Fromilid coated tablets 500 mg. №14

Description

Fromilid 500 mg Composition
active substance: clarithromycin;

1 coated tablet contains 500 mg clarithromycin;

auxiliary substances: corn starch, microcrystalline cellulose, colloidal silicon dioxide, corn starch, potassium polacrilin, talc, magnesium stearate, propylene glycol, iron dye yellow oxide (E172), titanium dioxide (E 171).

Fromilid 500 mg Dosage form
Film-coated tablets.

Basic physical and chemical properties: oval convex tablets of slightly brownish-yellow color, film-coated.

Fromilid 500 mg Pharmacotherapeutic group
Antimicrobial agents for systemic use. Macrolides, lincosamides and streptogramins. Clarithromycin. ATX code J01F A09.

Pharmacodynamics
Clarithromycin, a semi-synthetic antibiotic of the macrolide group, interacts with the 50S ribosomal subunit of bacteria, thus inhibiting protein synthesis.

Basically, it has a bacteriostatic, and in some cases also a bactericidal effect (against Streptococcus pyogenes, Streptococcus pneumoniae and Moraxella catarrhal).

The following microorganisms are sensitive to clarithromycin: Mycoplasma pneumoniae, Legionella pheumophila, Chlamydia trachomatis i Chlamydia pneumoniae, Ureaplasma urealyticum; Gram-positive organisms (Streptococcus and Staphylococcus, Listeria monocytogenes, Corynebacterium spp.) Gram-negative microorganisms (Haemophilus influenzae i Haemophilus ducreyi, Moraxella catarrhalis, Bordetella pertussis, Neisseria gonorrhoeae i Neisseria meningitidis, Borrelia burgdorferi, Pasteurella multocida, Campylobacter spp., and Helicobacter pylori) Some anaerobes (Eubacterium spp., Peptococcus spp., Peptostreptococus spp., Propionobacterium spp., Clostridium perfringens i Bacteroides melaninogenicus) Toxoplasma gondii and all mycobacteria except Mycobacterium tuberculosis.

Due to the changing structure of the ribosomes of human cells, macrolides do not bind to the ribosomal units of the human cell, which is the reason for the low toxicity of macrolides in humans.

Pharmacokinetics
Clarithromycin is well absorbed from the gastrointestinal tract. Bioavailability is approximately 55% after an oral dose. Food may slow absorption, but does not significantly affect the bioavailability of clarithromycin. About 20% of clarithromycin is immediately metabolized to form the main metabolite, 14-hydroxyclarithromycin, which exhibits the same biological effect as clarithromycin. In healthy individuals, it reaches serum concentrations proportional to the size of the oral doses.

Indications
Infections caused by microorganisms sensitive to clarithromycin.

Lower respiratory tract infections (bronchitis, acute lobar pneumonia and primary Antipova pneumonia).
Upper respiratory tract infections, i.e. nasopharynx (tonsillitis, pharyngitis) and sinus infections.
Skin and soft tissue infections (impetigo, folliculitis, erysipeloid, furunculosis, infected wounds).
Acute and chronic odontogenic infections.
Disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare. Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum, or Mycobacterium kansasii.
Eradication of Helicobacter pylori in patients with duodenal ulcer with inhibition of hydrochloric acid secretion (the activity of clarithromycin against Helicobacter pylori is higher at neutral pH than at acidic pH).
Attention should be paid to the official recommendations regarding the correct use of antibacterial agents.

Contraindications
Hypersensitivity to clarithromycin or other macrolide antibiotics or to any of the drug’s components.
Concomitant use with any of the following drugs: astemizole, cisapride, pimozide, terfenadine (this can lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and ventricular tachycardia pirouette (torsades de pointes) ergot ergotamine alkaloids, for example (this can lead to ergotoxicity) inhibitors of HMG-CoA reductase (statins), to a large extent mobilized by CYP3A4 (lovastatin or simvastatin), for an increased risk of myopathy, including rhabdomyolysis (see sections “Peculiarities of use”, “Interaction with other medicinal products drugs and other types of interactions. “) Simultaneous use of clarithromycin and midazolam (see sections” Peculiarities of use “,” Interaction with other drugs and other types of interactions “).
Patients with a history of prolongation of the QT interval or ventricular cardiac arrhythmias, including pirouette of ventricular tachycardia (torsades de pointes) (see Sections “Peculiarities of use”, “Interaction with other drugs and other types of interactions”).
Patients with hypokalemia (risk of prolongation of the QT interval).
Severe liver failure and concomitant renal failure.
Concomitant use of clarithromycin (and other strong CYP3A4 inhibitors) with colchicine in patients with renal or hepatic insufficiency (see Sections “Peculiarities of use”, “Interaction with other drugs and other types of interactions”).
Concomitant use of clarithromycin with ticagrelor or ranolazine.