Cefichew 200mg tablets chewable

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

cefixime (cefixime trihydrate)

Verfügbar ab:

SRS Pharmaceuticals Pvt. Ltd.

ATC-Code:

J01DD08

INN (Internationale Bezeichnung):

cefixime (cefixime trihydrate)

Dosierung:

200mg

Darreichungsform:

tablets chewable

Einheiten im Paket:

(10/1x10/) blister

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2015-02-20

Gebrauchsinformation

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

Fachinformation

1. NAME OF THE MEDICINAL PRODUCT : CEFICHEW 200
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
# 224.0
≈
200.0
5%
*235.2
23.52
Antibiotic
EXCIPIENTS
2.
Aspartame
-
-
10.0
1.0
Sweetening Agent
3.
Flavour Orange
-
-
10.0
1.0
Flavour
4.
Flavour Strawberry
-
-
5.00
0.50
Flavour
5.
Flavour Mixed Fruit
-
-
5.00
0.50
Flavour
6.
Mannitol
-
-
134.50
13.45
For pleasant
taste and
mouth feel
7.
Supersol M
-
-
286.30
28.63
Diluent
8.
Magnesium Stearate
-
-
9.00
0.90
Diluent
9.
Talc
-
-
5.00
0.50
Lubricant
# 224 mg of Cefixime Trihydrate equivalent to 200mg 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 :
The recommended adult dosage is 200mg-400mg daily accordance to the
severity of infection
given either as a single dose or in two divided doses.
PEDIATRIC DOSAGE :
Children older than 12 years of age or those weighing more than 50 kg
may receive the
usual adult dosage of cefixime.
4.3 CONTRAINDICATIONS:
Cefixime is con