Description
Latin name
Clarithromycin Ecozitrin
Release form
Film-coated tablets, pink, capsule-shaped, biconvex. Two layers are visible on the cross section, the inner layer is white or almost white.
Packing
7 pcs – blister packs (2) – packs of cardboard.
Pharmacological action
Broad-spectrum antibiotic.
Indications
Adults:
– pharyngitis
– tonsillitis
– acute sinusitis
– exacerbation of chronic bronchitis
– community-acquired pneumonia
– Uncomplicated somberculosis and rhinitis infection
– in combination with amoxicillin and omeprazole / lansoprazole as a triple therapy for infections caused by Helicobacter pylori, including duodenal ulcer.
For children:
– pharyngitis
– tonsillitis
– community-acquired pneumonia
– acute sinusitis
– acute otitis media
– uncomplicated infections of the skin and subcutaneous tissue
– disseminated infection caused by Mycobacteriumium mycobacterium av.
Contraindications
– hypersensitivity to clarithromycin, other antibiotics of the macrolide group, other components of the
preparation – severe liver failure occurring simultaneously with renal insufficiency
– porphyria
, hypokalemia syndromezinpymnosis, prymid apydenamidaemina piridaemina pirida ergot alkaloids
– simultaneous use with lovastatin and simvastatin, with midazolam for oral administration, with colchicine in patients with impaired function kidney or liver taking P-glycoprotein inhibitors or potent inhibitors of the CYP3A4
isoenzyme – patients have a history of prolonged QT interval, ventricular arrhythmias, or ventricular tachycardia such as pirouette
– cholestatic jaundice / hepatitis caused by the use of clarithromycin – 12 years of age (for this dosage form)
– period of lactation (breastfeeding)
– lactose intolerance or lactase deficiency, as well as glucose-galactose malabsorption.
Precautions:
– moderate to severe renal failure
– moderate to severe hepatic failure
– myasthenia gravis
– concomitant use with drugs inducing and metabolizing the isoenzyme CYP3A4, benzodiazepines (alprazolam, triazolam, midazolam for iv use), class IA and III antiarrhythmic drugs, slow calcium channel blockers that are metabolized by the isoenzyme CYP3A4
– CHD
– severe heart failure
– hypomagnesemia
severe bradycardia.
Use during pregnancy and lactation
Safety of clarithromycin during pregnancy has not been established. In pregnancy, especially in the first trimester, it is recommended to prescribe clarithromycin if the benefits of taking it exceed the potential risk to the fetus and / or there is no safer therapy with alternative drugs. If pregnancy occurs while taking the drug, the patient should be warned of a possible risk to the fetus.
If necessary, the appointment of the drug during lactation should decide on the abolition of breastfeeding.
Composition
1 tab. contains:
Active ingredient: clarithromycin – 250 mg.
Excipients: lactulose – 300 mg, povidone-K25 – 9.1 mg, magnesium stearate – 6.5 mg, colloidal silicon dioxide (aerosil) – 4.33 mg, talc – 13 mg, potassium polacryline – up to 650 mg.
Shell composition: hypromellose – 9.52 mg, talc – 1.14 mg, titanium dioxide – 5.171 mg, macrogol-4000 – 4.14 mg, dye azorubine – 0.029 mg.
Dosage and administration
Inside, swallowing whole, without chewing, with a small amount of liquid.
Adults and children over 12 years old, weighing more than 33 kg:
– for pharyngitis and tonsillitis caused by Streptococcus pyogenes – 250 mg every 12 hours for 10 days
– for acute sinusitis – 500 mg every 12 hours within 14 days
– with exacerbation of chronic bronchitis, caused by Haemophilus influenzae – 500 mg every 12 hours for 7-14 days caused by Haemophilus parainfluenzae – 500 mg every 12 hours for 7 days caused by Moraxella catarrhalis, Streptococcus pneumoniae – 250 mg every 12 hours for 7-14 days
– with community-acquired pneumonia caused by Haemophilus influenzae – 250 mg every 12 hours for 7 days caused by Streptococcus pneumoniae, Chlamydia pneumoniae, Mycoplasma pneumoniae – 250 mg every 12 hours for 7-14 days
– with uncomplicated infections of the skin and subcutaneous fiber caused by Staphylococcus aureus, Streptococcus pyogenes – 250 mg every 12 hours for 7-14 days
– for treatment and prevention and infections caused by Mycobacterium avium, – 500 mg 2 times a day. The maximum daily dose is 1000 mg. The duration of treatment is 6 months or more.
