Cefichew 400mg tablets chewable

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

cefixime (cefixime trihydrate)

Mevcut itibaren:

SRS Pharmaceuticals Pvt. Ltd.

ATC kodu:

J01DD08

INN (International Adı):

cefixime (cefixime trihydrate)

Doz:

400mg

Farmasötik formu:

tablets chewable

Paketteki üniteler:

(10/1x10/) blister

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2015-02-20

Bilgilendirme broşürü

100 x 220 mm
INSERT SIZE
Black
Cefichew 200/400
Cefixime Chewable Tablets
Carefully read the instruction before use
COMPOSITION:
CEFICHEW 200
Each chewable tablet contains:
Cefixime as trihydrate eq. to
Anhydrous Cefixime………200 mg
CEFICHEW 400
Each chewable tablet contains:
Cefixime as trihydrate eq. to
Anhydrous Cefixime…………400 mg
TRADE NAME:
1)Cefichew 200 (Cefixime Chewable tablets 200mg)
2)Cefichew 400 (Cefixime Chewable tablets 400mg)
ATC CODE :
J01DD08
INTERNATIONAL NONPROPRIETARY NAME:
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-
[[(2-amino-4-thiazolyl)[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-,
trihydrate, [6R
-[6,
α
7
β
(Z)]]-.(6R,
7R
)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-vinyl-5-thia-1-
2
azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7
-(Z)-[O-(carboxymethyl)oxime]trihydrate.
PHARMACOTHERAPEUTICAL GROUPS :
Third-generation cephalosporins
ROUTE OF ADMINISTRATION: Oral
PHARMACOLOGICAL ACTION:
Cefixime, like other Cephalosporins has a bactericidal action
resulting from the inhibition of cell wall
synthesis. Cefixime is highly stable in the presence of beta-lactamase
enzymes. Cefixime binds
with high affinity to penicillin – binding proteins in the bacterial
cell wall , thus interfering with
peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure
that provides the cell wall
with mechanical stability. The final stage in the synethesis of
peptidoglycan involves the completion
of the cross-linking. The terminal glycine residue of the petaglycine
bridge is linked to the forth
residue of the pentapeptide , the transpeptidase enzyme that performs
this step in inhibited by
cephalosporins and penicillins. As a result the bacterial cell wall is
weakened , and the cell swells
and then ruptures. Cefixime is bactericidal against a broad spectrum
of bacteria at easily achievable
plasma concentrations.
PHARMACOKINETICS :
Only 40 to 50% of an oral dose of cefixime is absorbed from the
gastrointestinal tract, whether taken
before or after meals, although t

Ürün özellikleri

1. NAME OF THE MEDICINAL PRODUCT : CEFICHEW 400
THE SUMMARY OF THE PRODUCT CHARACTERISTICS
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
with
indication
of
active
substances (International nonproprietary name or chemical name),
indication of
other excipients knowledge of which is essential for safe and proper
administration
of the medicinal product.
BATCH SIZE
: 100000 Tablets.
SR.
NO.
INGREDIENTS
LABEL CLAIM/
TABLET
(IN MG)
OVERAGES
QTY./TABLET
(IN MG)
QTY./BATCH (IN KG)
REASON FOR
INCLUSION
ACTIVE
1.
Cefixime Trihydrate
Eq. to Cefixime
# 448.0
≈
400.0
5%
*470.40
47.04
Antibiotic
EXCIPIENTS
2.
Aspartame
-
-
20.0
2.0
Sweetening
Agent
3.
Flavour Orange
-
-
10.0
1.0
Flavour
4.
Flavour Strawberry
-
-
7.0
0.700
Flavour
5.
Flavour Mixed Fruit
-
-
5.0
0.500
Flavour
6.
Mannitol
-
-
177.0
17.700
For pleasant
taste and
mouth feel
7.
Supersol M
-
-
292.60
29.260
Diluent
8.
Magnesium Stearate
-
-
12.0
1.200
Diluent
9.
Talc
-
-
6.0
0.600
Lubricant
# 448mg of Cefixime Trihydrate equivalent to 400mg of Cefixime.
* Quantity may vary as per assay & water content.
5% overages added to compensate loss during production.
3. PHARMACEUTICAL FORM: Chewable Tablet
4. CLINICAL CHARACTERISTICS :
4.1 INDICATIONS :
THERAPEUTIC INDICATIONS:
Cefixime is used for the treatment of acute otitis media, pharyngitis
and tonsillitis,
respiratory tract infections (acute bronchitis, acute exacerbations of
chronic bronchitis)
, or urinary tract infections.
4.2
POSOLOGY
AND
METHOD
OF
ADMINISTRATION
(WHERE
APPROPRIATE
DOSAGE
ADJUSTMENTS IN SPECIFIC PATIENT GROUP SHOULD BE STATED) :
Tablet for oral use
Cefixime chewable tablets should be chewed before swallowing. The
prescribed dose
may be administered without regard to meals.
ADULT DOSAGE :
For the treatment of acute otitis media, pharyngitis and tonsillitis,
respiratory tract
infections (acute bronchitis, acute exacerbations of chronic
bronchitis), or urinary
tract infections, the usual adult dose is 400 mg once daily or 200 mg
every 12 hours.
PEDIATRIC DOSAGE :
Children older than 12 years of age or t