amoxicillin + clavulanic acid




Full Prescribing Info
Each Film-Coated tablet contains: Amoxicillin 500 mg, Potassium clavulanate 125 mg.
Susceptible Organism: Co-Amoxiclav (COBIOMAX) is bactericidal to a wide range of Gram-positive and Gram-negative organisms including many clinical Important β-lactamase producing penicillin resistant pathogens: Staphylococcus epidermis, Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus viridans, Streptococcus faecalis, Listeria monocytogenes, Bacillus anthracis, Corynebacterium species, Clostridium species, Peptococcus species, Peptostreptococcus species, Cachirichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella species, Salmonella species, Bordotella pertussis, Haemophilus influenza, Brucella species, Neisseria meningtidis, Neisseria gonorrhoea, Yersinia enterocolitica, Gardnerella vaginalis, Branhamella catarrhalis, Haemophilus ducreyi, Pasteuralla multocida, Campylobacter leiuni, Vibrio choleae, Bacteroides species including Bacteroides fragilis (including β-lactamase producing strains resistant to ampicillin and amoxicillin).
Co-Amoxiclav (COBIOMAX) is indicated in the treatment of common bacterial infections where antibiotics therapy is indicated, including: Tonsilitis, Sinusitis, Otitis Media, acute and chronic bronchitis, pneumonia, thoracic emphysema, lung abscess, boils and abscesses, cellulites, wound infection, intra-abdominal sepsis, cystitis, urethritis, nephropyelitis, septic abortion, pelvic infection, chancroid, gonorrhea, osteomyelitis.
Dosage/Direction for Use
The usual adult dose is 1 tablet three times a day or as prescribed by the physician.
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances occurs rarely as problems of overdosage with Co-Amoxiclav (COBIOMAX), they may be symptomatically with attention to the water electrolyte balance. Co-Amoxiclav (COBIOMAX) can be removed from the circulation by haemodialysis.
Patients with penicillins hypersensitivity; Patients with infectious mononucleosis; Patients with a previous history of cholestatic jaundice or hepatic dysfunction.
Special Precautions
Caution administration: Patients with severe liver disorder; Patients with moderate or severe renal disorder; Patients with a history of hypersensitivity to penicillin or cephalosporin; Patients who have a predisposition to develop allergic reactions such as bronchial asthma, rash and urticaria; Patients with poor oral intake or receiving parenteral nutrition or aged patients (as vitamin K deficiency symptoms may appear, close observation should be made).
General precaution: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions or vascular neurological edema have been reported in patients on penicillin therapy. These reactions are more likely occur in individuals with a history of penicillin hypersensitivity or a history of sensitivity multiple allergens and more commonly occur during therapy with non-oral than oral.
As non-sensitive bacteria's overgrowth can occur sometimes in patients with prolonged treatment, carefully observe in case of over 14 days administration.
The change at liver function examination in some patients receiving this drug is reported. Clinical significance is uncertain but patients with hepatic dysfunction sign should use it with caution. Severe or generally reversible bile stasis jaundice is reported rarely. Any symptoms or signs cannot be revealed in 6 weeks after therapy has been discontinued.
This drug's dosage should be adjusted according to age and administration in patients with moderate or severe renal disorder.
As erythema eruption is associated with glandular fever due to amoxicillin use, carefully administer.
Use In Pregnancy & Lactation
Animal studies with orally and parenterally administered Co-Amoxiclav (COBIOMAX) have shown no teratogenics effects. The safety evidence for use in pregnancy has not been established, therefore the drug should not be administered to pregnant patients or women suspected of being pregnant esp. during the 1st trimester, except that the expected therapeutic benefit is thought to outweigh any possible risk.
During lactation, trace quantities of penicillin can be excreted in breast milk.
Adverse Reactions
Gastrointestinal: Diarrhea, pseudo membrane colitis, emesis, indigestion, nausea, stomatitis have been reported. Candidiasis, antibiotic-associated colitis (including pseudo membranous colitis and hemorrhagic colitis) has been reported rarely. The overall incidence of side effects, and in particular nausea, increased with the higher recommended dose.
If gastrointestinal reactions are evident, they made be reduced by taking Co-Amoxiclav (COBIOMAX) at the start of the meal. As with other antibiotics, the incidence of gastrointestinal side effects may be raised in children under two years. In clinical trials, however, only 4% of children under two years were withdrawn from treatment.
Liver: Moderate rise in AST (SGOT) and/ or ALT (SGPT) has been noted in patients treated with ampicillin class antibiotics but the significance of these findings is unknown. Hepatic dysfunction, including increases in serum transaminases (AST and/or ALT), serum bilirubin and/or alkaline phosphate, has been infrequently reported with amoxicillin; potassium Clavulanate. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/ symptoms of hepatic dysfunction may occur during or several weeks after therapy have been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. On rare occasions, deaths have been reported.
Hypersensitivity reactions: Skin rashes (urticarial and erythematous rashes) sometimes occur. Rarely erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, acute generalized exanthematous pustulosis, angioedema have been reported rarely. Treatment should be discontinued if one of these disorders occurs. In common with other β-lactamase antibiotics angioedema, anaphylaxis serum sickness-like syndrome and hypersensitivity vasculitis have been reported.
Blood: As antibiotic other β-lactam, reversible leucopenia (including if hypoeosinophilia and granulocytopenia), reversible thrombocytopenia and hemolytic anemia, thrombocytopenic purpura, osinophilia, leucosis, agranulocytosis have been reported.
Central Nervous System: Side effects, such as reversible hypersensitivity, dizziness, headache and convulsions have been reported rarely. Convulsion may occur in patients with impaired renal functions or those receiving high dose.
Renal: Interstitial nephritis and hematuria have been reported rarely.
Others: Sometimes, dental discoloration has been reported rarely in children.
Drug Interactions
Co-Administration of Probenecid cannot be recommended. Probenecid decreases the renal tubular secretion of Amoxicillin and may result in increased and prolonged blood levels of amoxicillin. It is not related with clavulanic acid.
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Do not co-administer with disulfiram.
Increased bleeding time and prothrombin time in patients receiving this drug have been reported so, Co-Amoxiclav (COBIOMAX) should be used with cautions in patients with anticoagulant therapy.
Notice patient that this drug may reduce the efficacy of oral contraceptives.
Interference with Laboratory Test: Oral administration of Co-Amoxiclav (COBIOMAX) will result in high urine concentrations of amoxicillin, High urine concentrations of ampicillin may result in false-positive reactions when testing for the glucose in urine using Clinitest, Benedict's solution or Fehling's Solution.
Store in a hermetic, light resistant container at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
FC tab 12's.
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