KLACID MR TABLET 500 mg

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Clarithromycin

Verfügbar ab:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC-Code:

J01FA09

Dosierung:

500 mg

Darreichungsform:

TABLET, EXTENDED RELEASE

Zusammensetzung:

Clarithromycin 500 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

Aesica Queenborough Limited

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

1998-07-09

Gebrauchsinformation

KLACID
® 
MR 

1. NAME OF THE MEDICINAL PRODUCT 
Clarithromycin 500 mg, Modified-Release Tablets (MR) 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Clarithromycin 500 mg, Modified-Release Tablets: 
One tablet contains 500 mg Clarithromycin. 
Excipient: Lactose 115 mg per tablet 
Tablet sodium content: 15.3 mg per tablet 

For the full list
of excipients, see PHARMACEUTICAL PARTICULARS, LIST OF
EXCIPIENTS. 

3. PHARMACEUTICAL FORM 
FORMULATION PHARMACEUTICAL 
FORM 
Clarithromycin MR Tablets 
Yellow, ovaloid film-coated tablet 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 

Klacid MR is indicated for
treatment of infections caused by susceptible organisms. Indications include: 

Lower respiratory tract infections for example, acute
and chronic bronchitis, and pneumonia. 

Upper
respiratory tract infections for example, sinusitus and pharyngitis. 

Klacid MR is also indicated in skin and soft tissue infections of mild to moderate
severity, for example folliculitis, 
cellulitis and erysipelas. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

DOSAGE AND ADMINISTRATION 
ADULTS: The usual recommended dosage of Klacid MR in adults
is one 500mg modified-release tablet daily to be 
taken with food. In more severe infections, the dosage can be increased
to two 500mg modified-release tablets 
daily. The usual duration of treatment is 7 to 14 days. 

CHILDREN OLDER THAN 12 YEARS: As for adults.  

CHILDREN YOUNGER THAN 12 YEARS: Use Klacid Paediatric
Suspension. The use of Klacid MR has not been 
studied in children less than 12 years of age. 

Klacid MR should not be used in patients with renal impairment (creatinine clearance less than 30 mL/min). 
Klacid immediate release tablets may be used in this patient
population (see SECTION 4.3). 

Do not crush or 

Fachinformation

KLACID
®
MR
1. NAME OF THE MEDICINAL PRODUCT
Clarithromycin 500 mg, Modified-Release Tablets (MR)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clarithromycin 500 mg, Modified-Release Tablets:
One tablet contains 500 mg Clarithromycin.
Excipient: Lactose 115 mg per tablet
Tablet sodium content: 15.3 mg per tablet
For the full list of excipients, see PHARMACEUTICAL PARTICULARS, List
of excipients.
3. PHARMACEUTICAL FORM
Formulation
Pharmaceutical Form
Clarithromycin MR Tablets
Yellow, ovaloid film-coated tablet
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Klacid
®
MR is indicated for treatment of infections caused by susceptible
organisms. Indications include:
Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia (see section 4.4
and 5.1 regarding Sensitivity Testing)
Upper respiratory tract infections for example, sinusitis and
pharyngitis.
Klacid
®
MR is also indicated in skin and soft tissue infections of mild to
moderate severity, for example folliculitis,
cellulitis and erysipelas (see section 4.4 and 5.1 regarding
Sensitivity Testing).
4.2 Posology and method of administration
Dosage and Administration
Adults: The usual recommended dosage of Klacid
®
MR in adults is one 500mg modified-release tablet daily to
be taken with food. In more severe infections, the dosage can be
increased to two 500mg modified-release
tablets daily. The usual duration of treatment is 7 to 14 days.
Children older than 12 years: As for adults.
Children younger than 12 years: Use Klacid
®
Paediatric Suspension. The use of Klacid
®
MR has not been
studied in children less than 12 years of age.
Klacid
®
MR should not be used in patients with renal impairment (creatinine
clearance less than 30 mL/min).
Klacid
®
immediate release tablets may be used in this patient population (see
section 4.3).
Do not crush or chew Klacid
®
MR tablets.
Renal Impairment
Clarithromycin modified release should not be used in patients with
significant renal impairment (creatinine
clearance less than 30 ml/mi