GlaxoSmithKline (Ireland) Ltd

Amoxil Vials 500mg, powder for solution for injection or infusion.

500mg amoxicillin per vial.

The amoxicillin is present as the sodium salt in 'Amoxil' injection.

For a full list of excipients, see section 6 .1.

Powder for solution for injection or infusion.

White to off-white sterile powder.

In the treatment of infections due to organisms sensitive to amoxicillin.

Amoxil is a broad-spectrum antibiotic, indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Lobar and bronchopneumonia

Cystitis, urethritis, pylelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

In children with urinary tract infection, the need for investigation should be considered.

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable and particularly for the urgent treatment of severe episodes of the above conditions.

Prophylaxis of endocarditis:

'Amoxil'may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Administration:

Intravenous or Intramuscular (intraperitoneal, intrapleural, intra-articular).

Parenteral therapy in adults:

Mild or moderate infections (Intramuscular): The usual total daily dosage is 750-2000mg in divided doses (i.e. 250-500mg IM eight-hourly or more frequently if necessary). This dose may be given by slow IV injection if more convenient.

When necessary (for intramuscular injection) the vial contents may be dissolved in a solution of 1% lignocaine hydrochloride or 0.5% procaine hydrochloride.

Severe infections (Intravenous): The usual total daily dosage is 4g in divided doses (i.e. 1g six-hourly by slow IV injection, taking 3-4 minutes if injecting directly or into drip tube or by IV infusion over a period of ½-1 hour.

Where it is desired to support systemic therapy with intraperitoneal, intrapleural or intra-articular injections, the adult dosage to be given locally into these sites is 500mg daily.

Parenteral therapy in children

For children it is suggested that dosage by injection is based on body weight, such that 50-100 mg/kg/day is given in divided doses.

Renal impairment: In patients with renal impairment the excretion of the antibiotic will be delayed and depending on the degree of impairment it may be necessary to reduce the total daily dosage.

In patients receiving peritoneal dialysis:

IV treatment: 1g stat, then 500mg/day

In patients receiving haemodialysis:

IV treatment: 1g at the end of dialysis then 500mg every 24h.

Amoxicillin may be removed from the circulation by haemodialysis.

Prophylaxis in endocarditis

(dental procedures, gentio-urinary surgery or instrumentation, obstetric and gynaecological procedures, gastrointestinal procedures and surgery or instrumentation of the upper respiratory tract).

Adults:

For those procedures where an oral dose is not appropriate, 1g Amoxil i.m. prior to anaesthesia (if given) or dental procedure, is given following by 500mg orally or i.m. after 6 hours, depending upon the condition. 120mg gentamicin i.m. may also be given with the initial Amoxil injection.

For children under 10:

Half the adult dose of Amoxil should be given and the dose of gentamicin should be 2mg/kg.

Use in patients with a history of hypersensitivity to beta lactam antibiotics including penicillins or cephalosporins.

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins. Cross-sensitivity between penicillins and cephalosporins is well documented.

Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. If an allergic reaction occurs, amoxicillin should be discontinued and appropriate alternative therapy instituted.

Amoxicillin should be avoided if infections mononucleosis (glandular fever) is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Prolonged use of an anti-infective may occasionally result in overgrowth of non-susceptible organisms.

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

Dosage should be adjusted in patients with renal impairment (see Section 4.2).

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9).

Lidocaine or benzyl alcohol may be used only when administering amoxicillin by the intramuscular route.

The sodium content must be taken into account in patients on a sodium restricted diet if the parenteral administration of high doses is necessary. Each 500mg vial of amoxicillin contains 38mg of sodium.

Probenecid decreases the renal tubular excretion of amoxicillin. Concurrent use with amoxicillin may result in increased and prolonged blood levels of amoxicillin.

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

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Use in pregnancy:

Animal studies with 'Amoxil' have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. Amoxicillin may be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be administered during the period of lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the infant.

Adverse effects on the ability to drive or operate machinery have not been observed.

The following convention has been utilised for the classification of undesirable effects: Very common (more than 1/10), common (more than 1/100, less than 1/10), uncommon (more than 1/1000, less than 1/100), rare (more than 1/10,000, less than 1/1000), very rare (less than 1/10,000).

The majority of the side-effects listed below are not unique to amoxicillin and may occur when using other penicillins.

Unless otherwise stated, the frequency of adverse events (AE's) has been derived from more than 30 years of post-marketing reports.

Gross overdosage will produce very high urinary concentrations, more so after parenteral administration. Symptoms of water/electrolyte imbalance should be treated symptomatically. Problems are unlikely to occur if adequate fluid intake and urinary output are maintained; however, amoxicillin crystalluria in some cases leading to renal failure,has been observed (see Section 4.4, Special Warnings and Special Precautions for Use). More specific measures may be necessary in patients with impaired renal function: the antibiotic is removed by haemodialysis.

Parenteral (Intravenous):

Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses. A regular check of patency should be maintained.

'Amoxil' is a broad-spectrum antibiotic which possesses the safety profile of the penicillins and is rapidly bactericidal against a wide range of Gram-negative and Gram-positive organisms.

'Amoxil' is well absorbed by the oral and parenteral routes, peak blood levels are achieved one to two hours after administration. Oral administration produces high serum levels independent of the time at which the food is taken. 'Amoxil' gives good penetration into the bronchial secretions and the high urinary concentrations of unchanged antibiotic. The average serum half life is 60 minutes. Elimination is mainly via the urine.

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

None.

'Amoxil' should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions.

If 'Amoxil' is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.3 and 6.6.

2 Years

Reconstituted:

When prepared for intramuscular or direct intravenous injection, 'Amoxil' should be administered immediately after reconstitution. Infusions should be administered over a period of one-half to one hour although 'Amoxil' maintains a satisfactory degree of activity at room temperature in various infusion fluids as follows:

Amoxicillin is less stable in infusions containing carbohydrate. Reconstituted solutions of amoxicillin may be injected into the drip tubing over a period of one-half to one hour.

Any residual antibiotic solution should be discarded.

Amoxicillin vials are not suitable for multi-dose use.

Do not store above 25°C.

For reconstituted product, see section 6.3.

Clear Type I glass vials, sealed with sterile butyl rubber stopper and aluminium seals. Packs of 10 vials.

Preparation of Injections

A transient pink coloration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour.

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Ireland

PA 1077/33/4

1^st April 1977/ 1 April 2007

November 2009