Amoxicillin is a semisynthetic antibiotic with broad spectrum of antibacterial activity against many gram-positive and gram-negative micro-organisms but ineffective against organisms producing p-lactamase enzyme due its susceptibility to degradation by p-lactamase enzyme. Clavulanic acid is a p-lactam antibiotic, structurally related to penicillins, possesses ability to inactivate wide range of p-lactamase enzymes commonly found in micro-organisms resistant to penicillins and Cephalosporins. Also good activity against clinically important plasmid mediated P-lactamases frequently responsible for transferred drug resistance. The presence of clavulanic acid in OXYNIC injection protects amoxicillin from p-lactamase degradation and effectively extends antibacterial spectrum of amoxicillin to include bacteria normally resistant to amoxicillin, other penicillins and Cephalosporins. Thus OXYNIC injection possesses distinctive properties of broad spectrum antibiotic and p-lactamase inhibitor.
Indications:
Amoxicillin & Potassium Clavulanate Injection is indicated for short term treatment of common bacterial infections such as:
Upper Respiratory Tract Infections (including ENT): e.g. tonsillitis, sinusitis, otitis media
Lower Respiratory Tract Infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia
Genito-urinary Tract Infections: e.g. cystitis, urethritis, pyelonephritis, female genital infection, Skin and Soft Tissue Infections, Bone and Joint Infections (e.g. osteomyelitis)
Other Infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infections. Also, indicated for prophylaxis against infection associated with major surgical procedures such as GI, pelvic, head and neck, cardiac, renal, joint replacement and biliary Tract surgery. Infections caused by amoxicillin susceptible organisms are amenable to Amoxicillin & potassium Clavulanate Injection treatment due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible organism in post- operatively.
Direction For Use:
It may be administered either by IV injection or by intermittent infusion. It is not suitable for intramuscular administration.
600mg Vial - To reconstitute dissolve in 10ml of Sterile Water for Injections
1.2g Vial - To reconstitute dissolve in 20ml of Sterile Water for Injections
Reconstituted solution should not be frozen. Use immediately after reconstitution
Contraindications:
In patients with history of hypersensitivity to P-lactams and/or history of Amoxicillin & Potassium Clavulanate Injection associated jaundice/hepatic dysfunction.
Adverse Effects:
Clostridium difficile-associated diarrhoea and colitis, abdominal discomfort, annorexia and flatulence, dyspepsia, gastritis, stomatitis, glossitis, black or hairy tongue and enterocolitis have been reported. Rarely, in <1% of patients, dizziness, headache, rash, urticaria, nausea, vomiting, diarrhoea, vaginitis, fever and slight thrombocytosis have been observed. Moderate increases in serum AST (SGOT) and/or ALT (SGPT), alkaline phosphatase and/or bilirubin have been observed. Hepatic dysfunction reflected as cholestatic, hepatocellular or mixed cholestatic hepatocellular changes have been reported most frequently in geriatric patients, males, or in patients receiving long-term therapy.
Pregnancy & Lactation:
Pregnancy: Safe use of Amoxicillin / Clavulanate combination during pregnancy has not been established. Present combination should not be used during pregnancy.
Lactation: Amoxicillin and Clavulanic Acid are distributed in breast milk. Hence, caution should be exercised if using Amoxicillin and Clavulanic Acid.
Dosage And Administration:
Dosage:
Children 0-3 months: 30mg/kg every 12 hours in infants <4kg and 30mg/kg every 8 hours in infants >4kg.
Children 3 months - 12 years: Usually 30mg/kg 8 hourly. In more serious infections, increase frequency to 6 hourly intervals.
Adults and Children 40kg and over: Usually 1.2g/ 8 hourly. In more serious infections, increase frequency to 6 hourly intervals.
Each 30mg of Amoxicillin and Potassium Clavulanate Injection provides 5mg Clavulanic acid with 25mg amoxicillin
Dosage for Surgical Prophylaxis:
Surgical prophylaxis with Amoxicillin and Pottassium Clavulanate Injection should aim to protect patient during period of risk of infection. Accordingly, procedures in adults lasting for less than 1 hour are successfully covered by 1.2g Amoxicillin and Pottassium Clavulanate Injection Intravenous given at induction of anaesthesia. Longer operations require subsequent doses of 1.2g Amoxicillin and Pottassium Clavulanate Injection IV (up to 4 doses in 24 hours), and continued for several days if procedures has significantly increased risk of infection. Clear clinical signs of infection at operation requires normal course of IV Amoxicillin and Pottassium Clavulanate Injection. Concomitant use with Amoxicillin and Pottassium Clavulanate Injection may result in increased and prolonged blood levels of amoxicillin, but not of Clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. No data on concomitant use of Amoxicillin and Pottassium Clavulanate Injection and allopurinol.
Amoxicillin and Pottassium Clavulanate Injection may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Overdose:
Gastrointestinal Systems and disturbance of fluid and electrolyte balances which may be treated symptomatically, with attention to water/electrolyte balance.
Amoxicillin crystalluria, in some cases leading to renal failure, has been observed.
Amoxicillin can precipitate in bladder catheters after IV administration of large doses. Maintain regular potency check. It can be removed from circulation by haemodialysis.
Storage:
Store at temperature not exceeding 30°C. Protect from light & moisture.
