Fleming Amoxicillin Clavulanic Tablets

FLEMING®
Amoxicillin + Clavulanic acid

 
PHARMACEUTICAL FORM

Fleming 375mg tablets: A white, oval shaped film-coated tablets.

Fleming 500mg/62.5mg tablets: A white oval shaped film-coated tablets.

Fleming 625mg tablets: A white oval shaped film-coated tablets.

Fleming 875mg/125mg tablets: A white elongated capsule shaped film-coated tablets.

Fleming 1g/125 mg tablets: A white, elongated capsule shaped film-coated tablets.

The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate.

 
QUALITATIVE AND QUANTITATIVE COMPOSITION

Fleming 375mg Tablets: Each film-coated tablet contains 250mg amoxicillin and 125mg clavulanic acid.

Fleming 500mg/62.5mg Tablets: Each film-coated tablet contains 500mg amoxicillin and 62.5mg clavulanic acid.

Fleming 625mg Tablets: Each film-coated tablet contains 500mg amoxicillin and 25mg clavulanic acid.

Fleming 875mg/125mg Tablets: Each film-coated tablet contains 875mg amoxicillin and 125mg clavulanic acid.

Fleming 1g/125mg Tablets: Each film-coated tablet contains 1g amoxicillin and 125mg clavulanic acid.

The amoxicillin is present as amoxicillin trihydrate and the clavulanic acid is present as potassium clavulanate.

 
EXCIPIENTS

Cross Carmellose Sodium, Magnesium Stearate, Microcrystalline cellulose, Purified Talc, Opaspray KIR-7000, Ethylcellulose, Propylene glycol, Hydroxypropyl Methyl Cellulose (HPMC E-15).

 
CLINICAL PARTICULARS

Therapeutic indications
Fleming is indicated for short-term treatment of bacterial infections at the following sites:

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

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

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

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

Other infections e.g. intra-abdominal sepsis.

Fleming is bactericidal to a wide range of organisms including:

Gram-positive
Aerobes: Bacillus anthracis*, Corynebacterium species, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes,Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus agalactiae, Streptococcus species, Staphylococcus aureus*, Coagulas negative staphylococci* (including Staphylococcus epidermidis).

Anaerobes: Clostridium species, Peptococcus species, Peptostreptococcus.

Gram-negative
Aerobes: Bordetella pertussis, Brucella species, Escherichia coli*, Gardnerella vaginalis, Haemophilus influenza*, Helicobacter pylori, Klebsiella species*, Legionella species, Moraxella catarrhalis* (Branhamella catarrhalis), Neisseria gonorrhoea*, Neisseria meningitidis*, Pasteurella multocido, Proteus mirabilis*, Proteus vulgari*, Salmonella species*, Shigella species*, Vibrio cholerae, Yersinia enterocolitica.

Anaerobes: Bacteroides species* including Bacteroides species*(including Bacteroides fragilis), Fusobacterium species*.

*Some members of these species of bacteria produce β-lactamase, rendering them insensitive to amoxicillin alone. Infections caused by amoxicillin-susceptible organisms are amenable to Fleming treatment due to its amoxicillin content. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Fleming-susceptible β-lactamose producing organisms may therefore be treated with Fleming.

 
Dosage and administration

Usual dosages for the treatment of infection

Adults and children over 12 years Mild – Moderate infections two tablets of 625mg = 562.5mg a day. One tablet of 1g/125mg = 1125 mg a day.

Children: The usual recommended daily dosage is 25mg/kg/day* in divided doses every eight hours.

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

* Each 25mg Fleming provides 20mg amoxicillin and 5mg clavulanic acid.

Fleming 375mg tablets are not recommended in children of 12 years and under.

Dosage in dental infections (e.g. dentoalveolar abscess)

Adults and children over 12 years: One Fleming 375mg tablet three times a day for five days.

 
Oral Administration

To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of Fleming is optimised when taken at the start of a meal. Treatment should not be extended beyond 14 days without review.

 
Contra-indications

Penicillin hypersensitivity.
Attention should be paid to possible cross-sensitivity with other β-lactam antibiotics, e.g. cephalosporins. A previous history of Fleming or penicillin associated jaundice/hepatic dysfunction.

 
Precautions

Changes in liver function tests have been observed in some patients receiving Fleming. The clinical significance of these changes is uncertain but Fleming 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 moderate or severe renal impairment Fleming dosage should be adjusted as recommended in the Dosage and administration section.

