Fromilid UNO tablets with modified release 500 mg. №7

Description

Fromilid UNO Composition
active substance: clarithromycin;

1 tablet contains 500 mg of clarithromycin;

excipients: sodium alginate sodium alginate calcium, lactose, povidone, polysorbate 80, colloidal silicon dioxide, magnesium stearate, talc, hypromellose, iron oxide yellow (E172), titanium dioxide (E 171), propylene glycol.

Fromilid UNO Dosage form
Modified release tablets.

Basic physical and chemical properties: oval, biconvex film-coated tablets, brownish-yellow in color with a displaced letter “U” on one side.

Fromilid UNO Pharmacotherapeutic group
Antibacterial agents for systemic use.

Macrolides, lincosamides and streptogramins. Clarithromycin. ATX code J01F A09.

Pharmacodynamics
Clarithromycin is a semi-synthetic antibiotic of the macrolide group. The antibacterial effect of clarithromycin is determined by its binding to the 5OS-ribosomal subunit of sensitive bacteria and inhibition of protein biosynthesis. Modified release tablets are a homogeneous crystalline base that, when passing through the gastrointestinal tract, provides a prolonged release of the active substance.

The drug is highly effective in vitro against a wide range of aerobic and anaerobic gram-positive and gram-negative microorganisms, including hospital strains. The minimum inhibitory concentration (MIC) of clarithromycin is usually half the MIC of erythromycin.

Clarithromycin is highly effective in vitro against Legionella pneumophila and Mycoplasma pneumonie. In vitro studies have shown that strains of Enterobacteriaceae and Pseudomonas, like gram-negative bacteria, do not ferment lactose and are insensitive to clarithromycin.

Microbiology

Clarithromycin is active in vitro and in clinical practice against most strains of the following microorganisms:

Aerobic gram-positive microorganisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Listeria monocytogenes.

Aerobic gram-negative microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhlis, Neisseria gonorrhoeae, Legionella pneumophila.

Indications
Treatment of infections caused by microorganisms sensitive to clarithromycin.

lower respiratory tract infections (bronchitis, pneumonia, etc.);
upper respiratory tract infections (sinusitis, pharyngitis, etc.);
infections of the skin and soft tissues (folliculitis, erysipelas, etc.).

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)) ergotamine alkaloids, for example dihydroergotamine (this can lead to ergotoxicity) inhibitors of HMG-CoA reductase (statins), which are largely metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis (see section “Peculiarities of use” and ” Interaction with other medicinal products and other types of interactions “);
simultaneous use of clarithromycin and midazolam (see sections “Peculiarities of use” and “Interaction with other drugs and other types of interactions”);
congenital or acquired lengthening of the QT interval or a history of ventricular arrhythmias, including ventricular tachycardia pirouette (torsade de pointes) (see sections “Peculiarities of use” and “Interaction with other medicinal products and other types of interactions”);
hypokalemia (risk of lengthening the QT interval);
severe hepatic impairment and concomitant renal impairment;
concomitant use of clarithromycin (and other strong CYP3A4 inhibitors) with colchicine in patients with renal or hepatic insufficiency (see sections “Peculiarities of use” and “Interaction with other drugs and other types of interactions”);
concomitant use of clarithromycin with ticagrelor or ranolazine;
creatinine clearance less than 30 ml / min (since this form does not allow the dose to be reduced below 500 mg per day).