Fromilid granules for suspension 250 mg/5 ml. 60 ml. oral use

Description

Fromilid granules Composition
active substance: clarithromycin;

5 ml of suspension (1 syringe) contains 250 mg of clarithromycin;

excipients: carbomer, povidone, hypromellose phthalate (HP 55), talc, purified castor oil, xanthan gum, orange flavoring, citric acid, sodium saccharin, monoammonium glycyrrhizinate, neohesperidine dihydrochalcone, silicon dioxide colloid dioxide (E1) , potassium sorbate.

Fromilid granules Dosage form
Granules for preparation of a suspension for oral administration.

Basic physical and chemical properties: small, inhomogeneous granules from white to almost white with an orange flavor.

Fromilid granules Pharmacotherapeutic group
Antimicrobial 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. 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 that of erythromycin.

Clarithromycin is highly effective against Legionella pneumophila and Mycoplasma pneumonie. Bactericidal against Helicobacter pylori, clarithromycin activity is higher at neutral pH than at acidic pH. Clarithromycin is effective against clinically relevant mycobacterial strains. In vitro studies have shown that strains of Enterobacteriaceae and Pseudomonas, as well as gram-negative bacteria that do not produce lactose, are insensitive to clarithromycin.

Clarithromycin is active in vitro and in clinical practice against most strains of these microorganisms.

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

Indications
Infections caused by microorganisms sensitive to clarithromycin:

lower respiratory tract infections (bronchitis, acute lobar pneumonia, primary atypical pneumonia)
upper respiratory tract infections (tonsillitis, pharyngitis) and sinus infections;
acute otitis media of the middle ear;
infections of the skin and its appendages (folliculitis, impetigo, erysipelas, furunculosis, infected wounds)
disseminated or localized mycobacterial infections caused by Mycobacterium avium or Mycobacterium intracellulare. Localized infections caused by Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium kansasii.

Contraindications
Hypersensitivity to clarithromycin or other macrolide antibiotics or to any of the drug’s components.
Concomitant use of astemizole, cisapride, pimozide, terfenadine (this can lead to a prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and ventricular tachycardia pirouette (torsades de pointes)), since these are ergot alkaloids, for example, ergotroamine lead to ergotoxicity), inhibitors of HMG-CoA reductase (statins), is largely metabolized by CYP3A4 (lovastatin or simvastatin), for an increased risk of myopathy, including rhabdomyolysis (see sections “Interaction with other drugs and other types of interactions”, “Features of the application”).
Simultaneous use of clarithromycin and midazolam (see Sections “Interaction with other medicinal products and other types of interactions”).
Congenital or acquired lengthening of the QT interval or a history of ventricular arrhythmias, including pirouette of ventricular tachycardia (torsades de pointes) (see Sections “Interaction with other medicinal products and other forms of interaction”, “Peculiarities of use”).
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 impairment (see Sections “Interaction with other medicinal products and other types of interactions”, “Peculiarities of use”).
Concomitant use of clarithromycin with ticagrelor or ranolazine.