|
Description
Colizole
(Tablets, D.S. Tablets, Paediatric suspension) is a synthetic
antibacterial combination product.
Composition
| COLIZOLE
Tablets |
|
|
| Each uncoated
tablet contains : |
|
|
| Trimethoprim
I P |
80
mg |
| Sulphamethoxazole
I P |
400
mg |
| COLIZOLE
DS Tablets |
|
|
| Each uncoated
tablet contains : |
|
|
| Trimethoprim
I P |
160
mg |
| Sulphamethoxazole
I P |
800
mg |
| COLIZOLE
Suspension |
|
|
| Each 5 ml contains
: |
|
|
| Trimethoprim
I P |
40
mg |
| Sulphamethoxazole
I P |
200
mg |
Actions
Combination
of trimethoprim and sulphamethoxazole interferes with the
bacterial cellular metabolism of folic acid due to sequential
blockade in biosynthesis of nucleotides, essential for growth
of many bacteria. Sulphamethoxazole inhibits bacterial synthesis
of dihydrofolic acid by competitive antagonism with para-aminobenzoic
acid and trimethoprim inhibits the enzyme dihydrofolate
reductase, thus blocking the conversion of dihydrofolic
acid to tetrahydrofolic acid. This consecutive two steps
blockade mechanism results in synergism to offer a bactericidal
response to the combination product.
Colizole is rapidly absorbed following oral administration
and on repeated administrations a steady state ratio of
trimethoprim to sulphamethoxazole levels in the blood of
about 1:20, required for synergistic response, is achieved
to provide effective clinical results. In vitro studies
have shown that bacterial resistance development occurs
more slowly on using the agents conjunctively than when
the components are used alone.
Indications
As a
bactericidal agent for the treatment of : (a) chronic
urinary tract infections (symptomatic or asymptomatic),
infections associated with urinary tract obstruction or
recurrent infections, pyelonephritis, pyelitis, cystitis
caused by susceptible organisms e.g. E. coli, Klebsiella,
Enterobacter, Proteus, (b) acute exacerbation of chronic
bronchitis due to susceptible strains of H. influenzae /
S. pneumoniae, (c) acute otitis media due to susceptible
strains of H. influenzae or S. pneumoniae, (d) enteritis
caused by susceptible strains of Shigella flexneri and Shigella
sonnei, (e) infections caused by S. typhi &
S. paratyphi.
Contraindications
Colizole
should not be used in patients with hypersensitivity to either
component, in infants under 2 months of age, patients
with established megaloblastic anaemia due to folate deficiency,
during pregnancy at term.
|
Adverse Reactions
Colizole
is usually
well-tolerated. Reported side effects are :
(a) Haematological-agranulocytosis, aplastic anaemia,
megaloblastic anaemia, thrombopenia, leukopenia, haemolytic
anaemia, purpura, etc. (b) Allergic-Stevens-Johnson Syndrome, generalised
skin erruption, urticaria, pruritus, exfoliative dermatitis,
arthralgia, etc.
(c) Gastro-intestinal-glossitis,
stomatitis, hepatitis, diarrhoea, nausea, vomiting, etc. (d) Central
Nervous SystemÑheadache, peripheral neuritis, tinnitus, vertigo,
nervousness, muscle weakness, etc. (e) MiscellaneousÑdrug
fever, chills, crystalluria etc.
Precautions
Judicious
use of Colizole
is
needed in patients with impaired kidney and liver functions,
with possible folate deficiency, with severe allergy. Haemolysis,
dose related, may occur in subjects deficient in the enzyme
glucose-6-phosphate dehydrogenase. Colizole
should
be used during pregnancy only if the potential benefit justifies
the potential risk to the foetus.
Drug Interactions
Diuretics (specially thiazides)-increased risk of thrombopenia
in elderly patients. Oral hypoglycemics, methotrexate, phenytoin,
thiopentalÑeffects of the drugs increased or prolonged with
enhanced toxicity.
WarfarinÑenhanced prothrombin time.
Dose
(a)
Urinary tract infections caused by susceptible
organisms :
Adults : Colizole tablets-2 tablets or
Colizole DS-1 tablet or
Colizole suspension-20 ml (4 t.s.f. approx.) every 12
hours for 10-14 days.
Children : 4 mg/kg Trimethoprim and 20 mg/kg Sulphamethoxazole
every 12 hours for 10 days or, between 2 months-5 monthsÑ
1/2 t.s.f every 12 hours; 5 months-5 yearsÑ
1 t.s.f. every 12 hours; 5 years-12 yearsÑ
2 t.s.f. or 1 tablet every 12 hours.
(b)
Acute otitis media in children caused by susceptible
organisms :
ChildrenÑdosage same as above.
(c)
Acute exacerbations of chronic bronchitis :
Adults-dosage same as above.
(d)
Shigellosis :
Adults-dosage same as above for 5 days.
Children- dosage
same as above for 5 days.
(e) Enteric
fever :
Adults-Colizole 3 tablets/Colizole DS
½ tablets every 12 hours.
Children- Trimethoprim 8-10 mg/kg and Sulphamethoxazole
40-50 mg/kg body weight daily in two divided doses.
(f) For
prolonged therapy
Colizole 1 tablet every 12 hours.
Packing
Colizole
Tablets
Strips of 10 tablets
Colizole
DS Tablets
Strips of 10 tablets
Colizole
Suspension
Phials 50 ml
|
