Sulfatrim
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Questions & Answers
Side Effects & Adverse Reactions
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.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. Clinical signs, such as rash, sore throat, fever, arthralgia, cough, shortness of breath, pallor, purpura or jaundice may be early indications of serious reactions. In rare instances a skin rash may be followed by more severe reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis or serious blood disorder. Complete blood counts should be done frequently in patients receiving sulfonamides.
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION SHOULD NOT BE USED IN THE TREATMENT OF STREPTOCOCCAL PHARYNGITIS. Clinical studies have documented that patients with group A β-hemolytic streptococcal tonsillopharyngitis have a greater incidence of bacteriologic failure when treated with this combination than do those patients treated with penicillin, as evidenced by failure to eradicate this organism from the tonsillopharyngeal area.
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
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Sulfamethoxazole and Trimethoprim Oral Suspension and other antibacterial drugs, Sulfamethoxazole and Trimethoprim Oral Suspension 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.
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 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, this combination offers some advantage over the use of a single antimicrobial agent.
Shigellosis:
For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
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.
Travelers’ Diarrhea In Adults:
For the treatment of travelers’ diarrhea due to susceptible strains of enterotoxigenic E. coli.
History
There is currently no drug history available for this drug.
Other Information
Sulfamethoxazole and Trimethoprim Oral Suspension is a synthetic antibacterial combination product.
Sulfamethoxazole is N1-(5-methyl-3- isoxazolyl) sulfanilamide. It is an 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 is a white to light yellow, odorless, bitter compound with a molecular weight of 290.32, and the following structural formula:
EACH 5 mL (ONE TEASPOONFUL) OF SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION USP CONTAINS 200 mg sulfamethoxazole and 40 mg trimethoprim.
INACTIVE INGREDIENTS: alcohol (less than 0.5%), carboxymethylcellulose sodium, citric acid, FD&C Red #40, FD&C Yellow #6, flavor, methylparaben, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, propylene glycol, propylparaben, purified water, saccharin sodium, simethicone emulsion, sucrose.
Sources
Sulfatrim Manufacturers
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Actavis Mid Atlantic Llc
![Sulfatrim (Sulfamethoxazole And Trimethoprim) Suspension [Actavis Mid Atlantic Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sulfatrim | Actavis Mid Atlantic Llc
Not recommended for use in infants less than 2 months of age.
Urinary Tract Infections And Shigellosis In Adults And Children And Acute Otitis Media In Children: Adults:The usual adult dosage in the treatment of urinary tract infections is 4 teaspoonfuls (20 mL) of the suspension 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 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 his dosage:
Children: 2 months of age or older.
Weight Dose –
every12 hours lb kg Teaspoonfuls 22 10 1 (5 mL) 44 20 2 (10 mL) 66 30 3 (15 mL) 88 40 4 (20 mL)For 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 - 30 ½ 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 4 teaspoonfuls (20 mL) of the suspension every 12 hours for 14 days.
Pneumocystis Carinii Pneumonia:
Treatment: Adults and children:The recommended dosage for treatment of 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.7 The following table is a guideline for the upper limit of this dosage.
Weight Dose – every 6 hours lb kg Teaspoonfuls 18 8 1 (5 mL) 35 16 2 (10 mL) 53 24 3 (15 mL) 70 32 4 (20 mL) 88 40 5 (25 mL) 106 48 6 (30 mL) 141 64 8 (40 mL) 176 80 10 (50 mL)For 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:
Adults:
The recommended dosage for prophylaxis in adults is 800 mg sulfamethoxazole and 160 mg trimethoprim daily.8
Children:
For 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.9 The following table is a guideline for the attainment of this dosage in children:
Body Surface Dose – every Area 12 hours (m2) Teaspoonfuls 0.26 ½ (2.5 mL) 0.53 1 (5 mL) 1.06 2 (10 mL)Travelers’ Diarrhea In Adults:
For the treatment of travelers’ diarrhea, the usual adult dosage is 4 teaspoonfuls (20 mL) of the suspension every 12 hours for 5 days.
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Sti Pharma Llc
Sulfatrim | Sti Pharma Llc
Not 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 four teaspoonfuls (20mL) Sulfamethoxazole and trimethoprim oral suspension 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 Teaspoonfuls 22 10 1 (5 mL) 44 20 2 (10 mL) 66 30 3 (15 mL) 88 40 4 (20 mL)For 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 Use standard regimen 15 to 30 ½ 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 four teaspoonfuls (20 mL) sulfamethoxazole and trimethoprim oral suspension every 12 hours for 14 days.
Pneumocystis Carinii Pneumonia TreatmentAdults and Children: The recommended dosage for treatment of 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.10 The following table is a guideline for the upper limit of this dosage:
Weight Dose - every 6 hours lb kg Teaspoonfuls 18 8 1 (5 mL) 35 16 2 (10 mL) 53 24 3 (15 mL) 70 32 4 (20 mL) 88 40 5 (25 mL) 106 48 6 (30 mL) 141 64 8 (40 mL) 176 80 10 (50 mL)For 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 four teaspoonfuls (20 mL) of the oral suspension daily.11
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.12 The following table is a guideline for the attainment of this dosage in children:
Body Surface Area Dose - every 12 hours (m2) Teaspoonfuls 0.26 ½ (2.5 mL) 0.53 1 (5 mL) 1.06 2 (10 mL) Travelers’ Diarrhea in AdultsFor the treatment of travelers' diarrhea, the usual adult dosage is four teaspoonfuls (20 mL) of sulfamethoxazole and trimethoprim oral suspension every 12 hours for 5 days.
![Sulfatrim (Sulfamethoxazole And Trimethoprim) Suspension [Sti Pharma Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ef596c8-689e-4349-a5dc-11645f8332ef&name=b848770a-figure-03.jpg)
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