Summary of medicine characteristics - PENBRITIN SYRUP 125 MG / 5ML, AMPICILLIN 125 MG / 5ML POWDER FOR ORAL SUSPENSION
1 NAME OF THE MEDICINAL PRODUCT
Penbritin Syrup (125 mg/5 ml)
Ampicillin 125mg/5ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted each 5 ml contains 125 mg ampicillin as Ampicillin Trihydrate.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
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.
Parenteral usage is indicated where oral dosage is appropriate.
4.2 Posology and method of administration
Usual adult dosage (including elderly patients):
| Ear, nose and throat infections: | 250 mg four times a day. |
| Bronchitis: Routine therapy: | 250 mg four times a day. |
| High-dosage therapy: | 1 g four times a day. |
| Pneumonia: | 500 mg four times a day. |
| Urinary tract infections: | 500 mg three times a day. |
| Gonorrhoea: | 2 g orally with 1 g probenecid as a single dose. Repeated doses are recommended for the treatment of females. |
| Gastro-intestinal infections: | 500–750 mg three to four times daily. |
| Enteric: Acute: | 1–2 g four times a day for two weeks. |
| Carriers: | 1–2 g four times a day for four to twelve weeks. |
Usual children’s dosage (under 10 years):
Half adult routine dosage.
All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals.
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 normal dose should be administered after the procedure.
Administration:
Oral
4.3. Contra-Indications
Ampicillin is a penicillin and should not be given 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 pencillins.
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).
Contains sodium benzoate.
Sodium content: Each 5ml contains 16.7 mg of sodium. This sodium content should be included in the daily allowance of patients on sodium restricted diets.
Sucrose: Each 5ml contains approximately 3.6g of sucrose.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
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 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.
Lactation:
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
Adverse effects on the ability to drive or operate machinery have not been observed.
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 Item 4.4 – Warnings) 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 haemolytic anaemia have been reported rarely.
Prolongation of bleeding time and prothrombin have also been reported rarely.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
4.9. OverdoseGastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Ampicillin may be removed from the circulation by haemodialysis.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Ampicillin trihydrate is an oral antibiotic, active against a wide range of Gram-negative and Gram-positive organisms.
5.2 Pharmacokinetic properties
Absorption: The oral administration of 250 mg and 500 mg of ampicillin on a fasting stomach produces maximum serum levels of ± 2 and ± 4 mcg per ml, respectively, after 2 hours.Bioavailability is 30 to 40%. The absorption of orally administered ampicillin can be diminished by food.
Distribution: Serum protein binding ampicillin is about 20 %. Plasma half-life is between 1 and 1 4 hours.
Ampicillin diffuses into most tissues and body fluids. Its presence in therapeutic concentrations has been detected in, among others, bronchial secretions sinuses, saliva, CSF (variable percentage depending on the degree of meningeal inflammation), bile, serous membranes and middle ear.
Crosses the meningeal barrier: There is little ampicillin diffusion into the cerebrospinal fluid, except in cases of inflamed meninges, in which it can reach therapeutic concentrations when administered in high doses and especially by the intravenous route.
Cross the placenta: Ampicillin diffuses through the placenta.
Passes into mother’s milk: Ampicillin is detected in small quantities in mothers’ milk.
Metabolism and Excretion: Ampicillin is eliminated chiefly through the urine. Approximately 30% of the dose administered orally and over 60 % of the dose administered parenterally are eliminated in active form in the urine during the 24 hours which follow the administration of ampicillin. Urinary concentrations are higher following parenteral administration.
A small percentage is eliminated in the bile where high concentrations are found. Excretion may be delayed in cases of renal failure in accordance with its severity.
5.3. Pre-clinical Safety Data
Not relevant.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Sodium Benzoate
Sodium Chloride
Apricot Dry Flavour
Caramel Dry Flavour
Peppermint Extra Dry Flavour
Methyl Polysiloxane
Sodium Citrate Anhydrous
Sucrose
6.2. Incompatibilities
None known.
6.6 Shelf life
Powder: 5 years
Once dispensed, the products remain stable for 14 days when stored at 2–8oC in a refrigerator.
6.4 Special precautions for storage
Do not store above 25oC.
Once dispensed, store at 2–8oC in a refrigerator (14 days).
6.5. Nature and Contents of Container
White flint glass bottle fitted with aluminium roll-on pilfer-proof (ROPP) cap.
Powder for reconstitution to 100ml.
6.6. Instruction for Use, Handling and Disposal
If dilution of the reconstitution syrup is required, Syrup BP should be used.
7. MARKETING AUTHORISATION HOLDER
Chemidex Pharma Limited
T/A Essential Generics or Chemidex Generics
Chemidex House,
Egham Business Village
Crabtree Road, Egham,
Surrey TW 20 8RB
United Kingdom