Rexocef powder for oral suspension

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

cefpodoxime (cefpodoxime proxetil)

Available from:

Alkaloid AD Skopje

ATC code:

J01DD13

INN (International Name):

cefpodoxime (cefpodoxime proxetil)

Dosage:

40mg/5ml

Pharmaceutical form:

powder for oral suspension

Units in package:

64.8g powder in 100ml plastic vial with, measuring cup and dosing syringe

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-11-03

Summary of Product characteristics

1
Rexocef

40 mg/5 ml powder for oral suspension
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rexocef
®
40 mg/5 ml powder for oral suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml oral suspension contains 40 mg cefpodoxime as cefpodoxime
proxetil
1 ml oral suspension contains 8 mg cefpodoxime as cefpodoxime proxetil
Excipients:
Sucrose 2465 mg/ 5 ml
Aspartame (E951) 20 mg/ 5 ml
Sodium benzoate (E211) 10 mg/ 5 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
Powder for oral suspension.
Almost white to pale yellow coloured powder. After it is mixed with
water it turns into off-white to pale
yellow suspension with a characteristic banana odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rexocef powder for oral suspension is indicated for the treatment of
the following infections when
caused by bacteria susceptible to cefpodoxime (see section 5.1) in
children at the age of 4 weeks to 12
years who need oral therapy.
_ _
Ear, nose and throat infections:
- tonsillitis, pharyngitis;
- sinusitis;
- acute otitis media.
Lower respiratory tract infections:
- pneumonia and bronchopneumonia;
- acute exacerbation of chronic bronchitis (AECB).
Non-complicated urinary tract infections.
Skin and soft tissue infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology _
ADULTS AND ELDERLY
Not applicable for this product.
PAEDIATRIC POPULATION
The dose for children at the age of 4 weeks to 12 years of age is 5 to
12 mg/kg body weight a day to be
taken as 2 separate doses on every 12 hours.
The usual dose is 2 x 4 mg/kg body weight a day to the maximum daily
dose of 2 x 100 mg cefpodoxime
(in children with body weight above 25 kg).
Note that:
5 ml of suspension contains the equivalent to 40 mg Cefpodoxime.
1 ml of suspension contains the equivalent to 8 mg Cefpodoxime.
THE DOSING SYRINGE IS GRADUATED IN KG (FROM 5 TO 2