KLACID FORTE TABLET 500 mg

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Clarithromycin

可用日期:

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

ATC代码:

J01FA09

剂量:

500 mg

药物剂型:

TABLET, FILM COATED

组成:

Clarithromycin 500 mg

给药途径:

ORAL

处方类型:

Prescription Only

厂商:

Aesica Queenborough Limited

授权状态:

ACTIVE

授权日期:

1997-02-13

资料单张

KLACID
® 
/ KLACID
® 
FORTE 

1. NAME OF THE MEDICINAL PRODUCT 
Clarithromycin 250mg, Immediate-Release Tablets 
Clarithromycin 500mg, Immediate-Release Tablets  

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Clarithromycin 250mg, Immediate-Release Tablet: 
One tablet contains 250mg Clarithromycin 
Tablet sodium content: 3.4 mg tablet 

Clarithromycin 500mg, Immediate-Release Tablet: 
One tablet contains 500mg Clarithromycin 
Tablet sodium content: 6.1 mg tablet 

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

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

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 

Klacid is indicated
for treatment of infections caused by one or more 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 is appropriate for initial therapy in community acquired respiratory infections and has
been shown to be 
active _in vitro _against common
and atypical respiratory pathogens as listed
in the microbiology section. 

Klacid is also indicated in skin and soft
tissue infections of mild to moderate severity. 

Klacid in the presence of acid suppression
effected by omeprazole is also indicated for the
eradication of _H. pylori _
in patients with proven duodenal ulcers. See Dosage and
Administration section. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

DOSAGE AND ADMINISTRATION 
RESPIRATORY TRACT/SKIN AND SOFT TISSUE INFECTIONS  

ADULTS: The usual dose in adults and children 12 years
of age or older, is 250 mg twice daily for 7 days although 
this may be increased t

产品特点

KLACID
®
/ KLACID
®
FORTE
1. NAME OF THE MEDICINAL PRODUCT
Clarithromycin 250mg, Immediate-Release Tablets (IR)
Clarithromycin 500mg, Immediate-Release Tablets (IR)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clarithromycin 250mg, Immediate-Release Tablet:
One tablet contains 250mg Clarithromycin
Tablet sodium content: 3.4 mg tablet
Clarithromycin 500mg, Immediate-Release Tablet:
One tablet contains 500mg Clarithromycin
Tablet sodium content: 6.1 mg tablet
For the full list of excipients, see PHARMACEUTICAL PARTICULARS, List
of excipients.
3. PHARMACEUTICAL FORM
Formulation
Pharmaceutical Form
Clarithromycin IR Tablets
Yellow, ovaloid film-coated tablet
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Klacid
®
is indicated for treatment of infections caused by one or more
susceptible organisms in adults and
children 12 years and older. Indications include:
1.
Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia (see
section 4.4 and 5.1 regarding Sensitivity Testing).
2.
Upper respiratory tract infections for example, sinusitis and
pharyngitis.
3.
Klacid
®
is appropriate for initial therapy in community acquired respiratory
infections and has been
shown to be active in vitro against common and atypical respiratory
pathogens as listed in the
microbiology section.
4.
Klacid
®
is also indicated in skin and soft tissue infections of mild to
moderate severity (see section 4.4
and 5.1 regarding Sensitivity Testing).
5.
Klacid
®
in the presence of acid suppression effected by omeprazole is also
indicated for the eradication
of H. pylori in patients with proven duodenal ulcers. See Dosage and
Administration section.
Consideration should be given to national official guidance on the
appropriate use of antibacterial agents.
4.2 Posology and method of administration
Dosage and Administration
Respiratory tract/skin and soft tissue infections
Adults: The usual dose in adults and children 12 years of age or
older, is 250 mg twice daily for 7 days although
this may be increased to