Xinolax DR 30 mg

INDICATIONS

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.

PHARMACOLOGY

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.

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

Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.

SIDE EFFECTS

The most commonly observed adverse events in Duloxetine hydrochloride 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 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 justifies the potential risk to the fetus.Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

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.

USE IN SPECIAL POPULATIONS

Use in the pediatric population: Safety and efficacy in pediatric patients have not been established

THERAPEUTIC CLASS

Serotonin-norepinephrine reuptake inhibitor (SNRI)

STORAGE CONDITIONS

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