Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2551
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Septra (Tablet)
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Contraindicated in pediatric
patients less than 2 months of age.<br/>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 SEPTRA DS (double strength) tablet,
two SEPTRA tablets, or four teaspoonfuls (20 mL) SEPTRA Suspension
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 two divided doses
every 12 hours for 10 days. An identical daily dosage is used for
5 days in the treatment of shigellosis. The following table is a guideline
for the attainment of this dosage: For Patients With Impaired Renal Function: Whenrenal function is impaired, a reduced dosage should be employed using
the following table:<br/>Acute Exacerbations of Chronic Bronchitis in Adults:: The usual adult dosage in the treatment of acute
exacerbations of chronic bronchitis is one SEPTRA DS (double strength)
tablet, two SEPTRA tablets, or four teaspoonfuls (20 mL) SEPTRA Suspension
every 12 hours for 14 days.<br/>Travelers' Diarrhea in Adults:: For the treatment of travelers' diarrhea,
the usual adult dosage is one SEPTRA DS (double strength) tablet,
two SEPTRA tablets, or four teaspoonfuls (20 mL) of SEPTRA Suspension
every 12 hours for 5 days.<br/>Pneumocystis Carinii Pneumonia:: Treatment: Adults and Pediatric
Patients: The recommended dosage for treatment
of 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. The following table
is a guideline for the upper limit of this dosage: For the lower limit dose (15 mg/kg trimethoprim
and 75 mg/kg sulfamethoxazole per 24 hours) administer 75% of the
dose in the above table. Prophylaxis: Adults: The recommended dosage for prophylaxis
in adults is one SEPTRA DS (double strength) tablet daily. Pediatric Patients: For pediatric patients, the
recommended dose is 150 mg/m/day trimethoprim with 750
mg/m/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 1,600 mg sulfamethoxazole.
The following table is a guideline for the attainment of this dosage
in pediatric patients:
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SEPTRA (trimethoprim and sulfamethoxazole) is a
synthetic antibacterial combination product. Each SEPTRA Tablet contains
80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients
docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium
stearate, povidone, and sodium starch glycolate. Each SEPTRA DS (double strength) Tablet contains 160 mg trimethoprim
and 800 mg sulfamethoxazole and the inactive ingredients docusate
sodium (0.8 mg per tablet), FD&C Red No. 40, magnesium stearate,
povidone, and sodium starch glycolate. Each
teaspoonful (5 mL) of SEPTRA Suspension contains 40 mg trimethoprim
and 200 mg sulfamethoxazole and the inactive ingredients alcohol 0.26%,
methylparaben 0.1% and sodium benzoate 0.1% (added as preservatives),
carboxymethylcellulose sodium, citric acid, FD&C Red No. 40 and
Yellow No. 6, flavor, glycerin, microcrystalline cellulose, polysorbate
80, saccharin sodium, and sorbitol. Each teaspoonful (5 mL) of SEPTRA
Grape Suspension contains 40 mg trimethoprim and 200 mg sulfamethoxazole
and the inactive ingredients alcohol 0.26%, methylparaben 0.1%, and
sodium benzoate 0.1% (added as preservatives),carboxymethylcellulose
sodium, citric acid, FD&C Red No. 40 and Blue No. 1, flavor, glycerin,
microcrystalline cellulose, polysorbate 80, saccharin sodium, and
sorbitol. Both tablet and suspension forms are for oral administration. Trimethoprim is 5-[(3,4,5-trimeth-oxyphenyl)methyl]-2,4-
pyrimidinediamine. It is a white to light yellow, odorless, bitter
compound with a molecular weight of 290.32, and the molecular formula
CHNO. The structural
formula is: Sulfamethoxazole is 4-amino-N-(5-methyl-3-isoxazolyl)benzenesulfonamide.
It is an almost white, odorless, tasteless compound with a molecular
weight of 253.28, and the molecular formula CHNOS. The structural formula is:
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SEPTRA is rapidly absorbed following oral administration.
Both sulfamethoxazole and trimethoprim exist in the blood as unbound,
protein-bound, and metabolized forms; sulfamethoxazole also exists
as the conjugated form. The metabolism of sulfamethoxazole occurs
predominately by N-acetylation, although the glucuronide
conjugate has been identified. The principal metabolites of trimethoprim
are the 1- and 3-oxides and the 3'- and 4'-hydroxy derivatives.
