Clarithromycin Teva coated pills 500mg N14
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Active ingredients
Clarithromycin
Release form
Pills
Composition
Active ingredient: Clarithromycin Concentration of active ingredient (mg): 500 mg
Pharmacological effect
Clarithromycin is a semisynthetic macrolide broad-spectrum antibiotic. The antibacterial effect of clarithromycin is accomplished by suppressing protein synthesis due to the binding of bacterial ribosomes to the 50s subunit. Clarithromycin has a pronounced activity against a wide range of aerobic and anaerobic gram-positive and gram-negative organisms. The minimum inhibitory concentration of clarithromycin (MPC) is half that of erythromycin for most microorganisms. The 14-hydroxy-metabolite of clarithromycin also has antimicrobial activity. The minimum inhibitory concentrations of this metabolite are equal to or exceed the MPK of clarithromycin; against H. influenzae 14-hydroxymetabolite twice as active as clarithromycin. Clarithromncin is a company that is apt to find the same organisms that are crypto-negative aerobic bacteria: Staphylococcus aureus (methicillin-sensitive), Streptococcus agalactiae, Streptococcus pyogen, and Icyo-Icyllinum, Ipros, Ipros, and Iptoxins. ; Gram-negative aerobic bacteria: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoea, Legionella pneumophila, Bordetella pertussis, Helicobacter pylori, Campylobacter jejuni predominantly intracellular microorganisms: Mycoplasma pneumonia, Ureaplasma urealyticum, Chlamydia trachomatis, Chlamydia pneumonia, Mycobacterium avium, Mycobacterium leprae, M. kansaii, M. chelonae, M. marinum, M. fortitum; anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Propionibacterium acnes, Peptococcus species; Peptostreptococcus species. In addition, the drug is active against the Toxoplasma species. Clarithromycin has bactericidal activity against several bacterial strains: Haemophilus influenzae; Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus agalactiae; Moraxella (Branhamella) catarrhalis; Neisseria gonorrhoeae; Helicobacter pylori and Campylobacter spp.
Pharmacokinetics
Clarithromycin is rapidly and well absorbed from the gastrointestinal tract after oral administration. The microbiologically active metabolite 14-hydroxylarithromycin is formed after the first passage through the liver. Meal does not affect the bioavailability of clarithromycin, however, somewhat slows the beginning of the absorption of clarithromycin and the formation of 14-hydroxymetabolite. The pharmacokinetics of clarithromycin are non-linear; at the same time, the equilibrium concentration is reached 2 days after the start of the drug intake. Clarithromycin is excreted in the urine, as well as in the feces, mainly through bile. When receiving 250 mg of clarithromycin 2 times / day, 15–20% of the administered dose is excreted unchanged in the urine.When taking 500 mg 2 times / day urinary excretion is about 36%. 14-hydroxylarithromycin is the main metabolite found in the urine, it accounts for about 10-15%. When receiving 500 mg of clarithromycin 3 times / day, the concentration of clarithromycin in plasma is higher than when taking this dose 2 times / day. The content of clarithromycin in tissues , including glandular and lung tissue, several times higher than in circulating blood. At therapeutic concentrations, clarithromycin is 80% bound to plasma proteins. Clarithromycin penetrates the gastric mucus. The level of clarithromycin in the mucus and tissues of the stomach increases with combination therapy with omeprazole. Clarithromycin passes into breast milk.
Indications
Infections caused by microorganisms sensitive to clarithromycin. Lower respiratory tract infections (including acute and chronic bronchitis, pneumonia); upper respiratory tract infections (including sinusitis and pharyngitis); skin and soft tissue infections; duodenal ulcer for eradication of H .pylori (as part of complex therapy with proton pump inhibitors);
Contraindications
hypersensitivity to macrolide antibiotics; simultaneous administration with ergot derivatives; simultaneous administration of the following drugs: cisapride, pimozide, terfenadine, children under 12 years of age, pregnancy and lactation. With caution: patients with impaired liver and kidney function.
Precautionary measures
Do not exceed the recommended dose. With care: patients with impaired liver and kidney function.
Use during pregnancy and lactation
The safety of clarithromycin during pregnancy and lactation has not been studied. The drug passes into breast milk. If necessary, use during lactation should stop breastfeeding.
Dosage and administration
Inside. Adults: the usual dose is 250 mg 2 times a day for 7 days, if necessary, the dose can be increased to 500 mg 2 times a day for a period of up to 14 days for severe infections. Children over 12 years old: dosing regimen as for adults. For the treatment of duodenal ulcers caused by H. pylori (adults): Triple therapy regimen (7-14 days): Clarithromycin 500 mg 2 times a day; lansoprazole 30 mg 2 times a day; Amoxicillin 1000 mg 2 times a day; Triple therapy regimen (7 days):Clarithromycin 500 mg 2 times a day; lansoprazole 30 mg 2 times a day; Metronidazole 400 mg 2 times a day. Triple therapy regimen (7 days): Clarithromycin 500 mg 2 times a day; omeprazole 40 mg per day; amoxicillin 1000 mg 2 times a day or metronidazole 400 mg 2 times a day; Triple therapy regimen (10 days): Clarithromycin 500 mg 2 times a day with amoxicillin 100 mg 2 times a day and omeprazole 20 mg per day; Dual therapy (14 days): Clarithromycin 500 mg 3 times a day, omeprazole orally 40 mg 1 time a day. In case of kidney damage: Usually, dose adjustment is not required, except for patients with severe kidney damage (creatinine clearance <30 ml / min), however, if necessary, the total daily dose should be halved, i.e. 250 mg 1 time per day or 250 mg 2 times a day for more severe infections. When co-administered with ritonavir for patients with impaired renal function, a dose adjustment is recommended as follows: For patients with creatinine clearance 30-60 ml / min, the dose of clarithromycin should be reduced by 50%. For patients with creatinine clearance less than 30 ml / min, the dose of clarithromycin should be reduced by 75%. When combined use of clarithromycin and ritonavir, do not use doses of clarithromycin over 1 g per day.
