Cefixime 200 mg film-coated tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Cefixime

זמין מ:

Orchid Europe Limited

קוד ATC:

J01D

INN (שם בינלאומי):

Cefixime

כמות:

200 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

OTHER BETA-LACTAM ANTIBACTERIALS

מצב אישור:

Not marketed

תאריך אישור:

2010-10-15

מאפייני מוצר

Health Products Regulatory Authority
23 November 2018
CRN008L3F
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefixime 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 223.81 mg Cefixime trihydrate
equivalent to 200 mg
Cefixime (anhydrous)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, circular, biconvex film-coated tablets debossed with ‘C’ on
one side and plain
surface on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefixime is indicated for the treatment of the following infections
when caused by
susceptible organisms (see sections 4.4 and 5.1):
Acute exacerbations of chronic bronchitis
Community-acquired Pneumonia
Lower urinary tract infections
Pyelonephritis
In the treatment of:
Otitis media
Sinusitis
Pharyngitis
The use of cefixime should be reserved for infections in which the
causative organism
is known or suspected to be resistant to other commonly used
antibacterial agents
or when treatment failure with other commonly used antibacterial
agents may carry
significant risk.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
Health Products Regulatory Authority
23 November 2018
CRN008L3F
Page 2 of 11
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
The recommended dose for adults is 200-400 mg daily according to the
severity of
infection,taken as a single dose (400 mg may also be taken as two
divided doses)
(see section 5.1).
_Elderly patients_
Elderly patients may be given the same dose as recommended for adults.
Renal
function should be assessed and dosage should be adjusted in severe
renal
impairment (See above and section 4.4).
_Adolescents ≥ 12 years of age _
Adolescents ≥ 12 years of agemay be given the same dose as
recommended for
adults.
_Children from 6 months to 11 years of age _
It is recommended that children from 6 months to 11 years of age be
given cefixime
as an oral suspension b