Klacid SR tablets modified-release film-coated

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

clarithromycin

Verfügbar ab:

Aesica Queenborough Limited

ATC-Code:

J01FA09 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ և թողարկման ձև

INN (Internationale Bezeichnung):

clarithromycin

Dosierung:

500mg (5/1x5/) in blister, (14/1x14/) in blister

Darreichungsform:

tablets modified-release film-coated

Einheiten im Paket:

500mg (5/1x5/) in blister, (14/1x14/) in blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2020-10-21

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTIC
CLARITHROMYCIN
1. NAME OF THE MEDICINAL PRODUCT
Klacid
®
SR 500 mg, Modified-Release Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Clarithromycin 500 mg, modified-Release Tablets:
One tablet contains 500 mg Clarithromycin.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clarithromycin 500 mg,Modified-Release Film-coated tablets
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Clarithromycin is indicated for treatment of infections due to
susceptible organisms in adults and
children 12 years and older:
•
Lower
respiratory
tract
infections
(e.g.,
bronchitis,
pneumonia)
(see
section
4.4
and
5.1
regarding Sensitivity Testing);
•
Upper respiratory tract infections (e.g., pharyngitis, sinusitis)
•
Skin and soft tissue infections (e.g., folliculitis, cellulitis,
erysipelas) (see section 4.4 and 5.1
regarding Sensitivity Testing)
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
_Adults _
The usual recommended dosage of clarithromycin tablets with a modified
action in adults and
children 12 years and older - 500 mg once a day with meals. In more
severe infections, the dosage
can be increased to 1000 mg once a day (500 mg 2 times). The usual
duration of therapy - from 5 to
14 days, except for the treatment of community-acquired pneumonia and
sinusitis, which require
therapy for 6-14 days.
Klacid
®
SR tablets not crush or chew, they must be swallowed whole.
_Impaired renal function _
In patients with severe renal impairment (creatinine clearance less
than 30 mL/min), the usual
recommended dose is 250 mg once daily. Because the modified-release
tablet cannot be split,
instead immediate-release tablets should be used. In more severe
infections, the recommended dose
is one 500 mg modified-release tablet once daily. No dose adjustment
is required for patients with
moderate renal impairment (creatinine clearance 30