Levofloxacin-Asteria tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

levofloxacin

Available from:

Hankook Korus Pharm Co.

ATC code:

J01MA12

INN (International Name):

levofloxacin

Dosage:

500mg

Pharmaceutical form:

tablets film-coated

Units in package:

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

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-30

Patient Information leaflet

ATC CODE: J01MA12 [LEVOFLOXACIN-ASTERIA]
(Levofloxacin)
[ COMPOSITION ]
Levofloxacin - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - - 500mg
Excipients : Lactose, Corn starch, Calcium Carboxymethyl Cellulose,
Hydroxypropylcellulose, Magnesium stearate, Hypromellose,
Poly-ethylene glycol 600,
Titanium Oxide
[ 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.
[DOSATE 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. Levoflocaxin
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

Summary of Product characteristics

Summary of Product Characteristics
1
SUMMARY OF PRODUCT CHARACTERISTIC (SPC)
LEVOFLOXACIN-ASTERIA TAB. 500MG
Summary of Product Characteristics
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
Summary of Product Characteristics
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 POSOLO