Serotal10 mg

Established (Approved) Uses

Serotal is approved for the treatment of Major Depressive Disorder (MDD) in adults and in adolescents 12 years of age and older. Serotal is also approved for the treatment of Generalized Anxiety Disorder (GAD) in adults and in children and adolescents 7 years of age and older.

Guideline-Supported / Regionally Approved Uses

Serotal is used, and is approved in many countries including Bangladesh and across Europe, for panic disorder (with or without agoraphobia) and for social anxiety disorder (social phobia) in adults, based on clinical trial evidence, although these uses are not FDA-approved indications in the United States.

Off-Label Use

Serotal is sometimes prescribed off-label for obsessive-compulsive disorder (OCD) in adults, based on the general antidepressant/anti-obsessional effect of SSRIs as a class, although Serotal does not carry a specific regulatory approval for OCD in most markets and other SSRIs have stronger evidence in this indication. Any off-label use of Serotal should be decided by a qualified physician after weighing individual benefits and risks.

Escitalopram is the S-enantiomer of the racemic antidepressant citalopram and is a selective serotonin reuptake inhibitor (SSRI). Escitalopram selectively inhibits the neuronal reuptake of serotonin (5-HT) in the central nervous system, with minimal effect on norepinephrine or dopamine reuptake, thereby increasing serotonergic neurotransmission.

Absorption: Escitalopram is well absorbed after oral administration, with peak plasma concentrations reached in about 5 hours; absolute bioavailability is approximately 80%, and food does not significantly affect absorption.

Distribution: Escitalopram is approximately 56% bound to plasma proteins.

Metabolism: Escitalopram is extensively metabolized in the liver, mainly via the CYP3A4 and CYP2C19 enzymes, to the less active metabolites S-desmethylcitalopram (S-DCT) and S-didesmethylcitalopram (S-DDCT).

Elimination: The elimination half-life of Escitalopram is approximately 27-32 hours with once-daily dosing, and steady-state concentrations are reached in about one week. A small proportion (roughly 7-8%) of an administered dose of Escitalopram is excreted unchanged in the urine.

• Take Serotal exactly as prescribed by the doctor, usually once daily.
• Serotal can be taken in the morning or evening, whichever time is easier to remember and maintain consistently.
• Serotal may be taken with or without food.
• Swallow the Serotal tablet with a glass of water; the oral solution form of Serotal should be measured with the dosing device provided.
• Do not crush or chew the tablet form of Serotal unless advised by the doctor.
• If a dose of Serotal is missed, take it as soon as remembered unless it is almost time for the next dose; do not double the dose.
• Do not stop taking Serotal suddenly without consulting a doctor, even if feeling better (see Precautions and Warnings for details).

• Monoamine Oxidase Inhibitors (MAOIs): Concurrent use of Serotal with an MAOI, or use of Serotal within 14 days of stopping an MAOI (or starting an MAOI within 14 days of stopping Serotal), is contraindicated because of the serious risk of serotonin syndrome.
• Other serotonergic drugs: Combining Serotal with other serotonergic medicines such as other SSRIs, SNRIs, triptans, tramadol, lithium, St. John's Wort, or linezolid increases the risk of serotonin syndrome, a potentially life-threatening condition (see Precautions and Warnings).
• Pimozide: Concurrent use of Serotal with pimozide is contraindicated because of the risk of clinically significant QT-interval prolongation.
• Other QT-prolonging drugs: Using Serotal together with other drugs known to prolong the QT interval (certain antiarrhythmics, antipsychotics, or antimicrobials) may increase the risk of abnormal heart rhythm; such combinations require caution and medical supervision.
• NSAIDs, aspirin, warfarin, and other anticoagulants: Serotal, like other SSRIs, may increase the risk of bleeding when combined with NSAIDs, aspirin, or anticoagulant/antiplatelet drugs, due to effects on platelet serotonin; patients on warfarin should have clotting parameters monitored.
• CYP2C19 inhibitors: Drugs that inhibit the CYP2C19 enzyme (such as omeprazole) can increase blood levels of Serotal; a lower dose of Serotal may be needed.
• Alcohol and other CNS depressants: Alcohol is not recommended during treatment with Serotal, as the combined sedative effect has not been fully evaluated.

Common Side Effects

• Nausea and other gastrointestinal upset (dyspepsia, diarrhea, or constipation)
• Insomnia or somnolence (drowsiness)
• Fatigue and dizziness
• Increased sweating
• Dry mouth
• Decreased appetite
• Sexual dysfunction, including delayed ejaculation, decreased libido, and difficulty reaching orgasm
• Mild tremor

Serious Side Effects – Seek Medical Attention

• Signs of serotonin syndrome (agitation, hallucinations, rapid heartbeat, fever, muscle stiffness or twitching, loss of coordination, sweating, diarrhea) – see Precautions and Warnings.
• New or worsening suicidal thoughts or behavior, or unusual changes in mood or behavior – see Precautions and Warnings.
• Signs of an allergic reaction (rash, swelling of the face/throat, difficulty breathing) or severe skin reactions such as blistering or peeling skin.
• Seizures.
• Unusual bleeding or bruising.
• Symptoms of low blood sodium (hyponatremia) such as headache, confusion, weakness, or unsteadiness, particularly in elderly patients.
• Eye pain, vision changes, or swelling/redness in or around the eye (possible angle-closure glaucoma).
• Irregular heartbeat, palpitations, or fainting (possible QT prolongation/arrhythmia).
• Symptoms of mania (abnormally elevated mood, racing thoughts, unusual risk-taking).

