Fromilid granules for suspension 125 mg/5 ml. 60 ml. oral use

Description

Fromilid suspension Storage
active substance: clarithromycin;

5 ml of suspension for oral administration (1 syringe) contain 125 mg of clarithromycin;

Excipients: carbomer, povidone, hypromellose phthalate (HP 55), talc, castor oil, xanthan gum, banana flavor, potassium sorbate, citric acid, colloidal anhydrous silica, titanium dioxide (E 171), sucrose.

Fromilid suspension Dosage form
Granules for oral suspension.

Main physical and chemical properties: small inhomogeneous granules from white to almost white with a banana aroma.

Fromilid suspension Pharmacotherapeutic group
Antimicrobials for systemic use. Macrolides. ATX code J01F A09.

Pharmacological properties

Pharmacodynamics.

Clarithromycin is a semi-synthetic antibiotic of the macrolide group. The antibacterial action of clarithromycin is determined by its binding to the 5OS ribosomal subunit of susceptible 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 concentrations (IPC) of clarithromycin are usually twice as low as the IPC of erythromycin.

Clarithromycin in vitro has high activity against Legionella pneumophila and Mycoplasma pneumonie. Acts bactericidal against Helicobacter pylori, clarithromycin activity is higher at neutral pH than at acidic pH. Clarithromycin is effective against clinically significant strains of mycobacteria. 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 the following microorganisms.

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

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

Indication
Infections caused by clarithromycin-sensitive microorganisms:

Infections of the upper respiratory tract, ie nasopharynx (tonsillitis, pharyngitis), and infections of the paranasal sinuses.
Infections of the lower respiratory tract (bronchitis, acute lobar pneumonia and primary atypical pneumonia).
Acute otitis media.
Skin and soft tissue infections (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 or Mycobacterium kansasii.

Contraindication
Hypersensitivity to macrolide antibiotics and to other components of the drug.
Concomitant use of astemizole, cisapride, domperidone, pimozide, terfenadine (as this may lead to prolongation of the QT interval and the development of cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation and pirouette ventricular tachycardia, erythema, this may lead to ergotoxicity), HMG-CoA reductase inhibitors (statins), which are extensively metabolised by CYP3A4 (lovastatin or simvastatin), due to an increased risk of myopathy, including rhabdomyolysis (see sections “Peculiarities” and “Interaction”). drugs and other types of interactions “).
Concomitant use of clarithromycin and oral midazolam (see section “Interaction with other medicinal products and other forms of interaction”).
History of QT prolongation or a history of ventricular arrhythmias, including pirouette ventricular tachycardia (torsade de pointes) (congenital or established acquired QT prolongation) (see sections “Special warnings and special precautions for use” and “Interaction with other medicinal products” and other interactions).
Water-salt imbalance (hypokalemia or hypomagnesemia) – due to the risk of prolongation of the QT interval.