Side effects
Clarithromycin is usually well tolerated by patients. On the gastrointestinal tract: Nausea, vomiting, dyspepsia, diarrhea, abdominal pain, stomatitis, glossitis, pancreatitis, oral candidiasis, discoloration of the tongue and teeth; rarely - pseudomembranous enterocolitis. Tooth discoloration is reversible and is usually restored with a special treatment in a dental clinic. As with the admission of other antibiotics from the group of macrolides, liver dysfunction is possible, including increased liver enzyme activity, hepatic cell and / or cholestatic hepatitis with or without jaundice. These abnormal liver functions can be severe, but usually they are reversible. Very rarely, there were cases of liver failure and death mainly due to severe concomitant diseases and / or concomitant drug therapy. From the blood system: In exceptional cases, leukopenia and thrombocytopenia; increased serum creatinine level. From the central and peripheral nervous system: Paresthesia, headache, olfactory disorders, change in taste; dizziness, agitation, insomnia, nightmares, fear, ringing in the ears, confusion, disorientation, hallucinations, psychosis,depersonalization; reversible hearing loss; convulsions. From the side of the cardiovascular system: As with other macrolides, prolongation of the QT interval, ventricular tachycardia. Polymorphic ventricular tachyarrhythmia (torsades de pointes). From the musculoskeletal system: Arthralgia, myalgia. From the side of the urinary system: Individual cases of an increase in creatinine. , interstitial nephritis, renal failure Allergic reactions: Urticaria, angioedema, anaphylactic shock, in rare cases - Stevene-Johnson syndrome, toxic epidermal necrosis Lys.Other: Rarely hypoglycemia in patients taking oral hypoglycemic agents or insulin
Overdose
Symptoms: symptoms of the gastrointestinal tract; In one of the patients, when receiving 8 g of clarithromycin, there was a case of mental disorder, paranoid behavior, hypoglycemia, hypoxemia. Treatment: gastric lavage, supportive therapy. Hemodialysis or peritoneal dialysis is ineffective, as for other macrolides.
Interaction with other drugs
With simultaneous administration of clarithromycin with cisapride, pimozide and terfenadine, elevated concentrations of these drugs are observed in the blood plasma, which can cause prolongation of the QT interval and heart rhythm disturbances, including ventricular tachycardia, ventricular fibrillation, arrhythmia and torsade de pointes; Similar effects are observed at the same time taking other makrolidov.Klaritromitsin astemizole and does not interact with oral kontratseptivami.Kak and the reception of other macrolide antibiotics, simultaneous clarithromycin and other drugs metabolized with participation of cytochrome P450 (warfarin, ergot alkaloids, triazolam, midazolam, disopyramide, lovastatin, rifabutin, phenytoin, cyclosporine and tacrolimus) may be accompanied by an increase in the concentration of these drugs in the blood serum. At the same time applying clarithromycin and HMG-KoA-reductase inhibitors (lovastatin, simvastatin) may develop rabdomioliza.Pri while appointing clarithromycin and theophylline increases the concentration of theophylline in serum and its purpose toksichnost.Odnovremennoe clarithromycin and warfarin or digoxin may be accompanied by an increase in the severity of theireffects. When simultaneously prescribing clarithromycin and carbamazepine, the effect of carbamazepine may increase as a result of a decrease in the rate of excretion of carbamazepine. When both clarithromycin and zidovudine (orally) are taken orally, HIV-infected adult patients may decrease the equilibrium concentration of zidovudine; this can be largely avoided by increasing the interval between taking clarithromycin and zidovudine to 1-2 hours. For children, this interaction was not observed. When taking ritonavir and clarithromycin for the latter at the same time, the pharmacokinetic parameters increase: AUC, Cmax, Cmin. For patients with normal renal function, dose adjustment is usually not required due to a wide therapeutic dose range of clarithromycin. With simultaneous use of clarithromycin and omeprazole, clarithromycin and lansoprazole, as well as clarithromycin and ranitidine, an increase in plasma concentrations is possible, but usually dose adjustment is not required. the simultaneous use of clarithromycin and hypoglycemic agents, including insulin, in rare cases may develop hypoglycemia.
special instructions
It is not recommended to take clarithromycin pills in children younger than 12 years of age. When simultaneously prescribing clarithromycin and warfarin, prothrombin time should be regularly monitored. In the case of simultaneous administration of clarithromycin and digoxin, the serum level of digoxin should be monitored.