In order to eradicate Helicobacter pylori:
Combined treatment with three drugs: clarithromycin – 500 mg 2 times a day, lansoprazole – 30 mg 2 times a day and amoxicillin – 1000 mg 2 times a day for 10-14 days
clarithromycin – 500 mg 2 times a day, omeprazole – 20 mg 2 times a day and amoxicillin – 1000 mg 2 times a day for 10 days.
Combined treatment with two drugs: clarithromycin – 500 mg 3 times a day, omeprazole – 40 mg / day for 14 days, with the appointment of omeprazole over the next 14 days at a dose of 20 mg / day.
For patients with chronic renal failure: (Cl creatinine less than 30 ml / min or serum creatinine concentrations more than 3.3 mg / 100 ml) the dose is reduced by 2 times, or the interval between doses is increased by 2 times. The maximum duration of treatment in patients of this group is 14 days.
Side effects
From the nervous system: headache, dizziness, anxiety, insomnia, nightmares, convulsions, depression, disorientation, hallucinations, psychosis, depersonalization, confusion.
From the digestive system: nausea, vomiting, gastralgia, diarrhea, stomatitis, glossitis, candidiasis of the oral mucosa, discoloration of the tongue and teeth, acute pancreatitis, increased activity of hepatic transaminases, hepatocellular and cholestatic hepatitis, cholestatic jaundice, rarely pseudomembra , liver failure with a fatal outcome, mainly against the background of severe concomitant diseases and / or concomitant drug therapy.
Lactulose, which is part of the Ecositrin® preparation, eliminates the risk of side effects associated with the negative effect of the antibiotic on intestinal microbiocenosis.
From the cardiovascular system: ventricular tachycardia, including type of “pirouette”, flutter and ventricular fibrillation, increased QT interval on the ECG.
On the part of the sensory organs: noise, tinnitus, taste change (dysgeusia), in isolated cases – hearing loss that occurs after discontinuation of the drug, impaired sense of smell.
From the musculoskeletal system: myalgia.
From the hemopoietic organs: rarely – thrombocytopenia, (unusual bleeding, hemorrhage).
From the urinary system: interstitial nephritis.
Laboratory indicators: leukopenia, hypercreatininemia, hypoglycemia (including while taking hypoglycemic drugs).
Allergic reactions: skin rash, itching, urticaria, skin hyperemia, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis, anaphylactic reactions.
Other: secondary infections (development of resistance of microorganisms).
Drug Interaction
When co-administered with clarithromycin and drugs initially metabolised by the CYP3A isoenzyme, it is possible to increase their concentrations mutually, which may enhance or prolong both therapeutic and side effects. Contraindication with co-administration with astemizole, cisapride, pimozide, terfenadine, ergotamine and other alprazolam ergot alkaloids is contraindicated, midazolam, triazolam. srdl srdl are prescribed with carbamazepine, cilostazol, cyclosporin, disopirmid, lovastatin, methylprednisolone, omeprazole, indirect anticoagulants (including warfarin), quinidamil, rifabutin, sildamil (metabolized through other cytochrome P450 isoenzymes).
When used together with cisapride, pimozide, terfenadine and astemizole, it is possible to increase the concentration of the latter in the blood, increase the QT interval, arrhythmia, including ventricular tachycardia, including like pirouette, and ventricular fibrillation. Need to adjust the dose of drugs and control the concentration in the blood.
When used together with ergotamine and dihydroergotamine, acute poisoning with ergotamine (vascular spasm, ischemia of the extremities and other tissues, including the CNS) is possible.
Efavirenz, nevirapine, rifampicin, rifabutin and rifapentin (cytochrome P450 inducers) reduce plasma clarithromycin and attenuate the therapeutic effect of the latter, and at the same time increase the level of 14-hydroxyclarithromycin.
Fluconazole 200 mg daily co-administration and clarithromycin 1 g / d may increase CSS and AUC of clarithromycin by 33% and 18%, respectively. No dose adjustment of clarithromycin is required.
