EUROCLOX-500 Ampicilline 250mg and Cloxacilline 250mg gelules
Composition, Clinical pharmacology, Absorption and excretion, Indications and usage, Contraindications, Interactions, Warnings, Precautions, Fertility, pregnancy and lactation effects, Adverse effects, Overdose, Dosage and administration, Storage, Presentation, Shelf life and Manufacturer of Euroclox 500 Capsule Medicine for Infections.
EUROCLOX-500 capsule: Each hard gelatin capsule contains:
Ampicillin Trihydrate equivalent to Ampicillin 250mg.
Cloxacillin Sodium equivalent to Cloxacillin 250mg.
Excipients Quantity sufficient Capsule shells contain approved colours.
EUROCLOX is a combination of Ampicillin and Cloxacillin. Ampicillin, an amino Penicillin and Cloxacillin, as isoxazoyl Penicillin have an identical mode of action. i.e. they inhibit bacteria cell wall synthesis. This results in the weakening of the bacterial cell wall and cell lysis. Ampicillin is susceptible to degradation by beta-lactamases and is therefore inactive against strains producing the enzyme. The combination displays synergy against some beta-lactamase producing organisms as Cloxacillin protects Ampicillin from enzymatic destruction by binding them.
Cloxacillin forms a relatively stable enzyme substrate complex with a beta-lactamase and competitively inhibits the activity of beta-lactamases; thus Cloxacillin when given in combination with Ampicillin protects the latter from destruction by beta-lactamase. The sparing of Ampicillin by this mechanism increases the availability of Ampicillin at the site of infection. This serves to retain the broad antibacterial spectrum of Ampicillin against Gram positive and Gram negative organisms including those that produce beta-lactamase.
ABSORPTION AND EXCRETION
Ampicillin and Cloxacillin are individually acid stable and easily absorbed when administered before meals to produce good serum and urine concentrations. Higher and more prolonged levels may be achieved in patients with normal renal function by the concurrent administration of probenecid. EUROCLOX is predominantly excreted by glomerular filtration and renal tubular secretion.
INDICATIONS AND USAGE
Ampicillin exerts bactericidal action against Gram positive organisms like S. Pneumoniae and other Streptococci, L. monocytogenes as well as Gram negative organisms like M.catarrhalis, N. gonorrhea, N. meningitides, E, coli, P. mirabilis, Salmonella, Shigella and H. influenza while Cloxacillin is active against Gram positive organisms including Penicillinase producing strains of Staphylococci. It is highly active against Staphylococcus aureus, Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, N. meningitidis, H. influenzae. EUROCLOX can be used to treat infections of the respiratory tract, ear, nose and throat, urinary tract, gastrointestinal tract, skin and soft tissues, Septicaemia, pelvic infections, Endocarditis and Orthopaedic infections.
History of hypersensitivity to Penicillin, Cephalosporins, Penicillin deritvatives or Penicilliamine.
Co-administration with bacteriostatic antibiotics such as Tetracyclines, Erythromycins or Sulphonamides may antagonize the bactericidal effect of
Penicillins. Probenecid decreases renal tabular secretion of Penicillins resulting in increased and more prolonged Penicillins concentrations.
Co-administration with Allopurinol leads to increased incidence of skin rash. It may decrease the efficacy of oestrogen containing oral contraceptives.
Keep all medicines out of the reach of children. To reduce the incidence of relapse, the development of resistance or failure of treatment, take at regular intervals and complete the prescribed course unless otherwise directed.
History of Gastrointestinal diseases especially antibiotic associated colitis (Ampicillin like other Penicillins may cause Pseudomembranous colitis), Ampicillin may cease skin rash is patients with infectious mononucleosis, renal impairment.
FERTILITY PREGNANCY AND LACTATION
Pregnancy: EUROCLOX capsules may be used in pregnancy as directed by the physician. EUROCLOX capsules are excreted into breast milk in small quantities with the possible risk of sensitization. So, it should only be used during breastfeeding after benefit/risk assessment by the physician in charge. Fertility: There are no data on the effects of EUROCLOX capsules on fertility in humans. Reproductive studies in animals have shown no effects on fertility.
Gastrointestinal reactions such as diarrhoea, nausea and heartburn. Allergic reactions which may include exfoliative dermatitis, other skin rashes, interstitial nephritis and vasculitis may occur. In this event EUROCLOX should be withdrawn and an antihistamine administered. Should a serious anaphylactic reaction occur, it should be discontinued and the patient treated with the usual agents (adrenalin, corticosteroids or antihistamines).
A generalized sensitivity reaction with urticaria, fever, joist pains and eosinophilia can develop within a few hours to several weeks after starting treatment. Superinfections by resistant species, such as Pseudomonas or Candida, which do not respond to Penicillin therapy may occur. A sore mouth or tongue and a black hairy tongue have been reported. Increase in liver enzyme values have been reported.
Care should be taken when treating patients with syphilis, as the Jarisch-Herxheimer reaction may occur shorty after starting treatment. This reaction, manifesting as fever, chills, headache and reactions at the site of the lesion, can be dangerous in cardiovascular syphilis or where there is a serious risk of increased local damage such as with optic atrophy. EUROCLOX contains Ampicillin and should preferably not be given to patients with infectious mononucleosis, lymphatic leukaemia and patients receiving Allopurinol treatment because of an increased risk of developing skin rashes.
Care should be taken when high doses are given to patients with renal impairment (because of the risk of neurotoxicity) or congestive heart failure. Renal and Haematological systems should be monitored during prolonged and high dose therapy. Haemolytic anaemia and Leucopenia, prolongation of bleeding time and defective platelete function have been observed usually following high intravenous doses. Convulsions and other signs of toxicity to the renal nervous system may occur particularly with intravenous administration or in patients with renal failure. EUROCLOX contains Cloxacillin Sodium, therefore disturbances of blood electrolytes may follow the administration of large doses. Treatment is symptomatic and supportive.
DOSAGE AND ADMINISTRATION
Best taken at least ½ to 1 hour before meals, 1-2 capsules every 6 hours. OR As directed by the physician.
Store below 30°C in a cool and dry place, away from sunlight. Keep all medicines out of the reach of children.
1. 10 capsules in one regular blister and tropical blister, two such tropical blisters in one clinical box.
2. 10 regular blisters in one clinical box.
Two years from the date of manufacturing.
Chris-Ejik Pharmaceuticals & Health Care Products Ltd.,
3, Oje-lmianvan Street, Oregun,
Ikeja, Lagos, Nigeria.