Amoxicillin 500mg Capsules BP

Amoxicillin trihydrate equivalent to 500mg Amoxycillin per capsule.

For a full list of excipients, see section 6.1.

Hard Capsules.

White to off-white granular powder filled in hard gelatine capsule shells size '0'. Scarlet colour cap, buff colour body printed with 'AMOXY' on cap and '500' on body.

The treatment of bacterial infections caused by amoxicillin-susceptible organisms.

It is principally indicated for respiratory, middle ear and urinary tract infections.

Respiratory tract - pneumonia, bronchitis

ENT - otitis media

Urinary tract - cystitis, pyelonephritis

Biliary and intra-abdominal infections

Gynaecological infections

Gonorrhoea

Septicaemia

Bacterial endocarditis

Skin and soft tissue infections

Meningitis (seek expert advice)

Enteric fevers (typhoid and paratyphoid fevers - seek expert advice)

Dental abscess (as an adjunct to surgical management)

The prevention of bacteraemia, associated with procedures (e.g. dental), in patients at risk of developing bacterial endocarditis

Route of administration: Oral

Adults: 250mg every 8 hours, increasing to 500mg every 8 hours in severe infections.

Amoxicillin Capsules BP 250mg, Amoxicillin Oral Suspension BP 125mg/5ml or Amoxicillin Oral Suspension BP 250mg/5ml may be required to achieve the recommended dose.

In those with severely impaired renal function dose reduction may be necessary.

Prophylaxis of Endocarditis

Dental procedures under local or no anaesthesia:

Patients who have not received more than a single dose of a penicillin in the previous month, including those with a prosthetic valve (but not those who have had endocarditis): oral amoxicillin 3g 1 hour before procedure.

Patients who have had endocarditis, amoxicillin + gentamicin, as under general anaesthesia.

Dental procedures under general anaesthesia:

No special risk (including patients who have not received more than a single dose of a penicillin in the previous month): either i/m or i/v amoxicillin 1g at induction, then oral amoxicillin 500mg 6 hours later. Children under 5 years: quarter the adult dose, 5–10 years: half the adult dose

Or oral amoxicillin 3g 4 hours before induction then oral amoxicillin 3g as soon as possible after procedure. Children under 5 years: quarter adult dose, 5–10 years: half adult dose.

Or oral amoxicillin 3g+oral probenecid 1g 4 hours before procedure.

Special risk (patients with a prosthetic valve or who have had endocarditis): i/v amoxicillin 1g+i/v gentamicin 120mg at induction, then oral amoxicillin 500mg 6 hours later. Children under 5 years: amoxicillin quarter adult dose, gentamicin 2mg/kg.

This product should not be used in patients who have received more than a single dose of penicillin in the previous month, or whom are allergic to penicillin.

Upper respiratory-tract procedures:

As for dental procedures: post-operative dose may be given parenterally if swallowing is painful.

Genito-urinary procedures:

As for special risk patients undergoing dental procedures under general anaesthesia. If urine infected, prophylaxis should also cover infective organism.

Obstetric, gynaecological and gastro-intestinal procedures:

(prophylaxis required for patients with prosthetic valves or those who have had endocarditis only) As for genito-urinary procedures.

Children's

Children weighing < 40 kg

The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).

*PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

Children weighing more than 40 kg should be given the usual adult dosage.

Special dosage recommendation

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media

In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.

Early Lyme disease (isolated erythema migrans)

50 mg/kg/day in three divided doses, over 14-21days.

Prophylaxis for endocarditis

50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.

Dosage in impaired renal function

The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2).

Renal impairment in children under 40 kg:

Amoxicillin is contra-indicated in patients with hypersensitivity to penicillins.

Attention should also be paid to possible cross-reactivity with other beta-lactam antibiotics e.g. cephalosporins.

It should not be given to patients with infectious mononucleosis (glandular fever) since they are especially susceptible to amoxicillin-induced skin rashes.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are most likely in those with a history of hypersensitivity to beta-lactam antibiotics.

Amoxicillin should be used with caution in those with impaired renal function and dose reduction may be necessary in severe impairment.

