Sertraline Hydrochloride

• SB-Serta 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 has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.

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).

Potential effects of co-administration of drugs that are highly bound to plasma proteins- As SB-Serta is tightly bound to plasma protein, the administration of SB-Serta to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound SB-Serta by other tightly bound drugs. SB-Serta may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.

Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.

SB-Serta may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.

Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.

Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. SB-Serta may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using SB-Serta in the elderly because they may be more sensitive to the effects of the drug. Do not take SB-Serta if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).

Do not store above 30°C. Keep out of the reach of children.