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 Contra-indications). Erythematous rashes have been associated with glandular fever in patients following the use of amoxicillin.

Fleming should be avoided if glandular fever is suspected. Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

 
Drug Interactions

Prolongation of bleeding time and prothrombin time have been reported in some patients receiving Fleming. Fleming should be used with care in patients on anti-coagulation therapy. In common with other broad-spectrum antibiotics, Fleming may reduce the efficacy of oral contraceptives and patients should be warned accordingly. Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with Fleming may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid. 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 Fleming and allopurinol.

 
Pregnancy and Lactation

Use in Pregnancy
Reproduction studies in animals (mice and rats) with orally and parenterally administered amoxicillin/clavulanate have shown no teratogenic effects. There is limited information on the use of Fleming in human pregnancy. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.

Use in Lactation
Fleming 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 detrimental effects for the infant.

 
Effects on ability to drive and use machines

None known.

 
Undesirable effects

Side effects, as with amoxicillin, are uncommon and mainly of a mild and transitory nature.

Gastrointestinal reactions – Effects include diarrhoea, indigestion, nausea and vomiting. Candidiasis, antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis) have been reported rarely. Nausea, although uncommon, is more often associated with higher oral dosages. If gastrointestinal side effects occur with oral therapy they may be reduced by taking Fleming at the start of meals. As with other antibiotics the incidence of gastrointestinal side effects may be raised in children under 2 years. In clinical trials however, only 4% of children under 2 years were withdrawn from treatment.

Hepatic effects – A moderate rise in AST and/or ALT has been noted in patients with semi synthetic penicillins but the significance of these findings is unknown. Hepatitis and cholestatic jaundice have been reported rarely with Fleming. They may however be severe and continue for several months. They are reported as occurring predominantly in adult or elderly patients and slightly more frequently in males. Signs and symptoms may occur during treatment but are more frequently reported after cessation o therapy with a delay of up to six weeks. The hepatic events are usually reversible. However, in extremely rare circumstances, deaths have been reported. Hepatic events have been reported predominantly in males and elderly patients and may be associated with prolonged treatment.

Hypersensitivity reactions – Urticarial and erythematous rashes sometimes occur. Rarely erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis have been reported. Treatment should be discontinued if one of these types of rash appears. In common with other β-lactam antibiotics angioedema oedemo anaphylaxis serum sickness like syndrome and hypersensitivity vasculitis have been reported. Interstitial nephritis can occur rarely.

Haematological effects – As with other β-lactam reversible leucopenia (including neutropenia or agranulocytosos) reversible thrombocytopenia and haemolytic anaemia have been reported rarely.

CNS effects – CNS effects have been seen very rarely. These include reversible hyperactivity, dizziness, headache and convulsions. Convulsions
may occur with impaired renal function or in those receiving high doses.

 

Overdosage

Cases of overdosage of Fleming are usually asymptomatic. If encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. They may be treated symptomatically with attention to the water electrolyte balance. Fleming can be removed from the circulation by haemodialysis.

 
PHARMACOLOGICAL PROPERTIES

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 Fleming anticipates this defence mechanism by blocking the β-lactamase enzymes, thus rendering the organisms sensitive 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 Fleming, it produces an antibiotic agent of broad spectrum with wide application in hospital and general practice.

Pharmacokinetic Properties
The pharmacokinetics of the two components of Fleming are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum. Doubling the dosage of Fleming approximately doubles the serum levels achieved.

 
PHARMACEUTICAL PARTICULARS

Incompatibilities
None known.

 
Shelf-life

The expiring date is indicated on the packaging.

 

Special precautions for storage

Fleming should be stored in a dry place below 25oC.

 
Nature and contents of container

Fleming 375mg. 562.5mg, 625mg, 1g and 1125mg Tablets: In the form of Blisters.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

Not all presentations are available in every country. Further information is available on request.
Revision date: February 2016.

 
Manufacturer

MEDREICH LIMITED

No. 14 & 15, Gundarahali Village, Sulibele Hobli,

Hoskote Taluk, Bangalore Rural District – 562 114, INDIA

For: SANOFI

ZeNTIVA

A SANOFI COMPANY

 

Manufacturer

MEDREICH LIMITED

12th Mile, Old Madaras Road,

Virgonagar, Bangalore – 560 049, INDIA

For: SANOFI

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