Duzela 20

Indications of Duzela 20

Duloxetine 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.

 

Pharmaceuticals Name of Duzela 20

Sun Pharmaceutical Ltd.

 

Pharmacology

Duloxetine Hydrochloride is an orally administered selective serotonin and norepinephrine reuptake inhibitor (SSNRI). Duloxetine is a less powerful dopamine reuptake inhibitor. In vitro, dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors have no appreciable affinity for duloxetine. Monoamine oxidase is not inhibited by duloxetine (MAO). D that is taken orally.

 

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.

 

Interaction of Duzela 20

Both the CYP1A2 and CYP2D6 isoenzymes are responsible for the metabolism of duloxetine. When duloxetine was used in combination with the potent CYP1A2 inhibitor fluvoxamine, the AUC, Cmax and t of duloxetine were increased. Other drugs that inhibit CYP1A2 metabolism include the antibacterials cimetidine and quinolone, such as ciprofloxacin and enoxacin, which are expected to have similar effects and these combinations should be avoided. Since CYP2D6 is involved in the metabolism of duloxetine, the combination of duloxetine and a strong CYP2D6 inhibitor may increase the concentration of duloxetine.

 

Contraindications

Duloxetine is contraindicated in patients who are known to be allergic to the drug or to any inactive ingredient. Duloxetine is not approved for the treatment of bipolar depression. Duloxetine should not be used in patients who drink heavily or have evidence of chronic liver disease. In clinical trials, duloxetine is associated with an increased risk of pupil dilation; therefore, it should be used with caution in patients with controlled narrow-angle glaucoma.

 

Side Effects of Duzela 20

Among patients treated with duloxetine hydrochloride, the most commonly observed adverse events were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, drowsiness, increased sweating, hyperhidrosis, and weakness. May raise blood pressure slightly. No clinically significant differences in QT, PR, and QRS intervals were observed between duloxetine-treated and placebo-treated patients.

 

Pregnancy & Lactation

Pregnancy: pregnancy category C. There are no adequate and well-controlled studies in pregnant women; therefore, duloxetine should be used during pregnancy only if the potential benefit proves a potential risk to the fetus.

Childbirth: The effect of duloxetine on childbirth and childbirth in humans is unclear. Duloxetine should be used during delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation period: It is not known whether duloxetine and/or its metabolites are excreted in human milk, but it is not recommended to breastfeed while taking duloxetine.

 

Precautions & Warnings

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 Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

 

Therapeutic Class

Serotonin-norepinephrine reuptake inhibitor (SNRI)

 

Storage Conditions

Keep below 30°C temperature in a dry place. Protected from light. Do not freeze. Keep out of the reach of children.

 

Generic of Duzela 20

Duloxetine Hydrochloride