The free forms of sulfamethoxazole and trimethoprim are considered
to be the therapeutically active forms. Approximately 44% of trimethoprim
and 70% of sulfamethoxazole are bound to plasma proteins. The presence
of 10 mg percent sulfamethoxazole in plasma decreases the protein
binding of trimethoprim by an insignificant degree; trimethoprimdoes
not influence the protein binding of sulfamethoxazole. 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 to 10 hours, respectively.
However, patients with severely impaired renal function exhibit an
increase in the half-lives of both components, requiring dosage regimen
adjustment (see DOSAGE AND
ADMINISTRATION). Detectable amounts of trimethoprim and
sulfamethoxazole are present in the blood 24 hours after drug administration.
During administration of 160 mg trimethoprim and 800 mg sulfamethoxazole
b.i.d., the mean steady-state plasma concentration of trimethoprim
was 1.72 mcg/mL. The steady-state minimal plasma levels of free and
total sulfamethoxazole were 57.4 mcg/mL and 68.0 mcg/mL, respectively.
These steady-state levels were achieved after 3 days of drug administration. 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 average percentage of the dose recovered in urine from
0 to 72 hours after a single oral dose is 84.5% for total sulfonamide
and 66.8% for free trimethoprim. Thirty percent of the total sulfonamide
is excreted as free sulfamethoxazole, with the remaining as N-acetylated metabolite.When administered together
as SEPTRA, neither sulfamethoxazole nor trimethoprim affects the urinary
excretion pattern of the other. Both trimethoprim
and sulfamethoxazole distribute to sputum, vaginal fluid, and middle
ear fluid; trimethoprim also distributes to bronchial secretions,
and both pass the placental barrier and are excreted in human milk.<br/>Geriatric Pharmacokinetics:: The pharmacokinetics of sulfamethoxazole 800 mg and
trimethoprim 160 mg were studied in 6 geriatric subjects (mean age:
78.6 years) and 6 young healthy subjects (mean age: 29.3 years) using
a non-US approved formulation. Pharmacokinetic values for sulfamethoxazole
in geriatric subjects were similar to those observed in young adult
subjects. The meanrenal clearance of trimethoprim was significantly
lower in geriatric subjects compared with young adult subjects (19
mL/h/kg vs. 55 mL/h/kg). However, after normalizing by body weight,
the apparent total body clearance of trimethoprim was an average 19%
lower in geriatric subjects compared with young adult subjects.<br/>Microbiology:: Sulfamethoxazole 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 and reversibly inhibiting the required enzyme,
dihydrofolate reductase. Thus, SEPTRA blocks two consecutive steps
in the biosynthesis of nucleic acids and proteins essential to manybacteria. In vitro studies have shown that bacterial resistance develops more slowly
with SEPTRA than with either trimethoprim or sulfamethoxazole alone. In vitro serial
dilution tests have shown that the spectrum of antibacterial activity
of SEPTRA includes the common urinary tract pathogens with the exception
of Pseudomonas aeruginosa.
The following organisms are usually susceptible: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and indole-positive Proteus species including Proteus vulgaris. The usual spectrum of antimicrobial activity of SEPTRA includes bacterial
pathogens isolated from middle ear exudate and from bronchial secretions
(Haemophilus influenzae, including
ampicillin-resistant strains, and Streptococcus
pneumoniae), and enterotoxigenic strains of Escherichia coli (ETEC) causing bacterial
gastroenteritis. Shigella flexneri and Shigella sonnei are also
usually susceptible. TMP=trimethoprim SMX=sulfamethoxazole *Rudoy RC, Nelson JD, Haltalin KC. Antimicrobial Agents and Chemotherapy. 1974;5:439-443.<br/>Susceptibility Testing:: The recommended quantitative disc susceptibility
method may be used for estimating the susceptibility of bacteria to
SEPTRA.With this procedure, a report from the laboratory
of���Susceptible to trimethoprim and sulfamethoxazole���indicates that the infection is likely to respond to therapy with
SEPTRA. If the infection is confined to the urine, a report of���Intermediate
susceptibility to trimethoprim and sulfamethoxazole���also indicates
that the infection is likely to respond. A report of���Resistant
to trimethoprim and sulfamethoxazole���indicates that the infection
is unlikely to respond to therapy with SEPTRA.
