AMPICILLIN

Main information

  • Trade name:
  • AMPICILLIN Capsule 500 mg Milligram
  • Dosage:
  • 500 mg Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMPICILLIN Capsule 500 mg Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0405/008/002
  • Authorization date:
  • 12-05-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Ampicillin CapsulesBP500 mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each capsulecontainsAmpicillin Trihydrate, equivalentto 500mg ofAmpicillin (anhydrous).

Forexcipients, see6.1

3PHARMACEUTICALFORM

Hard capsule

Red/dark grey size0+capsulesmarked 'AN500' and 'G', containing whitegranularpowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofinfectionsdueto organismssensitiveto ampicillin.

4.2Posologyandmethodofadminstration

Fororaladministration.

4.3Contraindications

Usein patientswith hypersensitivity to penicillinsorampicillin.

4.4Special warningsandspecialprecautionsforuse

Prolonged useofan anti-infectivemay resultin thedevelopmentofsuperinfection dueto organismsresistantto that

anti-infective.

Adults: Theusualdoseis250mg every six hours.

Fortreatmentofsevereinfectionsthedosage

may beincreased atthediscretion ofthephysician.

Children: Over10 yearsold

Asforadults.

up to 10 yearsold

Irish Medicines Board

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Date Issued 11/08/2005 CRN 2013198 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonehavebeen reported.

4.6Pregnancyandlactation

Anti-infectivesshould notbeused during pregnancy orlactation unlessconsidered essentialby thephysician.

Thedrug hasbeen shown to crosstheplacentaand isexcreted in breastmilk.Studiesin animalsand experienceof

human useto datehaveshown no evidenceofteratogeniceffects.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Sideeffectsincludemaculopapularrashes, urticariaand otherevidenceofhypersensitivity, gastrointestinal

disturbances,and diarrhoea. Transiently raised liverenzymesoccuroccasionally and Pseudomembranouscolitishas

been reported in afewcases.

4.9Overdose

Overdosewould beunlikely;an exacerbation ofthesideeffectsmay beseen, which should betreated symptomatically.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Abroad spectrumantibioticactivity.

5.2Pharmacokineticproperties

Abroad spectrumantibiotic, wellabsorbed afteroraladministration, reaching peak plasmalevelsafter1 to 2 hours.It

isexcreted in thebileand urinewith aplasmahalf-lifeof1 to 2 hours.

5.3Preclinical safetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CapsuleCore:

Talc

MagnesiumStearate

SodiumStarch Glycollate

MicrocrystallineCellulose

CapsuleShell

Gelatin

Iron oxides(E172)

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 11/08/2005 CRN 2013198 page number: 2

Erythrosine(E127)

PrintingInk

OpacodeS-1-8100HVcontaining Iron oxide(E172),

Soyalecithin

Polydimethylsiloxane

Shellac

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2 Years

6.4Special precautionsforstorage

Do notstoreabove25 °

Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenecapsulecontainerwith tamper-evidentpolyethylenecap.

Pack sizes:-20, 50, 100, 250, and 500.

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Generics[UK]Limited,

Station Close,

PottersBar,

HertsEN6 1TL,

England

8MARKETINGAUTHORISATIONNUMBER

PA405/8/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 12 th

May 1988

Dateoflastrenewal: 12 th

May 2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 11/08/2005 CRN 2013198 page number: 3

Irish Medicines Board

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Date Issued 11/08/2005 CRN 2013198 page number: 4

Irish Medicines Board

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Date Issued 11/08/2005 CRN 2013198 page number: 5