Pexep (escitalopram oxalate) represents a significant advancement in the pharmacological management of Major Depressive Disorder (MDD) and associated anxiety conditions. As a highly selective serotonin reuptake inhibitor (SSRI), it offers a refined mechanism of action targeting the serotonin transporter with superior affinity, resulting in enhanced efficacy and a potentially more favorable tolerability profile compared to earlier antidepressants. Clinically validated through extensive randomized controlled trials, Pexep provides healthcare professionals with a reliable first-line option for achieving and maintaining remission in patients experiencing moderate to severe depressive episodes. Its well-characterized pharmacokinetics allow for predictable dosing and simplified therapeutic drug monitoring in specialized cases.

Features

• Active pharmaceutical ingredient: Escitalopram oxalate
• Pharmacological class: Selective Serotonin Reuptake Inhibitor (SSRI)
• Available dosage forms: 5 mg, 10 mg, and 20 mg film-coated tablets
• High binding affinity for the human serotonin transporter (SERT)
• Minimal affinity for norepinephrine and dopamine transporters
• Linear pharmacokinetics across the therapeutic dosage range
• Mean elimination half-life of approximately 27-32 hours
• Steady-state plasma concentrations achieved within 7-10 days
• Primarily metabolized by CYP2C19, CYP3A4, and CYP2D6 isoenzymes

Benefits

• Achieves significant improvement in Montgomery-Åsberg Depression Rating Scale (MADRS) scores versus placebo within 1-2 weeks
• Demonstrates superior efficacy in preventing relapse and recurrence of major depressive episodes
• Provides effective relief from associated anxiety symptoms commonly present in depressive disorders
• Offers once-daily dosing convenience that enhances treatment adherence
• Presents a generally favorable side effect profile with lower incidence of activating effects compared to some SSRIs
• Maintains therapeutic effect during long-term management without requiring dosage escalation

Common use

Pexep is primarily indicated for the acute and maintenance treatment of Major Depressive Disorder in adults, characterized by persistent low mood, anhedonia, changes in appetite or sleep patterns, fatigue, and diminished concentration. It is also approved for the management of Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, and Obsessive-Compulsive Disorder. Off-label applications may include treatment of post-traumatic stress disorder, premenstrual dysphoric disorder, and vasomotor symptoms associated with menopause, though these require careful clinical consideration and patient-specific risk-benefit analysis.

Dosage and direction

Initiate treatment with 10 mg once daily, with or without food, typically in the morning to minimize potential sleep disturbances. Based on individual patient response and tolerability, dosage may be increased to a maximum of 20 mg daily after a minimum of one week. For elderly patients (over 65 years) or those with hepatic impairment, recommended starting dose is 5 mg daily with maximum dosage not exceeding 10 mg daily. Therapeutic effect may not be evident for 2-4 weeks, with full antidepressant benefits potentially requiring 6-8 weeks of continuous therapy. Do not crush, chew, or break tablets; swallow whole with water. Treatment should continue for at least 6 months after symptom remission to consolidate therapeutic gains and prevent relapse.

Precautions

Monitor patients closely for clinical worsening, suicide risk, or unusual changes in behavior, particularly during the initial months of therapy and following dosage adjustments. Use with caution in patients with history of mania/hypomania, as activation may precipitate a manic episode. Exercise care when prescribing to patients with conditions that might predispose to hyponatremia (elderly patients, those taking diuretics, or with volume depletion). Regular monitoring of sodium levels may be indicated in at-risk populations. Caution is advised in patients with narrow-angle glaucoma due to potential pupillary dilation effects. Patients should be advised regarding potential impairment of judgment, thinking, or motor skills, especially during dose titration.

Contraindications

Absolute contraindications include known hypersensitivity to escitalopram, citalopram, or any component of the formulation. Concomitant use with monoamine oxidase inhibitors (MAOIs) is contraindicated due to risk of serotonin syndrome; a minimum 14-day washout period must be observed when switching between these medications. Pexep is contraindicated in patients with congenital long QT syndrome or those with known QT prolongation. Avoid use in patients taking pimozide due to potential for serious cardiac effects. Not recommended during third trimester of pregnancy due to potential complications in newborns.

Possible side effects

Common adverse reactions (≥5% incidence) include nausea (15%), ejaculation disorder (9%), fatigue (6%), insomnia (6%), and increased sweating (5%). Less frequent effects may include diarrhea, constipation, dizziness, somnolence, and decreased libido. Sexual dysfunction, including anorgasmia and erectile dysfunction, may occur in approximately 7-14% of patients. Rare but serious adverse effects include serotonin syndrome, abnormal bleeding (particularly when combined with NSAIDs or anticoagulants), hyponatremia, angle-closure glaucoma, and QT interval prolongation at higher doses. Most side effects are dose-dependent and often diminish with continued therapy.

Drug interaction

Concomitant use with MAOIs may cause serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, and autonomic instability. Strong inhibitors of CYP2C19 (e.g., fluconazole, fluvoxamine) may increase escitalopram exposure requiring dosage adjustment. Drugs that prolong QT interval (e.g., antiarrhythmics, antipsychotics, antibiotics) may have additive effects. Enhanced anticoagulant effect may occur with warfarin coadministration, requiring increased INR monitoring. Serotonergic drugs (tramadol, triptans, other antidepressants) may increase serotonin syndrome risk. NSAIDs and aspirin may increase bleeding risk. Lithium and tryptophan may enhance serotonergic effects.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is close to the time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. Consistent daily administration at approximately the same time is recommended to maintain steady-state plasma concentrations. Use of pill organizers or reminder systems may help prevent missed doses, particularly during the maintenance phase of treatment.

Overdose

Symptoms of overdose may include dizziness, sweating, nausea, vomiting, tremor, somnolence, sinus tachycardia, and in severe cases, seizures, coma, or ECG changes including QT prolongation. Serotonin syndrome manifestations may include mental status changes, autonomic instability, neuromuscular symptoms, and gastrointestinal symptoms. There is no specific antidote; management involves supportive care and symptomatic treatment. Gastric lavage may be considered if presentation is early after ingestion. Activated charcoal may be administered. ECG monitoring is recommended for at least 24 hours due to potential QT prolongation. Dialysis is unlikely to be effective due to high protein binding.

Storage

Store at controlled room temperature 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F). Keep container tightly closed and protect from light and moisture. Dispense in original container with child-resistant closure. Keep out of reach of children and pets. Do not use if the seal under the cap is broken or missing. Properly dispose of unused or expired medication through medication take-back programs or according to local regulations. Do not flush medications down the toilet or pour into drain unless specifically instructed to do so.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Pexep is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual patient response may vary, and treatment decisions should be based on comprehensive clinical assessment. The prescribing physician should be familiar with the complete prescribing information and latest clinical data. Patients should not alter dosage or discontinue medication without consulting their healthcare provider. Report any adverse events to the appropriate regulatory authority.

Reviews

Clinical studies demonstrate Pexep’s significant advantage over placebo with response rates of 65-75% versus 30-35% for placebo in major depressive disorder. Meta-analyses confirm its position among the most efficacious antidepressants with standardized mean difference of -0.33 (95% CI: -0.41 to -0.25) on depression rating scales. Long-term maintenance studies show relapse rates of 13-26% versus 50-65% for placebo over 6-12 month periods. Patient-reported outcomes indicate improved quality of life measures and functional capacity. The number needed to treat (NNT) for response is approximately 6, while number needed to harm (NNH) for discontinuation due to adverse effects is 25-30, indicating favorable benefit-risk profile.