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SEPTRA is contraindicated in patients with a known
hypersensitivity to trimethoprim or sulfonamides and in patients with
documented megaloblastic anemia due to folate deficiency. SEPTRA is
also contraindicated in pregnant patients at term and in nursing mothers,
because sulfonamides pass the placenta and are excreted in the milk
and may cause kernicterus. SEPTRA is contraindicated in pediatric
patients less than 2 months of age.
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TABLETS (pink,
scored, round-shaped) containing 80 mg trimethoprim and 400 mg sulfamethoxazole:
Bottles of 100 (NDC 61570-052-01). Imprint on tablets���M052���. DS (DOUBLE STRENGTH) TABLETS (pink, scored, oval-shaped) containing 160 mg trimethoprim and 800
mg sulfamethoxazole: Bottles of 20 (NDC 61570-053-20), 100 (NDC 61570-053-01),
250 (NDC 61570-053-52) and 500 (NDC 61570- 053-05). Imprint on tablets���M053���. ORAL SUSPENSIONS (pink, cherry-flavored) containing 40
mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5
mL): Bottle of 1 pint (473 mL) (NDC 61570-050-16) and 100 mL���package
of 6 (NDC 61570-050-11); and (purple, grape-flavored) containing 40
mg trimethoprim and 200 mg sulfamethoxazole in each teaspoonful (5
mL): Bottle of 1 pint (473 mL) (NDC 61570-051-16). Tablets should be stored at 15��to 25��C (59��to 77��F)
in a dry place and protected from light. Suspensions
should be stored at 15��to 25��C (59��to 77��F)
and protected from light.
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General: Prescribing SEPTRA in the absence of a proven or
strongly suspected bacterial infection or a prophylactic indication
is unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria. SEPTRA should be given with caution to patients with impaired renal
or hepatic function, to those with possible folate deficiency (e.g.,
the elderly, chronic alcoholics, patients receiving anticonvulsant
therapy, patients with malabsorption syndrome, and patients in malnutrition
states), and to those with severe allergy or bronchial asthma. In
glucose-6-phosphate dehydrogenase-deficient individuals, hemolysis
may occur. This reaction is frequently dose-related .<br/>Use in the Elderly:: There may be an increased risk of severe adverse
reactions in elderly patients, particularly when complicating conditions
exist, e.g., impaired kidney and/or liver function, or concomitant
use of other drugs. Severe skin reactions, or generalized bone marrow
suppression ,
or a specific decrease in platelets (with or without purpura) are
the most frequently reported severe adverse reactions in elderly patients.
In those concurrently receiving certain diuretics, primarilythiazides,
an increased incidence of thrombocytopenia with purpura has been reported.
Appropriate dosage adjustments should be made for patients with impaired
kidney function .<br/>Use in the Treatment of and Prophylaxis for Pneumocystis carinii
Pneumonia in Patients with Acquired Immunodeficiency Syndrome (AIDS):: The incidence of side effects, particularly rash,
fever, leukopenia, and elevated aminotransferase (transaminase) values
in AIDS patients who are being treated with SEPTRA for Pneumocystis carinii pneumonia has been
reported to be greatly increased compared with the incidence normally
associated with the use of SEPTRA in non-AIDS patients. The incidence
of hyperkalemia and hyponatremia appears to be increased in AIDS patients
receiving SEPTRA. Adverse effects are generally less severe in patients
receiving SEPTRA for prophylaxis. A history of mild intolerance to
SEPTRA in AIDS patients does not appear to predict intolerance of
subsequent secondary prophylaxis. However, if a patient develops skin
rash or any sign of adverse reaction, therapy with SEPTRA should be
re-evaluated . The concomitant
use of leucovorin with trimethoprim-sulfamethoxazole for the acute
treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased
rates of treatment failure and morbidity in a placebo-controlled study.<br/>Information for Patients:: Patients should be counseled that antibacterial
drugs including SEPTRA should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When SEPTRA
is prescribed to treat a bacterial infection, patients should be told
that although it is common to feel better early in the course of therapy,
the medication should be taken exactly as directed. Skipping doses
or not completing the full course of therapy may (1) decrease the
effectiveness of the immediate treatment and (2) increase the likelihood
that bacteria will develop resistance andwill not be treatable with
SEPTRA or other antibacterial drugs in the future. Patients should be instructed to maintain an adequate fluid intake
in order to prevent crystalluria and stone formation. Diarrhea is a common problem caused by antibiotics which usually
ends when the antibiotic is discontinued. Sometimes after starting
treatment with antibiotics, patients can develop watery and bloody
stools (with or without stomach cramps and fever) even as late as
two or more months after having taken the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as
possible.<br/>Laboratory Tests:: Complete blood counts should be done frequently
in patients receiving SEPTRA; if a significant reduction in the count
of any formed blood element is noted, SEPTRA should be discontinued.
