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COTRIM
Caplet
COMPOSITION :
Each caplet contains Trimethoprim 80 mg and Sulfamethoxazole 400 mg.
Each forte caplet contains Trimethoprim 160 mg and Sulfamethoxazole 800 mg.

PHARMACOLOGY :
Cotrim contains 2 active ingredients acting sinergically by blockade of 2 enzymes that catalogue successive stages in the
biosynthesis of folinic acid in the micro-organism.  This mechanism usually results in bactericidal activity in-vitro in
concentrations at which the individual components are only bacteriostatic.

INDICATIONS :
Renal and urinary tract infections : cystitis, pyelonephiritis, pyelitis, urethritis.
Gastrointestinal tract infections : typhoid, paratyphoid and bacillary dysentery.
Respiratory tract infections : toxoplasmosis etc which other drug of choice can  not be administered.

DOSAGE :
To be taken twice daily ( morning and evening)
Cotrim caplet :
Adult : 2 caplet
Children 6-12 year, 1 caplet.
Cotrim forte caplet :
Adult : 1 caplet
Children 6-12 year : caplet
The recommended duration of therapy for urinary tract infections : 10-14 days and Shigellosis : 5 days.  For severe infections,
the dosage may be increased by 50 % in 3 divided dosage.

SPECIAL DOSAGE INSTRUCTION :
Patient with impaired kidney function :

Creatinine clearance (ml/min)        Recommended Dosage Schedule
> 30                                   Standard dosage
15-30                                 Half of Standard dosage
< 15                                   Use of Cotrim not recommended


CONTRAINDICATIONS :
Patients with marked liver parenchymal damage, also in patients with severe renal insufficiency when repeated
determinations of the plasma concentration can not be made.
Severe blood dyscrasia
Hypersensitivity to components of Cotrim.
Pregnancy. If pregnancy can not be excluded, possible risks should be weighed against the expected therapeutic effect.
Nursing mother, premature and new of life born infants during 2 months of life.

PRECAUTIONS :
In the event of renal impairment dosage should be adjusted according to the special dosage instructions.
If Cotrim is given over a prolonged period regular blood counts are required.  If a significant reduction in the count of
any  formed   blood element is noted.  Cotrim should be discontinued.
Treatment should be discontinued immediately at the first appearance of skin rash or any other serious adverse
reaction.
In  elderly patients or in patients  with  pre-existing folic acid deficiency or kidney failure hematological changes
indicative at folic acid deficiency may occur.  These are reversible by folinic acid therapy.
Cotrim is best taken after meals with an adequate amount of water.
In infection of pharyngitis due to group A  hematology streptococcus, the rate of eradication is not fully satisfactory.

ADVERSE REACTIONS :
Dermatology          : skin rash
Hematology           : leucopenia, neutropenia and thrombocytopenia
Very rarely              : agranulocytosis, megaloblastic anemia, or
Gastrointestinal      : nausea ( with or without vomiting  )
Others                    : syndrome Steven-Johnson and Lyelli.

DRUG INTERACTIONS :
Oral anti  coagulant
Increase the effect
Hypoglycaemic  agent
Cotrim may also affect the required dose of hypoglycaemic drugs
Pyrimethamin
Patient receiving pyrimethamine   as malaria prophylaxis  in doses exceeding 25 mg weekly, may develop
megalablastic anemia if Cotrim is  prescribed concurrently.

STORAGE :
Store in a  coal acid dry place far  from reach of children
Reg. No         Cotrim                : DKL8521000904B1
                     Cotrim forte        : DKL9421000904C1

On medical prescription only.



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(GMP).

Our Products have met the
International Level and
Requirement.

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for more information

email: info@pyridam.com
Phone: +62-21-536-90112
Fax     : +62-21-532-9049