Amoxil Syrup Sucrose-Free / Dye-Free 125mg / 5ml

1. Name Of The Medicinal Product

Amoxil® Syrup Sucrose-Free/Dye-Free 125 mg/5 ml

2. Qualitative And Quantitative Composition

Amoxil Syrup SF/DF 125 mg contains 125 mg amoxicillin per 5 ml dose.

The amoxicillin is present as the trihydrate.

3. Pharmaceutical Form

Amoxil Syrup SF/DF 125 mg/5 ml: citrus-flavoured sucrose-free/dye-free suspension in a sorbitol base. Presented as powder in bottles for preparing 100 ml.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Infection: 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

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

Osteomyelitis

Dental abscess (as an adjunct to surgical management)

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

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.

The wide range of organisms sensitive to the bactericidal action of Amoxil include:

Gram-positive Gram-negative

Streptococcus faecalis Haemophilus influenzae

Streptococcus pneumoniae Escherichia coli

Streptococcus pyogenes Proteus mirabilis

Streptococcus viridans Salmonella species

Staphylococcus aureus Shigella species

(penicillin-sensitive) Bordetella pertussis

Clostridium species Brucella species

Corynebacterium species Neisseria gonorrhoeae

Bacillus anthracis Neisseria meningitidis

Listeria monocytogenesVibrio cholerae

Pasteurella septica

4.2 Posology And Method Of Administration

Treatment of Infection:

Adult dosage (including elderly patients):

Oral:

Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.

Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.

Injectable:

500 mg IM eight hourly (or more frequently if necessary) in moderate infections. (This dose may be given by slow IV injection if more convenient.)

1 g IV six hourly in severe infections.

Children's dosage (up to 10 years of age):

Oral:

Standard children's dosage: 125 mg three times daily, increasing to 250 mg three times daily for more severe infections.

Amoxil Paediatric Suspension is recommended for children under six months of age.

Prophylaxis of endocarditis:

CONDITION		ADULTS' DOSAGE (INCLUDING ELDERLY)	CHILDREN'S DOSAGE	NOTES
Dental procedures : prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. (N.B. Patients with prosthetic heart valves should be referred to hospital - see below).	Patient not having general anaesthetic.	3 g 'Amoxil' orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.	Under 10: half adult dose. Under 5: quarter adult dose.	Note 1. If prophylaxis with 'Amoxil' is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month. Note 2 To minimise pain on injection, 'Amoxil' may be given as two injections of 500 mg dissolved in sterile 1% lignocaine solution (see Administration ).
Patient having general anaesthetic: if oral antibiotics considered to be appropriate.	Initially 3 g 'Amoxil' orally 4 hours prior to anaesthesia, followed by 3 g orally (or 1 g IV or IM if oral dose not tolerated) as soon as possible after the operation.
Patient having general anaesthetic: if oral antibiotics not appropriate.	1 g 'Amoxil' IV or IM immediately before induction; with 500 mg orally, 6 hours later.
Dental procedures : patients for whom referral to hospital is recommended: a) Patients to be given a general anaesthetic who have been given a penicillin in the previous month. b) Patients to be given a general anaesthetic who have a prosthetic heart valve. c) Patients who have had one or more attacks of endocarditis.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure. Followed by (6 hours later): 500 mg 'Amoxil' orally.	Under 10: the doses of 'Amoxil' should be half the adult dose; the dose of gentamicin should be 2 mg/kg.   Under 5: the doses of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Note 2. Note 3. 'Amoxil' and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on gentamicin.
Genitourinary Surgery or Instrumentation : prophylaxis for patients who have no urinary tract infection and who are to have genito-urinary surgery or instrumentation under general anaesthesia.   In the case of Obstetric and Gynaecological Procedures and Gastrointestinal Procedures– routine prophylaxis is recommended only for patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction. Followed by (6 hours later): 500 mg 'Amoxil' orally or IV or IM according to clinical condition.	See Notes 2, 3 and 4 above.
Surgery or Instrumentation of the Upper Respiratory Tract	Patients other than those with prosthetic heart valves.	1 g 'Amoxil' IV or IM immediately before induction; 500 mg 'Amoxil' IV or IM 6 hours later.	Under 10: half adult dose.   Under 5: quarter adult dose.	See Note 2 above. Note 5. The second dose of 'Amoxil' may be administered orally as 'Amoxil' Syrup SF/DF.
Patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg 'Amoxil' IV or IM.	Under 10: the dose of 'Amoxil' should be half the adult dose; the gentamicin dose should be 2 mg/kg.   Under 5: the dose of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Notes 2, 3, 4 and 5 above.

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.

Injectable:

50-100 mg/kg body weight a day, in divided doses.

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

In 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.

Prophylaxis of endocarditis: see table on previous page.

Administration:

Oral

4.3 Contraindications

Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

4.4 Special Warnings And Precautions For Use

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

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 Overdose).

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

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other broad spectrum antibiotics, amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

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

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

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

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. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be given during 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 breast-fed infant.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

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

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

Blood and lymphatic system disorders

Very rare: Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia.

Prolongation of bleeding time and prothrombin (see Section 4.5 - Interaction with other Medicaments and other Forms of Interaction)

Immune system disorders

Very rare: As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.

If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).

Nervous system disorders

Very rare: Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders

Clinical Trial Data

*Common: Diarrhoea and nausea.

*Uncommon: Vomiting.

Post-marketing Data

Very rare: Mucocutaneous candidiasis and antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).

Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Hepato-biliary disorders

Very rare: Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

Clinical Trial Data

*Common: Skin rash

*Uncommon: Urticaria and pruritus

Post-marketing Data

Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)

(See also Immune system disorders).

Renal and urinary tract disorders

Very rare: Interstitial nephritis.

Very rare: Crystalluria (see Section 4.9 Overdose).

*The incidence of these AE's was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).

Amoxicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amoxil is a broad spectrum antibiotic.

It is rapidly bactericidal and possesses the safety profile of a penicillin.

5.2 Pharmacokinetic Properties

Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Amoxil Syrup SF/DF 125 mg/5ml

The powder contains disodium edetate, sodium benzoate (E211), saccharin sodium, silica (E551), xanthan gum (E415), peach, strawberry and lemon dry flavours and sorbitol (E420).

6.2 Incompatibilities

None.

6.3 Shelf Life

Amoxil Syrup SF/DF 125 mg /5 ml

60M (once reconstituted: 14 days)

6.4 Special Precautions For Storage

Store powder in a dry place. Once dispensed, Amoxil Syrup SF/DF should be used within 14 days. If dilution of the reconstituted SF/DF product is required, water should be used.

6.5 Nature And Contents Of Container

Amoxil Syrup SF/DF 125 mg/5 ml: Original Pack of 100 ml with Patient InformationLeaflet.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Beecham Group plc

Great West Road

Brentford

Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT

And/or

Bencard or SmithKline Beecham Pharmaceuticals all at Mundells Welwyn Garden City, Hertfordshire AL7 1EY

8. Marketing Authorisation Number(S)

Amoxil Syrup SF/DF 125 mg/5 ml

0038/0326

9. Date Of First Authorisation/Renewal Of The Authorisation

14 May 1985 / 16 January 1998

10. Date Of Revision Of The Text

5^th July 2005

11. Legal Status

POM