Co-amoxiclav: Amoxicillin and clavulanic acid.
Augpac: 375 mg & 625 mg tablet: Each 375 and 625 mg film-coated tablet contains amoxicillin trihydrate BP equivalent to amoxicillin 250 or 500 mg, respectively, and diluted potassium clavulanate BP equivalent to clavulanic acid 125 mg.
1,000 mg tablet: Each Film coated tablet contains: Amoxicillin Trihydrate BP eq. to Amoxicillin 875 mg, Clavulanate Potassium BP eq. to Clavulanic Acid 125 mg.
Augpac Injection: 600 mg vial: Each vial contains amoxicillin (as sodium) 500 mg, clavulanate potassium 100 mg (as clavulanic acid).
1.2 g vial: Each vial contains: Amoxicillin sodium eq to Amoxicillin 1g, Clavulanate potassium eq to Clavulanic acid 0.2g.
Augpac: Pharmacology: Mechanism of action: The amoxicillin component of the formulation exerts a bactericidal action against many strains of Gram-positive and Gram-negative organisms. The clavulanic acid component has little or no antimicrobial action. It does, however, by inactivation of susceptible beta-lactamase protect amoxicillin from degradation by beta-lactamase enzymes produced by penicillin resistant strains of organisms.
Pharmacokinetics: The pharmacokinetics of amoxicillin and clavulanic acid are closely allied and neither are adversely affected by the presence of food in the stomach, and are stable in the presence of gastric acid. The oral bioavailability of amoxicillin and potassium clavulanate is approximately 90% and 75% respectively.
Peak serum levels of both occur about 1-2 hours after oral administration. Clavulanic acid has about the same plasma elimination half-life (1 hour) as that of amoxicillin (1, 3 hours). Amoxicillin and clavulanate potassium-cl is eliminated primarily unchanged through the renal route (glomerular filtration and tubular secretion). Approximately 50-78% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine within the first 6 hrs. after administration.
Microbiology: Antibacterial Activity: Clavulanic acid is an irreversible inhibitor of beta-lactamases produced by Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and Proteus vulgaris, H. influenzae, N. gonorrhoeae and B. fragilis (In-vitro activity does not necessarily imply in-vivo efficacy). Potassium clavulanate does not inactivate the chromosomally mediated (Sykes Type 1 Cephalosporinase) beta-lactamases produced by Acinetobacter species, Citrobacter species, Enterobacter, indole positive Proteus, Providencia species and Serratia marcescens.
Augpac: Amoxicillin and clavulanate potassium is indicated for the treatment of infections caused by amoxicillin resistant organisms producing beta-lactamase sensitive to clavulanic acid:
Upper respiratory tract infections: otitis media, tonsillitis, sinusitis.
Lower respiratory tract infections: bronchitis (caused by amoxicillin resistant beta-lactamases producing E. coli, H. influenzae and Haemophilus parainfluenzae), pneumonia.
Urinary tract infections: cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections.
Amoxicillin and clavulanate potassium formulations will also be effective in the treatment of infections caused by amoxicillin sensitive organisms at the appropriate amoxicillin dosage since in this situation the clavulanic acid component does not contribute to the therapeutic effect.
Augpac Injection: Upper respiratory tract infections, e.g. otitis media, sinusitis. Lower respiratory tract infections, e.g. bronchitis. Genito-urinary tract infections, e.g. cystitis, urethritis. Skin and soft tissues infections, e.g. severe dental abscess, wound infections, cellulitis.
Augpac: General information: For infections caused by amoxicillin sensitive organisms, the dosage is that approved for amoxicillin, as the clavulanic acid component does not contribute to the therapeutic effect.
Adults (oral): 1 Tablet 8 hourly for more severe infections and infections of the respiratory tract.
Children: The dose of Augpac in children is 25-50 mg/kg/day of the 4 parts amoxicillin 1 part clavulanic acid preparations (which corresponds to a daily dosage of the equivalent of 20-40 mg/kg/day of amoxicillin and 5-10 mg/kg of clavulanic acid) to be taken in divided doses every 8 hours at the start of a meal.
Augpac Injection: Intravenous injection: Dissolve one vial of amoxicillin sodium and clavulanate potassium for injection in 20ml Water for Injection BP. Inject slowly.
The constituted solution must be used up within 20 minutes below 25°C.
For treatment of infections: Adult and children over 12 years: 1.2g of amoxicillin sodium and clavulanate potassium for injection every 8 hours. In severe infections, increase frequency to six-hourly intervals. Children 3 months to 12 years: 30mg/kg* of amoxicillin sodium and clavulanate potassium for injection every 8 hours. In severe Infections, Increase frequency to six-hourly intervals. Children 0-3 months: 30mg/kg* of amoxicillin sodium and clavulanate potassium for injection every 12 hours in premature infants and in full-term infants during the perinatal period, increasing to eight hours thereafter. *each 30mg AUGPAC INJECTION provides 25mg amoxicillin and 5mg clavulanic acid.
Intravenous infusion: 600 mg vial: Dissolve one vial of amoxicillin sodium and clavulanate potassium for injection in 20 ml Water for Injection BP and then add the reconstituted solution to 100 ml Sodium Chloride intravenous Injection BP 0.9% w/v. Infuse over 30 minutes. The diluted solution must be used within 1 hour below 25°C.
