Inactive ingredients: 

E-MOXCLAV 375 mg Film coated Tablets: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose PH102, hydroxypropyl methylcellulose 2910, titanium dioxide, castor oil.

E-MOXCLAV 625 mg Film coated Tablets: Croscarmellose sodium, magnesium stearate, colloidal silicon dioxide (aerosil 200), microcrystalline cellulose PH102, hydroxypropyl methylcellulose 2910, titanium dioxide, castor oil.

E-MOXCLAV 1 g Film coated Tablets: Sodium starch glycolate, colloidal silicon dioxide (aerosil 200), microcrystalline cellulose PH102, magnesium stearate, hydroxypropyl methylcellulose 2910, titanium dioxide, castor oil.

E-MOXCLAV 156 mg and 312 mg Dry Mix: Syloid, colloidal silicon dioxide 200, xanthan gum, succinic acid, sucralose, orange flavour powder, sodium citrate anhydrous, sunset yellow, avicel.

E-MOXCLAV is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and in hospital.

The ß-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other ß-lactam antibiotics.

E-MOXCLAV should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.

E-MOXCLAV oral presentations are indicated for short-term treatment of bacterial infections at the following sites:

Upper respiratory tract infections (including ENT) e.g. tonsillitis, sinusitis, otitis media.

Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.

Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

Skin and Soft tissue infections e.g. boils, abscesses, cellulitis, wound infections.

Bone and joint infections e.g. osteomyelitis.

Dental infections e.g. dentoalveolar abscess.

Susceptibility to E-MOXCLAV will vary with geography and time (see Pharmacological Properties/Pharmacodynamics for further information).

Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

Infections caused by amoxicillin-susceptible organisms are amenable to E-MOXCLAV-treatment due to its amoxicillin content.

Mixed infections caused by amoxicillin susceptible organisms in conjunction with E-MOXCLAV-susceptible ß-lactamase-producing organisms may therefore be treated with E-MOXCLAV.

Dosage:

Usual Dose for Treatment of Infection: 

Adults and Children over 12 years: 

Mild-Moderate Infections: 

One E-MOXCLAV 375 mg Tablet 3 times daily.

Severe infections: 

One E-MOXCLAV 1 g twice daily, or one E-MOXCLAV 625 mg Tablet three times daily or two E-MOXCLAV 375 mg Tablets three times daily may be taken.

Children: 

The Usual Recommended Daily Dose is: 25 mg/kg/day^* in divided doses every eight hours.

Under 1 year: 25 mg/kg/day, for example a 7.5 kg child would require 2 ml E-MOXCLAV 156 mg Suspension 3 times a day.

1-6 years (10-18 kg):  5 ml E-MOXCLAV 156 mg Suspension 3 times a day.

Over 6 years (18-40 kg):  5 ml E-MOXCLAV 312 mg Suspension 3 times a day.

In more serious infections the dosage may be increased up to 50 mg/kg/day in divided doses every eight hours.

^* Each 25 mg of E-MOXCLAV provides 20 mg amoxicillin and 5 mg clavunate.

E-MOXCLAV Tablets are not recommended in children 12 years and under.

Dental infections (e.g. dentoalveolar abscess):

Adults and Children over 12 years: One E-MOXCLAV 375 mg Tablet 3 times a day for five days.

Dosage in renal impairment: 

Adults: 

Children: 

Dosage in hepatic impairment: 

Dose with caution and monitor hepatic function at regular intervals.

Administration: 

Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.

To minimise potential gastrointestinal intolerance, administer at the start of a meal.

The absorption of E-MOXCLAV is optimised when taken at the start of a meal.

Treatment should not be extended beyond 14 days without review.

E-MOXCLAV is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins or to any of the excipients.

E-MOXCLAV is contraindicated in patients with a previous history of E-MOXCLAV associated jaundice/hepatic dysfunction.

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

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 penicillin hypersensitivity (see Contraindications).

E-MOXCLAV should be avoided if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms; Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. If prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin plus clavulanic acid 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.

Changes In liver function tests have been observed in some patients receiving amoxicillin plus clavulanic acid. The clinical significance of these changes is uncertain. E-MOXCLAV should be used with caution in patients with evidence of hepatic dysfunction.

Cholestatic jaundice, which may be severe, but is usually reversible, has been reported rarely. Signs and symptoms may not become apparent for up to six weeks after treatment has ceased.

In patients with renal impairment E-MOXCLAV dosage should be adjusted as recommended. (see Dosage and Administration). 

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 Overdose).

Instruction for Use and Handling: 

E-MOXCLAV 156 mg and 312 mg Suspensions: 

At time of dispensing, the dry powder should be reconstituted to form an oral suspension as detailed below:

Check cap seal is intact before using.

Invert and shake bottle to loosen powder.

Add volume of water to the mark (indicated below). Invert and shake well.

Alternatively, fill the bottle with water to just below the mark.

Invert and shake well, then top up with water exactly to the mark, invert and shake again.

Shake the bottle well before each dose.

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with E-MOXCLAV may result in increased and prolonged blood levels of amoxicillin but not of clavulanate.

