AMOXICILLIN 125 MG / 5 ML ORAL SUSPENSION - summary of medicine characteristics

Amoxicillin 125 mg/5 ml Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains amoxicillin trihydrate equivalent to 125 mg amoxicillin per 5 ml.

For excipients, see 6.1.

Powder for Oral Suspension

Pale yellow powder which, when reconstituted gives a yellow suspension with a sweet lemon flavour and odour.

4.1 Therapeutic indications

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

Consideration should be given to official guidance regarding the appropriate use of antibacterial agents.

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

4.2 Posology and method of administration

Route of administration: Oral

Adults and children weighing over 40 kg: 250 mg every 8 hours, increasing to 500 mg every 8 hours in severe infections

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. In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14 – 21 days.

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:

Prophylaxis of Endocarditis

Dental procedures under local or no anaesthesia:

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

Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour preceding the surgical 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 penicillin in the previous month): either i/m or i/v amoxicillin 1 g at induction, then oral amoxicillin 500 mg 6 hours later.

Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour preceding the surgical procedure

Or

Oral amoxicillin 3 g 4 hours before induction then oral amoxicillin 3 g as soon as possible after procedure.

Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour preceding the surgical procedure

Or

Oral amoxicillin 3 g + probenicid 1 g 4 hours before procedure

Special risk (patients with a prosthetic valve or who have had endocarditis): i/v amoxicillin 1 g + i/v gentamicin 120 mg at induction, then oral amoxicillin 500 mg 6 hours later.

Children < 40 kg; 50 mg amoxicillin/kg weight, given as a single dose one hour preceding the surgical procedure

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 is infected, prophylaxis should also cover infective organism.

Obstetric, gynecological and gastro-intestinal procedures:

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

4.3 Contraindications

Amoxicillin should not be given to patients with hypersensitivity to penicillins. Attention should be given to the possibility of cross-sensitivity with other beta-lactam antibiotics eg: cephalosporins.

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

4.4 Special warnings and precautions for use

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse 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 anti-infectives 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.

4.5 Interaction with other medicinal products and other forms of interaction

The efficacy of oral contraceptives may be reduced with concurrent administration of amoxicillin. Patients should be advised accordingly.

Excretion of penicillins is reduced by probenecid.

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

4.6 Pregnancy and lactation

Use in pregnancy:

There is no evidence that amoxicillin is teratogenic or foetotoxic in humans. The product has been in extensive clinical use for many 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.

4.7 Effects on ability to drive and use machines

There is no reason to believe that amoxicillin will have any direct effect on the ability to drive or use machines.

4.8 Undesirable effects

Hypersensitivity reactions:

When amoxycillin 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) have 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.

Skin and subcutaneous tissue disorders:

Frequency ‘very rare’: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) (see section 4.4) and drug reaction with eosinophilia and systemic symptoms (DRESS).

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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 has been reported between amoxicillin and ampicillin.

5.2 Pharmacokinetic properties

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 oral dose of amoxicillin is excreted unchanged in the urine. It penetrates well into 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.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SPC.

6.1

Sodium benzoate

Sodium citrate

Colloidal anhydrous silica

Dispersible cellulose Saccharin sodium

Lemon flavouring powder Quinoline yellow (E104) Sucrose

6.2

Not Applicable

6.3

3 years before reconstitution

14 days after reconstitution

6.4 Special precautions for storage

Store in the original container. Do not store above 25°C prior to reconstitution.

After reconstitution, store suspension at 2°C – 8°C. Do not freeze.

6.5 Nature and contents of container

Amber glass bottle (Type III) with ROPP cap (aluminium closure / expanded polyethylene liner): 60 ml and 100 ml

HDPE tamper evident bottle with polypropylene tamper evident lid: 60 ml and 100 ml

6.6 Special precautions for disposal

Shake the bottle well before use.

60 ml bottle: Add 36 ml water, replace the lid and shake the bottle well.

100 ml bottle: Add 59 ml of water, replace the lid and shake the bottle well.

The reconstituted product gives a yellow suspension free from visible signs of contamination. It has a sweet lemon flavour and odour.

Once reconstituted, use within 14 days.

It is not recommended to further dilute the reconstituted product.