ROSETRAL TABLETS

Indications

• Major depressive disorder
• Obsessive-compulsive disorder
• Panic disorder
• Social anxiety disorder
• Post-traumatic stress disorder

Dosage

Children: Refer to the BNF for Children for specific pediatric dosing recommendations.

Adults: Refer to the BNF for specific dosing guidelines as it varies based on the condition being treated.

Mechanism of action

Sertraline works by selectively inhibiting the reuptake of serotonin (5-HT) at the synaptic cleft, thereby increasing serotonin levels in the brain. This modulation of serotonin transmission is believed to contribute to its anxiolytic and antidepressant effects.

Pharmacodynamics

The pharmacodynamic effects of sertraline include its ability to enhance serotonergic neurotransmission, which is associated with improved mood and lower levels of anxiety. The onset of action for antidepressant effects typically takes several weeks, while anxiolytic effects may be observed sooner. Sertraline also exhibits some affinity for other neurotransmitter receptors, but its primary action remains serotonin reuptake inhibition.

Pharmacokinetics

Sertraline is well absorbed after oral administration, with peak plasma concentrations occurring in approximately 4 to 6 hours. It is extensively metabolized in the liver, primarily via CYP2B6 and CYP2C19 enzymes, and has a long elimination half-life of about 24 hours. Steady-state concentrations are achieved within one week of consistent dosing. The drug is excreted mainly in the form of metabolites in urine, with less than 0.2% excreted unchanged.

Contra-indications

• Hypersensitivity to sertraline or any of its components
• Concurrent use of monoamine oxidase inhibitors (MAOIs)
• Use in patients with a history of serotonin syndrome or related conditions

Adverse effects

• Nausea
• Diarrhea
• Insomnia
• Dizziness
• Somnolence
• Sexual dysfunction
• Weight gain
• Dry mouth
• Increased sweating
• Tremors
• Anxiety

Interactions

• Serotonergic drugs (risk of serotonin syndrome)
• MAOIs (risk of severe interactions)
• Warfarin (increased risk of bleeding)
• NSAIDs (increased risk of bleeding)
• CYP2B6 and CYP2C19 substrates (sertraline may inhibit metabolism)
• Alcohol (may potentiate depressive effects)

Precautions

• Use with caution in patients with a history of seizures
• Monitor for worsening depression or suicidal thoughts, especially in young adults
• Caution in patients with liver impairment
• Discontinuation should be gradual to prevent withdrawal symptoms

Pregnancy

Sertraline is classified as Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Sertraline is excreted in breast milk. Caution is advised when administering to nursing mothers, considering the potential for adverse effects in the infant.

Storage

Store below 30°C, in a tightly closed container, protected from light.

Formulations

• Tablets (various strengths)
• Oral solution