Indications of Loxetine 30

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.

Pharmaceutical Name of Loxetine 30

ACI Limited

Pharmacology

Duloxetine hydrochloride is a selective serotonin-norepinephrine reuptake inhibitor (SSRI) for oral administration. Duloxetine is a weak dopamine reuptake inhibitor. Duloxetine does not have a significant affinity for dopamine, adrenergic, cholinergic, histamine, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Oral duloxetine hydrochloride is well absorbed. The elimination of duloxetine is mainly metabolized by the liver.

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 Loxetine 30

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 any inactive ingredients. Duloxetine is not approved for the treatment of bipolar depression. Duloxetine should not be used in patients who drink a lot of alcohol 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 Loxetine 30

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. There were no clinically significant variations in QT, PR, or QRS intervals between Duloxetine 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 demonstrates a potential risk to the fetus.

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

Lactation period: I do not know if duloxetine and / or its metabolites are excreted in human milk, but breastfeeding while taking duloxetine is not recommended.

Precautions & Warnings

All patients receiving antidepressant therapy for any indication should be fully monitored and closely observed for clinical deterioration, suicidal tendencies, and abnormal behavior changes, especially during the first few months of the drug treatment process or when the dose changes. Blood pressure should be measured before starting treatment and regularly throughout the course of treatment. Patients should be warned of the risk of bleeding caused by concurrent use of duloxetine and non-steroidal anti-inflammatory drugs, aspirin, or other drugs that affect blood clotting. Duloxetine should be used with caution in patients with a history of mania. Patients with a history of epilepsy should use duloxetine with caution.

Therapeutic Class

Inhibitor of serotonin-norepinephrine reuptake (SNRI).\

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Generic of Loxetine 30

Duloxetine Hydrochloride