Sutrim Forte

To the Medical and Pharmaceutical Profession.

Composition:
Each tablet contains:
Sulphamethoxazole     800.0 mg
Trimethoprim               160.0 mg


Properties:
Sutrim forte is a synthetic antibacterial combination product. Sulphamethoxazole inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA). Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to & reversibly inhibiting the required enzyme, dihydrofolate reductase. Thus, sutrim forte blocks two consecutive steps in the biosynthesis of nucleic acids & proteins essential to many bacteria. The spectrum of antibacterial activity of sutrim forte includes the common urinary tract pathogens with the exception of Pseudomonas aeruginosa, bacterial pathogens isolated from middle ear exudate & from bronchial secretions and entertoxigenic strains of Escherichia coli causing bacterial gastroenteritis.

Pharmakokinetics:
Sutrim forte is rapidly absorbed following oral administration. Both sulfamethoxazole and trimethoprim exist in the blood as unbound, protein-bound, and metabolized forms; sulfamethoxazole also exist as the conjugated form. Approximately 44% of trimethoprim and 70% of sulfamethoxazole are bound to plasma protein. Peak blood levels for the individual components occur 1 to 4 hours after oral administration, the mean serum half lives of sulfamethoxazole and trimethoprim are 10 and 8-10 hours, respectively. Excretion of sulfamethoxazole and trimethoprim is primarily by the kidney.

Indications & usage:
Sutrim forte is indicated in the treatment of the following conditions:
- Urinary tract infections due to Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis & Proteus vulgaris.
- Acute otitis media due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae.
- Acute exacerbations of chronic bronchitis in adults due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae.
- Traveler’s diarrhea in adults due to susceptible strains of entertoxigenic Escherichia coli.
- Enteritis caused by susceptible strains of Shigella flexneri & Shigella sonnei.

Contraindications:
Sutrim forte is contraindicated in:
1) Patients with a known hypersensitivity to trimethoprim or sulfonamides.
2) Patients with megaloblastic anemia due to folate deficiency.
3) Pediatric patients less than 2 months of age.

Side effects:
The most common side effects are gastrointestinal disturbances including nausea, vomiting, anorexia as well as allergic skin reactions. Fatalities associated with the administration of sulphonamides, although rare, have occurred due to severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, other blood dyscrasias & hypersensitivity of the respiratory tract.

Drug interactions:

-    In Elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported.
-    Sutrim forte may prolong the prothrombin time in patients who are receiving warfarin.
-    Sutrim forte, given at a common clinical dosage, increased the phenytoin half life by 39%& decreased the phenytion metabolic clearance rate by 27% leading to possible excessive phenytoin effect.
-    Sulfonamides can also displace methotrexate from plasma protein binding sites thus increase free methotrexate concentration.

Warnings & precautions:
- Sutrim forte should be discontinued at the first appearance of skin rash or any sign of adverse reaction.
- Pseudomembranous colitis may range in severity from mild to life threatening so it is important to consider this diagnosis in patients who present with diarrhea subsequent to administration of drug.
- Cough, shortness of breath & pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.
- Sulfonamides should not be used for the treatment of group-A beta-hemolytic streptococcal infections.
- Sutrim forte should be given with caution to patients with impaired renal or hepatic function, to those with possible folate deficiency (e.g. the elderly, patients receiving anticonvulsant therapy, patients with malabsorption syndrome, patients in malnutrition states) as well as to those patients with severe allergy or bronchial asthma and chronic alcoholics.
- In glucose-6-phosphate dehydrogenase-deficient individuals, dose related hemolysis may occur.
- An adequate fluid intake should be maintained in order to prevent crystalluria & stone formation.

Pregnancy:
Because Trimethoprim & Sulphamethoxazole may interfere with folic acid metabolism, Sutrim forte should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation:
Sutrim forte is contraindicated in nursing mothers.

Overdosage:
- Signs & symptoms of overdosage reported with sulfonamide & trimethoprim include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness, unconsciousness, bone marrow depression, pyrexia, hematuria & jaundice.
- General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids& the administration of intravenous fluids if urine output is low & renal function is normal.


Dosage & administration:
1- Urinary tract infections & Shigellosis in adults and pediatric patients and acute otitis media in pediatric patients:
    - Adults: One sutrim forte tablet every 12 hours for 10 to 14 days and for 5 days in the treatment of shigellosis
    - Pediatric patients: The recommended dose for pediatric patient weighing 40 Kg is one Sutrim forte tablet every 12 hours for 10 days in urinary tract infection or acute otitis media and for 5 days in treatment of Shigellosis.
    - For patients with impaired renal function: Dose depends on the creatinine clearance as follows:

Creatinine Clearance( ml/ min. ) Recommended dosage regimen
 Above 30 Use standard regimen
15-30 ½ the usual regimen
Below 15 Use is not recommended


2- Acute exacerbations of chronic bronchitis in adults:
- One sutrim forte tablet every 12 hours for 14 days.
3- Traveler's diarrhea in adults:
- One sutrim forte tablet every 12 hours for 5 days.
Therapeutic Category: Antibacterial agent.
Legal Category: Prescription only medicine (POM)
Packaging: Box containing 10 tablets Storage: Store in a dry place at a temperature 15º C – 25º C protect from light.

 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.