Pexep (escitalopram oxalate) represents a significant advancement in the pharmacological management of Major Depressive Disorder (MDD). As a highly selective serotonin reuptake inhibitor (SSRI), it offers a refined mechanism of action targeting the serotonin transporter with superior affinity. This monograph provides healthcare professionals with comprehensive clinical information regarding its therapeutic application, pharmacokinetic profile, and safety considerations. The following detailed analysis is intended to support evidence-based prescribing decisions and optimize patient outcomes in depressive disorders.

Features

• Active ingredient: Escitalopram oxalate 5mg, 10mg, 20mg film-coated tablets
• Pharmacological class: Selective Serotonin Reuptake Inhibitor (SSRI)
• Bioavailability: Approximately 80% following oral administration
• Protein binding: 56% bound to plasma proteins
• Metabolism: Hepatic, primarily via CYP2C19, CYP3A4, and CYP2D6 isoenzymes
• Elimination half-life: 27-32 hours in extensive metabolizers
• Steady-state concentration: Achieved within approximately one week of dosing
• Excretion: Primarily renal (8% as unchanged drug), with fecal elimination of metabolites

Benefits

• Demonstrated superior efficacy in reducing Montgomery-Åsberg Depression Rating Scale (MADRS) scores compared to other SSRIs in clinical trials
• Rapid onset of therapeutic action, with significant symptom improvement often observed within 1-2 weeks of initiation
• Favorable side effect profile with reduced incidence of activating side effects compared to other agents in its class
• Linear pharmacokinetics across the therapeutic dosage range, facilitating predictable dose-response relationships
• Minimal cytochrome P450 inhibition at therapeutic doses, reducing potential for drug-drug interactions
• Established long-term maintenance efficacy with sustained remission rates in continuation therapy

Common use

Pexep is primarily indicated for the acute and maintenance treatment of Major Depressive Disorder in adults. Clinical evidence supports its use in generalized anxiety disorder, panic disorder, social anxiety disorder, and obsessive-compulsive disorder. The therapeutic application extends to off-label uses including post-traumatic stress disorder, premenstrual dysphoric disorder, and vasomotor symptoms associated with menopause, though these indications require careful risk-benefit assessment. The medication demonstrates particular utility in patients who have experienced inadequate response or intolerance to other antidepressant therapies.

Dosage and direction

Initial dosing for Major Depressive Disorder begins at 10 mg once daily, with or without food. Based on clinical response and tolerability, the 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 initial dose is 5 mg daily, with maximum dose not exceeding 10 mg daily. Administration should occur at approximately the same time each day to maintain stable plasma concentrations. Dose adjustments should be made gradually, with at least one-week intervals between changes to assess therapeutic response and adverse effects. Treatment duration for acute episodes typically continues for 6-9 months following symptom remission to prevent relapse.

Precautions

Patients should be monitored closely for clinical worsening, suicide risk, or unusual changes in behavior, particularly during the initial months of therapy and following dosage adjustments. Caution is advised in patients with history of mania/hypomania, as SSRIs may precipitate manic episodes. Use with caution in patients with conditions that might predispose to hyponatremia (elderly patients, those taking diuretics, or otherwise volume-depleted). Regular monitoring of sodium levels may be appropriate in at-risk populations. SSRIs may increase the risk of bleeding events, particularly when used concomitantly with NSAIDs, aspirin, or other anticoagulants. Patients should be advised about the potential for impaired cognitive and motor performance, 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 taking medications known to prolong QT interval. Severe renal impairment (CrCl <30 mL/min) represents a contraindication due to limited safety data. The medication is contraindicated in patients with uncontrolled narrow-angle glaucoma.

Possible side effect

Common adverse reactions (≥5% incidence) include nausea (15%), insomnia (9%), ejaculation disorder (9%), fatigue (6%), and somnolence (6%). Less frequent side effects (1-5% incidence) encompass increased sweating, decreased libido, anxiety, agitation, diarrhea, and anorexia. Serious adverse effects requiring immediate medical attention include serotonin syndrome (agitation, hallucinations, tachycardia, hyperthermia), abnormal bleeding, hyponatremia, angle-closure glaucoma, and manic episodes. Sexual dysfunction may persist despite drug discontinuation in some patients. Weight changes (typically modest gain of 1-2 kg over year-long treatment) may occur in some individuals.

Drug interaction

Significant interactions occur with MAOIs (risk of serotonin syndrome), other serotonergic drugs (tramadol, fentanyl, lithium, tryptophan), drugs that prolong QT interval (antiarrhythmics, antipsychotics, antibiotics), and strong CYP2C19 inhibitors (omeprazole, fluconazole). Moderate interactions exist with warfarin (increased bleeding risk), CNS depressants (enhanced sedation), and tamoxifen (reduced efficacy through CYP2D6 inhibition). Caution advised with NSAIDs, aspirin, and other antiplatelet agents due to increased bleeding risk. Pexep may reduce the efficacy of drugs metabolized by CYP2D6 (e.g., codeine, metoprolol).

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is接近 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 double or extra doses to make up for a missed dose. Consistent daily administration is important for maintaining therapeutic plasma concentrations. Healthcare providers should educate patients about the importance of adherence and develop strategies to minimize missed doses, particularly during the initial treatment phase.

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. There is no specific antidote for escitalopram overdose. Management consists of supportive care and symptomatic treatment. Gastric lavage may be considered if performed soon after ingestion. Activated charcoal may be administered. ECG monitoring is recommended for at least 24 hours in cases of significant overdose. Serotonin syndrome should be suspected if neuromuscular symptoms, autonomic instability, or mental status changes occur.

Storage

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep container tightly closed and protect from moisture. Dispense in original container with child-resistant closure. Keep out of reach of children and pets. Do not use beyond the expiration date printed on packaging. Avoid storage in bathroom cabinets or other areas with high humidity. Tablets should be protected from light and excessive heat.

Disclaimer

This information is intended for healthcare professionals and should not replace clinical judgment. Prescribers should consult full prescribing information before initiating therapy. Treatment decisions must be based on individual patient factors, including medical history, concomitant medications, and risk-benefit assessment. Patients should be fully informed about potential benefits and risks before starting treatment. Regular follow-up and monitoring are essential components of safe antidepressant therapy.

Reviews

Clinical trials demonstrate Pexep’s efficacy with MADRS score reductions of 13.9 points versus 9.3 for placebo (p<0.001) in 8-week studies. Meta-analyses show number needed to treat (NNT) of 6 for response and 7 for remission. Long-term studies indicate relapse prevention with hazard ratio of 0.37 compared to placebo. Patient-reported outcomes show significant improvements in quality of life measures and functional capacity. Real-world evidence supports maintained efficacy in diverse patient populations, though individual response may vary based on pharmacogenetic factors and clinical characteristics.