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.

 

 

Interaction

Duloxetine metabolism is controlled by the CYP1A2 and CYP2D6 isozymes. The AUC, Cmax, and t of Duloxetine were all enhanced when it was given with fluvoxamine, a powerful CYP1A2 inhibitor. Cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin are examples of medicines that impede CYP1A2 metabolism, therefore these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, combining Duloxetine with CYP2D6 inhibitors may result in increased Duloxetine concentrations.

 

Contraindications

Patients who have a known hypersensitivity to duloxetine or any of its inactive components should avoid it. Duloxetine is not approved for the treatment of bipolar disorder. Patients with a history of heavy drinking or symptoms of chronic liver damage should not be prescribed duloxetine. Duloxetine has been linked to an increased risk of mydriasis in clinical trials, thus it should be used with caution in individuals with managed narrow-angle glaucoma.

 

Side Effects

Nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased perspiration, hyperhidrosis, and asthenia were the most commonly reported side effects in Duloxetine hydrochloride patients. It may cause a small rise in blood pressure. Between Duloxetine-treated and placebo-treated patients, there were no clinically significant variations in QT, PR, and QRS intervals.

 

Pregnancy & Lactation

Pregnancy is classified as Category C. Due to the lack of rigorous and well-controlled trials in pregnant women, Duloxetine should only be used during pregnancy if the potential benefit outweighs the risk to the fetus.Human Labor and Delivery: The effects of Duloxetine on human labor and delivery are unknown. Only if the possible benefit outweighs the risk to the fetus may duloxetine be administered during labor and delivery.Duloxetine and/or its metabolites are not known to be excreted in human milk, hence nursing while taking Duloxetine is not suggested.

 

Precautions & Warnings

All patients using antidepressants for any reason should be constantly monitored and evaluated for signs of clinical deterioration, suicidality, or unexpected changes in behavior, especially during the first few months of treatment or when doses are changed. Prior to starting treatment, blood pressure should be checked, and it should be checked again at regular intervals during treatment. Patients should be warned about the risk of bleeding when taking Duloxetine with NSAIDs, aspirin, or other coagulation-disrupting medications. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

 

Therapeutic Class

Inhibitor of serotonin-norepinephrine reuptake (SNRI)

 

Storage Conditions

Do not store at temperatures above 30°C. Keep out of the reach of youngsters and away from light.

 

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.