Sulfamethoxazole And Trimethoprim Double Strength
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS
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 SULFAMETHOXAZOLE/TRIMETHOPRIM, 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 disorders (see 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 treatment of group A β-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 sulfamethoxazole and trimethoprim, 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs. Sulfamethoxazole and trimethoprim tablets 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 empiric selection of therapy.
Urinary Tract InfectionsFor 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 MediaFor 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 and 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 and trimethoprim in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations of Chronic Bronchitis in AdultsFor 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 and trimethoprim offers some advantage over the use of a single antimicrobial agent.
ShigellosisFor the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis Carinii PneumoniaFor the treatment of documented Pneumocystis carinii pneumonia and for prophylaxis against Pneumocystis carinii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis carinii pneumonia.
Travelers’ Diarrhea In AdultsFor the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION
Sulfamethoxazole and trimethoprim tablets are a synthetic antibacterial combination product.
Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:
Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine. It occurs as a white to light yellow, odorless, bitter compound with a molecular weight of 290.32 and the following structural formula:
Each tablet, for oral administration, contains 800 mg sulfamethoxazole and 160 mg trimethoprim plus magnesium stearate, pregelatinized starch and sodium starch glycolate.
Sources
Sulfamethoxazole And Trimethoprim Double Strength Manufacturers
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Lake Erie Medical Dba Qualityl Care Products Lc
![Sulfamethoxazole And Trimethoprim Double Strength (Sulfamethoxazole And Trimethoprim ) Tablet [Lake Erie Medical Dba Qualityl Care Products Lc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sulfamethoxazole And Trimethoprim Double Strength | Lake Erie Medical Dba Qualityl Care Products Lc
DOSAGE AND ADMINISTRATIONNot recommended for use in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children
AdultsThe usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS tablet every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
ChildrenThe recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim 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:
Children: 2 Months Of Age Or Older Weight Dose - every 12 hours lb kg Tablets 22 10 – 44 20 1 66 30 1 1/2 88 40 2 or 1 DS tablet
For Patients With Impaired Renal FunctionWhen renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15-30 1/2 the usual regimen Below 15 Use not recommended
Acute Exacerbations of Chronic Bronchitis in AdultsThe usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet every 12 hours for 14 days.
Pneumocystis Carinii Pneumonia Treatment Adults and ChildrenThe recommended dosage for patients with documented Pneumocystis carinii pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage.
Weight Dose - every 6 hours lb kg Tablets 18 8 – 35 16 1 53 24 1 1/2 70 32 2 or 1 DS tablet 88 40 2 1/2 106 48 3 or 1 1/2 DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2 1/2 DS tabletsFor the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.
Prophylaxis AdultsThe recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.12
ChildrenFor children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week.
The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim. 13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area
(m2)Dose - every 12 hours
Tablets 0.26 – 0.53 1/2 1.06 1 Travelers’ Diarrhea in AdultsFor the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS tablet every 12 hours for 5 days.
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New Horizon Rx Group, Llc
Sulfamethoxazole And Trimethoprim Double Strength | New Horizon Rx Group, Llc
Sulfamethoxazole and trimethoprim tablets, USP are contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children:
Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet, USP every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole, USP and 8 mg/kg trimethoprim, USP 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:
Children 2 months of age and older: Weight Dose – every 12 hours lb kg Tablets 22 10 - 44 20 1 66 30 1 ½ 88 40 2 or 1 DS tabletFor Patients with Impaired Renal Function
When renal function is impaired, a reduced dosage should be employed using the following table:
Creatinine
Clearance (mL/min) Recommended
Dosage Regimen Above 30 Usual standard regimen 15 to 30 1/2 the usual regimen Below 15 Use not recommendedAcute Exacerbations of Chronic Bronchitis in Adults:
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet, USP, or 2 sulfamethoxazole and trimethoprim single strength tablets, USP, every 12 hours for 14 days.
Pneumocystis JiroveciPneumonia
Treatment: Adults and Children:
The recommended dosage for patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole, USP and 15 to 20 mg/kg trimethoprim, USP per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage.
Weight Dose – every 6 hours lb kg Tablets 18 8 - 35 16 1 53 24 1 ½ 70 32 2 or 1 DS tablet 88 40 2 ½ 106 48 3 or 1 ½ DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2 ½ DS tabletsFor the lower limit dose (75 mg/kg sulfamethoxazole, USP and 15 mg/kg trimethoprim, USP per 24 hours) administer 75% of the dose in the above table.
Prophylaxis
Adults:
The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet, USP daily.12
Children:
For children, the recommended dose is 750 mg/m2/day sulfamethoxazole, USP with 150 mg/m2/day trimethoprim, USP given orally in equally divided doses twice a day, on 3 consecutive days per week.
The total daily dose should not exceed 1600 mg sulfamethoxazole, USP and 320 mg trimethoprim, USP.13 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area Dose – every 12 hours (m2) Tablets 0.26 - 0.53 ½ 1.06 1Traveler’s Diarrhea in Adults:
For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet, USP or 2 sulfamethoxazole and trimethoprim single strength tablets, USP every 12 hours for 5 days.
![Sulfamethoxazole And Trimethoprim Double Strength (Sulfamethoxazole And Trimethoprim) Tablet [New Horizon Rx Group, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=804f8363-8ea1-4a57-bbd1-7fd9b6b4d29b&name=c3e59ee7-figure-01.jpg)
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