Febzin XL 500mg Prolonged-release Tablets
Each prolonged-release tablet contains 500mg of clarithromycin as clarithromycin citrate.
Excipient with known effect:
Each tablet contains 293.2mg of lactose monohydrate.
For the full list of excipients see section 6.1.
Prolonged-release tablet.
Yellow, oblong shaped, biconvex film-coated tablets19.15 ± 0.2mm long, 8.95 ± 0.2mm width and 7.55 ± 0.2mm thick with no markings.
Febzin XL 500mg Prolonged-release Tablets are indicated in adults and children older than12 years for treatment of infections caused by susceptible organisms.
Indications include:
- Lower respiratory tract infections for example acute bacterial exacerbation of chronic bronchitis and mild to moderate community acquired pneumonia.
- Upper respiratory tract infections for example acute bacterial sinusitis and bacterial pharyngitis.
- Skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas.
Consideration should be given to official guidance on the appropriate use of antibacterial agents
Posology
Adults:
The usual recommended dosage of Febzin XL 500mg Prolonged-release Tablets in adults is one 500mg prolonged-release tablet daily to be taken with food.
In more severe infections, the dosage can be increased to two 500mg prolonged-release tablets taken as one dose daily.
Dose must be taken at the same time every day.
The usual duration of treatment is 6 to 14 days.
Children older than 12 years:
Same dosage as for adults.
Children 12 years old and younger:
Use of Febzin XL 500mg Prolonged-release Tablets are not recommended for children 12 years old and younger. A more appropriate clarithromycin formulation should be used in this age group, such as paediatric suspension.
Patients with renal impairment:
Febzin XL 500mg Prolonged-release Tablets should not be used in patients with renal impairment (creatinine clearance less than 30 ml/min). The dosage of clarithromycin should be reduced by one-half, i.e. 250 mg once daily, or 250 mg twice daily in more severe infections. Treatment should not be continued beyond 14 days in these patients. Because the tablet cannot be split, the dose cannot be reduced from 500 mg daily. A more appropriate clarithromycin formulation should be used in this patient population, such as immediate-release tablets (see section 4.3).
Method of administration
Tablets must be swallowed whole.
Dose must be taken at the same time every day.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Clarithromycin is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs.
As the dose cannot be reduced from 500 mg daily, Febzin XL 500mg Prolonged-release Tablets is contraindicated in patients with creatinine clearance less than 30 ml/min.
Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide and terfenadine as this may result in QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointe (see section 4.5).
Concomitant administration with ticagrelor or ranolazine is contraindicated
Concomitant administration of clarithromycin and ergotamine or dihydroergotamine is contraindicated, as this may result in ergot toxicity (see section 4.5).
Clarithromycin should not be given to patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointe (see sections 4.4 and 4.5).
Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibito
