Fromilid Uno coated pills with prolonged action 500mg N14
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Active ingredients
Clarithromycin
Release form
Pills
Composition
1 tab. clarithromycin 500 mg. Excipients: sodium alginate - 80 mg, sodium calcium alginate - 90 mg, lactose monohydrate - 225 mg, povidone - 30 mg, polysorbate 80 - 30 mg, silica colloidal anhydrous - 5 mg, magnesium stearate - 10 mg, talc - 30 mg.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and upper respiratory tract (tonsillitis, pharyngitis, sinusitis, acute otitis media) - lower respiratory infections (bronchitis, community-acquired pneumonia) - infections of the skin and soft tissues (in including folliculitis, erysipelas).
Contraindications
- chronic renal failure severe (KK less than 30 ml / min) - episodes of cholestatic jaundice and / or abnormal liver function that occurred during the administration of clarithromycin (in history) - porphyria - I trimester of pregnancy - lactation (breastfeeding) - age up to 18 years (efficacy and safety not established) - simultaneous use with astemizole, cisapride, pimozide, terfenadine, ergotamine and other ergot alkaloids, midazolam, alprazolam, triazolam - lactose intolerance, deficiency pots, glucose-galactose malabsorption - hypersensitivity to clarithromycin, and other components of the drug - increased sensitivity to other macrolide antibiotics. With caution: II-III trimesters of pregnancy, mild to moderate renal insufficiency (CC> 30 ml / min), liver failure, myasthenia gravis, simultaneous use of drugs metabolized in the liver.
Dosage and administration
The drug is taken orally during meals. Tablets should be swallowed whole, not breaking and not chewing. Adults are prescribed in a dose of 500 mg (1 tab.) 1 time / day. In severe infections: 1000 mg (2 tab.) 1 time / day. The course of treatment is 5-14 days, with community-acquired pneumonia and sinusitis - 6-14 days. Elderly patients do not need to change the dose of clarithromycin, except in cases of pronounced renal dysfunction. It is not necessary to apply Fromilid uno with CC less than 30 ml / min. In patients with hepatic insufficiency, dose adjustment is not required.
Side effects
Classification of the incidence of side effects (WHO): very often (1/10); often (from 1/100 to less than 1/10); infrequently (from 1/1000 to less than 1/100); rarely (from 1/10 000 to less than 1/1000); very rarely (from less than 1/10 000), including individual messages; frequency unknown (cannot be estimated based on available data). In each group, unwanted effects are presented in order of decreasing severity. On the part of the digestive system: often - dyspepsia, nausea, abdominal pain, increased activity of liver enzymes; infrequently - vomiting, diarrhea, stomatitis, glossitis, candidiasis of the oral mucosa, discoloration of the teeth and tongue, acute pancreatitis, hepatocellular and cholestatic hepatitis, cholestatic jaundice, pseudomembranous colitis, anorexia, constipation, dry oral mucosa, pneumogranous colitis, anorexia, constipation, dry mucous membrane gastritis; very rarely - cases of fatal liver failure were reported, mainly due to severe concomitant diseases and / or concomitant drug therapy. From the skin and subcutaneous tissue: often - increased perspiration; frequency is unknown - drug rash with eosinophilia and systemic symptoms, acne, erysipelas, erythrasma. From the nervous system: often - headache; infrequently - paresthesias, drowsiness, anxiety, hallucinations, convulsions, psychosis, dizziness, confusion, fear, insomnia, nightmares, depersonalization, disorientation, tremor, depression; frequency unknown - mania. From the senses: often - a distortion or loss of taste (dysgeusia); infrequently - noise, ringing in the ears, isolated cases of hearing loss (after drug withdrawal, hearing is restored), vertigo; very rarely - cases of change in smell. Since the cardiovascular system: infrequently - ventricular tachycardia, including such as "pirouette", fluttering and ventricular fibrillation, prolongation of the QT interval on the ECG. On the part of the hematopoietic system: rarely - thrombocytopenia (unusual bleeding, hemorrhage), leukopenia; frequency is unknown - agranulocytosis. From the musculoskeletal system: infrequently - myalgia, arthralgia; frequency unknown - myopathy. From the urinary system: infrequently - interstitial nephritis; the frequency is unknown - renal failure.Allergic reactions: rarely - skin rash, pruritus, urticaria, skin flushing, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), anaphylactic reactions; the frequency is unknown - Scheinlein-Henoch purpura. Laboratory indicators: infrequently - increase in the concentration of creatinine, hypoglycemia (including with the simultaneous use of hypoglycemic drugs), increased activity of alkaline phosphatase, increased bilirubin content; unknown frequency - increased INR, prolongation of prothrombin time. Other: secondary infections (development of resistance to microorganisms); infrequently - asthenia.