Augclav

625 mg tablet: Each tablet contains Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg and Clavulanate Potassium equivalent to Clavulanic Acid 125 mg.
1000 mg tablet: Each tablet contains 875 mg Amoxicillin in the form of trihydrate and 125 mg of Clavulanic Acid in the form of potassium salt in the ratio 7:1.
228 mg/5 mL dry syrup: Each teaspoonful (5 mL) of oral suspension contains 200 mg of Amoxicillin in the form of trihydrate and 28 mg of Clavulanic Acid in the form of potassium salt in the ratio 7:1.
457 mg/5 mL dry syrup: Each teaspoonful (5 mL) of oral suspension contains 400 mg of Amoxicillin in the form of trihydrate and 57 mg of Clavulanic Acid in the form of potassium salt in the ratio 7:1.

Pharmacology: Augclav is a combination of amoxicillin, penicillin antibiotic with a broad spectrum of bactericidal activity and clavulanic acid, an irreversible β-lactamase inhibitor which produces stable nonactive complexes and protects amoxicillin from degradation.
Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus.
Augclav processes a broad spectrum of activity. It is active against amoxicillin-susceptible microorganisms as well as against resistant β-lactamase producing bacteria including: Gram-positive aerobes (S. pneumonia, S. pyogenes, S. viridans, S. bovis, S. aureus, S. epidermidis, Listeria spp., Enterococcus spp.); Gram-negative aerobes (H. influenzae, Moraxella catarrhalis, E. coli, Proteus spp., Klebsiella spp., N. gonorrhoeae, N. meningitidis, Pasteurella multocida); Anaerobes (Peptococcus spp., Peptostreptococcus, Clostridium spp., Bacteroides spp., Actinomyces israelii).
The basic pharmacokinetic properties of amoxicillin and clavulanic acid are similar. Both components of Augclav are well absorbed after oral administration. Food has no effect on the degree of absorption. Peak serum concentration is achieved approximately 1 hour of ingestion or 1-2.5 hour after dosing (Augclav 625 mg tablet). The biologic half-life of amoxicillin is 78 minutes and that of clavulanic acid is 60-70 minutes.
Both components diffuse readily into most body tissues and fluids (lung, middle ear effusions, pleural and peritoneal fluid, uterus, ovarium, etc.). Both amoxicillin and clavulanic acid are excreted in urine; amoxicillin mainly unchanged, clavulanic acid partially metabolised. Small amounts may be excreted in the feces and exhaled breath.
In patients with impaired renal function, excretion of the drug from the body is delayed and it accumulates in the blood proportionately to the degree of renal impairment.
625 mg tablet: Augclav 625 is not active against Pseudomonas spp. and majority of Enterobacter and Serratia species.

Upper respiratory tract infections (acute and chronic sinusitis, acute and chronic otitis, peritonsillar abscess); Lower respiratory tract infections (chronic bronchitis, pneumonia); Urinary tract infections; Gynecological infections; Gonorrhoea (1000 mg tablet only); Bites of animals and man (dry syrup only); Skin and soft tissue infections; Gastrointestinal infections (625 mg tablet only); Bone and joint infections; Cholecystitis; Chancroid; Odontogenic infections.
Treatment of mixed infections due to gram-negative and gram-positive microorganisms and anaerobes: chronic sinusitis and otitis, peritonsillar abscess, mammary abscess, aspiration pneumonia, peritonitis, cholangitis, postoperative intra-abdominal complications, abdominal infections (1000 mg tablet and dry syrup only).