Patients with infectious mononucleosis (glandular fever), lymphatic leukaemia and possibly with HIV infection are particularly prone to developing erythematous rashes with amoxicillin. Amoxicillin should be discontinued if a skin rash occurs.

Prolonged use of an anti-infective may result in the overgrowth of non-susceptible organisms (superinfection).

Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

Prolongation of prothrombin time has been reported in patients taking amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently.

In common with other broad spectrum antibiotics Amoxicillin may reduce the efficacy of the oral contraceptive pill and patients should be warned appropriately, and extra precautions taken.

Excretion of penicillins is reduced by probenecid

Use in pregnancy:

There is no evidence that amoxicillin is teratogenic or foetotoxic in humans. The product has been in extensive clinical use form any years and is considered safe in pregnancy.

Use in lactation:

Amoxicillin is considered safe in lactation. However it should be noted that amoxicillin is excreted in breast milk in small quantities with the possible risk of sensitisation and subsequent allergic reactions in a sensitised infant.

Not applicable.

Hypersensitivity reactions:

When amoxicillin is administered to a hypersensitive patient anaphylactic shock with collapse and sometimes death may occur within minutes.

If any hypersensitivity reaction occurs the treatment should be discontinued.

Skin rashes are the most common side effects with pruritus and urticaria. Rarely skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous and exfoliative dermatitis have been reported.

Severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness and vasculitis have been reported rarely.

Interstitial nephritis can occur rarely

Gastrointestinal reactions:

Mild gastrointestinal upsets: nausea, vomiting diarrhoea. Muco-cutaneous candidiasis. Antibiotic-associated colitis (including pseudo-membranous colitis).

Hepatic effects:

Transiently raised liver enzymes (AST and/or ALT) has been noted. As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely.

Haematological effects:

As with other beta-lactams reversible leucopenia (including agranulocytosis), thrombocytopenia and haemolytic anaemia, and coagulation disorders (prolonged prothrombin and bleeding times) have been reported rarely.

CNS effects:

Rare effects include dizziness, convulsions and paraesthesia. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Problems of overdosage with amoxicillin are unlikely to occur. If encountered, gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.

Amoxicillin is bactericidal. Like all penicillins it acts by interfering with the synthesis of the cell wall of the bacterium.

Amoxicillin is inactivated by penicillinase. Penicillinase-producing strains of Staphylococcus aureus and Gram negative organisms (e.g. Escherichia coli, Proteus, Klebsiella) are resistant.

Complete cross-resistance occurs with ampicillin and amoxicillin.

Amoxicillin is stable in the acid gastric secretion and is rapidly absorbed from the gastrointestinal tract after oral administration. The presence of food does not interfere with this process. Peak plasma concentrations are obtained in about two hours, producing around 2.5 times the peak concentration resulting from comparable doses of ampicillin.

Protein binding is similar to that of ampicillin: up to 25%.

Effective levels in the cerebrospinal fluid are obtained only in the presence of inflammation and then irregularly. About 60% of an orally administered dose is excreted unchanged in the urine. It penetrates well in to purulent and mucoid sputum.

In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Magnesium Stearate (E572)

Silica Colloidal Anhydrous

Capsule shell components:

Body:

Iron Oxide Red (E172)

Iron Oxide Yellow (E172)

Titanium Dioxide (El71)

To 100% Gelatin

Cap:

Indigo Carmine (E132)

Erythrosine (E127)

Titanium Dioxide (E171)

To 100% Gelatin

Composition of Ink

Shellac

Dehydrated Alcohol

Isopropyl Alcohol

Butyl Alcohol

Propylene Glycol

Strong Ammonia Solution

Potassium Hydroxide

Black Iron Oxide (E172)

Not applicable.

3 years: Polypropylene/polyethylene containers.

2 years: Blister strips

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

Polypropylene/polyethylene containers and tamper evident closures/ 1000, 500, 100, 21, 20 and 15 capsules.

Blister strips: 15 and 21 capsules.

Not all pack sizes may be marketed.

Not applicable.

Milpharm Limited,

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

PL 16363/0045

04/02/2009

11/02/2011