SPOTCLAV (Amoxicillin Trihydrate&Clavulanate Potassium)

SPOTCLAV (Amoxicillin Trihydrate&Clavulanate Potassium)

SPOTCLAV (Amoxicillin Trihydrate&Clavulanate Potassium)

SPOTCLAV (beta-lactam antibacterial penicillin co-formulated with a beta-lactamase inhibitor) is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamse inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.

Microbiology

Amoxicillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative micro-organisms. Amoxicillin is, however susceptible to degradation by beta-lactamases and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes.

Clavulanic acid is a beta-lactam, structurally related to the penicillins, which possesses the ability to inactivate a wide range of beta-lactamase enzymes commonly found in micro-organisms resistant to penicillins and cephalosporins. In particular, it has good activity against the clinically important plasmid mediated beta-lactamases frequently chromosomally-mediated type 1 beta-lactamases.

The presence of clavulanic acid in SPOTCLAV formulations protects amoxicillin from degradation by beta-lactamase enzymes and effectively extends the antibacterial spectrum of amoxicillin to include bacteria normally resistant to amoxicillin and other penicillins and cephalosporins. Thus SPOTCLAV possesses the distinctive properties of a broad spectrum antibiotic and a beta-lactamase inhibitor.

Commonly susceptible species

Gram-positive

  • Bacilliusanthracis
  • Enterococcus faecalis
  • Listeria monocytogenes
  • Nocardia asteroids
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Staphylococcus aureus
  • Staphylococcus saprophyticus
  • Borreliaburgdorferi
  • Leptospiralivtterohaemorrhagiae
  • Treponemapallidum
  • Clostridium spp
  • Peptococcusniger
  • Peptostreptococcus micros
  • Peptostreptococcusmagnus
  • Escherichia coli
  • Klebsiellaoxytoca
  • Klebsiella pneumonia
  • Proteus mirabilis
  • Salmonella spp
  • Shigellaspp

Gram-negative

  • Bordetella pertussis
  • Haemophilus influenza
  • Haemophilusparainfluenzae
  • Helicobacter pylori
  • Moraxella catarrhalis
  • Neisseria gonorrhoeae
  • Pasteurellamultocida
  • Vibrio cholera
  • Bacteroidesfragilis
  • Bacteroides spp.
  • Fusobacteriumspp
  • Eikenellacorrodens
  • Porphyromonasspp
  • Corynebacteriumspp
  • Enterococcus faecium
  • Streptococcus pneumonia
  • Viridans group streptococcus

Therapeutic indications

SPOTCLAV should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data.

SPOTCLAV is indicated for the short term treatment of common bacterial infections such as:

  • Upper respiratory tract infections (including ENT): e.g. tonsillitis, sinusitis, otitis media
  • Lower respiratory tract infections: e.g. acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia
  • Genito-urinary tract infections:
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    e.g. cystitis, urethritis, pyelonephritis, female genital infections
  • Skin and soft tissue infections
  • Bone and joint infections: e.g. osteomyelitis
  • Other infections: e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis, septicaemia, peritonitis, post-surgical infections susceptibility to SPOTCLAV will vary with geography and time. 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 SPOTCLAV treatment due to its amoxicillin content. Mixed infections caused by amoxicillin susceptible organisms in conjunction with SPOTCLAV susceptible beta-lactamase producing organisms may therefore be treated by SPOTCLAV.

Dosage and administration

Premature: No dosage recommendations can be made for this categoty

Adults and children over 12 years

Mild to moderate infectionsOne SPOTCLAV 275 thrice a day or one SPOTCLAV 625 twice a day
Severe infectionsOne SPOTCLAV  1000 twice a day

Children 12 years and below

SPOTCLAV OSChildren 1-6 years(10-18kg): 5ml every 8 hours or 0.8m//kg daily in 3 divided doses
SPOTCLAV DSChildren 6-12 years (18-40kg): 5ml every 8 hours or 0.4ml/kg daily in 3 divided doses
SPOTCLAV FORTEChildren 6-12 years (18-40kg): 2.5ml every 8 hours or 0.2ml/kg daily in 3 divided doses

In severe infections, the dose may be increased depending on the severity.

SPOTCLAV 375, SPOTCLAV 625 & SPOTCLAV 1000 tablets are not recommended in children of 12 years and under.

Dosage in renal impairment:

Adults and children over 12 years:

Mild impairment (Creatinine clearance> 30ml/min): No change in dosage

Moderate impairment (creatinine clearance 10-30ml/min: one SPOTCLAV 375 tablet or one SPOTCLAV 625 tablet every 12 hours

Severe impairment (creatinine clearance <10ml/min): not more than on SPOTCLAV 375 tablet every 24 hours. SPOTCLAV 625 & SPOTCLAV 1000 tablets are not recommended.

Children 12 years and below:

For children with a GFR of >30ml/min no adjustment in dosage is required. For children with a GFR of <30ml/min SPOTCLAV FORTE is not recommended.

Dosage in hepatic impairment:

Dose with caution; monitor hepatic function at a regular intervals. There is, as yet, insufficient evidence on which to base a dosage recommendation.

Administration

SPOTCLAV Syrup: slowly add pre-boiled, cold water up to the ring mark on the bottle. Shake vigorously. Adjust the volume up to the ring mark by adding more water, if necessary.

Once reconstituted, the suspension must be stored in a refrigerator (at 2°c to 8°c) and used within 4 to 7 days.

Shake well before taking each dose.

To minimize potential gastrointestinal intolerance, administer at the start of a meal. The absorption of SPOTCLAV is optimized when taken at the start of a meal. Treatment should not be extended beyond 7 days without review. Therapy can be started parentally and continued with an oral preparation.

For administrations of suspensions to children below 3 months, a syringe graduated to permit accurate and reproducible volumes to be dispensed, should be used.

Contraindications

In patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.

SPOTCLAV is contraindicated in patients with a previous history of SPOTCLAV associated jaundice/hepatic dysfunction.

Warnings and precautions

Before initiating therapy with SPOTCLAV careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactams. 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. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral therapy. These reactions are more likely to occur in individuals with a history beta-lactam hypersensitivity. If an allergic reaction occurs, SPOTCLAV should be discontinued and appropriate alternative therapy instituted.

SPOTCLAV should be avoided if infectious mononucleosis is suspected since the occurrence of a morbiliform rash has been associated with this condition following the use of Amoxicillin.

Special caution is essential in the newborn because of the risk of hyperbilirubinaemia.

During prolonged treatments (e.g. osteomyelitis, endocarditis), regular monitoring of hepatic and renal functions is recommended. Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

SPOTCLAV Suspension contain aspartame, which is a source of phenylanine and should be used with caution in patients with phenylketonuria.

Use during pregnancy and lactation

Use in pregnancy: Reproduction studies in animals (mice and rats at doses up to 10 times the human dose) with orally and parentally administered SPOTCLAV have shown no teratogenic effects. In a single study in women with preterm, premature rupture of the foetal membrane (pPROM), it was reported that prophylactic treatment with SPOTCLAV may be associated with an increased risk of necrotizing enterocolitis in neonates. As with all medicines, use should be avoided in pregnancy, unless considered essential by the physician.

Use in lactation: SPOTCLAV 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 known detrimental effects for the breastfed infant.

Effects on the ability to drive and operate machinery

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

Interactions

Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use with SPOTCLAV 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 SPOTCLAV and allopurinol.

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In common with other antibiotics, SPOTCLAV may affect the gut flora, leading to lower oestrogen reabsorption are reduce efficacy of combined oral contraceptives.

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

In patients receiving mycophenolatemofetil, 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.

Overdosage

Gastrointestinal symptoms and disturbances of the fluid and electrolyte balance may be evident. They may be treated symptomatically, with attention to the water/electrolyte balance.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed

When present at high concentrations in urine at room temperature, amoxicillin may precipitate in bladder catheters. A regular check of potency should be maintained.

SPOTCLAV can be removed from the circulation by haemodialysis.

A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying.

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