Co-administration of ritonavir with 600 mg / day and clarithromycin 1 g / day may reduce clarithromycin metabolism (Cmax increase by 31%, CSS by 182% and AUC by 77%), complete suppression of the formation of 14-hydroxyclarithromycin. In patients with chronic renal insufficiency, dose adjustment is necessary: with Cl creatinine 30-60 ml / min the clarithromycin dose should be reduced by 50%,
When combined with quinidine and disopyramide, ventricular tachycardia of the type “pirouette” may occur. ECG monitoring (QT interval increase), serum concentrations of these drugs are needed.
Clarithromycin increases concentrations of HMG-CoA reductase inhibitors (lovastatin, simvastatin). The development of rhabdomyolysis in patients taking these drugs may be possible.
Clarithromycin and omeprazole may increase Cmax, AUC and T1 / 2 omeprazole by 30, 89 and 34%, respectively. The average pH in the stomach for 24 h was 5.2 – when receiving only omeprazole and 5, 7 – when taking omeprazole together with clarithromycin.
When using clarithromycin and indirect anticoagulants, the latter may be enhanced.
When using clarithromycin with sildenafil, tadalafil or vardenafil (phosphodiesterase-5 inhibitors), an increase in the inhibitory effect on phosphodiesterase may occur. Dose reduction of sildenafil, tadalafil and vardenafil may be required.
When used together with clarithromycin with theophylline and carbamazepine, it is possible to increase the concentration of the latter in the systemic circulation.
Reduction of tolterodine in the presence of clarithromycin (CYP3A inhibitor) may be required when using clarithromycin with tolterodine in patients with low metabolism through CYP2D6.
Co-administration of clarithromycin (1 g / day) with midazolam (orally) may increase the midazolam AUC by 7-fold. Co-administration of clarithromycin with midazolam and other benzodiazepines metabolised by CYP3A (triazolam and alprazolam) should be avoided. Dose adjustments may be required with midazolam (I / O) and clarithromycin. The same precautions should be applied to other benzodiazepines metabolised by CYP3A. For benzodiazepines whose elimination is independent of CYP3A (temazepam, nitrazepam, lorazepam), clinically significant interaction with clarithromycin is unlikely.
When administered with clarithromycin with colchicine, colchicine may be enhanced. Control of the possible development of clinical symptoms of colchicine intoxication is necessary, especially in the elderly and in patients with chronic renal failure (fatal cases have been reported).
When co-administered with clarithromycin and digoxin, serum digoxin concentration should be carefully monitored (possibly increasing its concentration and developing potentially lethal arrhythmias).
Concurrent administration of clarithromycin and zidovudine to adult HIV-infected patients may result in decreased CSS of zidovudine. Dose selection of clarithromycin and zidovudine is required. This type of interaction does not occur in HIV-infected children receiving clarithromycin as a suspension with zidovudine.
Co-administration of clarithromycin (1 g / day) and atazanavir (400 mg / day) may increase the atazanavir AUC by 28%, clarithromycin 2-fold, and decrease the AUC of 14-hydroxyclarithromycin by 70%. In patients with Cl creatinine 30-60 ml / min, the clarithromycin dose should be reduced by 50%. Clarithromycin at doses in excess of 1 g / day should not be administered with protease inhibitors.
Co-administration of clarithromycin and intraconazole may increase the plasma concentrations of drugs. Patients receiving itraconazole and clarithromycin should be closely monitored for possible enhancement or prolongation of the pharmacological effects of these drugs.
With the simultaneous administration of clarithromycin (1 g / day) and saquinavir (in soft gelatin capsules, 1200 mg 3 times daily), it is possible to increase the AUC and CSS of saquinavir by 177 and 187%, respectively, and clarithromycin by 40%. With the joint administration of these two drugs for a limited time in the doses / dosage forms indicated above, No dose adjustment is required.
Co-administration with verapamil may reduce blood pressure, bradyarrhythmia and lactic acidosis.
Overdose
Symptoms: abdominal pain, nausea, vomiting, diarrhea.
Treatment: gastric lavage, maintenance therapy. It is not removed during peritoneal or hemodialysis.
Active ingredient
Clarithromycin
drugstore conditions
drugstore
lekarstvennaja tablet form
Indications
Chlamydia, Skin infections, Gastrointestinal infections, Bronchitis, Pharyngitis, Otitis media, Sinusitis, Pneumonia
Possible Product Names
Clarithromycin Ecositrin tablets coated. about. 250 mg 14 pcs.
