Tralin 50

Generic

Sertraline Hydrochloride

 

Indications

Major Depressive Disorder, Obsessive Compulsive Disorder (OCD), Panic Disorder, Posttraumatic Stress Disorder (PTSD), Premenstrual Dysphoric Disorder (PMDD), Social Anxiety Disorder

 

Pharmacology

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.

 

Dosage & 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).

 

Interaction

Sertraline is closely linked to plasma protein, so giving it to a patient who is also taking another medicine that is tightly bound to protein (e.g. warfarin, digitoxin) could produce a shift in plasma concentrations, potentially causing an undesirable impact. Displacement of protein-bound Sertraline by other firmly bound medicines, on the other hand, may have negative consequences. Sertraline may interact with other medications including Cimetidine, CNS active pharmaceuticals like Diazepam, Hypoglycemic meds, and Atenolol, among others.

 

Contraindications

Sertraline is not recommended for patients who have a known hypersensitivity to the medicine or any of its excipients. It is not indicated for persons with moderate to severe hepatic impairment.

 

Side Effects

Sertraline can cause stomach upset, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight gain, sleepiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitation, and a sore throat, among other things.

 

Pregnancy & Lactation

Sertraline's safety during human pregnancy has not been demonstrated, despite the fact that no indication of teratogenicity has been found in animal research. Sertraline has been found to pass through breast milk. Its impact on nursing infants has yet to be determined. If Sertraline medication is required, it may be essential to stop breastfeeding.

 

Precautions & Warnings

If you have liver disease, kidney disease, seizures, heart disease, or allergies, you should use caution. This medication may cause drowsiness or dizziness. Activities that necessitate alertness, such as driving or operating machinery, should be approached with caution. When taking this medicine in the elderly, use caution because they may be more susceptible to the drug's effects. If you've used a monoamine oxidase inhibitor in the recent five weeks, don't take this medication. Suicidal ideation and behavioural changes are a possibility (close monitoring of the patient after 2 to 3 weeks of use is required).

 

Therapeutic Class

SSRIs & related anti-depressant drugs

 

Storage Conditions

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

 

Pharmaceutical Name

Silva Pharmaceuticals Ltd.