AMPICILLIN Syrup 125 MG/5ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
AMPICILLIN TRIHYDRATE
Available from:
Regent Laboratories Limited
Dosage:
125 MG/5ml
Pharmaceutical form:
Syrup
Authorization date:
1991-01-29
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ampicillin Syrup BP 125 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml spoonful of reconstituted suspension contains ampicillin
trihydrate BP equivalent to 125 mg of ampicillin.
3 PHARMACEUTICAL FORM
Powder for syrup 125 mg/5 ml.
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
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity to ampicillin,
penicillins or cephalosporins.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
This drug should be used with caution in patients with a history
of allergy.
Care must be taken when giving this drug especially in high
dosage to patients with impaired renal function.
Patients with infectious mononucleosis are particularly prone to
develop rashes with ampicillin.
Route of administration: Oral
Adults and Children over 20 kg b.w.
ENT infections
1000 mg daily in divided doses
Bronchitis
1000 mg - 4000 mg daily in divided doses
Pneumonia
2000 mg daily in divided doses
Urinary tract infection
1500 mg daily in divided doses
Gastrointestinal infections
1500 mg - 3000 mg daily in divided doses
Children under 20 kg b.w.
Moderately severe infections
50 - 100 mg/kg/day in divided doses every 6-8 hours
Severe infections
200 mg/kg/day in divided doses every 6 hours
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 16/11/2005_
_CRN 2016870_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
1.
Ampicillin should not be mixed with blood
products or other proteinaceous fluids (e.g. protein
hydrolysates).
2.
Ampicillin may reduce the efficacy of oral contraceptives.
3.
Food can interfere with absorption of ampic
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