صيدلية اونلاين

KLACID XL 500MG

$75.00 $19.70
1. Name of the medicinal product

klaricare XL 500mg Prolonged-release Tablets

2. Qualitative and quantitative composition

Each prolonged-release tablet contains 500mg of clarithromycin as clarithromycin citrate.

Excipient with known effect:

Each tablet contains 293.2mg of lactose monohydrate.

3. Pharmaceutical form

Prolonged-release tablet.

4. Clinical particulars
4.1 Therapeutic indications

klaricare 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

4.2 Posology and method of administration

Posology

Adults:

The usual recommended dosage of Klaricare 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 Klaricare 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:

Klaricare 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 .

Method of administration

Tablets must be swallowed whole.

Dose must be taken at the same time every day.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients .

Clarithromycin is contra-indicated in patients with known hypersensitivity to macrolide antibiotic drugs.

As the dose cannot be reduced from 500 mg daily, Klaricare 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.

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 .

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 .

Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins), that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy including rhabdomyolysis.

Clarithromycin should not be given to patients with hypokalaemia (this may result in QT interval prolongation).

Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment.

As with other strong CYP3A4 inhibitors, clarithromycin should not be used in patients taking colchicine.

4.4 Special warnings and precautions for use

The physician should not prescribe clarithromycin to pregnant women without carefully weighing the benefits against risk, particularly during the first three months of pregnancy .

Caution is advised in patients with severe renal insufficiency .

Clarithromycin is principally excreted by the liver. Therefore, caution should be exercised in administering the antibiotic to patients with impaired hepatic function.

Caution should also be exercised when administering clarithromycin to patients with moderate to severe renal impairment 

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