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APO-LINEZOLID is a brand name for Linezolid, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-LINEZOLID (linezolid) tablets are indicated for: Treatment of adult patients with the following infections, when caused by susceptible strains of the designated aerobic Gram-positive micro-organisms: Note: APO-LINEZOLID is not indicated for the treatment of Gram-negative infections. It is critical that specific…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 02/2023 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 04/2024 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 04/2024 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 ....................................................................................................................
5 2 CONTRAINDICATIONS ..................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ....................................................................................
1 Dosing Considerations ................................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ............................................................................................................
5 Missed Dose ............................................................................................................... 7 5 OVERDOSAGE .................................................................................................................
7
section). Hematologic Myelosuppression Myelosuppression (anemia including pure red blood cell aplasia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving linezolid. Thrombocytopenia may occur more often in patients with moderate to severe renal insufficiency, whether or not on dialysis, and in patients with moderate to severe hepatic impairment.
In cases where the outcome is known, when linezolid was discontinued, the affected hematologic parameters have risen toward pretreatment levels. Complete blood counts should be monitored at least weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two APO-LINEZOLID (linezolid tablets) Page 11 of 47 weeks, patients who are at increased risk for bleeding, those with pre-existing myelosuppression, who have moderate to severe renal insufficiency or moderate to severe hepatic impairment, those receiving concomitant drugs that produce bone marrow suppression, or decreased hemoglobin levels or platelet counts or function, or those with a chronic infection who have received previous or concomitant antibiotic therapy.
Discontinuation of therapy with linezolid should be considered in patients who develop or have worsening myelosuppression. Hepatic Thrombocytopenia may occur more often in patients with moderate to severe hepatic impairment. (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Myelosuppression).
Monitoring and Laboratory Tests Complete blood counts should be monitored at least weekly in patients who receive linezolid, particularly in those: • who receive linezolid for longer than two weeks, • who are at increased risk for bleeding, • with pre-existing myelosuppression, • receiving concomitant drugs that produce bone marrow suppression, or decreased hemoglobin levels or platelet counts or function, • with moderate to severe renal or moderate to severe hepatic impairment, or • with a chronic infection who have received previous or concomitant antibiotic therapy (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Myelosuppression).
4 Geriatrics 02/2023 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests 04/2024 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 04/2024 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 ....................................................................................................................
5 2 CONTRAINDICATIONS ..................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ....................................................................................
1 Dosing Considerations ................................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ............................................................................................................
5 Missed Dose ............................................................................................................... 7 5 OVERDOSAGE .................................................................................................................
APO-LINEZOLID is contraindicated for use in patients who have known hypersensitivity to linezolid or any of the other product components. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. g. phenelzine, isocarboxazid) or within two weeks of taking any such medicinal product.
, dopamine, dobutamine). Potential Serotonergic Interactions Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, linezolid is contraindicated in patients with: • carcinoid syndrome and/or patients taking any of the following medications: • serotonin re-uptake inhibitors, APO-LINEZOLID (linezolid tablets) Page 6 of 47 • tricyclic antidepressants, • serotonin 5-HT1 receptor agonists (triptans), • buspirone or • opioids including meperidine.
4 Drug-Drug Interactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Linezolid 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.
Serum sodium levels should be monitored regularly in: • the elderly, • patients taking diuretics, and • patients at risk of hyponatremia (see 7 WARNINGS AND PRECAUTIONS, Renal). Consider regular monitoring of creatine kinase (CK) levels in: • patients with an increased risk of myopathy or rhabdomyolysis • patients who recently received or are currently taking other medications known to be associated with myopathy or rhabdomyolysis • patients who develop any signs or symptoms of rhabdomyolysis, including muscle pain or weakness (see 7 WARNINGS AND PRECAUTIONS, Musculoskeletal) Musculoskeletal Rhabdomyolysis associated with creatine kinase (CK) elevations has been reported with the use of linezolid.
In some cases, rhabdomyolysis led to acute kidney injury. If signs or symptoms of APO-LINEZOLID (linezolid tablets) Page 12 of 47 rhabdomyolysis are observed, such as muscle pain, weakness, or dark urine, linezolid should be discontinued and appropriate therapy initiated.
