INDICATIONS
Tablets and Suspensions
Urinary Tract Infections: For the treatment
of urinary tract infections due to susceptible strains
of the following organisms: Escherichia coli, Klebsiella
species, Enterobacter species, Morganella morganii, Proteus
mirabilis and Proteus vulgaris. It is recommended that
initial episodes of uncomplicated urinary tract infections
be treated with a single effective antibacterial agent
rather than the combination.
Acute Otitis Media: For the treatment
of acute otitis media in pediatric patients due to susceptible
strains of Streptococcus pneumoniae or Haemophilus influenzae
when, in the judgment of the physician, sulfamethoxazole;
trimethoprim offers some advantage over the use of other
antimicrobial agents. To date, there are limited data
on the safety of repeated use of sulfamethoxazole; trimethoprim
in pediatric patients under two years of age. Sulfamethoxazole;
trimethoprim is not indicated for prophylactic or prolonged
administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in
Adults: For the treatment of acute exacerbations
of chronic bronchitis due to susceptible strains of Streptococcus
pneumoniae or Haemophilus influenzae when, in the judgment
of the physician, sulfamethoxazole; trimethoprim offers
some advantage over the use of a single antimicrobial
agent.
Pneumocystis Carinni Pneumonia: For
the treatment of documented Pneumocystis carinii pneumonia.
For prophylaxis against Pneumocystis carinni pneumonia
in individuals who are immunosuppressed and considered
to be at an increased risk of developing Pneumocystis
carinni pneumonia.
Travelers' Diarrhea In Adults: For the
treatment of travelers' diarrhea due to susceptible strains
of enterotoxigenic E. coli.
Shigellosis: For the treatment of enteritis
caused by susceptible strains of Shigella flexneri and
Shigella sonnei when antibacterial therapy is indicated.
IV Infusion
Pneumocystis Carinii Pneumonia: Sulfamethoxazole;
trimethoprim IV is indicated in the treatment of Pneumocystis
carinii pneumonia in pediatric patients and in adults.
Shigellosis: Sulfamethoxazole; trimethoprim
IV is indicated in the treatment of enteritis caused by
susceptible strains of Shigella flexneri and Shigella
sonnei in pediatric patients and adults.
Urinary Tract Infections: Sulfamethoxazole;
trimethoprim IV is indicated in the treatment of severe
or complicated urinary tract infections due to susceptible
strains of Escherichia coli, Klebsiella species, Enterobacter
species, Morganella morganii and Proteus species when
oral administration of sulfamethoxazole; trimethoprim
is not feasible and when the organism is not susceptible
to single-agent antibacterials effective in the urinary
tract.
Although appropriate culture and susceptibility studies
should be performed, therapy may be started while awaiting
the results of these studies.
DOSAGE AND ADMINISTRATION
Tablets and Suspensions
Contraindicated in pediatric patients less than
two months of age.
Urinary Tract Infections and Shigellosis in Adults
and Pediatric Patients, and Acute Otitis Media in Pediatric
Patients
Adults: The usual adult dosage in the
treatment of urinary tract infections is one sulfamethoxazole;
trimethoprim DS (double strength) tablet, two sulfamethoxazole;
trimethoprim tablets, or 4 teaspoonfuls (20 ml) of sulfamethoxazole;
trimethoprim suspensions every 12 hours for 10 to 14 days.
An identical daily dosage is used for 5 days in the treatment
of shigellosis.
Pediatric Patients: The recommended
dose for pediatric patients with urinary tract infections
or acute otitis media is 8 mg/kg trimethoprim and 40 mg/kg
sulfamethoxazole per 24 hours, given in 2 divided doses
every 12 hours for 10 days. An identical daily dosage
is used for 5 days in the treatment of shigellosis. TABLE
3 is a guideline for the attainment of this dosage.
| TABLE 3
Pediatric Patients Two Months of Age or Older |
| Weight |
Dose--every
12 hours |
| lb |
kg |
Teaspoonfuls |
Tablets |
| 22 |
10 |
1 (5 ml) |
¾ |
| 44 |
20 |
2 (10 ml) |
1 |
| 66 |
30 |
3 (15 ml) |
1½ |
| 88 |
40 |
4 (20 ml) |
2 (or 1 DS tablet) |
For Patients with Impaired Renal Function: When
renal function is impaired, a reduced dosage should be employed
using TABLE 4.
| TABLE 4
Dosage for Patients with Impaired Renal Function |
| Creatinine Clearance
(ml/min) |
Recommended Dosage Regimen |
| Above 30 |
Usual standard regimen |
| 15-30 |
½ the usual regimen |
| Below 15 |
Use not recommended |
Acute Exacerbations of Chronic Bronchitis in Adults
The usual adult dosage in the treatment of acute exacerbations
of chronic bronchitis is one sulfamethoxazole; trimethoprim
DS (double strength) tablet, 2 sulfamethoxazole; trimethoprim
tablets or 4 teaspoonfuls (20 ml) of sulfamethoxazole;
trimethoprim suspensions 12 hours for 14 days.
