Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Additionally, an allergy to penicillin and type I reaction to cephalosporins.
Local requirements on the appropriate use of antibacterial agents should be followed. Initial determination of the causing organisms and their susceptibility should be performed.
Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions have occurred in patients receiving penicillin. If an allergic reaction occurs, the drug should be discontinued and the patient should receive appropriate treatment.
Cross-hypersensitivity between penicillins, cephalosporins, cephamycins, 1-oxa-beta-lactams and carbapenems is possible. Before initiating therapy with dicloxacillin, careful enquiry should be made concerning previous hypersensitivity reactions to antibiotics.
It is recommended to obtain white blood cell and differential cell counts prior to initiation of therapy and at least weekly during therapy.
Use of antibiotics may result in overgrowth of non-susceptible organisms. If new infections due to bacteria or fungi occur, appropriate treatment should be initiated and discontinuation of treatment with dicloxacillin should be considered.
Antibiotic-associated colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening (see section 4.8). Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, a physician should be consulted and an appropriate therapy initiated. Anti-peristaltic medicinal products are contra-indicated in this situation.
In neonates inclompletely developed renal function may result in insufficient excretion of dicloxacillin and high serum levels. Frequent monitoring of plasma concentration and close monitoring of adverse reactions should be performed (see section 4.2).
Increases in serum creatinine levels have been observered in assocation with prophylactic use at high doses in elderly patients that have had total hip arthroplasty. Renal function should therefore be monitored prior to and during treatment with dicloxallin.
Organ functions including kidney, liver and the haematopoetic system should be monitored regularly during prolonged treatment.
It is recommended to obtain white blood cell and differential cell counts prior to initiation of therapy and at least weekly during therapy.
This medicinal product contains 0.6 mmol (12.7 mg) sodium in one 250 mg capsule and 1.1 mmol (25.3 mg) sodium in one 500 mg capsule. To be taken into consideration by patients on a controlled sodium diet.
Probenecid inhibits the renal tubular excretion resulting in an increase in and prolongation of the plasma concentration of penicillin.
Bacteriostatic drugs, such as the tetracyclines, may interfere with the bactericidal effect of penicillin. Such concomitant use should be avoided.
In rare cases systemic antibiotics may reduce the effect of the contraceptive pill by affecting the intestinal reabsorption.
Concomitant treatment with methotrexate may result in increased effect/toxicity of methotrexate due to reduced elimination.
The effect of warfarin/dicumarol may be reduced by concomitant treatment with dicloxacillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored and adjustments in the dose of oral anticoagulants may be necessary.
Long clinical experience indicates low risk of harmful effects during pregnancy or to the foetus or newborn child.
Penicillins are excreted in human milk at low levels. Harmful effects to breast-fed babies are unlikely, though there may be a risk of effect on the oral and intestinal flora. Small quantities of the active ingredient in breast milk may give an increased risk of sensitizing. Caution should therefore be exercised when prescribing dicloxacillin to breast-feeding women.
Dicloxacillin has no or negligible influence on the ability to drive and use machines.
Approximately 5% of the treated patients can expect side effects. The most common side effects are nausea, vomiting and diarrhoea.
As with other penicillins allergic reactions both humoral hypersensitivity (immediate type) and cellular hypersensitivity (delayed type) occur. These are mostly mild, but serious allergic reactions, including fatalities have been reported.
Delayed allergic reactions to penicillin generally occur after 48 hours and in certain cases as late as 2-4 weeks after initiation of treatment. Manifestation of this type of reactions includes serum sicknesslike symptoms.
The following terminologies have been used in order to classify the occurrence of undesirable effects:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Not known: Fungal infection in oral cavity and abdomen.
Rare: Agranulocytosis, eosinofilia, thrombocytopenia, neutropenia, bone marrow depression, haemolytic anaemia, leucopenia, granulocytopenia.
Rare: Anaphylactic reactions.
Not known: Hypersensitivity, serum sickness.
Rare: Hypotension, vascular collapse and death.
Rare: Bronchospasm, laryngospasm, asthmatic respiration, sneezing, larynx oedema.
Common: Diarrhoea, nausea, vomiting, dyspepsia, flatulence.
Rare: Pain in oesophagus, oesophagitis, oesophageal ulceration, abdominal pain, pseudomembranous colitis
Rare: Cholestatic hepatitis.
Not known: Hepatotoxicity.
Common: Skin rash.
Uncommon: DUrticaria, pruritus.
Rare: Angioneurotic oedema (Quincke’s oedema).
Rare: Arthralgia, myalgia.
Not known: Muscle twitching.
Rare: Rare Renal insufficiency, interstitial nephritis, tubular disorder, toxic nephropathia, haematuria, proteinuria.
Rare: Fever
Not known: Malaise
Not known: Increase in serum creatinine. Transient, asymptomatic increase in alkaline phosphatase, AST and ALT.
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 national reporting system listed in Appendix V.
Aminoglycosides and penicillins can mutually inactivate each other in vitro.
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