Urinalyses with careful microscopic examination and renal function
tests should be performed during therapy, particularly for those patients
with impaired renal function.<br/>Drug Interactions:: In elderly patients concurrently receiving certain
diuretics, primarily thiazides, an increased incidence of thrombocytopenia
with purpura has been reported. In the literature, two cases of hyperkalemia
in elderly patients have been reported after concomitant intake of
trimethoprim/sulfamethoxazole and an angiotensin converting enzyme
inhibitor. It has been reported that SEPTRA
may prolong the prothrombin time in patients who are receiving the
anticoagulant warfarin. This interaction should be kept in mind when
SEPTRA is given to patients already on anticoagulant therapy, and
the coagulation time should be reassessed. SEPTRA
may inhibit the hepatic metabolism of phenytoin. SEPTRA, given at
a common clinical dosage, increased the phenytoin half-life by 39%
and decreased the phenytoin metabolic clearance rate by 27%. When
administering these drugs concurrently, one should be alert for possible
excessive phenytoin effect. Sulfonamides can
also displace methotrexate from plasma protein binding sites, thus
increasing free methotrexate concentrations.<br/>Drug/Laboratory Test Interactions:: SEPTRA, specifically the trimethoprim component,
can interfere with a serum methotrexate assay as determined by the
competitive binding protein technique (CBPA) when a bacterial dihydrofolate
reductase is used as the binding protein. No interference occurs,
however, if methotrexate is measured by a radioimmunoassay (RIA). The presence of trimethoprim and sulfamethoxazole may
also interfere with the Jaff��alkaline picrate reaction assay
for creatinine, resulting in overestimations of about 10% in the range
of normal values.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Carcinogenesis: Long-term studies in animals to evaluate carcinogenic potential
have not been conducted with SEPTRA. Mutagenesis: Bacterial mutagenic studies
have not been performed with sulfamethoxazole and trimethoprim in
combination. Trimethoprim was demonstrated to be non-mutagenic in
the Ames assay. In studies at two laboratories, no chromosomal damage
was detected in cultured Chinese hamster ovary cells at concentrations
approximately 500 times human plasma levels; at concentrations approximately
1,000 times human plasma levels in these same cells, a low level of
chromosomal damage was induced at one of the laboratories. No chromosomal
abnormalities were observed in cultured human leukocytes at concentrations
of trimethoprim up to 20 times human steady-state plasma levels. No
chromosomal effects were detected in peripheral lymphocytes of human
subjects receiving 320 mg of trimethoprim in combination with up to
1,600 mg of sulfamethoxazole per day for as long as 112 weeks. Impairment of Fertility: No adverse effects on fertility or general reproductive performance
were observed in rats given oral dosages as high as 70 mg/kg/day trimethoprim
plus 350 mg/kg/day sulfamethoxazole.<br/>Pregnancy:<br/>Teratogenic Effects:: Pregnancy Category C. In rats, oral doses of 533
mg/kg sulfamethoxazole or 200 mg/kg trimethoprim produced teratological
effects manifested mainly as cleft palates. The highest dose which
did not cause cleft palates in rats was 512 mg/kg sulfamethoxazole
or 192 mg/kg trimethoprim when administered separately. In two studies
in rats, no teratogenicity was observedwhen 512 mg/kg of sulfamethoxazole
was used in combination with 128 mg/kg of trimethoprim. In one study,
however, cleft palates were observed in one litter out of nine when
355 mg/kg of sulfamethoxazole was used in combination with 88 mg/kg
of trimethoprim. In some rabbit studies, an
overall increase in fetal loss (dead and resorbed and malformed conceptuses)
was associated with doses of trimethoprim six times the human therapeutic
dose. While there are no large, well-controlled
studies on the use of trimethoprim and sulfamethoxazole in pregnant
women, Brumfitt and Pursell,in a retrospective study,
reported the outcome of 186 pregnancies during which the mother received
either placebo or trimethoprim and sulfamethoxazole. The incidence
of congenital abnormalities was 4.5% (3 of 66) in those who received
placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole.
