GP CLARITHROMYCIN XR FILM-COATED TABLET 500MG

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Clarithromycin Citrate eqv Clarithromycin

Disponível em:

GOLDPLUS UNIVERSAL PTE LTD

Código ATC:

J01FA09

Forma farmacêutica:

TABLET, FILM COATED, EXTENDED RELEASE

Composição:

Clarithromycin Citrate eqv Clarithromycin 500mg

Via de administração:

ORAL

Tipo de prescrição:

Prescription Only

Fabricado por:

Ind-Swift Limited

Status de autorização:

ACTIVE

Data de autorização:

2022-05-13

Folheto informativo - Bula

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

Características técnicas

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