Augpac/Augpac Injection

Augpac/Augpac Injection

amoxicillin + clavulanic acid

Manufacturer:

Pacific Pharma (Korea)

Distributor:

AA Medical
Full Prescribing Info
Contents
Co-amoxiclav: Amoxicillin, clavulanic acid.
Description
Augpac: Each film-coated tablet contains amoxicillin trihydrate BP equivalent to amoxicillin 250 or 500 mg and diluted potassium clavulanate BP equivalent to clavulanic acid 125 mg.
Augpac Injection: Each vial contains amoxicillin (as sodium) 500 mg, clavulanate potassium 100 mg (as clavulanic acid).
Action
Augpac: Pharmacology: Pharmacodynamics: 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 β-lactamase, protect amoxicillin from degradation by β-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 hrs after oral administration. Clavulanic acid has about the same plasma elimination half-life (1 hr) as that of amoxicillin (1-3 hrs). Amoxicillin and clavulanate potassium 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: Clavulanic acid is an irreversible inhibitor of β-lactamases produced by Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Haemophilus influenzae, Neisseria gonorrhoeae and Bacteroides fragilis (in vitro activity does not necessarily imply in vivo efficacy). Potassium clavulanate does not inactivate the chromosomally mediated (Sykes type 1 cephalosporinase) β-lactamases produced by Acinetobacter spp, Citrobacter spp, Enterobacter, indole positive Proteus, Providencia spp and Serratia marcescens.
Indications/Uses
Augpac: Infections Caused by Amoxicillin-Resistant Organisms Producing β-Lactamases Sensitive to Clavulanic Acid: Upper Respiratory Tract Infections: Otitis media, tonsillitis, sinusitis.
Lower Respiratory Tract Infections: Bronchitis (caused by amoxicillin-resistant β-lactamases producing E. coli, H. influenzae and H. 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.
Dosage/Direction for Use
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: Severe Infections and Infections of the Respiratory Tract: 1 tablet every 8 hrs.
Children: 25-50 mg/kg/day of Augpac 625 mg (which corresponds to a daily dosage of the equivalent of amoxicillin 20-40 mg/kg and clavulanic acid 5.1 mg/kg) to be taken in divided doses every 8 hrs at the start of a meal.
Augpac Injection: Intravenous injection: Dissolve one vial of amoxicillin sodium and clavulanate potassium for injection in 20 ml Water for Injection BP. Inject slowly.
The constituted solution must be used up within 20 minutes below 25°C.
Intravenous infusion: 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.
For treatment of infections: Adult and children over 12 years: 1.2 g 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: 30 mg/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: 30 mg/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 30 mg AUGPAC INJECTION provides 25 mg amoxicillin and 5 mg clavulanic acid.
Overdosage
Augpac: Symptoms: Nausea, vomiting and diarrhoea may occur with overdosage.
Treatment: Treatment is symptomatic and supportive.
Amoxicillin and clavulanic acid may be removed from the circulation by haemodialysis.
Contraindications
Augpac: Hypersensitivity to penicillins and cephalosporins. Previous history of amoxicillin and potassium clavulanate associated jaundice/hepatic dysfunction.
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 crosssensitivity with other β-lactam antibiotics, e.g. cephalosporins. Previous history of amoxicillin or penicillin-associated jaundice/hepatic dysfunction.
Special Precautions
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: 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 loses stability in infusions containing glucose, dextran or bicarbonate.
Use In Pregnancy & Lactation
Augpac: Use in pregnancy: Safety in pregnancy has not been established.
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 Augpac without first talking to the physician 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.
Adverse Reactions
Augpac: The most common adverse reactions 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, diarrhoea, 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 site has been reported occasionally.
Drug Interactions
Augpac: Concurrent use of amoxicillin and clavulanate potassium with probenecid may result in increased and prolonged blood 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; nonsteroidal 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.
Storage
Augpac: Store below 30°C in a dry place. Protect from light.
Shelf-Life: 24 months.
Augpac Injection: Store in a cool, dry place.
Shelf-Life: 3 years.
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.
Presentation/Packing
Augpac: FC tab 375 mg x 6's. 625 mg x 6's.
Augpac Injection: Powd for inj (vial) x 1's.
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