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SANDOZ DULOXETINE is a brand name for Duloxetine, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE .................................................................................................... 3 CONTRAINDICATIONS ..................................................................................................................... 5 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
General Potential Association with Behavioural and Emotional Changes, Including Self-Harm Pediatrics: Placebo-Controlled Clinical Trial Data • Recent analyses of placebo-controlled clinical trial safety databases from selective serotonin reuptake inhibitors (SSRIs) and other newer antidepressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
• The small denominators in the clinical trials database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.
Adults and Pediatrics:
Additional data • There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, and depersonalization.
In some cases, the events occurred within several weeks of starting treatment. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes.
An FDA meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients ages 18 to 24 years with psychiatric disorder showed an increased risk of suicidal behaviour with antidepressants compared to placebo.
Akathisia/Psychomotor Restlessness The use of SSRI’s and other newer antidepressants, including duloxetine, has been very rarely associated with the development of akathisia, which is characterized by a subjectively unpleasant or distressing restlessness and a need to move, often accompanied by an inability to sit or stand.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Discontinuation Symptoms Patients currently taking SSRIs or newer antidepressants should NOT be discontinued abruptly, due to risk of discontinuation symptoms.
At the time that a medical decision is made to discontinue an SSRI or other newer antidepressant drug, a gradual reduction in the dose rather than an abrupt cessation is recommended (see WARNINGS AND PRECAUTIONS: Dependence: Discontinuation of Treatment; ADVERSE REACTIONS: Adverse Events Following _____________________________________________________________________________________________ Sandoz Duloxetine Product Monograph Page 7 of 90 Discontinuation of Treatment; and DOSAGE AND ADMINISTRATION: Discontinuation of Treatment).
Hypersensitivity Sandoz Duloxetine (duloxetine delayed-release capsules) is contraindicated in patients with a known hypersensitivity to the drug or the other components of the product. Monoamine Oxidase Inhibitors (MAOIs) Sandoz Duloxetine should not be used concomitantly with a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and the thiazine dye methylthioninium chloride (methylene blue) which are less well-known examples of MAOIs, or within at least 14 days of discontinuing treatment with an MAOI.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Sandoz Duloxetine before starting an MAOI (see WARNINGS AND PRECAUTIONS: General: MAOIs). Hepatic Impairment Sandoz Duloxetine is contraindicated in patients with any liver disease resulting in hepatic impairment (see WARNINGS AND PRECAUTIONS: General: Hepatic Impairment; and DOSAGE AND ADMINISTRATION: Dosage for Patients with Hepatic Impairment).
Uncontrolled Narrow-Angle Glaucoma In clinical trials, duloxetine delayed-release capsules were associated with an increased risk of mydriasis; therefore, its use should be avoided in patients with uncontrolled narrow-angle glaucoma (see WARNINGS AND PRECAUTIONS: General: Ophthalmologic).
e. creatinine clearance <30 mL/min) or end-stage renal disease (see WARNINGS AND PRECAUTIONS: Renal Impairment). Thioridazine Concomitant use of Sandoz Duloxetine and thioridazine is contraindicated (see WARNINGS AND PRECAUTIONS: General: Thioridazine).
g. g. ciprofloxacin or enoxacin) (see DRUG INTERACTIONS). _____________________________________________________________________________________________ Sandoz Duloxetine Product Monograph Page 6 of 90 WARNINGS AND PRECAUTIONS General Potential Association with Behavioural and Emotional Changes, Including Self-Harm Pediatrics: Placebo-Controlled Clinical Trial Data • Recent analyses of placebo-controlled clinical trial safety databases from selective serotonin reuptake inhibitors (SSRIs) and other newer antidepressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Duloxetine 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.
Monoamine Oxidase Inhibitors (MAOIs):
In patients receiving a serotonin reuptake inhibitor in combination with a MAOI, there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and are then started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. The effects of combined use of duloxetine delayed-release capsules (duloxetine hydrochloride) and MAOIs have not been evaluated in humans or animals.
