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Solutab 125mg: a white, to almost white, oblong shaped tablet, with inscription 181 on one side and a bisect line on the other side, and containing 125mg amoxicillin. Approx. 12mm x 6.5mm. Average weight 238mg.
Solutab 250mg: a white, to almost white, oblong shaped tablet, with inscription 182 on one side and a bisect line on the other side, and containing 250mg amoxicillin. Approx. 16mm x 8.5mm. Average weight 476mg.
Solutab 375mg: a white, to almost white, oblong shaped tablet, with inscription gbr183 on one side and a bisect line on the other side, and containing 375mg amoxicillin. Approx. 17.5mm x 9mm. Average weight 714mg.
Solutab 500mg: a white, to almost white, oblong shaped tablet, with inscription gbr184 on one side and a bisect line on the other side, and containing 500mg amoxicillin. Approx. 20mm x 10.5mm. Average weight 952mg.
Solutab 750mg: a white, to almost white, oblong shaped tablet, with inscription gbr185 on one side and a bisect line on the other side, and containing 750mg amoxicillin. Approx. 22mm 118.5mm. Average weight 1428mg.
Solutab 1000mg: a white, to almost white, oblong shaped tablet, with inscription gbr186 on one side and a bisect line on the other side, and containing 1000mg amoxicillin. Approx. 24mm x 12.5mm. Average weight 1904mg.
Amoxicillin is a bactericidal antibiotic with a relatively broad spectrum of activity. It belongs to the penicillin group.
The following table shows the in vitro sensitivity to amoxicillin of several clinically important micro-organisms.
| In vitro activity | Average minimal inhibitory concentration (MIC) | ||
|---|---|---|---|
| 0.01-0.1 mcg/ml | 0.1-1 mcg/ml | 1-10 mcg/ml | |
| Gram-positive micro-organisms | Str. β haemolyticus Str. α haemolyticus Str. pneumoniae Cl. tetani Cl. Welchii |
Staph. aureus (penicillinase negative) B. anthracis B. subtilis Listeria monocyto-genes |
Str. Faecalis |
| Gram-negative micro-organisms | N. gonorrhoeae N. meningitidis |
H. influenzae Bordetella pertussis |
E. coli P. mirabilis S. typhi Sh. Sonnei V. cholerae |
Amoxicillin is not active against penicillinase-producing micro-organisms,
Pseudomonas, Klebsiella, indole-positive Proteus and
Enterobacter strains. The resistance rates of naturally sensitive
micro-organisms may vary from place to place through the acquisition of
R-plasmids.
Amoxicillin is rapidly and virtually completely absorbed (85-90%) following the oral administration of FLEMOXIN SOLUTAB tablets. Amoxicillin absorption is not influenced by food intake.
Maximum plasma concentrations are attained after 1-2 hours. Values of approximately 6mcg/ml are found following a dose of 375mg. Half or double doses produce half or double the plasma levels.
Amoxicillin plasma protein binding is approximately 20%. The substance remains extracellular. The tissue concentrations depend on the circulation in those tissues and on the quantity of extracellular fluid. Amoxicillin diffuses adequately into the sputum, mucosa, bone tissue and aqueous humor of the eye to produce therapeutically active levels.
The concentrations in the bile are two to four times higher, or even higher than those in the blood.
In the amniotic fluid and umbilical cord blood 25-30% of the mother's blood levels are attained.
Amoxicillin diffuses poorly into the cerebrospinal fluid of patients with normal meninges. In inflamed meninges the concentrations are approximately 20% of those found in the blood.
Amoxicillin is partly metabolized; the main degradation product is penicilloic acid which is microbiologically inactive but which has allergenic properties.
Amoxicillin is primarily eliminated via the kidneys, largely (ca. 80%) via tubular excretion, for the remainder (ca. 20%) via glomerular filtration. In normal renal function the plasma half-life of amoxicillin is 1-1.5 hours, and in premature babies, newborns and infants up to 6 months, 3-4 hours. In impaired renal function (creatinine clearance 15mL/min or less) the half-life may increase, and in anuria up to 8.5 hours. Disturbed hepatic function has no effect on the half-life.
Infections caused by amoxicillin-sensitive micro-organisms, i.e.
Note: In such generalized infections as sepsis, and in meningitis, endocarditis and peritonitis, parenteral therapy is to be preferred.
In mild to moderately severe infections the following scheme may be used:
2 x 500-750mg or 3 x 375-500mg daily
2 x 375mg or 3 x 250mg daily
2 x 250mg or 3 x 125mg daily
2 x 125mg or 3 x 100mg daily
* 30mg/kg daily in 2-3 doses is generally administered
For infections that are of difficult access e.g. acute bacterial otitis media, a tid dose is preferred.
