KLACID GRANULES FOR ORAL SUSPENSION

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

CLARITHROMYCIN

Fáanlegur frá:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Alþjóðlegt nafn):

CLARITHROMYCIN

Einingar í pakka:

60 ml 1 mL; 30 ml 1 Units mL; 60ml mL; 100ml mL; 60 mL; 30 mL; 100 mL

Framleitt af:

P.T. ABBOTT INDONESIA

Upplýsingar fylgiseðill

Not available

Vara einkenni

1 NAME OF THE MEDICINAL PRODUCT
KLACID GRANULES FOR ORAL SUSPENSION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of the granules contains 125mg of clarithromycin
Excipients: Sucrose 550mg/ml
3
PHARMACEUTICAL FORM
White to off-white granules for suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clarithromycin is indicated for treatment of infections due to
susceptible organisms in children
6months to 12years. Such infections include:
1.
Upper respiratory infections (e.g., streptococcal pharyngitis).
2.
Lower respiratory infections (e.g., bronchitis, pneumonia).
3.
Acute otitis media.
4.
Skin and skin structure infections (e.g., impetigo, folliculitis,
cellulitis, abscesses).
5.
Disseminated or localized mycobacterial infections due to
_Mycobacterium avium _
or
_Mycobacterium intracellulare_
. Localized infections due to
_Mycobacterium chelonae_
,
_Mycobacterium fortuitum_
, or
_Mycobacterium kansasii_
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Pediatric patients under 12 years of age _
Clinical trials have been conducted using clarithromycin pediatric
suspension in children 6 months
to 12 years of age. Therefore, children under 12 years of age should
use clarithromycin pediatric
suspension (granules for oral suspension)
The recommended daily dosage of Clarithromycin Pediatric Suspension
(125 mg/5 mL) in children
is 7.5 mg/kg b.i.d. up to a maximum dose of 500 mg b.i.d. for
nonmycobacterial infections. The
usual duration of treatment is for 5 to 10 days depending on the
pathogen involved and the severity
of the condition. The prepared suspension can be taken with or without
meals, and can be taken
with milk.
The following table is a suggested guide for determining dosage based
on the weight of the child
and the concentration of the suspension:
DOSAGE GUIDELINES FOR PEDIATRIC PATIENTS
BASED ON BODY WEIGHT
WEIGHT *
7.5mg/kg b.i.d dosage in ml given twice daily
KG
LBS.
125 MG/5 ML
8-11
18-25
2.5ml
12-19
26-43
5ml
20-29
44-64
7.5ml
30-40
65-88
10ml
* Children < 8 kg or < 18 lbs. should be dosed on