Indications
Acute bacterial sinusitis; Acute streptococcal tonsillitis and pharyngitis; Acute exacerbations of chronic bronchitis (AECB)/acute exacerbation of chronic obstructive pulmonary disease (AECOPD); Community acquired pneumonia;Acute otitis media; Acute cystitis; Acute pyelonephritis; Asymptomatic bacteriuria in pregnancy; Typhoid and paratyphoid fevers; Dental abscess with spreading cellulitis; Prosthetic joint infections; Helicobacter pylori eradication; Lyme disease

Dosage and Administration

Usage:Oral

Dosage: The dosage and duration of therapy should be determined by the type of infection and the response of the patient, and should generally be as short as possible.

Precautions & Warning:

1.Hypersensitivity reactions: Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.  

2. Non-susceptible microorganisms: Amoxicillin 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.

3.Convulsions: Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors.

4.Renal impairment: In patients with renal impairment, the dose should be adjusted according to the degree of impairment

5.Skin reactions: The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis (AGEP). This reaction requires amoxicillin discontinuation and contra-indicates any subsequent administration.

6.Jarisch-Herxheimer reaction

7.Overgrowth of non-susceptible microorganisms

8.Prolonged therapy

9.Crystalluria

10.Anticoagulants

Contraindications:

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

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; Vomiting

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 time

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

6.Nervous system disorders: Hyperkinesia, dizziness, convulsions; Aseptic meningitis

7.Hepatobiliary disorders: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

Renal and urinary tract disorders: Interstitial nephritis;  Crystalluria

Drug interactions:

1.Probenecid: Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin

2.Allopurinol: Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

3.Tetracyclines: Tetracyclines and other bacteriostatic drugs may interfere with the bactericidal effects of amoxicillin.

4.Methotrexate: Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Storage instructions:

Do not store above 25° C. Store in the original package and keep containers tightly closed.