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Hymox
®
Amoxycillin
Broad spectrum Antibiotic
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COMPOSITION
Amoxycillin
Trihydrate B.P.
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PROPERTIES
Hymox is
a broad spectrum penicillin combining bactericidal activity with
proven safety. It is active against a wide range of Gram-negative
and Gram-positive bacteria including:
- Streptococcus spp.; Staphylococcus (penicillin sensitive); Haemophilus
influenzae; Escherichia coli; Proteus mirabilis; Salmonella spp.;
Neisseria spp. Pharmacokinetics Hymox is well absorbed and produces
high serum levels regardless of the presence of food. Administration
of higher doses results in a proportionate increase in serum levels.
In patients with normal renal function, higher and more prolonged
blood levels may be achieved by the concurrent administration of
probenecid.
Hymox is excreted unchanged in the urine, over 60% being recovered
within six hours.
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INDICATIONS
Respiratory tract infections; Ear, nose and throat infections; Urinary
tract infections; Gastro-intestinal infections; Enteric fever; Skin
and soft tissue infections; Biliary tract infections; Orthopaedic
infections; Pelvic infections; Gonorrhoea (non penicillinase producing
strains); Syphilis; Endocarditis; Peritonitis; Dental abscess (as
an adjunct to surgical management). Prophylaxis of endocarditis
: Hymox may be used for the prevention of bacteraemia, associated
with procedures such as dental extraction, in patients at risk of
developing bacterial endocarditis, in cases where oral antibiotic
therapy is suitable.
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DOSAGE
AND ADMINISTRATION
Hymox is effective in a wide range of dosage
regimens. The recommendations given here are those commonly applied.
Further details are available on request.
General Recommendations Adult 250-500mg every 8 hours or more frequently
if necessary.
Children 125mg every 8 hours, increasing to 250mg every 8 hours
for more severe infections
Children under 6 months of age : Based on body weight 35 - 100mg/kg/day.
Renal Insufficiency For patients with renal insufficiency monitoring
of plasma and urine levels should be undertaken.
Suggested dosages :
- Moderate insufficiency creatinine clearance 10-30ml/min
- 1g followed by 500mg every 12 hours.
- Severe insufficiency creatinine clearance less than
10 ml/min
- 1g followed by 500mg every 24 hours.
Specific Dosage Recommendations Typhoid and Paratyphoid
Adults
- 4g daily in divided doses for 14-21 days
Children
- 100mg/kg/day in divided doses for 14-21 days.
Typhoid Carrier states 3-4g daily in divided doses for a minimum
of one month.
Gonorrhoea A single dose of 3g plus 1g probenecid where infection
is caused by penicillin - sensitive organisms. Uncomplicated Urinary
Tract Infection A single dose of 3g. Syphilis A dosage of 250mg
every 6 hours has been used in all stages of syphilis.
Duration of treatment varied from 4 weeks up to 5 months according
to the stage of disease and serological response. Severe or Recurrent
Lower Respiratory Tract Infection A dosage of 3g twice daily is
recommended in appropriate cases for the treatment of severe or
recurrent purulent infection of the respiratory tract.
Dental Abscess Two 3g doses with 8 hours between doses. Otitis Media
in severe or recurrent otitis media, especially where compliance
may be a problem, 750 mg twice a day for two days may be used in
children 3 - 10 years.
Children Dosage years Under 10 years : Half adult dose.
Under 5 years : Quarter adult dose.
Notes.
If prophylaxis with Hymox is given twice within one month, emergence
of resistant streptococci is unlikely to be a problem. Alternative
antibiotics are recommended if more frequent prophylaxis is required,
or if the patient has received a course of treatment with a penicillin
during the previous month. Contra- indications Hymox should not
be administered to patients hypersensitive to penicillin.
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PRECAUTIONS
During treatment with high doses of Hymox,
an adequate fluid intake and urinary output must be maintained.
Indwelling urinary catheters should be checked regularly for patency
since at room temperature high urinary concentrations of some drugs,
including Hymox, may precipitate out of solution.
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USE
IN PREGNANCY AND LACTATION
Animal studies with Hymox have shown no teratogenic
effects. The product has been in extensive clinical use since 1972
and its suitability in human pregnancy has been well documented
in clinical studies. When antibiotic therapy is required during
pregnancy, Hymox may be considered appropriate. During lactation,
trace quantities of Hymox can be detected in breast milk.
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SIDE
EFFECTS
Side effects, as with other penicillins, are
usually of a mild and transitory nature: they may include diarrhoea,
indigestion or an occasional rash, either urticarial, which suggests
penicillin hypersensitivity, or erythematous. An erythematous rash
may be caused in patients with glandular fever, in which case it
is advisable to discontinue treatment.
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OVERDOSAGE
Since Hymox is a penicillin, problems of overdosage
are unlikely to be encountered. Gross overdosage will produce very
high urinary concentrations. Problems are unlikely if adequate fluid
intake and urinary output are maintained; however, crystalluria
is a possibility. More specific measures may be necessary in patients
with impaired renal function: the antibiotic is removed by haemodialysis.
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PRESENTATION
Capsules Gelatin
capsules containing 250mg or 500mg Amoxycillin*.
Syrup Powder for preparing fruit flavoured syrup.
When dispensed each 5ml contains 125mg Amoxycillin*.
Syrup Forte Powder for preparing fruit flavoured syrup.
When dispensed each 5ml contains 250mg Amoxycillin*.
* As Amoxycillin Trihydrate B.P.
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STORAGE
Hymox should be stored in a dry place, below
25°C. Once dispensed the syrups should be used within 14 days.
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