AMPICILLIN 500 mg Milligram Capsule

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

AMPICILLIN TRIHYDRATE

Verfügbar ab:

Generics (UK) Limited

INN (Internationale Bezeichnung):

AMPICILLIN TRIHYDRATE

Dosierung:

500 mg Milligram

Darreichungsform:

Capsule

Berechtigungsstatus:

Withdrawn

Berechtigungsdatum:

2007-04-27

Fachinformation

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ampicillin Capsules BP 500 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Ampicillin Trihydrate, equivalent to 500mg
of Ampicillin (anhydrous).
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Hard capsule
Red/dark grey size 0+ capsules marked 'AN 500' and 'G', containing
white granular powder.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
For the treatment of infections due to organisms sensitive to
ampicillin.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration.
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity to
penicillins or ampicillin.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prolonged use of an anti-infective may result in
the development of superinfection due to organisms resistant to
that 
anti-infective.
Patients with infectious mononucleosis are particularly prone to
develop rashes with ampicillin. 
Adults:
The usual dose is 250mg every six hours. 
For treatment of severe infections the dosage
may be increased at the discretion of the physician.
Children:
Over 10 years old
As for adults.
up to 10 years old
This strength is unsuitable for the appropriate dosage.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 11/08/2005_
_CRN 2013198_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
None have been reported.
4.6 PREGNANCY AND LACTATION
Anti-infectives should not be used during pregnancy or lactation
unless considered essential by the physician.
The drug has been shown to cross the placenta and is excreted in
breast milk. Studies in animals and experience of 
human use to date have shown no evidence of teratogenic effects.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES