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SEPTRA is a brand name for Trimethoprim, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SEPTRA Injection (sulfamethoxazole and trimethoprim) 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…
Verbatim from this product's HC label. Tap a section to expand.
). 2 CONTRAINDICATIONS SEPTRA Injection: • 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 SEPTRA Injection: • 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 04/2024 7 WARNINGS AND PRECAUTIONS, Immune 04/2024 7 WARNINGS AND PRECAUTIONS, Respiratory 04/2024 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 6 2 CONTRAINDICATIONS .................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 10 5 OVERDOSAGE............................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 11 7 WARNINGS AND PRECAUTIONS ................................................................................ 19 8 ADVERSE REACTIONS ................................................................................................
20 9 DRUG INTERACTIONS ................................................................................................ 25 10 CLINICAL PHARMACOLOGY .......................................................................................
26 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 28 PART II: SCIENTIFIC INFORMATION .......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Trimethoprim in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
29 13 PHARMACEUTICAL INFORMATION ............................................................................ 29 15 MICROBIOLOGY ........................................................................................................
30 16 NON-CLINICAL TOXICOLOGY ............................................................................................ 36 PATIENT MEDICATION INFORMATION ..................................................................................
41 Product Monograph Master Template Template Date: September 2020 SEPTRA® Injection Sulfamethoxazole and Trimethoprim Page 4 of 52 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SEPTRA Injection (sulfamethoxazole and trimethoprim) 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.
These tests should be repeated if there is a failure to respond, relapse or early recurrence.
Product Monograph Master Template Template Date:
September 2020 SEPTRA® Injection Sulfamethoxazole and Trimethoprim Page 5 of 52 […]