SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the medicinal product

Ampicillin Sodium for Injection 500 mg
2. Qualitative and quantitative composition
Each vial contains ampicillin sodium equivalent to 500 mg ampicillin.
Excipient with known effect
Each vial contains approximately 33.7 mg (1,5mmol) sodium.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Powder for solution for injection/infusion.
A white or off-white powder or crystalline powder.
4. Clinical particulars
4.1 Therapeutic indications
Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range
of bacterial infections caused by ampicillin-sensitive organisms. Typical indications
include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections,
gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis,
meningitis, enteric fever, gastro-intestinal infections.
Extraperitoneal application of Ampicillin to wounds can be used to prevent infection
following abdominal surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
Routes of administration: Intramuscular, intravenous, intraperitoneal, intrapleural,
intra-articular, extraperitoneal.
4.2 Posology and method of administration
Posology
Usual adult dosage (including elderly patients):

Septicaemia, 500 mg four to six times a day IM or IV for one to six

endocarditis, weeks.
osteomyelitis:

Peritonitis, 500mg four times a day IM or IV.

intra-abdominal sepsis:

Meningitis: Adult dosage: 2 g six-hourly IV.

Children dosage: 150 mg/kg daily IV in divided doses.
Ampicillin may also be administered by other routes of conjunction with systemic
therapy.

Intraperitoneal: 500 mg daily in up to 10 ml water for injections.

Intrapleural: 500 mg daily in 5-10 ml water for injections.
Intraarticular: 500 mg daily, in up to 5 ml water for injections or sterile
0.5% procaine hydrochloride solution.

Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound
extraperitoneally or into muscle layers to prevent wound infection post operatively.
Paediatric population
Half adult routine dosage for children under 10 years.
All recommended dosages are a guide only. In severe infections the above dosages
may be increased.
Renal Impairment
In the presence of severe renal impairment (creatinine clearance <10ml/min) a
reduction in dose or extension of dose interval should be considered. In cases of
dialysis, an additional dose should be administered after the procedure.
Method of administration

Intramuscular: Add 1.5 ml water for injections to 500mg vial contents.

Intravenous: Dissolve 500 mg in 10 ml water for injections.
Administer by slow injection (three to four minutes). Ampicillin
may also be added to infusion fluids or injected, suitably diluted,
into the drip tube over a period of three to four minutes.

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section
6.1.
Ampicillin is a penicillin and should not be give to patients with a history of
hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins)
or excipients.
4.4 Special warnings and precautions for use
Before initiating therapy with ampicillin, careful enquiry should be made concerning
previous hypersensitivity reactions to beta-lactam antibiotics.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been
reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more
frequent following parenteral therapy, it has occurred in patients on oral penicillins.
These reactions are more likely to occur in individuals with a history of beta-lactam
hypersensitivity.
Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic
leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been
associated with these conditions following the administration of ampicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Dosage should be adjusted in patients with renal impairment (see section 4.2).
This medicine contains 33.7 mg of sodium per vial, equivalent to 1.7% of the WHO
recommended maximum daily intake of 2 g sodium for an adult.
4.5 Interaction with other medicinal products and other forms of interaction
If Ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics
should not be mixed in the syringe, intravenous fluid container or giving set because
loss of activity of the aminoglycoside can occur under these conditions.
Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.
In common with other oral broad-spectrum antibiotics, ampicillin may reduce the
efficacy of oral contraceptives and patients should be warned accordingly.
Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with
ampicillin may result in increased and prolonged blood levels of ampicillin.
Concurrent administration of allopurinol during treatment with ampicillin can
increase the likelihood of allergic skin reactions.
It is recommended that when testing for the presence of glucose in urine during
ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the
high urinary concentrations of ampicillin, false positive readings are common with
chemical methods.
4.6 Fertility, pregnancy and lactation
Pregnancy
Animal studies with Ampicillin have shown no teratogenic effects. The product has
been in extensive clinical use since 1961 and its use in human pregnancy has been
well documented in clinical studies. When antibiotic therapy is required during
pregnancy, Ampicillin may be considered appropriate.
Breast-feeding
During lactation, trace quantities of penicillins can be detected in breast milk.
Adequate human and animal data on use of Ampicillin during lactation are not
available.
4.7 Effects on ability to drive and use machines
No studies on the effects to drive and use machines have been performed. Based on
reported adverse drug reactions, it is presumed that ampicillin has no or negligible
influence on the ability to drive and use machines.
4.8 Undesirable effects
Hypersensitivity reactions:
If any hypersensitivity reaction occurs, the treatment should be discontinued.
Skin rash, pruritis and urticaria have been reported occasionally. The incidence is
higher in patients suffering from infectious mononucleosis and acute or chronic
leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions
such as erythema multiforme and Stevens Johnson syndrome, and toxic epidermal
necrolysis have been reported.
As with other antibiotics, anaphylaxis (see section 4.4) has been reported rarely.
Renal effects:
Interstitial nephritis can occur rarely.
Gastrointestinal reactions:
Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and
haemorrhagic colitis has been reported rarely.
Hepatic effects:
As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been
reported rarely. As with most other antibiotics, a moderate and transient increase in
transaminases has been reported.
Haematological effects:
As with other beta-lactams, haematological effects including transient leucopenia,
transient thrombocytopenia and haemolyticanaemia have been reported rarely.
Prolongation of bleeding time and prothrombin time has also been reported rarely.
4.9 Overdose
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and
should be treated symptomatically.
Ampicillin may be removed from circulation by haemodialysis.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Penicillins with extended spectrum, ampicillin
ATC code: J01CA01
Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range
of bacterial infections caused by ampicillin sensitive organisms.
5.2 Pharmacokinetic properties
Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1 – 2
hours.
5.3 Preclinical safety data
No further information of relevance.
6. Pharmaceutical particulars
6.1 List of excipients
None.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with
blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with
intravenous lipid emulsions.
6.3 Shelf life
3 years
Reconstituted/diluted solution should be used immediately.
6.4 Special precautions for storage
Store below 30℃, away from light and moisture.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Molded glass vials sealed with halogenated butyl rubber stoppers with aluminium
caps.
Pack size: 10 vials/box, 50 vials/box.
6.6 Special precautions for disposal and other handling
Ampicillin vials are not suitable for multidose use.
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.
Intravenous fluids
Sodium chloride 0.9% (normal saline)
Ampicillin has been shown to be compatible with heparin sodium in intravenous
infusions and these agents may be administered concurrently in normal saline.
If Ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics
should not be mixed in the syringe, intravenous fluid container or giving set because
loss of activity of the aminoglycoside can occur under these conditions.
7. Marketing authorisation holder
North China Pharmaceutical Co., Ltd.
No.388 Heping East Road, Shijiazhuang, Hebei, P.R. China.
Telephone number: +86-311-85528588
Fax: +86-311-85051711
8. Marketing authorisation number(s)
05120/07264/NMR/2019
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 15 Apr 2020
10. Date of revision of the text
15-Sep-2021