Contents

Co-amoxiclav (amoxicillin & clavulanic acid). Per 5 mL of 200 mg/28.5 mg susp Amoxicillin 200 mg clavulanic acid 28.5 mg. Per 5 mL of 400 mg/57 mg susp Amoxicillin 400 mg clavulanic acid 57 mg

Indication

For the treatment of the following infections caused by susceptible microorganisms: Upper respiratory tract infections (including ENT infections): Tonsillitis, sinusitis, otitis media.Lower respiratory tract infections: Acute and chronic bronchitis, pneumonia, lung abscess.Genito-urinary tract and abdominal infections: Cystitis, urethritis, pyelonephritis, female genital infections, septic abortion, pelvic or puerperal sepsis, intra-abdominal sepsis.Skin and skin structure infections: Furuncle and abscess, cellulitis, wound infections.Bone and joint infections: Osteomyelitis.Dental infection: Dentoalveolar abscess.Other infections: Septicemia, peritonitis, post-surgical infections.Step down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral Co-amoxiclav.

Dosage / Direction For Use

200 mg/28.5 mg/5 mL Childn >6 yr w/ body wt 18-40 kg Mild to moderate infections 5-10 mL. Severe infections 10-20 mL. Childn 1-6 yr w/ body wt 10-18 kg Mild to moderate infections 2.5-5 mL. Severe infections 5-10 mL. Childn <1 yr w/ body wt <10 kg Mild, moderate, severe infections 2.5 mL. 400 mg/57 mg/5 mL Childn >6 yr w/ body wt 18-40 kg Mild to moderate infections 2.5-5 mL. Severe infections 5-10 mL. Childn 1-6 yr w/ body wt 10-18 kg Mild to moderate infections 2.5 mL. Severe infections 2.5-5 mL. To be given 12 hrly.

Overdosage

Clinical features of overdosage with Co-amoxiclav may include gastrointestinal symptoms, fluid and electrolyte imbalance. Amoxicillin crystalluria, leading to renal failure, has also been observed in some cases.Symptomatic treatment is recommended. Co-amoxiclav can be removed by hemodialysis.

Administration

May be taken with or without food: Preferably taken at the start of meals for better absorption & to reduce GI discomfort.

Contraindication

–

Special Precaution

Known hypersensitivity to penicillin or any ingredient in this product.Cross-sensitivity with other β-lactam antibiotics, e.g., cephalosporins.Patients with a previous history of jaundice/liver impairment associated with Co-amoxiclav or penicillin.Patients with glandular fever or lymphatic lymphoma should not be given Co-amoxiclav as the amoxicillin component is likely to cause a maculopapular rash.

Adverse Reactions

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Careful inquiry should be made concerning previous hypersensitivity to penicillins, cephalosporins, or other drugs before initiating therapy with Co-amoxiclav. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should also be instituted.Clostridium difficile: associated diarrhea and colitis have been reported with nearly all antibacterial agents, and may range in severity from mild to life-threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.Since hepatic toxicity has been associated with Co-amoxiclav therapy, the drug should be used with caution in patients with evidence of hepatic dysfunction.In patients with renal impairment, the dose of Co-amoxiclav should be adjusted based on the degree of impairment (see Dosage & Administration).During administration of high doses of amoxicillin, it is recommended to maintain adequate fluid intake and urinary output in order to reduce the possibility of crystalluria associated with amoxicillin therapy.Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly with Co-amoxiclav since prolongation of prothrombin time has been reported rarely in patients receiving Co-amoxiclav.Although Co-amoxiclav has a low toxicity profile, the renal, hepatic, and hematopoietic status of patients undergoing prolonged treatment with the drug should be evaluated periodically.As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi.Use in Pregnancy: (Pregnancy Category B). There are no adequate or controlled studies in pregnant women and safe use in pregnancy has not been definitely established. However, oral Co-amoxiclav has been administered to pregnant women, particularly in the treatment of urinary tract infections, without evidence of adverse effects to the fetus.Use in Lactation: Since Co-amoxiclav is distributed in human milk, use with caution when breastfeeding.Use in children: Children weighing over 40 kg should be dosed based on recommended dosing in adult patients. The safety and efficacy of Co-amoxiclav tablets in children weighing less than 40 kg have not been established.Use in elderly patients: Since elderly patients have increased risk of renal impairment, dose adjustment and renal function monitoring may be necessary.

Drug Interaction

Interference with Laboratory Tests: High urine concentrations of ampicillin may result in false-positive reactions when testing for urinary glucose using cupric sulfate (e.g., Clinitest, Benedict’s Solution). Since this effect may also occur with amoxicillin, glucose oxidase methods (e.g., Clinistix) should be used when urinary glucose determinations are indicated in patients receiving Co-amoxiclav.Although not reported to date with Co-amoxiclav, positive direct antiglobulin (Coombs’) test results have been reported in patients who received ticarcillin and clavulanic acid and appear to be caused by clavulanic acid. This reaction may interfere with hematologic studies or transfusion cross-matching procedures and therefore should be considered in patients receiving Co-amoxiclav.

Storage

Store in a dry place at temperatures not exceeding 25°C.

Description

Co-amoxiclav (Amoclav) 228.5 mg/5 mL suspension: After reconstitution, each 5 mL (1 teaspoonful) suspension contains: Amoxicillin (as trihydrate) 200 mg; Clavulanic acid (as potassium clavulanate) 28.5 mg.Co-amoxiclav (Amoclav) 457 mg/5 mL suspension: After reconstitution, each 5 mL (1 teaspoonful) suspension contains: Amoxicillin (as trihydrate) 400 mg; Clavulanic acid (as potassium clavulanate) 57 mg.

Action

Pharmacology: Pharmacodynamics: Amoxicillin (an aminopenicillin antibiotic) and potassium clavulanate (a β-lactamase inhibitor) [Co-amoxiclav] is usually bactericidal in action. Concurrent administration of clavulanic acid does not alter the mechanism of action of amoxicillin. However, because clavulanic acid has a high affinity for and binds to certain β-lactamases that generally inactivate amoxicillin by hydrolyzing its β-lactam ring, concurrent administration of the drug with amoxicillin results in synergistic bactericidal effect which expands amoxicillin’s spectrum of activity against many strains of β-lactamase-producing bacteria resistant to amoxicillin alone.