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M-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 ................................................................................................................ 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Major Depressive Disorder (MDD):
Duloxetine hydrochloride has been evaluated for safety in 2418 patients diagnosed with MDD who participated in multiple-dose pre-marketing trials, representing 1099 patient-years of exposure. Among these 2418 duloxetine hydrochloride -treated patients, 1139 patients participated in eight 8- or 9-week, placebo-controlled trials at doses ranging from 40 to 120 mg/day, while the remaining 1279 patients were followed for up to 1-year in an open-label safety study using flexible doses between 80 and 120 mg/day.
Two placebo-controlled studies with doses of 80 and 120 mg/day had 6-month maintenance extensions. Of these 2418 patients, 993 duloxetine hydrochloride -treated patients were exposed for at least 180 days and 445 duloxetine hydrochloride - treated patients were exposed for at least 1 year.
The long-term safety of duloxetine hydrochloride in MDD patients has also been evaluated in 533 patients in one long-term maintenance of effect study consisting of a 12-week, open-label, acute phase followed by a 26-week, double-blind continuation phase and in 514 patients in another long-term maintenance of effect study consisting of a 4 to 10 week, open-label, acute phase, a 24-week, open-label, continuation phase followed by a 52-week, double- blind, maintenance phase.
Generalized Anxiety Disorder (GAD):
Duloxetine hydrochloride has also been evaluated for safety in 1797 patients with GAD. Most patients in the acute placebo-controlled studies received duloxetine hydrochloride 60 mg QD or 120 mg QD as their final dose. 13 patient-years of exposure.
Among these 1429 duloxetine hydrochloride -treated patients, 800 patients participated in three 12- to 13-week, placebo- controlled trials at doses ranging from 20 to 120 mg/day. An additional 449 patients were enrolled in an open- label safety study using 120 mg/day for a duration of 6 months (87 patients continued on to an open- label extension phase for an additional 24 weeks).
Another 57 patients, originally treated with placebo, were exposed to duloxetine hydrochloride for up to 12 months at 60 mg twice daily in an extension phase. Among these 1429 patients, 881 had ≥6 months of exposure to duloxetine hydrochloride, and 515 had greater than 12 months of exposure.
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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99 patient-years exposure to duloxetine). 3%) received duloxetine hydrochloride 60 mg QD. 2%) received duloxetine 120 mg QD at some point during the acute phase.
Chronic Pain Associated with Osteoarthritis (OA) of the Knee:
Duloxetine hydrochloride has been evaluated for safety in 503 duloxetine-treated patients with OA of the knee in two 13-week, placebo-controlled trials and one 10-week placebo-controlled “add-on” M-DULOXETINE (duloxetine hydrochloride) Page 19 sur 81 trial with NSAIDs (see CLINICAL TRIALS).
Clinical Trial Adverse Drug Reactions The data in the following tables and text cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials.
Similarly, the cited frequencies cannot be compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. The cited data provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence in the population studied.
Adverse Events Reported as Reasons for Discontinuation of Treatment Placebo-Controlled MDD Trials: Approximately 10% of the 1139 patients who received duloxetine hydrochloride in acute placebo-controlled trials discontinued treatment due to an adverse event, compared with 4% of the 777 patients receiving placebo.
, discontinuation occurring in at least 1% of the duloxetine hydrochloride-treated patients and at a rate of at least twice that of placebo). 3% of the 665 patients receiving placebo. 5%) were the common adverse events reported as reasons for discontinuation and considered to be drug-related (as defined under MDD Trials, above).
Placebo-Controlled Trials for Neuropathic Pain Associated with DPN:
Approximately 12% of the 800 patients who received duloxetine hydrochloride in acute placebo-controlled trials discontinued treatment due to an adverse event, compared with 5% of the 339 patients receiving placebo. 2%, placebo 0%) were the common adverse events reported as reasons for discontinuation and considered to be drug- related (as defined under MDD Trials, above).
3% of the 441 patients receiving placebo. Common adverse reactions […]