Augpac: Nausea, vomiting and diarrhoea may occur with overdosing. Treatment is symptomatic and supportive.
Amoxicillin and clavulanic acid may be removed from the circulation by haemodialysis.
Augpac: Allergy to penicillins and cephalosporins. Safety in pregnancy has not been established. Amoxicillin and clavulanate potassium is contra-indicated in patients with a previous history of amoxicillin and potassium clavulanate associated jaundice/hepatic dysfunction. Amoxicillin and clavulanate potassium is also contraindicated in infectious mononucleosis. Patients with lymphatic leukemia and patients with hyperuricaemia having been treated with allopurinol may also be at an increased risk of developing skin rashes.
Augpac Injection: Penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other β-lactam antibiotics, e.g. cephalosporins. Previous history of amoxicillin or penicillin-associated jaundice/hepatic dysfunction.
Augpac: Transient hepatitis and cholestatic jaundice has been reported hence, Amoxicillin and clavulanate potassium should be used with caution in patients with evidence of hepatic dysfunction.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, Amoxicillin and clavulanate potassium should be discontinued and the appropriate therapy instituted: adrenaline, corticosteroids and antihistamines.
Effects on the Ability to Drive or Operate Machinery: 375 mg & 625 mg tablet: Patients experiencing dizziness or other central nervous disturbances, including visual disturbances, should not drive or operate machinery.
Augpac Injection: Before starting therapy with amoxicillin sodium and clavulanate potassium for injection, previous hypersensitivity reactions (e.g. penicillin hypersensitivity) should be enquired.
Use amoxicillin sodium and clavulanate potassium for injection with caution in patients with hepatic dysfunction and dosage adjustment should be made in patients with kidney dysfunction.
Amoxicillin sodium and clavulanate potassium for injection cannot be used for intramuscular administration.
Amoxicillin sodium and clavulanate potassium for injection is less stable in infusions containing glucose, dextran or bicarbonate.
Augpac: Amoxicillin and clavulanate potassium is in the FDA pregnancy category B.
This means that it is not expected to be harmful to an unborn infant. Do not, however, take this medication without first talking to the doctor if the patient is pregnant or could become pregnant during treatment.
Augpac Injection: Use in pregnancy should be avoided. Amoxicillin sodium and clavulanate potassium for injection may be given during lactation. With the exception of the risk of sensitization, associated with the excretion of trace amount in breast milk, there are no detrimental effects for the infant.
Augpac: The most common adverse effects are hypersensitivity reactions: especially skin rashes; anaphylaxis occasionally occurs and has sometimes been fatal.
Hepatitis and cholestatic jaundice have been reported with the combination amoxicillin with clavulanic acid; the clavulanic acid component has been implicated.
Augpac Injection: Hypersensitivity reactions: Urticarial and erythematous rashes.
Gastrointestinal reactions: nausea, vomiting, diarrhea, indigestion.
Hepatic effects: moderate rises in AST and/or ALT have been reported occasionally. Hepatitis and cholestatic jaundice have been reported rarely.
Rare effects on the central nervous system may occur, such as reversible hyperactivity, dizziness, headache and convulsions.
Phlebitis at the injection sites has been reported occasionally.
Augpac: Concurrent use of Amoxicillin and clavulanate potassium with probenecid may result in increased and prolonged levels of amoxicillin but since the excretion of clavulanic acid is unchanged by probenecid, its blood level remains unaffected. Interaction of Amoxicillin and clavulanate potassium with coumarin or indandione-derivative anticoagulants, heparin, non-steroidal anti-inflammatory drugs (NSAIDS) especially, aspirin, other platelet aggregation inhibitors or thrombolytic agents may be clinically significant. Amoxicillin and clavulanate potassium may decrease the efficacy of oestrogen-containing oral contraceptives.
The concurrent administration of allopurinol and amoxicillin substantially increases the incidence of rashes in patients receiving both agents as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricaemia present in these patients. There are no data on amoxicillin/clavulanate combination and allopurinol administered concurrently.
Augpac Injection: Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.
Amoxicillin sodium and clavulanate potassium for injection should be used with care in patients on anti-coagulation therapy e.g. warfarin, as prolongation of bleeding time and prothrombin time have been reported in some patients. Amoxicillin sodium and clavulanate potassium for injection may reduce the efficacy of oral contraceptives.
Augpac: 375 mg & 625 mg tablet: Store below 30°C in a dry place, protected from light.
Shelf life: 24 months.
1,000 mg tablet: Store at a temperature not exceeding 30°C. Protect from light and moisture.
Shelf life: 36 months.
Augpac Injection: 600 mg vial: Store in a cool, dry place.
1.2 g vial: Store in a dry place below 25°C. Use immediately after reconstitution, do not freeze.
Shelf-life: 3 years.
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Augpac: FC tab 375 mg x 6's. 625 mg x 6's. 1,000 mg x 6's.
Augpac Injection: Powd for inj (vial) 600 mg x 1's. 1.2 g + WFI (amp) 10 mL x 1's.
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