BACTRIM ® - (trimethoprim /sulfamethoxazole)
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
|[0 to 80 mg] [100 ml] [60 min]
[81 to 120 mg] [150-250 ml] [90 min]
[121 to 240 mg] [250 ml] [90 min]
[241 to 450 mg] [500 ml] [90 min] Minimum dilution: 80 mg TMP/ 75 ml.
Stability / Miscellaneous
|EXP: (room temperature). Note: stability is based on the concentration. The stability of the various dilutions listed above must be based on the actual amount of drug added to the various solutions above. Use the following data:
Multiples of 80mg/ 125 ml fluid - 6hr stability [ concentration: 0.64 mg/mL]
Example: 375mg/500mL [Conc = 0.75 mg/mL]
Label: Do not Refrigerate
Non-PCP: 10mg/kg/day ( based on TMP component) divided q6h or q8h or q12h.
Excretion of sulfamethoxazole and trimethoprim is primarily by the kidneys through both glomerular filtration and tubular secretion. Urine concentrations of both sulfamethoxazole and trimethoprim are considerably higher than are the concentrations in the blood. The percent of dose excreted in urine over a 12-hour period following the intravenous administration of the first dose of 1200 mg of sulfamethoxazole and 240 mg of trimethoprim on day 1 ranged from 7% to 12.7% as free sulfamethoxazole and 17% to 42.4% as free trimethoprim; and 36.7% to 56% as total (free plus the N4-acetylated metabolite) sulfamethoxazole. When administered together, neither sulfamethoxazole nor trimethoprim affects the urinary excretion pattern of the other. Both sulfamethoxazole and trimethoprim distribute to sputum and vaginal fluid; trimethoprim also distributes to bronchial secretions, and both pass the placental barrier and are excreted in breast milk.
In vitro studies have shown that bacterial resistance develops more slowly with this combination than with either sulfamethoxazole or trimethoprim alone.
In vitro serial dilution tests have shown that the spectrum of antibacterial activity of sulfamethoxazole and trimethoprim injection includes common bacterial pathogens with the exception of Pseudomonas aeruginosa. The following organisms are usually susceptible: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, indole-positive Proteus species including Proteus vulgaris, Haemophilus influenzae (including ampicillin-resistant strains), Streptococcus pneumoniae, Shigella flexneri and Shigella sonnei. It should be noted, however, that there are little clinical data on the use of sulfamethoxazole and trimethoprim injection in serious systemic infections due to Haemophilus influenzae and Streptococcus pneumoniae.
INDICATIONS AND USAGE
Urinary Tract Infections
Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies.
SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS SMX AND TMP INJECTION, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE SKIN RASH OR ANY SIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders. (See package insert for PRECAUTIONS.)
Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura, or jaundice may be early indications of serious reactions.
Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.
The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including SMX and TMP injection, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of 'antibiotic-associated colitis'.
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration would be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug effective against C. difficile.
Sulfamethoxazole and trimethoprim injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Contains benzyl alcohol. In newborn infants, benzyl alcohol has been associated with an increased incidence of neurological and other complications which are sometimes fatal.
DOSAGE AND ADMINISTRATION
Pneumocystis Carinii Pneumonia
Severe Urinary Tract Infections And Shigellosis
For Patients With Impaired Renal Function
Renal Dosing -------------------------------------------------------------------------
Above 30: Standard regimen
Alternative (LESS SUPPORT): 2.5mg/kg q24h (Avoid if possible due to risk of crystalluria/ nephrolithiasis)
Alternative (LESS SUPPORT): 5mg/kg q24h (Avoid if possible due to risk of crystalluria/ nephrolithiasis)
INDICATION/RENAL FUNCTION DOSE
CrCl 15 to 30 ml/min
CrCl < 15 ml/min
CrCl 15 to 30 ml/min
CrCl < 15 ml/min
CrCl 15 to 30 ml/min
CrCl less than 15 ml/min
Method Of Preparation
The following infusion systems have been tested and found satisfactory: unit-dose glass containers; unit-dose polyvinyl chloride and polyolefin containers. No other systems have been tested and therefore no others can be recommended.
Note: In those instances where fluid restriction is desirable, each 5 mL may be added to 75 mL of 5% dextrose in water. Under these circumstances the solution should be mixed just prior to use and should be administered within 2 hours. If upon visual inspection there is cloudiness or evidence of crystallization after mixing, the solution should be discarded and a fresh solution prepared.
DO NOT MIX SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION 5% DEXTROSE IN WATER WITH DRUGS OR SOLUTIONS IN THE SAME CONTAINER.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
5 mL single dose amber vials packaged 10 per shelf pack.
STORE AT ROOM TEMPERATURE 15°–30° C (59°–86° F).