There were no abnormalities in the 10 children whose mothers receivedthe drug during the first trimester. In a separate survey, Brumfitt
and Pursell also found no congenital abnormalities in 35 children
whose mothers had received oral trimethoprim and sulfamethoxazole
at the time of conception or shortly thereafter. Because trimethoprim and sulfamethoxazole may interfere with folic
acid metabolism, SEPTRA should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.<br/>Nonteratogenic Effects:: See CONTRAINDICATIONS section.<br/>Nursing Mothers:: See CONTRAINDICATIONS section.<br/>Pediatric Use:: SEPTRA is not recommended for pediatric patients
younger than 2 months of age .<br/>Geriatric Use:: Clinical studies of SEPTRA did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. There may
be an increased risk of severe adverse reactions in elderly patients,
particularly when complicating conditions exist, e.g., impaired kidney
and/or liver function, possible folate deficiency, or concomitant
use of other drugs. Severe skin reactions, generalized bone marrow
suppression , a
specific decrease in platelets (with or without purpura), and hyperkalemia
are the most frequently reported severe adverse reactions in elderly
patients. In those concurrently receiving certain diuretics, primarily
thiazides, an increased incidence of thrombocytopenia withpurpura
has been reported. Increased digoxin blood levels can occur with concomitant
Septra therapy, especially in elderly patients. Serum digoxin levels
should be monitored. Hematological changes indicative of folic acid
deficiency may occur in elderly patients. These effects are reversible
by folinic acid therapy. Appropriate dosage adjustments should be
made for patients with impaired kidney function and duration of use
should be as short as possible to minimize risks of undesired reactions
. The trimethoprim component of Septra may cause hyperkalemia
when administered to patients with underlying disorders of potassium
metabolism, with renal insufficiency, or when given concomitantly
with drugs known to induce hyperkalemia, such as angiotensin converting
enzyme inhibitors. Close monitoring of serum potassium is warranted
in these patients. Discontinuation of Septra treatment is recommended
to help lower potassium serum levels. Septra Tablets contain 1.8 mg
(0.08 mEq) of sodium per tablet. Septra DS Tabletscontain 3.6 mg
(0.16 mEq) of sodium per tablet. Pharmacokinetics
parameters for sulfamethoxazole were similar for geriatric subjects
and younger adult subjects. The mean maximum serum trimethoprim concentration
was higher and mean renal clearance of trimpethoprim was lower in
geriatric subjects compared with younger subjects.
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Acute:: The amount of a single dose of SEPTRA that is either
associated with symptoms of overdosage or is likely to be life-threatening
has not been reported. Signs and symptoms of overdosage reported with
sulfonamides include anorexia, colic, nausea, vomiting, dizziness,
headache, drowsiness, and unconsciousness. Pyrexia, hematuria, and
crystalluria may be noted. Blood dyscrasias and jaundice are potential
late manifestations of overdosage. Signs of acute overdosage with
trimethoprim include nausea, vomiting, dizziness, headache, mental
depression, confusion, and bone marrow depression. General principles of treatment include the institution of gastric
lavage or emesis; forcing oral fluids; and the administration of intravenous
fluids if urine output is low and renal function is normal. Acidification
of the urine will increase renal elimination of trimethoprim. The
patient should be monitored with blood counts and appropriate blood
chemistries, including electrolytes. If a significant blood dyscrasia
or jaundice occurs, specific therapy should be instituted for these
complications. Peritoneal dialysis is not effective and hemodialysis
is only moderately effective in eliminating trimethoprim and sulfamethoxazole.<br/>Chronic:: Use of SEPTRA at high doses and/or for extended periods
of time may cause bone marrow depression manifested as thrombocytopenia,
leukopenia, and/or megaloblastic anemia. If signs of bone marrow depression
occur, the patient should be given leucovorin; 5 to 15 mg leucovorin
daily has been recommended by some investigators.
