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SEPTRA PEDIATRIC is a brand name for Sulfamethoxazole, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SEPTRA Injection and SEPTRA PEDIATRIC ORAL SUSPENSION (sulfamethoxazole and trimethoprim) are 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…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 09 / 2025 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 09 / 2025 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 09 / 2025 Sections or subsections that are not applicable at the time of authorization are not listed.
TABLE OF CONTENTS 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 ............................................................. 7 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution .....................................................................................................
4 Administration ..................................................................................................... 11 5 OVERDOSAGE.............................................................................................................
11
). Appropriate dosage adjustments should be made (see 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS SEPTRA Injection and SEPTRA PEDIATRIC ORAL SUSPENSION: • are 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). • are 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.
• are contraindicated in patients with marked renal impairment where repeated measurements monitoring plasma drug concentrations cannot be performed (see also 7 WARNINGS AND PRECAUTIONS). • are contraindicated in pregnant patients and in nursing mothers, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus.
• are 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
4 Administration 09 / 2025 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 09 / 2025 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 09 / 2025 Sections or subsections that are not applicable at the time of authorization are not listed.
TABLE OF CONTENTS 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 ............................................................. 7 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution .....................................................................................................
4 Administration ..................................................................................................... 11 5 OVERDOSAGE.............................................................................................................
11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 12 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations..............................................................................................
1 Pregnant Women ................................................................................................. 2 Breastfeeding .......................................................................................................
3 Pediatrics ............................................................................................................. 4 Geriatrics .............................................................................................................
20 8 ADVERSE REACTIONS ................................................................................................. 1 Adverse Reaction Overview ................................................................................. 21 9 DRUG INTERACTIONS .................................................................................................
3 Drug-Behavioural Interactions............................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 25 10 ACTION AND CLINICAL PHARMACOLOGY ...................................................................
1 Mechanism of Action........................................................................................... 3 Pharmacokinetics ................................................................................................ 27 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
28 PART II: SCIENTIFIC INFORMATION ........................................................................................ 29 13 PHARMACEUTICAL INFORMATION .............................................................................
29 15 MICROBIOLOGY ......................................................................................................... 30 16 NON-CLINICAL TOXICOLOGY ......................................................................................
36 PATIENT MEDICATION INFORMATION ................................................................................... 40 PATIENT MEDICATION INFORMATION ...................................................................................
52 PrSEPTRA® (sulfamethoxazole &trimethoprim) Page 4 of 62 Protected B / Protégé B PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SEPTRA Injection and SEPTRA PEDIATRIC ORAL SUSPENSION (sulfamethoxazole and trimethoprim) are 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 […]
03 / 2024
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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