Maximum daily dosage for Clavulanic Acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg body weight for children.
Maximum daily dosage for Amoxicillin is 6 grams for adults and 45 mg/kg body weight for children.
In moderate renal insufficiency (creatinine clearance 10 to 30 mL/min), the dose should be reduced, or the dosage interval prolonged to 12 hours, respectively, and in anuria to 48 hours or more.
625 mg tablet: Adults and children over 12 years of ago: in severe infections 1 tablet 3 times daily.
Treatment with Augclav 625 must not exceed 14 days without medical re-examination.
1000 mg tablet: Adults and children over 12 years (40 kg body weight): The usual daily dose in moderate infections is 1 tablet of Augclav 625 mg every 12 hours. In severe infections the dose is 1 tablet of Augclav 1000 mg every 12 hours.
Children: Tablets should not be given to children under 12 years (40 kg body weight).
Dosage in renal insufficiency: In patients w/ moderate renal insufficiency (creatinine clearance 10 to 30 mL/min), the dose is 1 tablet of Augclav 625 mg every 12 hours.
In patients with severe renal insufficiency (creatinine clearance less than 10 mL/min), the dose is 1 tablet of Augclav 625 mg every 24 hours.
228 mg/5 mL and 457 mg/5 mL dry syrup: In children (above 3 months of age) the exact doses are based on body weight. Depending upon severity of infection, the daily dose in children under 40 kg body weight is 25-45 mg/kg body weight/day (based on amoxicillin component), divided into two equal doses.
Dosage of Augclav 228/457 Dry Syrup in children: In otitis, sinusitis, lower respiratory tract infections, and other severe infections, the usual dosage in children is 45 mg/kg/daily (based on the amoxicillin component) every 12 hours.
In moderate infections, the daily dosage is 25 mg/kg/daily every 12 hours.
Reconstitution: Shake the bottle to loosen the powder, add water in two portions, first to 2/3 and then to the mark, and shake vigorously each time.

Intoxication with Augclav is unlikely to occur. However, ingestion of larger quantity of drug may produce agitation, insomnia, dizziness, in some cases seizures. Treatment is symptomatic. Amoxicillin can be removed by hemodialysis.

Hypersensitivity to amoxicillin, clavulanic acid, penicillin group of antibiotics and any other ingredients of the medicine. Lymphatic leukemia, infectious mononucleosis.

Augclav should be used with caution in patients with a history of allergic reactions or renal impairment in anamnesis (tablet and 457 mg/5 mL dry syrup only) or hepatic impairment (228 mg/5 mL dry syrup only).
In patients with severe renal impairment, the dosage should be adequately adjusted or the dosing interval prolonged.
1000 mg tablet and dry syrup: The drug should not be used in patients with infectious mononucleosis, cholestatic jaundice or hepatic dysfunction caused by penicillins or amoxicillin/clavulanic acid combinations.
Influence on mental and/or Physical ability: No special warnings.
Use in Pregnancy & Lactation: 625 mg tablet: Safety for use of Augclav 625 in pregnancy has not been established although animal studies revealed no evidence of teratogenicity.

There is no evidence of teratogenic effect to the fetus. Both amoxicillin and clavulanic acid belong to category labeled B according to Food and Drug Administration (FDA) definitions.
Augclav can be used during pregnancy if clearly indicated.
Both amoxicillin and clavulanic acid has been shown to be excreted (in minor quantities-dry syrup only) in breast milk.

Side effects are generally mild and transient. The most frequently reported are gastrointestinal disturbances (nausea, vomiting, diarrhea). These reactions can be minimised if the drug is taken with meals.
Bacterial resistance or superinfections may develop during treatment. Stomatitis, vaginitis or pseudomembranous colitis with severe diarrhea may occur. If a patient develops diarrhea, he/she should consult the physician to rule out the possibility of pseudomembranous colitis. Skin reactions (pruritus, maculopapular exanthema, rash, angioneurotic edema, anaphylactic shock) may occur, if rash occurs, Augclav should be discontinued. A rise in hepatic enzymes may rarely occur. Cholestatic jaundice, hepatitis, interstitial nephritis are very rare. Leukopenia, thrombocytopenia, eosinophilia may occur.

1000 mg tablet and dry syrup: The concurrent administration of amoxicillin and methotrexate increases methotrexate toxicity.
Concomitant use with allopurinol appears to increase incidence of exanthema.
Amoxicillin and aminoglycosides use in combination are physically and chemical incompatible.
In some cases the drug may prolong prothrombin time, therefore, caution is required when oral anticoagulants are given concomitantly with Augclav.
Concomitant use with disulfiram should be avoided.
Laboratory test interactions: With Benedict's reagent, Augclav produces false positive glucose reaction in urine and positive Coombs test. It is recommended that the glucose tests based on enzymatic glucose oxidase reactions be used.

Store below 25°C, in original packaging and protected from moisture (tablet) and from light and humidty (dry syrup).
228 mg/5 mL and 457 mg/5 mL dry syrup: The reconstituted suspension must be stored in the refrigerator and use it within 7 days.

Penicillins

J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.

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