Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Medochemie Ltd., 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Monoclox is contraindicated to patients with hypersensitive to the active substance or other penicillins, cephalosporins, or penicillamine.
Monoclox should not be administered by sub-conjunctival injection.
The administration of cloxacillin in newborns is contraindicated.
Cloxacillin should be given with caution to patients who have had previous hypersensitivity reactions (anaphylactic reactions) to the cephalosporin’s, penicillin’s or other drugs. If serious acute hypersensitivity or allergic reactions take place, patients should be treated with pressor amines, antihistamines corticosteroids and/or other emergency measures. Hypersensitivity reactions can sometimes be quite severe or even fatal. Even though anaphylaxis is more likely to happen after parenteral administration they have also been induced by oral administration as well.
Extensive use of antibiotics may encourage the overgrowth of non-susceptible organisms, including fungi. In such a case, appropriate measures should be taken. It is also advised to evaluate, periodically, the renal, hepatic and hematopoietic systems.
In streptococcal infections, treatment must be adequate to eliminate the organism (10 days minimum); otherwise the sequelae of streptococcal disease may occur. The cultures should be taken when the treatment has finished so to determine whether streptococci have been eradicated.
Bacteriostatic antibiotics given concurrently with cloxacillin might decrease the bacteriocidal effect of penicillins as it has been shown in vitro. Nevertheless, the clinical significance of this interaction is not well documented.
Beta-adrenergic blockers given with cloxacillin can induce anaphylactic reactions that would make it even more difficult to treat anaphylaxis due to allergic reaction.
Chloramphenicol and cloxacillin co-administration would result to weaken the penicillin’s effect and to increase the half-life of chloramphenicol.
Oral anticoagulants or heparin administrated in conjunction with high dosage of IV penicillins turn the anticoagulants agents less effective and possibly increase the risk of bleeding.
Probenecid tends to block the renal tubular secretion of penicillins and in consequence penicillins stays longer in the blood circulation.
Oral contraceptives and concomitant use of penicillins has been related with unintended pregnancies and menstrual changes. The reason being that penicillins interfere with the absorption of oral contraceptives.
In clinical practice, analysis of a large number of exposed pregnancies did not appear to reveal any malformative or foetotoxic effect of penicillins.
Therefore, cloxacillin may be prescribed during pregnancy if necessary.
Because cloxacillin passes into breast milk, possible suspension of breast feeding should be envisaged.
Cloxacillin does not influence the patient’s ability to drive or operate machinery.
Cloxacillin, as other penicillins produces rarely adverse reactions and they are usually mild and ephemeral.
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency categories are defined according to the following convention: 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: Hematological reactions which are reversible including anemia, thrombopenia and leucopenia.
Very rare: anaphylactic shock.
Not known: Allergic reactions have been reported whose symptoms are fever, urticarial rash, eosinophilia, Quincke’s edema.
Not known: High dosage of cloxacillin given to patients especially to those with renal insufficiency, may induce encephalopathies which includes conscience troubles, non-physiological movement and sudden attacks of convulsion.
Rare: pseudo membranous colitis; in such case the uptake of cloxacillin should be discontinued.
Not known: nausea, vomiting, diarrhea.
Very rare: Augmentation of the transaminase enzymes ASAT and ALAT and hepatic icterus.
Not known: Cholestatic jaundice.
Very rare: Stevens-Johnson syndrome and polymorph erythema.
Not known: Skin rashes maculopapular which may be of allergic origin or not.
Not known: Possibility of acute immuno-allergic interstitial nephritis.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
Cloxacillin is incompatible with solutions of aminoacids, lipid emulsions and blood for transfusion.
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