Dual action chemotherapeutic agent with bactericidal
PROPERITES
COMPOSITION
The active ingredients of Bactrim are Trimethoprim (TM ) and Sulfamethoxazole (SMZ)
| FORM | TM | SMZ |
| 1 Tablet Forte 1 tablet 1 Measure (5ml) Syrup | 160 mg 80 mg 40 mg | 800 mg 400 mg 200 mg |
PROPERTIES, EFFECTS
Bactrim is a chemotherapeutic agent based on recently acquired scientific knowledge .Its bactericidal action is achieved in an original way: by the blockage of two enzymes that catalyze consecutive reactions in the biosynthesis of folinic acid in microorganisms. Bactrim is already bactericidal in concentrations where the components trimethoprim and Sulfamethoxazole are usually only bacteriostatic when they are singly used. Thus it is often effective against organisms that are resistant to these substances. In addition, the risk that resistance may develop is minimized. The antibacterial effect of Bactrim covers a wide range of gram-positive and gram –negative organisms, such as streptococci, staphylococci, pneumococci and neisseriae. Bactrim is particularly effective against the “problem germs” Haemophilus influenza.
INDICATIONS
Upper and lower respiratory tract infections: Acute and chronic bronchitis, bronchiectasis, pneumonia (including pneumocystis carinii pneumonia); Pharyngitis, tonsillitis (in infections due to group A ß-hemolytic streptococci, the rate of eradication is not fully satisfactory), sinusitis, and otitis media.
Renal and urinary tract infections: Acute and chronic cystitis, pyelonephritis, urethritis, prostatitis.
Genital infections in both sexes, including gonococcal urethritis.
STANDARD DOSAGE
| For adults & children over 12 years | Tablets | | Forte tablets | |
| | Morning | Evening | Morning | Evening |
| standard dosage |
2 | 2 | 1 | 1 |
| Minimum dosage & dosage for long-term therapy (longer than 14 days) | 1 | 1 | ½ | ½ |
| High dosage (for particularly severe cases) | 3 | 3 | 1 ½ | 1 ½ |
Bactrim is best taken after meals, with an adequate amount of fluid.
SPECIAL DOSAGE INSTRUCTIONS
Dosage for gonorrhea: 5 tablets in the morning and in the evening.
Dosage for acute uncomplicated infections of the urinary tract: For women a single dose of 6 tablets is recommended. The tablets should, if possible be taken in the evening after a meal or before retiring.
The recommended dosage for patients with pneumocystis, carinii pneumonia is up to 20 mg TM/kg, and up to 100 mg SMZ/kg in 24 hours, given in equal divided doses every six hours for 14 days.
DOSAGE FOR CHILDREN
| Children age | Syrup (teaspoonful) | Syrup (teaspoonful) |
| morning | evening |
| 6 weeks to 5 months | ½ | ½ |
| 6 months to 5 years | 1 | 1 |
| 6 years to 12 years | 2 | 2 |
The above schedules for children are approximately equivalent to a daily dose of 6 mg TM and 30 mg SMZ per kg bodyweight. For severe infections the dosage shown for children may be increased by 50 % .
RESTRICTIONS ON USE
Bactrim is contraindicated in patients with marked liver parenchymal damage. It is also contraindicated in patients with severe renal insufficiency when repeated determinations of the plasma concentration cannot be made. In order to minimize the risk of undesirable reactions, the duration of treatment with Bactrim should be as short as possible, particularly in elderly patients. In the event of renal and/or liver impairment, dosage should be adjusted according to the special dosage instructions. If Bactrim 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, Bactrim should be discontinued. Other than in exceptional cases, Bactrim should not be given to patients with serious hematological disorders. Owing to the possibility of hemolysis Bactrim should not be given to patients with G6PD deficiency unless absolutely essential, and then only in minimal doses. Treatment should be discontinued immediately at the first appearance of skin rash or any other serious adverse reaction. Bactrim should not be administered to patients with a history of hypersensitivity to sulfonamides or trimethoprim . For safety reasons, Bactrim is contraindicated during pregnancy. Bactrim must not be given to premature and newborn infants during the first few weeks of life. Although TM &SMZ pass into the breast milk, the use of Bactrim by nursing mothers is virtually without risk for the infant. Patients undergoing long-term treatment with Bactrim (in particular, patients with kidney failure) should be examined regularly for urine values and kidney function. An adequate fluid intake should be ensured during treatment.
UNDESIRABLE EFFECTS
At the recommended dosage, Bactrim is usually well tolerated. Side effects, if any, are usually mild . The following effects have been reported (in order of frequency):
Gastrointestinal side effects: nausea (with or without vomiting), stomatitis, diarrhea, rare cases of hepatitis and isolated cases of pseudomembranous entercolitis.
Drug-induced skin rashes: these are generally mild and quickly reversible after withdrawal of medication.
DRUG INTERACTIONS
Thrombocytopenia with purpura has been observed in elderly patients concurrently receiving certain diuretics, primarily thiazides. Bactrim may prolong the prothrombin time in patients receiving anticoagulant warfarin. The coagulation time should be, determined anew. Bactrim may inhibit the hepatic metabolism of phenytoin, and may also affect the required dose of hypoglycemic drugs .
PACKS
Syrup : 40 mg TM/200 mg SMZ 60 ml& 100 ml.
Tablets : 80 mg TM/400 mg SMZ 20 Tabs
Forte tabs 160 mg TM/800 mg SMZ 10 Tabs.