SB-Serta 50

Generic

Sertraline Hydrochloride

 

Indications

Sertraline is used to treat the following conditions: Major depressive disorder (MDD)

Obsessive-compulsive disorder (OCD) is a kind of obsessive-compul (OCD)

Anxiety disorder (PD)

Post-traumatic stress disorder (PTSD) is a type of anxiety condition that occurs (PTSD)

Anxiety about social situations (SAD)

Premenstrual dysphoric disorder (PMDD) is a kind of premenstrual dysphor (PMDD).

 

Pharmacology

Sertraline inhibits CNS neuronal 5-HT absorption in a strong and selective manner, resulting in higher 5-HT concentrations at synaptic clefts and acceleration of sustained 5-HT activity at postsynaptic receptor sites. It eventually leads to a reduction in depression. Sertraline's effect is additionally complicated by the fact that it reduces serotonin turnover in the brain. Because of its lengthy elimination half-life, it can be taken just once a day.

 

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 firmly attached to plasma protein, thus giving it to a patient who is also taking another medication that is tightly bound to protein (e.g. warfarin, digitoxin) might produce a change 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 medicines like Diazepam, Hypoglycemic meds, and Atenolol, among others.

 

Contraindications

Sertraline is not recommended for individuals who have a known allergy to the medication or any of its excipients. It is not advised for people with moderate to severe hepatic impairment.

 

Side Effects

Sertraline can cause stomach trouble, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight gain, sleepiness, dizziness, headache, discomfort, 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 proved, 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 breastfeeding infants has yet to be determined. If Sertraline therapy is required, it may be essential to stop breastfeeding.

 

Precautions & Warnings

If you have liver illness, renal disease, seizures, heart disease, or allergies, you should use care. This medication may induce drowsiness or dizziness. Activities that need attentiveness, such as driving or operating machinery, should be approached with caution. When taking this medication in the elderly, exercise caution because they may be more susceptible to the drug's effects. If you've used a monoamine oxidase inhibitor in the previous 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 at temperatures above 30°C. Keep out of children's reach.

 

Pharmaceutical Name

Sunman-Birdem Pharma Ltd.