Dulox 30 Tablet 1 Strip

✔️ Overdose

Symptoms

Experience with duloxetine overdose is limited. Symptoms may vary depending on the amount ingested and the presence of other substances.

Management

There is no specific antidote for duloxetine overdose. Treatment is supportive and may include:

• Ensuring a clear airway and adequate breathing
• Monitoring heart rhythm and vital signs
• Providing oxygen and ventilation if necessary
• Considering gastric lavage shortly after ingestion when appropriate
• Administering activated charcoal to reduce absorption

Inducing vomiting is generally not recommended.

✔️ Common side effects include:

• Nausea
• Dizziness
• Dry mouth
• Constipation
• Reduced appetite
• Fatigue
• Drowsiness (somnolence)
• Excessive sweating (hyperhidrosis)
• Weakness (asthenia)

✔️ Dosage and Administration

Major Depressive Disorder (MDD)

• Starting dose: 40–60 mg daily
• Target dose:
  • Acute treatment: 40 mg daily (20 mg twice daily) to 60 mg daily (once daily or 30 mg twice daily)
  • Maintenance treatment: 60 mg daily
• Maximum dose: 120 mg daily

Generalized Anxiety Disorder (GAD)

• Starting dose: 60 mg daily
• Target dose: 60 mg once daily
• Maximum dose: 120 mg daily

Diabetic Peripheral Neuropathic Pain (DPNP)

• Starting dose: 60 mg daily
• Target dose: 60 mg once daily
• Maximum dose: 60 mg daily

Fibromyalgia

• Starting dose: 30 mg daily
• Target dose: 60 mg once daily
• Maximum dose: 60 mg daily

Chronic Musculoskeletal Pain

• Starting dose: 30 mg daily
• Target dose: 60 mg once daily
• Maximum dose: 60 mg daily

Some patients may benefit from beginning treatment with 30 mg once daily. Doses above 60 mg per day generally do not provide additional benefit and may increase the likelihood of side effects. To minimize withdrawal or discontinuation symptoms, the dose should be reduced gradually when stopping treatment.

✔️ Duloxetine should not be used in:

• Patients with known hypersensitivity to duloxetine or any of its ingredients
• Individuals with substantial alcohol consumption or chronic liver disease
• Patients being treated for bipolar depression, as it is not approved for this indication

Caution is advised in patients with controlled narrow-angle glaucoma because duloxetine may increase the risk of pupil dilation (mydriasis).

✔️ Interaction

Duloxetine is metabolized mainly by the CYP1A2 and CYP2D6 enzyme systems.

• Fluvoxamine, a potent CYP1A2 inhibitor, can significantly increase duloxetine blood levels and should generally not be used together.
• Other CYP1A2 inhibitors, including cimetidine, ciprofloxacin, and enoxacin, may have similar effects and should be used cautiously or avoided.
• Strong CYP2D6 inhibitors may also increase duloxetine concentrations, potentially raising the risk of adverse effects.

✔️ Pregnancy & Lactation

Pregnancy

• Classified as Pregnancy Category C.
• Adequate studies in pregnant women are lacking.
• Use during pregnancy only when the expected benefits outweigh potential risks to the fetus.

Labor and Delivery

• The effects of duloxetine during labor and delivery are not well established.
• It should be used only when the anticipated benefits justify potential risks.

Breastfeeding

• It is unknown whether duloxetine or its metabolites pass into human breast milk.
• Breastfeeding is generally not recommended during treatment.

✔️ Precautions & Warnings

Patients receiving duloxetine should be monitored carefully, especially during the first few months of treatment or following dosage adjustments, for:

• Worsening depression
• Suicidal thoughts or behaviors
• Unusual behavioral changes

Additional precautions include:

• Monitoring blood pressure before and during treatment
• Using caution when combined with NSAIDs, aspirin, or other medications affecting blood clotting, due to an increased risk of bleeding
• Careful use in patients with a history of mania
• Cautious prescribing in individuals with seizure disorders
• Safety and effectiveness in children and adolescents have not been established.

✔️ Storage:

• Store below 30°C.
• Protect from light.
• Keep out of the reach of children.