In chronic, recurrent and severe infections the above dosage may be increased to 3 x 750mg-1g daily, and in children up to 60mg/kg daily.
Gonorrhoea (acute, uncomplicated): 3g is administered as a single dose in combination with 1g probenecid.
Only when the creatinine clearance drops below 10mL/min need the dosage be reduced (by 15-50%).
Disturbed hepatic function has no effect on the half-life.
FLEMOXIN SOLUTAB may be taken before, during or after meals. FLEMOXIN SOLUTAB tablets of all strengths may be swallowed whole with a glass of water, or first dissolved in at least 20ml water and stirred thoroughly before swallowing.
In mild to moderately severe infections a treatment period of 5-7 days will generally suffice. Streptococcal infections, however, should be treated for a minimum of 10 days. The duration of treatment for serious or chronic infections and infections at sites where low concentrations are reached depends on the clinical picture. In general, treatment will have to be continued for 48 hours after the clinical symptoms have disappeared.
Hypersensitivity to penicillins.
Patients with infectious mononucleosis or lymphatic leukaemia frequently (in 60-100% of cases) react with exanthema, the cause of which is not based on the characteristic penicillin hypersensitivity. This form of erythroderma in the patient's history does not constitute a contraindication for the use of penicillins.
Cross-resistance and cross-hypersensitivity have been observed with other penicillins and sometimes also with cephalosporins. As is the case with other penicillins with a broad-spectrum, superinfections may occur.
Should severe diarrhoea develop pseudomembranous colitis is to be considered as a diagnosis. If this is the case the appropriate measures should be taken. The necessary measures must also be taken if haemorrhagic colitis or hypersensitivity reactions occur.
As far as is known, amoxicillin may be given during pregnancy without any danger to the foetus.
Amoxicillin is excreted only in small quantities in breast milk. The risk for the infant is negligible except for the possibility of sensitization.
Adverse effects on the ability to drive vehicles or operate machines have not been described.
G.I. Tract
Gastrointestinal disorders especially diarrhoea, and anal pruritis. Pseudomembranous and haemorrhagic colitis occur, but only rarely.
Skin
Allergic skin reactions occur distinctly more frequently than with the other penicillins, but probably less often than with ampicillin, and they generally have a specific maculopapular character unlike the mainly urticarial aspect seen with the other penicillins.
Erythema multiforme and the Stevens-Johnson's syndrome occur rarely.
Urinary tract
Interstitial nephritis is occasionally observed.
Blood
Abnormalities (agranulocytosis, thrombocytopenia) do occur, but only rarely.
Others
Anaphylactic shock and angioneurotic oedema have been observed.
Probenecid, phenylbutazone, oxyphenbutazone, and to a lesser extent acetyl salicylic acid, indomethacin and sulfinpyrazone inhibit the tubular secretion of penicillins, prolonging plasma half-life and increasing plasma levels. Amoxicillin is also therapeutically used in combination with probenecid.
Allopurinol has not been reported to increase the risk of skin reactions as is the case with ampicillin.
The bactericidal effect may be neutralized by some bacteriostatic agents, such as the tetracyclines, macrolides and chloramphenicol.
The concomitant use of aminoglycosides is possible (synergistic effect); in this case mixing in vitro should be avoided in view of the possible inactivation of the aminoglycosides by amoxicillin.
After an overdose such gastrointestinal symptoms as nausea, vomiting and diarrhoea may occur and affect the fluid and electrolyte balance.
Vomiting should be induced or gastric lavage carried out, followed by the administration of active charcoal and an osmotically active laxative (sodium sulphate). The fluid and electrolyte balance should be maintained.
Shelf-life
FLEMOXIN SOLUTAB may be kept at room temperature up to the date mentioned on the package.
Prescription Medicine.
FLEMOXIN SOLUTAB 125: 20 and 50 tablets per box
FLEMOXIN SOLUTAB 250: 20 and 50 tablets per box
FLEMOXIN SOLUTAB 375: 20 and 50 tablets per box
FLEMOXIN SOLUTAB 500: 20 and 50 tablets per box
FLEMOXIN SOLUTAB 750: 20 and 50 tablets per box
FLEMOXIN SOLUTAB 1000: 20 tablets per box
FLEMOXIN SOLUTAB contains the following excipients:
Microcrystalline cellulose, hydroxypropylcellulose, vanillin, saccharin, colloidal silicon dioxide, magnesium stearate and an apricot flavour.
CSL (New Zealand) Limited
666 Great South Rd
Central Park
Auckland
New Zealand
Ph: 0800 502 757
14 November 2001
FLEMOXIN SOLUTAB™ is a trademark of Yamanouchi Europe BV.