Indications

1.Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms)

2.Acute exacerbations of chronic bronchitis; Community acquired pneumonia; Acute cystitis; Acute pyelonephritis; Severe dental abscess with spreading cellulitis; Prosthetic joint infections; Lyme disease; Bacterial meningitis

3.Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Dosage and Administration

Usage: The standard recommended route of administration is by intravenous injection or intravenous infusion. Intramuscular administration should only be considered when the intravenous route is not possible or less appropriate for the patient

1.Intravenous: Amoxicillin Sodium for Injection may be administered either by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or via a drip tube or by infusion over 20 to 30 minutes.

2.Intramuscular

The maximum single dose is 1 g in adults and children ≥ 40 kg.

Do not inject more than 60 mg/kg at one time in children < 40 kg.

Dosage:

1.Adults and children ≥ 40 kg:750 mg to 2 g every 8 hours, or 2 g every 12 hours, maximum of 12 g/day.

2.The dosage and duration of therapy should be determined by the type of infection and the response of the patient.

Precautions & Warning:

1.Hypersensitivity reactions:

Before initiating therapy with Amoxicillin Sodium for Injection, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents

2.Non-susceptible microorganisms:Amoxicillin Sodium for Injection is not suitable for the treatment of some types of infection unless the pathogen is already documented and known to be susceptible or there is a very high likelihood that the pathogen would be suitable for treatment with Amoxicillin Sodium for Injection

3.Convulsions

4.Renal impairment; Skin reactions; Jarisch-Herxheimer reaction.

5.Overgrowth of non-susceptible microorganisms.

6.Prolonged therapy; Anticoagulants; Crystalluria.

7.Interference with diagnostic tests.

Contraindications:

1.Hypersensitivity to the active substance or to any of the penicillins.

2.History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).

Adverse Reactions:

1.Gastrointestinal disorders:Diarrhoea and nausea;omiting.

2.Skin and subcutaneous tissue disorders: Skin rash;Urticaria and pruritus.

3.Infections and infestations:Mucocutaneous candidiasis

4.Blood and lymphatic system disorders:Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.Prolongation of bleeding time and prothrombin

5.Immune system disorders:Severe allergic reactions, including angioneurotic oedema, anaphylaxis, serum sickness and hypersensitivity vasculitis

6.Nervous system disorders:Hyperkinesia, dizziness and convulsions

7.Hepato-biliary disorders:Hepatitis and cholestatic jaundice; a moderate rise in AST and/or ALT.

8.Renal and urinary disorders:Interstitial nephritis, crystalluria

Drug interactions:

1.Probenecid

2.Allopurinol

3.Tetracyclines

4.Oral anticoagulants

5.Methotrexate

Storage instructions:

Store below 25° C