Dulox 20 mg

Description

Indications

Dulox is a serotonin and norepinephrine reuptake inhibitor (SNRI) used for the following conditions:

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia
• Chronic Musculoskeletal Pain

Use the medication according to the advice of a registered medical professional.

Pharmacology

Duloxetine Hydrochloride is an SSNRI designed for oral use. While it primarily inhibits the reuptake of serotonin and norepinephrine, it is a weaker inhibitor of dopamine reuptake. Duloxetine does not exhibit significant binding to dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, or GABA receptors in vitro, nor does it inhibit monoamine oxidase (MAO). Upon oral administration, Duloxetine is well absorbed and primarily metabolized by the liver.

Dosage & Administration

• Major Depressive Disorder (MDD):

  • Starting Dose: 40 mg/day to 60 mg/day
  • Target Dose: Acute phase: 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

In some cases, patients may benefit from beginning treatment at 30 mg once daily. Doses higher than 60 mg/day have not shown additional benefits, though some adverse reactions are dose-dependent. A gradual dose reduction is recommended to avoid withdrawal symptoms.

Use the medication according to the advice of a registered medical professional.

Interactions

Dulox is metabolized by both CYP1A2 and CYP2D6 isozymes. Co-administration with fluvoxamine, a potent CYP1A2 inhibitor, can increase Dulox plasma levels, including AUC, Cmax, and half-life. Other CYP1A2 inhibitors, such as cimetidine and quinolone antibiotics like ciprofloxacin and enoxacin, may have similar effects and should be avoided in combination with Dulox. Additionally, concurrent use with potent CYP2D6 inhibitors can raise Dulox concentrations.

Contraindications

Dulox should not be used by individuals with a known hypersensitivity to this drug or any of its inactive ingredients. It is not approved for the treatment of bipolar depression. Patients with significant alcohol use or chronic liver disease should avoid Dulox. As clinical trials have shown an increased risk of mydriasis, caution is advised when prescribing Dulox to patients with controlled narrow-angle glaucoma.

Side Effects

Common side effects associated with Dulox include nausea, dizziness, dry mouth, constipation, loss of appetite, fatigue, sleepiness, excessive sweating, and weakness. It may slightly increase blood pressure. No significant changes in QT, PR, and QRS intervals have been observed between Dulox-treated and placebo-treated patients.

Pregnancy & Lactation

• Pregnancy: Category C. There are no adequate and well-controlled studies in pregnant women, so Duloxetine should only be used during pregnancy if the potential benefits justify the potential risks to the fetus.

• Labor and Delivery: The effect of Duloxetine on labor and delivery is unknown, and it should only be used if the potential benefits outweigh the risks.

• Lactation: It is not known if Duloxetine is excreted in human milk, so nursing while using Duloxetine is not recommended.

Precautions & Warnings

Patients receiving antidepressant therapy, including Dulox, should be monitored for clinical worsening, suicidality, and unusual behavioral changes, especially during the initial months or when adjusting doses. Blood pressure should be checked before starting treatment and periodically during therapy. Caution is necessary if Dulox is used with NSAIDs, aspirin, or other drugs affecting blood coagulation. Dulox should be used carefully in individuals with a history of mania or seizure disorders.

Use in Special Populations

• Pediatric Use: The safety and efficacy of Dulox in children have not been established.

Overdose Effects

Although limited clinical experience exists with Dulox overdose, general overdose management measures should be followed. This includes ensuring a clear airway, oxygenation, and monitoring vital signs. Emesis should not be induced, but gastric lavage may be indicated if done shortly after ingestion. Activated charcoal can help limit absorption.

Therapeutic Class

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Storage Conditions

Store below 30°C. Protect from light and keep out of reach of children.