Andep

Approved Uses:

• Major Depressive Disorder (MDD) in adults
• Obsessive-Compulsive Disorder (OCD) in adults and pediatric patients aged 6 years and older
• Panic Disorder with or without agoraphobia in adults
• Post-Traumatic Stress Disorder (PTSD) in adults
• Social Anxiety Disorder (SAD) in adults
• Premenstrual Dysphoric Disorder (PMDD) in adult women

Off-label Uses:

• Generalized Anxiety Disorder (GAD)
• Premature ejaculation
• Binge Eating Disorder
• Body Dysmorphic Disorder
• Fibromyalgia and other chronic pain syndromes

Adults:

• MDD, OCD:
  Start with 50 mg orally once daily. Dose may be increased in 50 mg increments at intervals of at least one week, up to a maximum of 200 mg daily.
• Panic Disorder, PTSD, SAD:
  Start with 25 mg once daily for one week, then increase to 50 mg once daily. Maximum dose is 200 mg daily.
• PMDD:
  Either continuous dosing at 50 mg daily throughout the menstrual cycle or luteal-phase dosing (50 mg daily starting 14 days before menstruation until onset of menses). Maximum dose up to 150 mg daily.

Pediatrics (OCD only):

• Ages 6-12 years: Start at 25 mg daily; may increase gradually to 200 mg daily.
• Ages 13-17 years: Start at 50 mg daily; max 200 mg daily.

Elderly:

• Start at 25 mg daily; titrate slowly with careful monitoring.

Renal Impairment:

• No dosage adjustment usually needed.

Hepatic Impairment:

• Initiate at 25 mg daily; increase cautiously. Maximum doses may need reduction.

Administration:

• Oral route, once daily, with or without food, preferably same time each day.

Sertraline is a selective serotonin reuptake inhibitor (SSRI). It inhibits the serotonin transporter (SERT) on presynaptic neurons, blocking the reabsorption of serotonin (5-HT) into the presynaptic cell. This results in increased serotonin availability in the synaptic cleft, enhancing serotonergic neurotransmission. Improved serotonergic activity in brain regions associated with mood and anxiety regulation leads to its therapeutic effects. Sertraline exhibits minimal affinity for other neurotransmitter receptors, which helps reduce side effects.

• Absorption: Well absorbed orally; bioavailability approximately 44% due to first-pass metabolism.
• Time to peak plasma concentration: 4.5 to 8.4 hours post-dose.
• Distribution: Widely distributed; approximately 98% plasma protein bound.
• Metabolism: Extensively metabolized in the liver by CYP2B6, CYP2C19, and CYP3A4 enzymes to the active metabolite desmethylsertraline.
• Elimination half-life: Sertraline ~26 hours; desmethylsertraline ~62-104 hours.
• Excretion: Primarily eliminated via feces (~40-45%) and urine (~12-15%).
• Steady-state: Achieved within 1 week of daily dosing.

• Pregnancy:
  Classified as Category C (older FDA classification). Should be used during pregnancy only if benefits justify the potential risks. Some studies suggest possible risk of persistent pulmonary hypertension in the newborn and neonatal adaptation syndrome when used in late pregnancy.
• Lactation:
  Sertraline is excreted into breast milk in small amounts but is generally considered safe. Infants should be monitored for adverse effects such as irritability or feeding difficulties.

• Primary: Antidepressant
• Subclass: Selective Serotonin Reuptake Inhibitor (SSRI)

• Known hypersensitivity to sertraline or any component of the formulation
• Concurrent or recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs)
• Concurrent use with pimozide due to risk of cardiac arrhythmias
• Use of disulfiram with sertraline oral concentrate (due to alcohol content)

• Risk of suicidal ideation and behavior, especially in children, adolescents, and young adults during initial therapy. Close monitoring is required.
• Serotonin syndrome risk when used with other serotonergic agents.
• Caution in patients with a history of mania or bipolar disorder.
• Increased bleeding risk with concomitant use of anticoagulants or antiplatelet drugs.
• Hyponatremia, particularly in elderly and patients on diuretics.
• Hepatic impairment requires cautious dose adjustment.
• Avoid abrupt discontinuation to prevent withdrawal symptoms.

Common:

• Gastrointestinal: Nausea, diarrhea, dry mouth
• Neurological: Insomnia, dizziness, tremor, fatigue
• Sexual dysfunction: Decreased libido, delayed ejaculation, anorgasmia
• Others: Sweating, appetite changes, weight fluctuations

Less Common:

• Headache, agitation, blurred vision, palpitations, rash

Serious but Rare:

• Serotonin syndrome
• Seizures
• Stevens-Johnson syndrome
• Hepatotoxicity
• Suicidal ideation or behavior

• Contraindicated with MAOIs, linezolid, methylene blue due to serotonin syndrome risk.
• Increased bleeding risk with NSAIDs, anticoagulants, and antiplatelets.
• Inhibits CYP2D6 moderately; may increase levels of drugs metabolized by this enzyme.
• Avoid pimozide concomitantly due to risk of QT prolongation.
• Alcohol may increase CNS depression and impair alertness.

• Emphasis on monitoring for suicidal ideation especially in younger populations as per FDA warnings.
• Sertraline remains first-line for depression, OCD, PTSD, and anxiety disorders in guidelines from NICE and APA.
• No significant changes in approved indications or dosing in recent updates.
• Continued caution advised regarding serotonin syndrome and gradual discontinuation to prevent withdrawal.

• Store at 20°C to 25°C (68°F to 77°F).
• Allowable excursions between 15°C and 30°C.
• Keep container tightly closed, protect from moisture and light.
• For oral concentrate, protect from freezing and shake well before use.
• Keep out of reach of children.