Clacin-Asteria 500mg tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

clarithromycin

Available from:

Hankook Korus Pharm Co.

ATC code:

J01FA09

INN (International Name):

clarithromycin

Dosage:

500mg

Pharmaceutical form:

tablets

Units in package:

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

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-29

Patient Information leaflet

CLACIN-ASTERIA
Tab. 500mg
(Clarithromycin)
To be prescribed
ATC Code : J01FA09
CLACIN-ASTERIA Tab. 500mg
설명서(120*270)
C-0 M-0 Y-0 K-100
[COMPOSITION]
Each film coated tablet contains:
Active ingredient
Clarithromycin---------------------------------------------------------------------------------------------------------------------------
500mg(potency)
Excipients : Microcrystalline cellulose, Gelatinized starch, Povidone,
Croscarmellose sodium, Colloidal Silicon Dioxide, Stearic Acid,
Magnesium
stearate, Talc, Hydroxypropyl methylcellulose 2910, Diacetylated
Monoglycerides, Titanium oxide, Ethyl Vanillin, Sorbic acid, Yellow
No. 5
[INDICATION]
Lower respiratory tract Infection : Bronchitis, pneumonia
Upper respiratory tract Infection : Pharryngitis, sinusitis
Disseminates mycobacterial infections due to Mycobacterium avium, or
Mycobacterium intracellulare
H.pylori eradication to reduce the risk of duodenal ulcer recurrence
[DOSAGE AND ADMINISTRATION]
The dosage of Clarithromycin film-coated Tablets depends on the
clinical condition of the patient and has to be defined in any case by
the
physician.
_Children older than 12 years and adults:_
Standard dosage: The usual dose is 250 mg twice daily.
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice daily in severe infections.
_Elimination of Helicobacter pylori in adults:_
In patients with gastro-duodenal ulcers due to H. pylori infection
clarithromycin can be used in a dose of 500 mg twice daily during the
eradication therapy in combination with amoxicillin 1000 mg twice
daily and omeprazole 20 mg twice daily.
_Dosage in renal functional impairment:_
The maximum recommended dosages should be reduced proportionately to
renal impairment. At creatinine clearance rate of less than 30
ml/min, the dosage should be halved to 250 mg daily or in the most
severe infections to 250 mg twice daily. The duration of treatment
should
not exceed 14 days in these patients.
_Duration of therapy:_
The duration of therapy with Clarithromycin

Summary of Product characteristics

_Summary of Product Characteristics_
1.
NAME OF THE MEDICINAL PRODUCT
Clacin-Asteria Tab. 500mg
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION Active ingredient
No.
Chemical Name
Quantity/Tab.
Use
1
Clarithromycin
500.0mg
Active
(potency)
ingredient
Excipient(s)
No.
Chemical Name
Quantity/Tab.
Use
1
Microcrystalline cellulose
90.0mg
Inactive
2
Gelatinized starch
75.0mg
Inactive
3
Povidone
20.0mg
Bonding agent
4
Croscarmellose sodium
40.0mg
Disintegrant
5
Colloidal Silicon Dioxide
7.5mg
Disintegrant
6
Stearic Acid
12.5mg
Lubricant
7
Magnesium stearate
7.5mg
Lubricant
8
Talc
17.5mg
Lubricant
9
Hydroxypropyl
24.0mg
Coating agent
methylcellulose 2910
10
Diacetylated Monoglycerides
2.0mg
Coating agent
11
Titanium oxide
4.0mg
Coating agent
12
Ethyl Vanillin
q.s
flavoring agent
13
Sorbic acid
0.6mg
Antioxidant
14
Yellow No. 5
q.s
Coloring agent
_Summary of Product Characteristics_
3.
PHARMACEUTICAL FORM
Film coated Tablets
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Lower respiratory tract Infection : Bronchitis, pneumonia
Upper respiratory tract Infection : Pharryngitis, sinusitis
Disseminates
mycobacterial
infections
due
to
Mycobacterium
avium,
or
Mycobacterium
intracellulare
H.pylori eradication to reduce the risk of duodenal ulcer recurrence
4.2 Posology and method of administration
The dosage of Clarithromycin film-coated Tablets depends on the
clinical condition of the
patient and has to be defined in any case by the physician.
Children older than 12 years and adults:
Standard dosage: The usual dose is 250 mg twice daily.
High dosage treatment (severe infections): The usual dose may be
increased to 500 mg twice
daily in severe infections.
Elimination of Helicobacter pylori in adults:
In patients with gastro-duodenal ulcers due to H. pylori infection
clarithromycin can be used in
a dose of 500 mg twice daily during the eradication therapy in
combination with amoxicillin
1000 mg twice daily and omeprazole 20 mg twice daily.
Dosage in renal functional impairment:
The maximum recommended dosages should be reduced