SULFATRIM PEDIATRIC

). 2 CONTRAINDICATIONS SULFATRIM Tablets: • is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing (see

). Appropriate dosage adjustments should be made (see 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS SULFATRIM Tablets: • is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • is contraindicated in patients with a history of drug-induced immune thrombocytopenia, with use of trimethoprim and/or sulfonamides, and in patients with documented megaloblastic anemia due to folate deficiency, evidence of marked parenchymal damage, or blood dyscrasias.

• is contraindicated in patients with marked renal impairment where repeated measurements monitoring plasma drug concentrations cannot be performed (see 7 WARNINGS AND PRECAUTIONS). • is contraindicated in pregnant patients and in nursing mothers, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus.

• is contraindicated in premature babies and full-term infants less than two months of age. • should not be given to patients with acute porphyria. • must not be given in combination with dofetilide (see

, General 01/2025 7 WARNINGS AND PRECAUTIONS, Immune 01/2025 7 WARNINGS AND PRECAUTIONS, Respiratory 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES.............................................................................................

2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

4 1 INDICATIONS ............................................................................................................... 1 Pediatrics ............................................................................................................

2 Geriatrics ............................................................................................................ 6 2 CONTRAINDICATIONS ..................................................................................................

6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 6 4 DOSAGE AND ADMINISTRATION.................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................

7 5 OVERDOSAGE .............................................................................................................. 42 SULFATRIM, SULFATRIM DS, SULFATRIM PEDIATRIC (Sulfamethoxazole and Trimethoprim Tablets) Page 4 of 52 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SULFATRIM (sulfamethoxazole and trimethoprim tablets) is indicated for treatment of infections associated with the following gram-positive and gram-negative organisms: Gram-Negative Organisms Haemophilus influenzae Neisseria gonorrhoeae Escherichia coli Klebsiella species Enterobacter (Aerobacter) aerogenes Proteus mirabilis Proteus vulgaris Salmonella species Shigella species Vibrio cholerae Gram-Positive Organisms Streptococcus pyogenes Streptococcus viridans Staphylococcus albus Staphylococcus aureus Diplococcus pneumoniae Other Organisms Brucella melitensis Nocardia asteroides Nocardia brasiliensis Paracoccidioides brasiliensis Pneumocystis jiroveci Streptomyces somaliensis Sensitivity tests should be performed wherever possible to determine choice of therapy.