Diliner DR
Cheaper & Alternative Brands
Same generic (Duloxetine Hydrochloride), same form (Capsule (Delayed Release))
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Deloxi is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-
Major Depressive Disorder (MDD)
Generalized Anxiety Disorder (GAD)
Diabetic Peripheral Neuropathic Pain (DPNP)
Fibromyalgia and
Chronic Musculoskeletal Pain.
Dosage & Administration
Major Depressive Disorder (MDD)-
Starting Dose
: 40 mg/day to 60 mg/day
Target Dose
: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
Maximum Dose
: 120 mg/day
Generalized Anxiety Disorder (GAD)-
Starting Dose
: 60 mg/day
Target Dose
: 60 mg/day (once daily)
Maximum Dose
: 120 mg/day
Diabetic Peripheral Neuropathic Pain (DPNP)-
Starting Dose
: 60 mg/day
Target Dose
: 60 mg/day (once daily)
Maximum Dose
: 60 mg/day
Fibromyalgia-
Starting Dose
: 30 mg/day
Target Dose
: 60 mg/day (once daily)
Maximum Dose
: 60 mg/day
Chronic Musculoskeletal Pain-
Starting Dose
: 30 mg/day
Target Dose
: 60 mg/day (once daily)
Maximum Dose
: 60 mg/day
Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.
Contraindications
Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.
Side Effects & Adverse Reactions
The most commonly observed adverse events in Deloxi treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Deloxi-treated and placebo-treated patients.
Warnings & Precautions
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Deloxi and NSAIDs, aspirin, or other drugs that affect coagulation. Deloxi should be used cautiously in patients with a history of mania. Deloxi should be prescribed with care in patients with a history of a seizure disorder.
Pharmacology & Mechanism of Action
Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.