For lyme disease: 6.7-13.3 mg/kg body weight every eight hours for ten to thirty days.

In impaired renal function
Dosage adjustments are required for patients with renal impairment or for patients undergoing haemodialysis.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

HEALTH 2000 Amoxicillin 125 mg/5ml Rediuse is indicated in the treatment of the following infections
· Acute otitis media, pharyngitis, tonsillitis and sinusitis caused by Streptococci, Pneumococci, non-penicillinase producing Staphylococci and Haemophilus influenzae.

· Lower respiratory tract infections including pneumonia, bronchitis and acute exacerbation of chronic bronchitis caused by susceptible organisms.

· Urinary tract infections caused by susceptible organism

· Skin and soft tissue infections, including burn wound lnfections; caused by Streptococci, non penicillinase — producing Staphylococci, E.coli and Proteus mirabilis.

· Helicobacter pylori associated gastritis or Peptic ulcer in combination with other drugs.

· Lyme disease

· Typhoid fever

(iii) DESCRIPTION OF DOSAGE FORM

Amoxicillin is a semi synthetic penicillin which exerts its bactericidal action by inhibition of cell wall synthesis. It acts against a broad spectrum of gram positive and gram negative microorganisms.

(iv) CONTRAINDICATIONS
Hypersensitivity reactions to penicillins.

WARNINGS AND PRECAUTIONS
DRUG INTERACTIONS
Allopurinol: A significant increase in skin rashes is observed when allopurinol and ampicillin are given concurrently. A similar interaction can occur with amoxicillin.
Bacteriostatic drugs like chloramphenicol, erythromycin and tetracyclines may reduce the bactericidal action of amoxicillin.
PREGNANCY
The drug can be used safely throughout pregnancy at the normal adult doses.
NURSING MOTHERS
Amoxicillin is secreted into breast milk in small amounts. The potential risk is for sensitisation and skin rash in the child.

IN IMPAIRED RENAL FUNCTION
See Dosage and Administration.
OTHERS
Serious and occasionally fatal anaphylactoid reactions have been reported in patients taking penicillins. Though such reactions are more common with parenteral therapy, they have occurred with oral penicillins also. Before prescribing penicillins, patients or relatives should be questioned about any previous allergic reactions to penicillins, cephalosporins or other allergens. Amoxicillin should be withdrawn if any allergic reaction occur and appropriate therapy instituted.
Crosssensitivity occurs among penicillins and cephalosporins. Amoxicillin should preferably not be given to patients with infectious mononucleosis because of greater occurrence of rash in such patients.
(v) SIDE EFFECTS
As with penicillins, adverse reactions to amoxicillin are generally those related to allergic response. These are more common in patients with a previous history of penicillin allergy or asthma, hay fever or urticaria. Skin reactions are the commonest allergic reactions. Nausea, vomiting and diarrhoea are less common with amoxicillin.
Reversible hyperactivity, agitation, anxiety, insomnia, confusion, behavioural changes and dizziness have been reported rarely.

(vi) TOXIC EFFECTS

TERATOGENICITY
Animal studies with amoxicillin have shown no teratogenic effects. Amoxicillin has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, amoxicillin may be considered appropriate.

CARCINOGENICITY
Not expected to produce cancer in humans under occupational exposure conditions.

MUTAGENICITY
Not expected to produce adverse effects on fertility or development under occupational exposure conditions. No adverse effects have been reported following extensive use or exposure in humans.