Neurologic Peripheral neuropathy has been reported primarily in patients treated for longer than the maximum recommended duration of 28 days with linezolid. When outcome was known, recovery was reported in only some cases following linezolid withdrawal.
If symptoms of peripheral neuropathy such as numbness, tingling, prickling sensations or burning pain occur, the continued use of APO-LINEZOLID should be weighed against the potential risk. Convulsions have been reported to occur rarely in patients when treated with linezolid.
In most of these cases, a history of seizures or risk factors for seizures was reported. Ophthalmologic Optic neuropathy has been reported in patients treated with linezolid, primarily those treated for longer than the maximum recommended duration of 28 days.
When outcome was known, recovery was reported in some cases following linezolid withdrawal. In cases of optic neuropathy that progressed to loss of vision, patients were treated for longer than the maximum recommended duration. Visual blurring has been reported in some patients treated with linezolid for less than 28 days.
Visual function should be monitored in all patients taking APO-LINEZOLID for longer than the maximum recommended duration and in all patients reporting new visual symptoms regardless of length of therapy with APO-LINEZOLID. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, blurred vision, or visual field defect, prompt ophthalmologic evaluation is recommended.
If optic neuropathy occurs, the continued use of APO-LINEZOLID in these patients should be weighed against the potential risks. Renal Hyponatremia and/or Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) have been observed in some patients treated with linezolid.
It is recommended that serum sodium levels be monitored regularly in the elderly, in patients taking diuretics, and in other patients at risk of hyponatremia. Thrombocytopenia may occur more often in patients with moderate to severe renal insufficiency, whether or not on dialysis (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Myelosuppression).
APO-LINEZOLID (linezolid tablets) Page 13 of 47 Sensitivity /Resistance Prescribing APO-LINEZOLID in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
1 Pregnant Women There are no adequate and well-controlled studies in pregnant women. APO-LINEZOLID should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 2 Breast-feeding Because linezolid is excreted in human milk, caution should be exercised when APO-LINEZOLID is administered to a breast-feeding woman.
Breast-feeding women should be advised to monitor a breastfed infant for diarrhea and vomiting. 3 […]
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 8 7 WARNINGS AND PRECAUTIONS ...................................................................................... 1 Special Populations...................................................................................................
1 Pregnant Women .................................................................................................. 2 Breast-feeding .......................................................................................................
3 Pediatrics............................................................................................................... 4 Geriatrics ...............................................................................................................
13 8 ADVERSE REACTIONS .................................................................................................... 1 Adverse Reaction Overview ......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................ 3 Less Common Clinical Trial Adverse Reactions ......................................................... 5 Post-Market Adverse Reactions ...............................................................................
17 9 DRUG INTERACTIONS ................................................................................................... 1 Serious Drug Interactions .........................................................................................
2 Drug Interactions Overview ...................................................................................... 4 Drug-Drug Interactions .............................................................................................
5 Drug-Food Interactions............................................................................................. 6 Drug-Herb Interactions .............................................................................................
7 Drug-Laboratory Test Interactions............................................................................ 23 10 CLINICAL PHARMACOLOGY ........................................................................................... 1 Mechanism of Action ................................................................................................
3 Pharmacokinetics ..................................................................................................... 23 11 STORAGE, STABILITY AND DISPOSAL.............................................................................
28 PART II: SCIENTIFIC INFORMATION ........................................................................................ 29 13 PHARMACEUTICAL INFORMATION ...............................................................................
29 14 CLINICAL TRIALS ........................................................................................................... 1 Clinical Trials by Indication .......................................................................................
3 Comparative Bioavailability Studies.......................................................................... 32 15 MICROBIOLOGY ............................................................................................................
33 16 NON-CLINICAL TOXICOLOGY ......................................................................................... 37 17 SUPPORTING PRODUCT MONOGRAPHS ....................................................................... 40 PATIENT MEDICATION INFORMATION ...................................................................................
41 APO-LINEZOLID (linezolid tablets) Page 4 of 47 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS […]