Full Prescribing Info
Contents
Co-amoxiclav: Amoxicillin, clavulanic acid.
Description
Co-amoxiclav Tablets BP 250 mg/125 mg: Each film-coated tablet contains: Amoxicillin Trihydrate Ph.Eur. equivalent to Amoxicillin 250 mg and Potassium Clavulanate Ph.Eur. equivalent to Clavulanic Acid 125 mg.
Co-amoxiclav Tablets BP 500 mg/125 mg: Each film-coated tablet contains: Amoxicillin Trihydrate Ph. Eur. equivalent to Amoxicillin 500 mg and Potassium Clavulanate Ph. Eur. equivalent to Clavulanic Acid 125 mg.
Co-amoxiclav Tablets BP 875 mg/125 mg: Each film-coated tablet contains: Amoxicillin Trihydrate Ph. Eur. equivalent to Amoxicillin 875 mg and Potassium Clavulanate Ph. Eur. equivalent to Clavulanic Acid 125 mg.
The preparation contains penicillin.
Excipients/Inactive Ingredients: Cellulose, Microcrystalline, Purified Water, Sodium Starch Glycolate, Silica, Colloidal anhydrous, Magnesium Stearate, Hypromellose, Titanium Dioxide, Macrogol, Isopropyl alcohol and Methylene chloride.
Action
Pharmacology: Pharmacodynamics: Resistant to many antibiotics is caused by bacterial enzymes which destroy the antibiotic before it can act on the pathogen. The clavulanate in Co-amoxiclav anticipates this defence mechanism by blocking the β-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 Co-amoxiclav, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.
Co-amoxiclav is bactericidal to a wide range of organisms including: Gram-positive: Aerobes: Enterococcus faecalis, Streptococcus pnemoniae, Streptococcus pyogenes, Streptococcus viridans, *Staphylococcus aureus, *coagulase negative staphylococci (including Staphylococcus epidermidis), Corynebacterium species, Bacillus anthracis, Listeriamonocytogenes.
Anaerobes: Clostridium species, Peptococcus species, Peptostreptococcus.
Gram-negative: Aerobes: *Haemophilus influenzae *Escherichia coli, *Proteus mirabilis, *Proteus vulgaris, *Klebsiella species, *Moraxella catarrhalis, *salmonella species, *Shigella species, Bordetella pertussis, Brucella species, *Neisseria gonorrhoeae, Neisseria meningitidis, Vibrio cholerae, pasteurella multocida.
Anaerobes: *Bacteroides spp. including B.fragilis.
*including β-lactamase producing strains resistant to ampicillin and amoxicillin.
Pharmacokinetics:
The pharmacokinetics of the two components of Co-amoxiclav are closely matched. Peak serum levels of both occur about 1 hour after oral administration. Absorption of Co-amoxiclav is optimized at the start of a meal.
Doubling the dosage of Co-amoxiclav approximately doubles the serum levels achieved.
Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum.
Indications/Uses
Co-amoxiclav is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The β-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other β-lactam antibiotics.
Co-amoxiclav oral presentations for twice daily dosing, 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.
Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.
A comprehensive list of susceptible organisms is provided in the pharmacodynamics section (see Pharmacology: Pharmacodynamics under Actions).
Co-amoxiclav should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.
Susceptibility to Co-amoxiclav will vary with geography and time (see Pharmacology: Pharmacodynamics under Actions). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.
Dosage/Direction for Use
Usual dosages for the treatment of infection: Adults and children over 12 years*: Mild-Moderate infections: One 375 mg tablet of Co-amoxiclav three times daily. One 625 mg tablet of Co-amoxiclav twice daily.
Severe infections: One Co-amoxiclav 1 g tablet twice daily.
Therapy can be started parenterally and continued with an oral preparation.
* Co-amoxiclav 375 mg, 625 mg and 1 g tablets are not recommended in children of 12 years and under.
Dosage in renal impairment: Adults: The Co-amoxiclav 1 g tablet should only be used in patients with glomerular filtration rate of >30 ml/min. (See table.)

Click on icon to see table/diagram/image

Dosage in hepatic impairment:
Dose with caution; 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 minimize potential gastrointestinal intolerance, administer at the start of the meal.
The absorption of Co-amoxiclav is optimized when taken at the start of a meal.
Treatment should not be extended beyond 14 days without review.
Overdosage
Gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may 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.
Co-amoxiclav can be removed from the circulation by haemodialysis.
Contraindications
Co-amoxiclav is contraindicated in patients with a history of hypersensitivity to betalactams, e.g. penicillins and cephalosporins.
Co-amoxiclav is contraindicated in patients with previous history of Co-amoxiclav-associated jaundice/hepatic dysfunction.
Special Precautions
Before initiating therapy with Co-amoxiclav careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity. If an allergic reaction occurs, Co-amoxiclav must be discontinued and appropriate alternative therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids and airway management (including intubation) may also be required.
Co-amoxiclav should be avoided if infections 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 nonsusceptible Organisms.
Abnormal prolongations of prothrombin time (increases INR) have been reported rarely in patients receiving Co-amoxiclav 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 Co-amoxiclav. The clinical significance of these changes is uncertain. Co-amoxiclav 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 Co-amoxiclav dosage should be adjusted as recommended in 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.
Effects on Ability to Drive and Use Machines: Adverse effects on the ability to drive or operate machinery have not been observed.
Use In Pregnancy & Lactation
Treatment with Co-amoxiclav may be associated with an increased risk of necrotising enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
Co-amoxiclav may be administered during the period of lactation. With the exception of the risk of sensitisation, associated with the excretion of trace quantities in breast milk, there are no known detrimental effects for the breast-fed infant.
Adverse Reactions
The following convention has been used for the classification of frequency:  Very common >1/10; Common >1/100 and <1/10;  Uncommon >1/1000 and <1/100; rare >1/10,000 and <1/1000; very rare <1/10,000.
Infections and infestations: Common: Mucocutaneous candidiasis.
Blood and lymphatic system disorders: Rare: Reversible leucopenia (including neutropenia) and thrombocytopenia. Very rare: Reversible agranulocytosis and haemolyticanaemia. 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. Convulsions 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.
All populations: Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking Co-amoxiclav at the start of a meal.
Uncommon: Indigestion. Very rare: Antibiotic-associated collitis (including pseudomembranous colitis and haemorrhagic colitis). Black hairy tongue.
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 and cholestatic jaundice. These events have been noted with other penicillins 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 generalized exanthemous pustulosis (AGEP); Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued.
Renal and urinary disorders: Very rare: Interstitial nephritis, crystalluria.
Drug Interactions
Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with Co-amoxiclav 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 Co-amoxiclav and allopurinol.
In common with other antibiotics, Co-amoxiclav may effect 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 normalized ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If coadministration is necessary, the prothrombin time or international normalized ratio should be carefully monitored with the addition or withdrawal of Co-amoxiclav.
Caution For Usage
Incompatibilities: None.
Storage
Store in a dry place at or below 30°C. Protect from moisture.
Shelf-Life: 24 months.
MIMS Class
ATC Classification
J01CR02 - amoxicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 375 mg (white oval shaped, debossed with 'A' on one side and '63' on the other side) x 3 x 5's. 625 mg (white oval shaped, debossed with 'A' on one side and '64' on the other side) x 3 x 5's. 1 g (white oval shaped, debossed with 'A' on one side and with a score line in between '6' and '5' on the other side) x 3 x 5's.
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