Sertraline tablet is indicated for the treatment of:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Panic Disorder (PD)
• Post-Traumatic Stress Disorder (PTSD)
• Social Anxiety Disorder (SAD)
• Premenstrual Dysphoric Disorder (PMDD)

Sertraline is a potent and selective inhibitor of serotonin (5-HT) reuptake in the central nervous system. This leads to increased serotonin levels in the synaptic cleft, enhancing and prolonging its activity at postsynaptic receptor sites. The overall effect contributes to improvement in depressive symptoms. It may also reduce serotonin turnover in the brain, which is considered part of its therapeutic action. Due to its long elimination half-life, Sertraline allows convenient once-daily dosing.

Adults
Major depressive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50–200 mg

Obsessive-compulsive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50–200 mg

Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50–200 mg

Pediatric Patients (ages 6–12 years old)-
Obsessive-compulsive disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50–200 mg

The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

• Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
• Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).

Sertraline is highly bound to plasma proteins; therefore, concurrent use with other highly protein-bound drugs such as warfarin or digitoxin may lead to displacement from protein-binding sites, potentially altering plasma concentrations and increasing the risk of adverse effects. Similarly, Sertraline itself may be displaced by other strongly protein-bound drugs, which may also lead to unwanted effects. Sertraline may interact with several medicines including cimetidine, CNS-active agents such as diazepam, hypoglycemic drugs, atenolol, and others.

Sertraline is contraindicated in patients with known hypersensitivity to Sertraline or any of its excipients. It is not recommended in patients with moderate to severe hepatic impairment.

Sertraline may cause side effects such as nausea, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, tingling or burning sensation in hands or feet, agitation, and sore throat.

Although animal studies have not shown evidence of teratogenic effects, the safety of Sertraline during human pregnancy has not been fully established. Sertraline is excreted in breast milk, and its effects on nursing infants are not clearly known. If treatment is necessary, discontinuation of breastfeeding should be considered.

Use with caution in patients with liver disease, kidney disease, seizure disorders, heart conditions, or known allergies. Sertraline may cause dizziness or drowsiness; therefore, caution is required during activities such as driving or operating machinery. Elderly patients may be more sensitive to its effects. Avoid use if monoamine oxidase inhibitors (MAOIs) have been taken within the last five weeks. Patients should be closely monitored for suicidal thoughts or behavioral changes, especially during the initial 2–3 weeks of treatment.

Selective Serotonin Reuptake Inhibitors (SSRIs) and related antidepressants

Store below 30°C. Keep out of reach of children.