Co-Fluampicil Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS.
1. NAME OF THE MEDICINAL PRODUCT
Co-Fluampicil Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Co-Fluampicil Capsules contain 250mg flucloxacillin as Flucloxacillin Sodium and 250mg ampicillin as Ampicillin Trihydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Blue/grey capsules coded FXN/AMP on cap and twin triangle logo on body, size 0.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Co-fluampicil Capsules are indicated for the treatment of severe infections where the causative organism is unknown and for mixed infections involving P-lactamase producing staphylococci.
In general practice the capsules can be used for chest infections, ENT infections, skin and soft tissue infections and patients with an underlying pathology which makes them more susceptible to infections.
In hospital use, if laboratory results are not yet available, it can be used for severe respiratory infections, post-operative chest and wound infections.
Septic abortion and puerperal fever. Septicaemia, prophylaxis in major surgery and infections in patients receiving immunosuppressive therapy.
The products spectrum makes it suitable for the treatment of many mixed infections, particularly those where penicillinase-producing staphylococci are suspected or confirmed.
Parenteral usage is indicated where oral dosage is inappropriate.
4.2 Posology and method of administration
Posology
Adults and children over 10 years 1 capsule four times a day, one hour before meals.
Children under 10 years
It is recommended they use an alternative syrup presentation.
Elderly As for adults.
The above dosages may be doubled where necessary.
Doses should be administered half to one hour before meals.
Route of administration Oral
4.3 Contraindications
Co-fluampicil should not be prescribed for patients with a history of hypersensitivity to P-lactam antibiotics.
Co-fluampicil is contraindicated in patients with a history of flucloxacillin-associated jaundice/hepatic dysfunction.
4.4 Special warnings and precautions for use
Before initiating therapy with Co-fluampicil careful enquiries should be made concerning previous hypersensitivity reactions to P-lactam antibiotics. If hypersensitivity reactions do occur, the drug should be withdrawn. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving P-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients receiving oral therapy. These reactions are more likely to occur in individuals with a hypersensitivity to P-lactam antibiotics.
Co-fluampicil contains ampicillin and 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.
Caution should be exercised in patients with porphyria.
Cholestatic jaundice may occur up to several weeks after treatment with Co-Fluampicil has been stopped. Administration for more than 2 weeks and increasing age are risk factors.
Caution should be taken in patients who have a history of allergy, renal impairment and possibly those who have HIV infection.
During prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is recommended.
Prolonged use may occasionally result in the selection of resistant strains of organisms.
Sodium Content: Co-fluampicil Capsules contain 13.0mg sodium per capsule. This should be included in the daily allowance of patients on sodium restricted diets.
4.5 Interactions with other medicinal products and other forms of interaction
Ampicillin may decrease the efficacy of oestrogen-containing oral contraceptives. It may also affect the absorption of other drugs due to its effect on the gastrointestinal flora. The possibility of a prolonged bleeding time following oral treatment with a broad-spectrum antibiotic like ampicillin should be borne in mind in patients receiving anticoagulants (e.g. coumarins, phenindione). There may be antagonism between ampicillin, a bactericidal agent, and bacteriostatic agents such as chloramphenicol. Incompatibility in vitro with other drugs may occur. Like ampicillin, flucloxacillin may decrease the efficacy of oestrogen-containing oral contraceptives. Probenecid reduces the excretion of penicillins.
Co-fluampicil may interact with methotrexate giving rise to an increased risk of toxicity.
Co-fluampicil contains ampicillin. It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used because false positive readings are common with chemical methods due to the high urinary concentrations of ampicillin. Ampicillin may also interact with allopurinol resulting in an increased risk of rash.
Co-fluampicil is an antibacterial agent and as such interacts with typhoid vaccine. The oral typhoid vaccine is inactivated by concomitant antibiotic administration.
4.6 Fertility, pregnancy and lactation
Pregnancy
Animal studies have shown no teratogenic effects. The brand leader has been in clinical use since 1971 and the limited number of reported cases of use in human pregnancy have shown no evidence of untoward effect. The use of Co-fluampicil in pregnancy should be reserved for cases considered essential by the clinician.
Breastfeeding
During lactation, trace quantities of ampicillin and flucloxacillin can be detected in breast milk. The possibility of hypersensitivity reactions must be considered in breast-fed infants.
Therefore Co-fluampicil should only be administered to a breast-feeding mother when the potential benefit outweighs the potential risks associated with treatment.
4.7 Effects on ability to drive and use machines
No known adverse effects are reported.