Pneumocystis Carinii Pneumonia
Treatment: Adults and Pediatric Patients:
The recommended dosage for patients with documented Pneumocystis
carinii pneumonia is 15 to 20 mg/kg trimethoprim and 75
to 100 mg/kg sulfamethoxazole per 24 hours given in equally
divided doses every 6 hours for 14 to 21 days. TABLE 5
is a guideline for the upper limit of this dosage.
| TABLE 5
Dosage for Patients with Pneumocystis carinii |
| Weight |
Dose¾every
6 hours |
| lb |
kg |
Teaspoonfuls |
Tablets |
| 18 |
8 |
1 (5 ml) |
-- |
| 35 |
16 |
2 (10 ml) |
1 |
| 53 |
24 |
3 (15 ml) |
1½ |
| 70 |
32 |
4 (20 ml) |
2 (or 1 DS tablet) |
| 88 |
40 |
5 (25 ml) |
2½ |
| 106 |
48 |
6 (30 ml) |
3 (or 1½ DS tablets) |
| 141 |
64 |
8 (40 ml) |
4 (or 2 DS tablets) |
| 176 |
80 |
10 (50 ml) |
5 (or 2½ DS tablets) |
For the lower limit dose (15 mg/kg trimethoprim and 75 mg/kg
sulfamethoxazole per 24 hours) administer 75% of the dose
in TABLE 5.
Prophylaxis
Adults: The recommended dosage for prophylaxis
in adults is 1 sulfamethoxazole; trimethoprim DS (double
strength) tablet daily.8
Pediatric Patients: For pediatric patients,
the recommended dose is 150 mg/m2/day trimethoprim with
750 mg/m2/day sulfamethoxazole given orally in equally
divided doses twice a day, on 3 consecutive days per week.
The total daily dose should not exceed 320 mg trimethoprim
and 1600 mg sulfamethoxazole. TABLE 6) is a guideline
for the attainment of this dosage in pediatric patients.
| TABLE 6
Dosage for Patients with Prophylaxis |
| Body Surface Area |
Dose¾every
12 hours |
| (m2) |
Teaspoonfuls |
Tablets |
| 0.26 |
½ (2.5 ml) |
¾ |
| 0.53 |
1 (5 ml) |
½ |
| 1.06 |
2 (10 ml) |
1 |
IV Infusion
CONTRAINDICATED IN PEDIATRIC PATIENTS LESS THAN
TWO MONTHS OF AGE. CAUTION¾ SULFAMETHOXAZOLE;
TRIMETHOPRIM IV INFUSION MUST BE DILUTED IN 5% DEXTROSE
IN WATER SOLUTION PRIOR TO ADMINISTRATION. DO NOT MIX
SULFAMETHOXAZOLE; TRIMETHOPRIM IV INFUSION WITH OTHER
DRUG OR SOLUTIONS. RAPID INFUSION OR BOLUS INJECTION MUST
BE AVOIDED.
Dosage
Pediatric Patients and Adults
Pneumocystis Carinii Pneumonia: Total
daily dose is 15 to 20 mg/kg (based on the trimethoprim
component) given in 3 to 4 equally divided doses every
6 to 8 hours for up to 14 days. One investigator noted
that a total daily dose of 10 to 15 mg/kg was sufficient
in 10 adult patients with normal renal function.9
Severe Urinary Tract Infections and Shigellosis:
Total daily dose is 8 to 10 mg/kg (based on the trimethoprim
component) given in two to four equally divided doses
every 6, 8, or 12 hours for up to 14 days for severe urinary
tract infections and 5 days for shigellosis. The maximum
recommended daily dose is 60 ml per day.
For Patients with Impaired Renal Function:
When renal function is impaired, a reduced dosage should
be employed while using TABLE 7
| TABLE 7
Dosage for Patients with Impaired Renal Function |
| Creatine Clearance (ml/min) |
Recommended Dosage Regimen |
| Above 30 |
Usual standard regimen |
| 15-30 |
½ the usual regimen |
| Below 15 |
Use not recommended |
Method of Preparation
Sulfamethoxazole; trimethoprim IV infusion must be diluted.