Therefore, because duloxetine is an inhibitor of both serotonin and norepinephrine reuptake, it is recommended that Sandoz Duloxetine not be used in combination with a MAOI, including the antibiotic linezolid and methylene blue, a surgical dye, or within at least 14 days of discontinuing treatment with a MAOI.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Sandoz Duloxetine before starting a MAOI (see CONTRAINDICATIONS: MAOIs; and DRUG INTERACTIONS).
Hepatic Impairment:
Patients with clinically evident hepatic impairment have decreased duloxetine metabolism and elimination. After a single non-therapeutic (20 mg) dose of duloxetine delayed-release capsules, 6 cirrhotic patients with moderate liver impairment (Child-Pugh Class B) had a mean plasma duloxetine clearance about 15% that of age- and gender-matched healthy subjects, with a 5- fold increase in mean exposure (AUC).
Although Cmax was similar to normals in the cirrhotic patients, the half-life was about 3 times longer. Sandoz Duloxetine is contraindicated in patients with any liver disease resulting in hepatic impairment (see CONTRAINDICATIONS: Hepatic Impairment; ACTION AND CLINICAL PHARMACOLOGY: Hepatic Impairment; and DOSAGE AND ADMINISTRATION: Dosage for Patients with Hepatic Impairment).
Hepatotoxicity:
Duloxetine delayed-release capsules increase the risk of elevation of serum aminotransferase levels. In clinical trials, the median time to detection of the aminotransferase elevation was about two months. In most patients, these were usually transient and self-limiting with continued use, or resolved upon discontinuation of duloxetine delayed-release capsules.
3% (89/29,435) of duloxetine delayed-release capsules-treated patients. 2% (2/1200) of placebo-treated patients. In placebo-controlled trials in DPN, elevations of ALT to >3 times the upper limit of normal occurred in 2% (13/662) of duloxetine delayed-release capsules-treated patients and in 0% (0/281) of placebo-treated patients.
_____________________________________________________________________________________________ Sandoz Duloxetine Product Monograph Page 8 of 90 In the […]
• The small denominators in the clinical trials database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among these drugs.
Adults and Pediatrics:
Additional data • There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others. The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, and depersonalization.
In some cases, the events occurred within several weeks of starting treatment. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes.
An FDA meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients ages 18 to 24 years with psychiatric disorder showed an increased risk of suicidal behaviour with antidepressants compared to placebo.
Akathisia/Psychomotor Restlessness The use of SSRI’s and other newer antidepressants, including duloxetine, has been very rarely associated with the development of akathisia, which is characterized by a subjectively unpleasant or distressing restlessness and a need to move, often accompanied by an inability to sit or stand.
This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental. Discontinuation Symptoms Patients currently taking SSRIs or newer antidepressants should NOT be discontinued abruptly, due to risk of discontinuation symptoms.
At the time that a medical decision is made to discontinue an SSRI or other newer antidepressant drug, a gradual reduction in the dose rather than an abrupt cessation is recommended (see WARNINGS AND PRECAUTIONS: Dependence: Discontinuation of Treatment; ADVERSE REACTIONS: Adverse Events Following _____________________________________________________________________________________________ Sandoz Duloxetine Product Monograph Page 7 of 90 Discontinuation of Treatment; and DOSAGE AND ADMINISTRATION: Discontinuation of Treatment).
Monoamine Oxidase Inhibitors (MAOIs):
In patients receiving a serotonin reuptake inhibitor in combination with a MAOI, there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and are then started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. The effects of combined use of duloxetine delayed-release capsules (duloxetine hydrochloride) and MAOIs have not been evaluated in humans or animals.
Therefore, because duloxetine is an inhibitor of both serotonin and norepinephrine reuptake, it is recommended that Sandoz Duloxetine not be used in combination with a MAOI, including the antibiotic linezolid and methylene blue, a surgical dye, or within at least 14 days of discontinuing treatment with a MAOI.
Based on the half-life of duloxetine, at least 5 days should be allowed after stopping Sandoz Duloxetine before starting a MAOI (see CONTRAINDICATIONS: […]