromycin
Release form
Pills
Composition
Clarithromycin 500 mg; Auxiliary substances: microcrystalline cellulose, corn starch, pregelatinized starch, polyvinylpyrrolidone, purified talc, sodium starch glycolate, colloidal silicon dioxide, stearic acid, magnesium stearate .; Shell composition: isopropanol, hydroxypropylmethylcellulose, titanium dioxide, purified talcum, polyethylene glycol 6000, methylene chloride, lemon flavoring, peppermint powder.
Pharmacological effect
An antibiotic of macrolide group II of a wide spectrum of antimicrobial action. It has a bacteriostatic effect. Disrupts the synthesis of protein microorganisms - binds to the 50S subunit of the ribosome membrane of the microbial cell .; Clarithromycin is active against Streptococcus agalactiae (Streptococcus pyogenes, Streptococcus viridans, Sreptococcus pneumoniae), Haemophilus influenzae (parainfluenzae), Haemophilus ducreyi, Neisseria gonorrhoeae, Neisseria meningitidis, Listeria monocytogenes, Legionella pneumophila, Mycoplasma pneumoniae, Helicobacter (Campilobacter) pylori, Campilobacter jejuni, Chlamidia pneumoniae (trachomatis), Moraxella (Branhamella) catarrhalis, Bordetella pertussis, Propionibacterium acnes, oreapromaciona, optfuyuyuyuyuyuyuyufuyufuyufuyufuyuyuyuyuyuyuyuyuyuyuyushi investori isyushuyuyuyuyuyyyyyyyyyyyyyyyyu (Sukhova) , Clostridium perfringens, Bacteroides melaninogenicus) and all mycobacteria (including Mycobacterium avium, Mycobacterium leprae), except Mycobacterium tuberculosis.
Pharmacokinetics
Absorption; After oral absorption is fast. Food slows down absorption without significantly affecting bioavailability. The bioavailability of clarithromycin in the form of a suspension is equivalent to or slightly higher than when taken in pill form .; After a single dose, 2 Cmax peaks are recorded. The second peak is due to the ability of the drug to concentrate in the gallbladder, followed by a gradual or rapid release. The time to reach Cmax when taken orally at a dose of 250 mg is 1-3 hours; Distribution and metabolism; Plasma protein binding - more than 90% .; After ingestion, 20% of the accepted dose is rapidly hydroxylated in the liver with the participation of cytochrome P450 isoenzymes with the formation of the main metabolite, 14-hydroxylaritromycin, with pronounced antimicrobial activity against Haemophilus influenzae .; With regular intake of 250 mg / day, the Css of the unchanged drug and its main metabolite is 1 and 0.6 mcg / ml, respectively; T1 / 2 3-4 h and 5-6 h, respectively. When increasing the dose to 500 mg / day, the Css of unchanged drug and its plasma metabolite is 2.7–2.9 and 0.83–0.88 mcg / ml, respectively; T1 / 2 - 4.8-5 h and 6.9-8.7 h, respectively. At therapeutic concentrations, it accumulates in the lungs, skin and soft tissues (in which the concentration is 10 times higher than the level in blood serum) .; Withdrawal; excreted by the kidneys and feces (20-30% - unchanged, the rest - in the form of metabolites). With a single dose in doses of 250 mg and 1.2 g, 37.9 and 46% are excreted in the urine, with feces 40.2 and 29.1%, respectively.
Indications
Treatment of infectious diseases caused by microorganisms sensitive to the drug: - infections of the lower respiratory tract (bronchitis, pneumonia); - infections of the upper respiratory tract (pharyngitis, sinusitis); - otitis; - infections of the skin and soft tissues (folliculitis, erysipelas); - common or localized mycobacterial infections caused by Mycobacterium avium and Mycobacterium intracellulare; - localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum and Mycobacterium kansasii; - for the eradication of Helicobacter pylori and reduce the frequency of recurrence of duodenal ulcer.
Contraindications
- severe abnormal liver function; - Severe renal dysfunction; - simultaneous use of ergot alkaloids; - simultaneous use of cisapride, pimozide, astemizole, terfenadine; - Hypersensitivity to macrolide antibiotics.
Use during pregnancy and lactation
The safety of clarithromycin during pregnancy and lactation has not been established .; Therefore, during pregnancy, Clarbact is prescribed only in the absence of alternative therapy, if the intended benefit exceeds the possible risk to the fetus .; Clarithromycin is excreted in breast milk, so you should use the drug with caution during lactation.
Dosage and administration
The drug is taken orally .; For adults, the average dose is 250 mg 2 times / day. If necessary, you can assign 500 mg 2 times / day. The duration of treatment is 6-14 days .; For children, the drug is prescribed at a dose of 7.5 mg / kg of body weight per 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, the drug is administered orally for 1 g 2 times / day. The duration of treatment may be 6 months or more .; In patients with renal failure (CC less than 30 ml / min), the dose should be reduced by 2 times. The maximum duration of treatment in patients of this group is 14 days.
Side effects
On the part of the digestive system: most often - nausea, dyspepsia, abdominal pain, vomiting and diarrhea; possible pseudomembranous colitis (from moderate to life-threatening), taste disorders and transient increases in liver enzymes, glossitis, stomatitis, oral mucosa candidiasis, discoloration of the tongue during clarithromycin treatment, discoloration of teeth (reversible in most cases); rarely - hepatitis with increased levels of liver enzymes in the blood,the development of cholestasis and jaundice (these liver damage in some cases were severe and, as a rule, reversible); in rare cases - liver failure with a fatal outcome .; On the part of the central nervous system and peripheral nervous system: transient headache, dizziness, anxiety, fear, fear, insomnia, nightmares, tinnitus, confusion, disorientation, hallucinations, psychosis and depersonalization are possible; rarely - paresthesias .; On the part of the senses: possible hearing loss (restored after discontinuation of the drug), changes in the perception of taste, as a rule, arising together with a violation of taste .; Since the cardiovascular system: rarely - an increase in the QT interval, ventricular arrhythmia (including ventricular paroxysmal tachycardia, flutter or ventricular fibrillation) .; From the urinary system: rarely - an increase in the content of serum creatinine, interstitial nephritis, renal failure .; From the hematopoietic system: in some cases - thrombocytopenia, leukopenia .; Allergic reactions: if taken orally, urticaria, skin rash, anaphylactic reactions, Stevens-Johnson syndrome are possible .; Other: rarely - hypoglycemia (in some cases, while taking oral hypoglycemic agents or insulin).
Overdose
Symptoms: nausea, vomiting, diarrhea, headache, confusion .; Treatment: immediate gastric lavage and symptomatic treatment is necessary. Hemodialysis and peritoneal dialysis do not lead to a significant change in the level of clarithromycin in serum.
Interaction with other drugs
With simultaneous use of clarithromycin increases the concentration in the blood of drugs metabolized in the liver with the participation of isoenzymes of the cytochrome P450 system: indirect anticoagulants, carbamazepine, theophylline, triazolam, midazolam, cyclosporine, disopyramide, phenytoin, rifabutin, lovastatin, syrup, sylvolam, cyclosporine, disopyramide, phenytoin, rifabutin, tefillina, triazolam, midazolam, cyclosporine, disopyramide, phenytoin, rifabutin. With simultaneous use with clarithromycin, there is a significant increase in the concentration of cisapride, pimozide, astemizole and terfenadine (by a factor of 2-3) in the blood plasma, and the QT interval may be prolonged and cardiac arrhythmias, including ventricular paroxysmal tachycardia, may developventricular fibrillation and flutter or ventricular fibrillation (this combination is contraindicated) .; Rare cases of acute necrosis of skeletal muscles that coincide in time with the simultaneous appointment of clarithromycin and HMG-CoA reductase inhibitors - lovastatin and simvastatin are reported .; There are reports of increased concentrations of digoxin in the plasma of patients receiving both digoxin and clarithromycin pills. In such patients, it is necessary to constantly monitor the content of digoxin in the serum in order to avoid digitalis 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 alkaloids) can lead to acute ergotamine intoxication, manifested by severe peripheral vasospasm and impaired sensitivity .; Co-administration of oral zidovudine and clarithromycin pills to HIV-infected adults can lead to a decrease in Css zidovudine. Considering that clarithromycin probably alters the absorption of simultaneously administered zidovudine, this interaction can be largely avoided when taking clarithromycin and zidovudine at different times of the day (at least 4 hours apart) .; With the simultaneous appointment of clarithromycin and ritonavir, the serum concentration of clarithromycin increases. Correction of the dose of clarithromycin in these cases for patients with normal renal function is not required. However, in patients with creatinine clearance from 30 to 60 ml / min, the dose of clarithromycin should be reduced by 50%. When QA is less than 30 ml / min, the dose of clarithromycin should be reduced by 75%. With simultaneous treatment with ritonavir, clarithromycin should not be administered in doses of more than 1 g / day.
special instructions
In the presence of chronic liver disease, it is necessary to regularly monitor the activity of liver enzymes .; Be wary appointed on the background of taking drugs that are metabolized in the liver; it is recommended to determine their concentration in the blood plasma .; In the case of combined use with warfarin or with other indirect anticoagulants, it is necessary to control the prothrombin time .; With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended .; Attention is drawn 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 may develop superinfection (growth of insensitive bacteria and fungi).