Levofloxacin-Asteria 500mg tablets film-coated

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

levofloxacin

Tilgjengelig fra:

Hankook Korus Pharm Co.

ATC-kode:

J01MA12

INN (International Name):

levofloxacin

Dosering :

500mg

Legemiddelform:

tablets film-coated

Enheter i pakken:

(10/1x10/) in blister and(100/10x10/) in blister

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2015-12-29

Informasjon til brukeren

LEVOFLOXACIN-ASTERIA TAB. 500MG
(LEVOFLOXACIN)
[COMPOSITION]
Levofloxacin
---------------------------------------------------------------------500mg
EXCIPIENTS : Lactose, Corn starch, Calcium Carboxymethyl Cellulose,
Hydroxypropylcellulose,
Magnesium stearate, Hypromellose, Poly-ethylene glycol 600, Titanium
[ INDICATION ]
In adults with infection of mild or moderate severity, Levoflocaxin
tablet are indicated for the
treatment of the following infections when due to
levofloxacin0susceptible microorganisms :
- Acute bacterial sinusitis (adequately diagnosed according to
national and/or local guidelines
on the treatment of respiratory tract infections)
- Acute exacerbation of chronic obstructive pulmonary disease
including bronchitis
- Community-acquired pneumonia
- Uncomplicated urinary tract infections
- Acute pyelonephritis and complicated urinary tract infections
- Chronic bacterial prostatitis.
- Complicated skin and soft tissue infections / Complicated skin and
skin structure infections.
[ DOSAGE AND ADMINISTRATION]
Levofloxacin tablets are administered once or twice daily. The dosage
depends on the type and
severity of the infection and the sensitivity of the presumed
causative pathogen.
_Duration of treatment : _The duration of treatment varies according
to the course of the disease.
As with antibiotic therapy in general, administration of Levofloxacin
tablets should be
continued for a minimum of 48 to 72 hours after the patient has become
afebrile or evidence of
bacterial eradication has been obtained.
_Method of administration :_ The tablets may be taken during meals or
between meals.
Levofloxacin tablets should be taken at least two hours before or
after iron salts, antacids and
sucralfate administration since reduction of absorption can occur.
_Posology : _
_1) Dosage in patients with normal renal function_ (creatinine
clearance > 50 ml/min)
Indication
Daily dose regimen
_(according to severity)_
Duration of
treatment
Acute sinusitis
500 mg once daily
10 - 14 days
Acute exacerbation of chroni

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTIC (SPC)
OF
LEVOFLOXACIN-ASTERIA TAB. 500MG
HANKOOK KORUS PHARM. CO., LTD.
11, GEODUDANJI 1-GIL, DONGNAE-MYEON, CHUNCHEON-SI, GANGWON-DO, KOREA
2
1. NAME OF THE MEDICINAL PRODUCT
Levofloxacin-Asteria Tab. 500mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
No.
Chemical Name
Quantity/Tab.
Use
1
Levofloxacin
500mg
Active
ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
Lactose
56 mg
Inactive
2
Corn starch
50 mg
Inactive
3
Calcium Carboxymethyl
Cellulose
8 mg
Disintegrant
4
Hydroxypropylcellulose
14 mg
Binder
5
Magnesium stearate
10 mg
Lubricant
6
Hypromellose
8 mg
Coating
7
Polyethylene glycol 6000
4 mg
Coating
8
Titanium Oxide
3 mg
Screening agent
3. PHARMACEUTICAL FORM
Film coated Tablets
3
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults with infection of mild or moderate severity, Levoflocaxin
tablet are indicated for the
treatment of the following infections when due to
levofloxacin0susceptible microorganisms :
- Acute bacterial sinusitis (adequately diagnosed according to
national and/or local guidelines on the
treatment of respiratory tract infections)
- Acute exacerbation of chronic obstructive pulmonary disease
including bronchitis
- Community-acquired pneumonia
- Uncomplicated urinary tract infections
- Acute pyelonephritis and complicated urinary tract infections
- Chronic bacterial prostatitis.
- Complicated skin and soft tissue infections / Complicated skin and
skin structure infections.
In Acute bacterial sinusitis, Acute exacerbation of chronic
obstructive pulmonary disease including
bronchitis, Uncomplicated urinary tract infections and Complicated
skin and soft tissue infections /
Complicated skin and skin structure infections, Levofloxacin -Asteria
Tab. 500m should be used only
when it is considered inappropriate to use other antibacterial agents
that are commonly recommended
for the treatment of these infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY