Cefichew tablets chewable

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefixime (cefixime trihydrate)

Available from:

Maxim Pharmaceuticals Pvt. Ltd.

ATC code:

J01DD08

INN (International Name):

cefixime (cefixime trihydrate)

Dosage:

400mg

Pharmaceutical form:

tablets chewable

Units in package:

(10/1x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-02-21

Patient Information leaflet

PACK INSERT
CEFICHEW 200/400
(Cefixime Chewable Tablets)
COMPOSITION:
CEFICHEW 200
Each chewable tablet contains:
Cefixime USP as trihydrate
eq. to Anhydrous Cefixime…………200 mg
CEFICHEW 400
Each chewable tablet contains:
Cefixime USP as trihydrate
eq. to Anhydrous Cefixime…………400 mg
ATC CODE: J01DD08
INTERNATIONAL NONPROPRIETARY NAME:
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
acid,
7-[[(2-amino-4-thi
azolyl)[(carbo-
xymethoxy)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-azabicyclo[4.2.0]oct-2-ene-
2-carboxylic acid, 7-(Z)-[O-(carboxy methyl)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 the rate of absorption
may be decreased in the
presence
of
food.
Absorption
is
fairly
slow;
peak
plasma
concentrations
of
2
to
3
micrograms/mL and 3.7 to 4.6 microgr

Summary of Product characteristics

THE SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT : CEFICHEW 400
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 :
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