EACH 5 ML SHOULD BE ADDED TO 125 ML OF 5% DEXTROSE IN
WATER. After diluting with 5% dextrose in water, the solution
should not be refrigerated and should be used within 6
hrs. If a dilution of 5 ml per 100 ml of 5% dextrose in
water is desired, it should be used within 4 hours. If
upon visual inspection there is cloudiness or evidence
of crystallization after mixing, the solution should be
discarded and a fresh solution prepared.
Multidose Vials: After initial entry
into the vial, the remaining contents must be used within
48 hours.
The following infusion systems have been tested and found
satisfactory: unit-dose glass containers; unit-dose polyvinyl
chloride and polyolefin. No other systems have been tested
and, therefore no others can be recommended.
Dilution: EACH 5 ML OF SULFAMETHOXAZOLE;
TRIMETHOPRIM IV INFUSION SHOULD BE ADDED TO 125 ML OF
5% DEXTROSE IN WATER.
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; trimethoprim IV INFUSION-5%
DEXTROSE IN WATER WITH DRUGS OR SOLUTIONS IN THE SAME
CONTAINER.
Administration
The solution should be given by intravenous infusion
over a period of 60 to 90 minutes. Rapid infusion or bolus
injection must be avoided. Sulfamethoxazole; trimethoprim
IV infusion should not be given intramuscularly.
HOW SUPPLIED
Septra Tablets and Suspensions
Tablets: Pink, scored, round-shaped,
containing 80 mg trimethoprim and 400 mg sulfamethoxzole.
DS (Double Strength) Tablets: Pink,
scored, oval-shaped, containing 160 mg of trimethoprim
and 800 mg of sulfamethoxazole. Imprint on tablets "SEPTRA
DS" and "02C."
Oral Suspensions: Pink, cherry-flavored,
containing 40 mg trimethoprim and 200 mg sulfamethoxazole
in each teaspoonful (5 ml); and purple, grape-flavored,
containing 40 mg trimethoprim and 200 mg sulfamethoxazole
in each teaspoonful (5 ml).
Storage: Tablets: Stored at 15-25°C
(59-77°F) in a dry place and protected from light.
Suspension: Stored at 15-25°C (59-77°F) and protected
from light.
Septra IV Infusion
5-ml vials, containing 80 mg trimethoprim
(16 mg/ml) and 400 mg sulfameethoxazole (80 mg/ml) for
infusion with 5% dextrose in water. Contains benzyl alcohol
(see WARNINGS).
10-ml multiple-dose vials, containing
160 mg trimethoprim (16 mg/ml) and 800 mg sulfamethoxazole
(80 mg/ml) for infusion with 5% dextrose in water. Contains
benzyl alcohol (see WARNINGS).
20-ml multiple-dose vials, containing
320 mg trimethoprim (16 mg/ml) and 1600 mg sulfamethoxazole
(80 mg/ml) for infusion with 5% dextrose in water. Contains
benzyl alcohol (see WARNINGS).
Storage: Store at 15-25°C (59-77°F).
DO NOT REFRIGERATE.
REFERENCES
1. Kremers P, Duvivier J, Heusghem C.
Pharmacokinetic studies of co-trimoxazole in man after
single and repeated doses. J Clin Pharmacol. 1974; 14:112-117.
2. Kaplan SA, Weinfeld RE, Abruzzo CW,
McFaden K, Jack ML, Weissman L. Pharmacokinetic profile
of trimethoprim-sulfamethoxazole in man. J Infect Dis.
1973; 128(suppl): S547-S555..
3. Antibiotic susceptibility discs;
certification procedure. Federal Register. 1972; 37:20527-20529.
4. Bauer AW, Kirby WMM, Sherris JC,
Turck M. Antibiotic susceptibility testing by a standardized
single disk method. Am J Clin Path. 1966;45:493-496.
5. Brumfitt W, Pursell R. Trimethoprim-sulfamethoxazole
in the treatment of bacteriuria in women. J Infect Dis.
1973;128(suppl):S657-S663.
6. Grose WE, Bodey GP, Loo TL. : Clinical
pharmacology of intravenously administered trimethoprim-sulfamethoxazole.
Antimicrob Agents Chemother. 1979;15:447-451.
7. Siber GR, Gorham C, Durbin W, Lesko
L, Levin MJ. Pharmacology of iIntravenously administered
trimethoprim-sulfamethoxazole in children and adults.Current
Chemotherapy and Infectious Disease. Washington D.C: American
Society for Microbiology; 1980;1-691-692.
8. National Committee for clinical Laboratory
Standards. Performance standards for antimicrobial disk
susceptibility tests, 2nd ed. Villanova, PA. 1979.
9. Winston DJ, Lau WK, Gale RP, Young LS.
Trimethoprim-sulfamethoxazole for the treatment of Pneumocystis
carinii pneumonia. Ann Intern Med. 1980;92:762-769.
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