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of amoxicillin/clavulanic acid combination and allopurinol.

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

In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of E-MOXCLAV.

In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid of approximately 50% has been reported following commencement of oral amoxicillin plus clavulanic acid. The change in pre-dose level may not accurately represent changes in overall MPA exposure.

Pregnancy:

Reproduction studies in animals (mice and rats) with orally administered amoxicillin plus clavulanic acid have shown no teratogenic effects.

In a single study in women with pre-term premature rupture of the fetal membrane (PPROM), it was reported that prophylactic treatment with amoxicillin plus clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates.

As with all medicines, E-MOXCLAV use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.

Lactation: 

E-MOXCLAV may be administered during the period of lactation.

With the exception of the risk of sensitization associated with the excretion of trace quantities in breast milk, there are no detrimental effects for the infant.

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

Data from large clinical trials were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

The following convention has been used for the classification of frequency: 

Very common (> 1/10); Common (> 1/100 to < 1/10); Uncommon (> 1/1,000 to < 1/100); Rare (> 1/10,000 to < 1/1,000); Very rare (< 1/10,000).

Infections and Infestations: 

Common: Mucocutaneous candidiasis.

Blood and Lymphatic system disorders: 

Rare: Reversible leucopenia (including neutropenia), thrombocytopenia.

Very rare: Reversible agranulocytosis, haemolytic anaemia, prolongation of bleeding time and prothrombin time.

Immune system disorders: 

Very rare: Angioneurotic oedema, anaphylaxis, serum sickness-like syndrome, hypersensitivity vasculitis.

Nervous system disorders: 

Uncommon: Dizziness, headache.

Very rare: Reversible hyperactivity and convulsions. Convulsion may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders: 

Adults: 

Very Common: Diarrhoea.

Common: Nausea, vomiting.

Children: 

Common: Diarrhoea, nausea, vomiting.

Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking E-MOXCLAV at the start of a meal.

Uncommon: Indigestion.

Very rare: Antibiotic-associated colitis (including Pseudomembranous colitis and haemorrhagic colitis; see Warnings and Precautions), black hairy tongue; superficial tooth discolouration has been reported very rarely in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.

Hepatobiliary disorders: 

Uncommon: A moderate rise in AST and/or ALT has been noted in patients treated with beta-lactam class antibiotics, but the significance of these findings is unknown.

Very rare: Hepatitis, cholestatic jaundice. These events have been noted with other pencillins and cephalosporins.

Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment. These events have been very rarely reported in children.

Signs and symptoms usually occur during or shortly after treatment, but in some cases, may not become apparent until several weeks after treatment has ceased.

These are usually reversible. Hepatic events may be severe and in extremely rare circumstances, deaths have been reported. These have almost always occurred in patients with serious underlying disease or taking concomitant medications known to have the potential for hepatic effects.

Skin and Subcutaneous tissue disorders: 

Uncommon: Skin rash, pruritus, urticaria.

Rare: Erythema multiforme.

Very rare: Stevens-Johnson Syndrome, toxic epidermal necrolysis, bullous exfoliative-dermatitis, acute generalised exanthemous pustulosis (AGEP).

If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.

Renal and urinary disorders: 

Very rare: Interstitial nephritis, crystalluria (see Overdose).

Gastrointestinal symptoms and disturbance of the fluid and electrolyte balancesmay be evident. Gastrointestinal symptoms may be treated symptomatically with attention to the water electrolyte balance.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (See Warning and Precautions).

E-MOXCLAV can be removed from the circulation by haemodialysis.

Pharmacodynamic properties: 

Resistance to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in E-MOXCLAV anticipates this defense mechanism by blocking the ß-lactamase enzymes, thus rendering the organisms susceptible to amoxicillin's rapid bactericidal effect at concentrations readily attainable in the body.

Clavulanate by itself has little antibacterial activity; however, in association with amoxicillin as E-MOXCLAV, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.

E-MOXCLAV is a bactericidal to a wide range of organisms.

Pharmacokinetics: 

The pharmacokinetics of the two components of E-MOXCLAV are closely matched. Peak serum levels of both occur about 1 hour after oral administration.

Absorption of E-MOXCLAV is optimised at the start of a meal.

Doubling the dosage of E-MOXCLAV approximately doubles the serum levels achieved.

Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.

Store in a dry place at a temperature not exceeding 25^°C. Protect from light and moisture.

After reconstitution, the suspension should be stored at 2^°C - 8^°C in the refrigerator and used only within 7 days.

E-MOXCLAV 375 mg Film coated Tablets: Box containing amber glass bottle of 10 film coated tablets.

E-MOXCLAV 625 mg Film coated Tablets: Box containing amber glass bottle of 10 film coated tablets.

E-MOXCLAV 1 gm Film coated Tablets: Box containing amber glass bottle 10 film coated tablets.

E-MOXCLAV 156 mg ml Dry Mix: Box containing bottle of 60 or 100 ml after reconstitution.

E-MOXCLAV 312 mg ml Dry Mix: Box containing bottle of 60 or 100 ml after reconstitution.