GP CLARITHROMYCIN XR FILM-COATED TABLET 500MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Clarithromycin Citrate eqv Clarithromycin

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

J01FA09

Pharmaceutical form:

TABLET, FILM COATED, EXTENDED RELEASE

Composition:

Clarithromycin Citrate eqv Clarithromycin 500mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Ind-Swift Limited

Authorization status:

ACTIVE

Authorization date:

2022-05-13

Patient Information leaflet

1
CLARIPLUS EXTENDED RELEASE FILM-COATED TABLETS 500MG
COMPOSITION:
Each film coated extended-release tablet contains
Clarithromycin Citrate equivalent to Clarithromycin 500mg
LIST OF EXCIPIENTS:
_TABLET CORE _
Lactose Monohydrate, Hydroxypropyl methylcellulose, Purified Water,
Hydroxypropyl methyl cellulose phthalate,
Purified Talc and Magnesium Stearate
_ _
_FILM COAT _
Opadry II Yellow 31G52300 (consist of Hypromellose, Lactose
Monohydrate, Titanium Dioxide, Polyethylene
Glycol, Talc and Quinoline Yellow Aluminium Lake) and Purified Water
PRESENTATION:
Blisters composed of Rigid PVC film coated with PVdC Pharma Grade and
Printed Aluminium foil.
Blister packs are supplied in cartons of 7, 10, 70 or 100 tablets.
PRODUCT DESCRIPTION:
Yellow colored, film coated, oblong shaped, biconvex tablet, with both
sides plain.
PROPERTIES:
Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically,
it is 6-0-methylerythromycin. The molecular
formula is C
38
H
69
NO
13
, and the molecular weight is 747.96. The structural formula is
O
H
3
C
O
CH
3
CH
3
H
3
C
H
3
C
H
3
C
HO
OH
OCH
3
CH
3
O
O
O
H
3
C
CH
3
O
C
H
3
HO
O
O
N
HO
CH
3
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
22
19
20
21
1"
2"
1'
2'
3'
4'
5'
6'
3"
4"
6"
5"
CH
3
CH
3
8'
7'
7"
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
Pharmacotherapeutic group: Antibacterial for systemic use, macrolide
ATC-Code: J01FA09
Clarithromycin is a semi-synthetic macrolide antibiotic obtained by
substitution of a CH3O group for the hydroxyl
(OH) group at position 6 of the erythromycin lactonic ring.
Specifically clarithromycin is 6-O-methyl erythromycin A. The white to
off-white antibiotic powder is bitter,
practically odorless, essentially insoluble in water, and slightly
soluble in ethanol, methanol, and acetonitrile. Its
molecular weight is 747.96.
2
A study in community acquired pneumonia investigated the effect of
clarithromycin vs amoxicillin on plasma
concentrations of IL-6, IFNγ and IL-10 before starting therapy [1st
day] and at the 3rd and 7th days of therapy.
Twenty-three

Summary of Product characteristics

1
GP
CLARITHROMYCIN
X
R TABLET 500MG
COMPOSITION:
Each film coated extended-release tablet contains
Clarithromycin Citrate equivalent to Clarithromycin 500mg
LIST OF EXCIPIENTS:
_TABLET CORE _
Lactose Monohydrate, Hydroxypropyl methylcellulose, Purified Water,
Hydroxypropyl methyl cellulose phthalate,
Purified Talc and Magnesium Stearate
_FILM COAT _
Opadry II Yellow 31G52300 (consist of Hypromellose, Lactose
Monohydrate, Titanium Dioxide, Polyethylene
Glycol, Talc and Quinoline Yellow Aluminium Lake) and Purified Water
PRESENTATION:
Blisters composed of Rigid PVC film coated with PVdC Pharma Grade and
Printed Aluminium foil.
Blister packs are supplied in cartons of 5, 7, 10, 50, 70 or 100
tablets.
PRODUCT DESCRIPTION:
Yellow colored, film coated, oblong shaped, biconvex tablet, with both
sides plain.
PROPERTIES:
Clarithromycin is a semi-synthetic macrolide antibiotic. Chemically,
it is 6-0-methylerythromycin. The molecular
formula is C
38
H
69
NO
13
, and the molecular weight is 747.96. The structural formula is
O
H
3
C
O
CH
3
CH
3
H
3
C
H
3
C
H
3
C
HO
OH
OCH
3
CH
3
O
O
O
H
3
C
CH
3
O
C
H
3
HO
O
O
N
HO
CH
3
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
22
19
20
21
1"
2"
1'
2'
3'
4'
5'
6'
3"
4"
6"
5"
CH
3
CH
3
8'
7'
7"
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
Pharmacotherapeutic group: Antibacterial for systemic use, macrolide
ATC-Code: J01FA09
Clarithromycin is a semi-synthetic macrolide antibiotic obtained by
substitution of a CH3O group for the hydroxyl
(OH) group at position 6 of the erythromycin lactonic ring.
Specifically clarithromycin is 6-O-methyl erythromycin A. The white to
off-white antibiotic powder is bitter,
practically odorless, essentially insoluble in water, and slightly
soluble in ethanol, methanol, and acetonitrile. Its
molecular weight is 747.96.
2
A study in community acquired pneumonia investigated the effect of
clarithromycin vs amoxicillin on plasma
concentrations of IL-6, IFNγ and IL-10 before starting therapy [1st
day] and at the 3rd and 7th days of therapy.
Twenty-three patients receiv