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trimethoprim and sulfamethoxazole
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Septra (Tablet)
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The most common adverse effects are gastrointestinal
disturbances (nausea, vomiting, anorexia) and allergic skin reactions
(such as rash and urticaria). FATALITIES
ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE,
HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME,
TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS,
APLASTIC ANEMIA, OTHER BLOOD DYSCRASIAS, AND HYPERSENSITIVITY OF THE
RESPIRATORY TRACT (SEE WARNINGS).<br/>Hematologic:: Agranulocytosis, aplastic anemia, thrombocytopenia,
leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia,
methemoglobinemia, eosinophilia.<br/>Allergic:: Stevens-Johnson syndrome, toxic epidermal necrolysis,
anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative
dermatitis, angioedema, drug fever, chills, Henoch- Sch��nlein
purpura, serum sickness-like syndrome, generalized allergic reactions,
generalized skin eruptions, photosensitivity, conjunctival and scleral
injection, pruritus, urticaria, and rash. In addition, periarteritis
nodosa and systemic lupus erythematosus have been reported.<br/>Gastrointestinal:: Hepatitis, including cholestatic jaundice and hepatic
necrosis, elevation of serum transaminase and bilirubin, pseudo-membranous
enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis,
abdominal pain, diarrhea, anorexia.<br/>Genitourinary:: Renal failure, interstitial nephritis, BUN and serum
creatinine elevation, toxic nephrosis with oliguria and anuria, and
crystalluria.<br/>Metabolic:: Hyperkalemia, hyponatremia.<br/>Neurologic:: Aseptic meningitis, convulsions, peripheral neuritis,
ataxia, vertigo, tinnitus, headache.<br/>Psychiatric:: Hallucinations, depression, apathy, nervousness.<br/>Endocrine:: The sulfonamides bear certain chemical similarities
to some goitrogens, diuretics (acetazolamide and the thiazides), and
oral hypoglycemic agents. Cross-sensitivity may exist with these agents.
Diuresis and hypoglycemia have occurred rarely in patients receiving
sulfonamides.<br/>Musculoskeletal:: Arthralgia and myalgia.<br/>Respiratory System:: Cough, shortness of breath, and pulmonary infiltrates
.<br/>Miscellaneous:: Weakness, fatigue, insomnia.
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FATALITIES ASSOCIATED
WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED
DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC
EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS,
APLASTIC ANEMIA, AND OTHER BLOOD DYSCRASIAS. SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING
PRODUCTS SUCH AS TRIMETHOPRIM/SULFAMETHOXAZOLE, SHOULD BE DISCONTINUED
AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by a more severe
reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis,
hepatic necrosis, and serious blood disorder . 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. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly
all antibacterial agents, including SEPTRA, and may range in severity
from mild diarrhea to fatal colitis. Treatment with antibacterial
agents alters the normal flora of the colon leading to overgrowth
of C. difficile. C. difficile produces toxins A and B which contribute
to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections
can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea
following antibiotic use. Careful medical history
is necessary since CDAD has been reported to occur over two months
after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against C. difficile may need
to be discontinued. Appropriate fluid and electrolyte management,
protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation
should be instituted as clinically indicated.
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To reduce the development of drug-resistant bacteria
and maintain the effectiveness of SEPTRA and other antibacterial drugs,
SEPTRA should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should
be considered in selecting or modifying antibacterial therapy. In
the absence of such data, local epidemiology and susceptibility patterns
may contribute to the empiric selection of therapy.<br/>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.<br/>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,
SEPTRA offers some advantage over the use of other antimicrobial agents.
To date, there is limited data on the safety of repeated use of SEPTRA
in pediatric patients under two years of age. SEPTRA is not indicated
for prophylactic or prolonged administration in otitis media at any
age.<br/>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,
SEPTRA offers some advantage over the use of a single antimicrobial
agent.<br/>Travelers' Diarrhea in Adults:: For the treatment of travelers' diarrhea due
to susceptible strains of enterotoxigenic E. coli.<br/>Shigellosis:: For the treatment of enteritis caused by susceptible
strains of Shigella flexneri and Shigella sonnei when
antibacterial therapy is indicated.<br/>Pneumocystis Carinii Pneumonia:: For the treatment of documented Pneumocystis carinii pneumonia. For
prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered
to be at an increased risk of developing Pneumocystis carinii pneumonia.
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Septra
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