4.8 Undesirable effects
Blood and lymphatic system disorders
As with other p-lactam antibiotic, haematological effects including reversible leucopenia, reversible thrombocytopenia and haemolytic anaemia have been reported rarely.
Gastrointestinal disorders
Minor gastrointestinal disturbances, including occasionally nausea, vomiting and diarrhoea may occur during treatment. Pseudomembranous colitis has been reported rarely.
Renal and urinary diasorders
Interstitial nephritis may occur.
Immune system disorders
If any hypersensitivity reaction occurs, the treatment should be discontinued.
Skin rash, pruritis and urticaria have been reported occasionally. The incidence of rash is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura, fever, eosinophilia and sometimes angioneurotic oedema have also been reported. Rarely, skin reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Reactions such as fever,arthralgia, and myalgia can develop more than 48 hours after the start of the treatment.
Anaphylaxis (see section 4.4-Warnings) has been reported rarely.
Hepatobiliary disorders
Hepatitis and cholestatic jaundice have been reported rarely. These may be delayed for up to two months after withdrawal of treatment. In some cases the course of these conditions has been protracted and lasted for several months. Very rarely deaths have been reported from hepatic effects but are mostly limited to patients with serious underlying disease.
As with most other antibiotics, a moderate transient increase in transaminases has been reported.
There is evidence that the risk of flucloxacillin induced liver injury is increased in subjects carrying the HLA-B*5701 allele. Despite this strong association, only 1 in 500-1000 carriers will develop liver injury. Consequently, the positive predictive value of testing the HLA- B*5701 allele for liver injury is very low (0.12%) and routine screening for this allele is not recommended.
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
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Co-fluampicil contains flucloxacillin. Haemodialysis does not lower the serum levels of flucloxacillin.
Co-fluampicil contains ampicillin, which may be removed from the circulation by haemodialysis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Flucloxacillin is used for the treatment of infections due to staphylococci resistant to benzylpenicillin. It is also used for mixed streptococcal and staphylococcal infections when the staphylococci are penicillin-resistant.
Ampicillin is a broad spectrum antibiotic which is bactericidal for both gram-positive and gram-negative bacteria.
There is evidence that the risk of flucloxacillin induced liver injury is increased in subjects carrying the HLA-B*5701 allele. Despite this strong association, only 1 in 500-1000 carriers will develop liver injury. Consequently, the positive predictive value of testing the HLA-B*5701 allele for liver injury is very low (0.12%) and routine screening for this allele is not recommended.
5.2 Pharmacokinetic properties
Flucloxacillin after an oral dose of 250mg to 500mg in fasting subjects shows peak serum concentrations at 1 hour ranging from 3-27mcg/ml. Therapeutic concentrations persist for about 4 hours. Doubling the dose can double the plasma concentrations. About 95% of flucloxacillin in the circulation is bound to plasma proteins. Flucloxacillin is metabolised to a limited extent and the unchanged drug and metabolites are excreted in the urine.
Ampicillin is relatively stable in gastric secretion and is well absorbed from the gastrointestinal tract producing peak concentrations in about two hours. Doubling the dose can produce double the concentration. Ampicillin diffuses across the placenta into the foetal circulation and concentrations can persist in amniotic fluid. Concentrations can be detected in the milk of nursing mothers. There is little diffusion into the cerebro-spinal fluid except when the meninges are infected, when high concentrations are achieved. Concentration of ampicillin are found in ascetic, pleural, joint, and ocular fluids. 30% of the orally administered dose is excreted unchanged in the urine in about six hours.
5.3 Preclinical safety data
None available.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium Stearate
Capsule shell: HSE Cap
Indigo Carmine E132 Titanium Dioxide E171 Gelatin
Body
Black Oxide E172 Titanium Dioxide E171 Gelatin
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store in a cool dry place.
6.5 Nature and contents of container
Polypropylene tubular container with an open end equipped to accept a polyethylene closure with a tamper-evident tear strip in pack sizes of 7, 14, 15, 20, 21, 28, 30, 50, 56, 60, 100, 250, 500 and 1000 capsules.
6.6 Instructions for Use/Handling
None.
7 MARKETING AUTHORISATION HOLDER
Norton Healthcare Limited
T/A IVAX Pharmaceuticals UK
Ridings Point
Whistler Drive
Castleford
West Yorkshire
WF10 5HX.
8. MARKETING AUTHORISATION NUMBER
PL 00530/0178
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
|
Authorisation granted: |
18/01/1985 |
|
Last renewal granted: |
25/06/99 |
10 DATE OF REVISION OF THE TEXT
15/12/2014