Pregnancy

Serotal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use of Serotal and other SSRIs late in the third trimester of pregnancy has been associated with poor neonatal adaptation, including respiratory distress, feeding difficulty, jitteriness, and the need for prolonged hospitalization in the newborn; some data have also raised a possible association with persistent pulmonary hypertension of the newborn (PPHN), although the overall evidence on this link is not conclusive. Untreated depression or anxiety during pregnancy also carries risks to both mother and baby, so the decision to continue, adjust, or stop Serotal during pregnancy should be individualized and made together with a doctor, and Serotal should never be stopped abruptly without medical advice.

Breastfeeding

Serotal passes into breast milk in small amounts. Breastfed infants of mothers taking Serotal should be monitored for possible effects such as excessive sleepiness, poor feeding, irritability, or inadequate weight gain. The decision to breastfeed during treatment with Serotal should be made by the mother and her doctor after weighing the benefits of breastfeeding against the infant's potential drug exposure.

• Boxed warning – Suicidal thoughts and behaviors: Serotal, like other antidepressants, increased the risk of suicidal thinking and behavior in short-term studies in children, adolescents, and young adults (up to age 24) with depression and other psychiatric disorders. This risk must be balanced against the clinical need for treatment. Patients of all ages started on Serotal should be monitored closely for clinical worsening, unusual changes in behavior, or emergence of suicidal thoughts, especially during the first few months of treatment and after dose changes. Serotal is not approved for use in children below the ages specified for its approved indications (see Pediatric Uses).
• Do not stop abruptly: Stopping Serotal suddenly can cause a discontinuation syndrome with symptoms such as dizziness, irritability, anxiety, sensory disturbances, sleep disturbance, and low mood. Serotal should be tapered gradually under medical supervision rather than stopped abruptly.
• Serotonin syndrome: A potentially life-threatening reaction can occur when Serotal is combined with other serotonergic drugs; watch for agitation, hallucinations, rapid heart rate, fever, and loss of coordination, and seek urgent medical care if these occur.
• Activation of mania or hypomania: Serotal should be used with caution in patients with a personal or family history of bipolar disorder, as antidepressants can trigger a manic or hypomanic episode.
• Hyponatremia: Low blood sodium levels, sometimes severe, have been reported with SSRIs including Serotal, particularly in elderly patients and those on diuretics; symptoms include headache, confusion, and weakness.
• Abnormal bleeding: Serotal may increase the risk of bleeding, especially when combined with NSAIDs, aspirin, or anticoagulants; caution is advised in patients with a bleeding tendency.
• QT-interval prolongation: Serotal can cause dose-dependent prolongation of the QT interval; caution is required in patients with congenital long QT syndrome, other cardiac conditions, or electrolyte disturbances, and in those taking other QT-prolonging medicines.
• Angle-closure glaucoma: SSRIs including Serotal may rarely precipitate angle-closure glaucoma in susceptible individuals; report any eye pain or vision changes promptly.
• Seizures: Serotal should be used cautiously in patients with a history of seizures, and treatment should be discontinued if seizures occur.

Overdose of Serotal most commonly causes dizziness, sweating, nausea, vomiting, tremor, and drowsiness. In more severe overdose, or when Serotal is taken together with alcohol or other drugs, effects can include seizures (which may be delayed in onset), altered level of consciousness or coma, abnormal heart rhythm including QT/QRS prolongation, changes in blood pressure, and serotonin syndrome. Anyone suspected of having taken an overdose of Serotal should seek emergency medical attention or contact a poison control service immediately; vomiting should not be induced unless specifically directed by a healthcare professional or poison control. Management in a medical facility is generally supportive and may include monitoring of heart rhythm and vital signs.

Children

Serotal is approved for Major Depressive Disorder in adolescents 12 years and older and for Generalized Anxiety Disorder in children and adolescents 7 years and older; safety and effectiveness have not been established for other pediatric indications or younger ages. The boxed warning on suicidal thoughts and behavior applies especially to this age group (see Precautions and Warnings and Pediatric Uses).

Elderly

Elderly patients generally require a lower maximum dose of Serotal (usually 10 mg once daily) because of reduced drug clearance and increased sensitivity to side effects such as hyponatremia and QT prolongation.

Renal Impairment

No dose adjustment of Serotal is generally needed in mild-to-moderate renal impairment; Serotal should be used with caution in patients with severe renal impairment, for whom data are limited.

Hepatic Impairment

A maximum dose of 10 mg once daily of Serotal is recommended in patients with hepatic impairment, as clearance of Serotal is reduced.

Other Populations

Patients who are known or suspected to be poor CYP2C19 metabolizers, or who are taking a CYP2C19-inhibiting drug, may have higher blood levels of Serotal and may need a lower dose; this should be assessed individually by the prescribing doctor.

The duration of treatment with Serotal depends on the condition being treated and individual response, and should be decided by the prescribing doctor. For depression and anxiety disorders, Serotal typically needs to be taken for at least 2-4 weeks before a noticeable improvement occurs, and full benefit may take longer. Once a good response is achieved, treatment with Serotal is generally continued for a period of months to help prevent relapse, with the exact duration reassessed periodically by the doctor based on the patient's progress and history. Serotal should not be stopped as soon as symptoms improve, and any decision to reduce or stop Serotal should be made gradually and under medical supervision.

Serotal is approved for the treatment of Major Depressive Disorder in adolescents 12 years of age and older, and for Generalized Anxiety Disorder in children and adolescents 7 years of age and older. Serotal has not been established as safe and effective for other psychiatric indications in children, or for use below these age thresholds. As with other antidepressants, Serotal carries a boxed warning regarding an increased risk of suicidal thoughts and behavior in children, adolescents, and young adults, particularly during the early weeks of treatment and after dose changes (see Precautions and Warnings for full details). Pediatric patients taking Serotal should have their weight and growth monitored, since decreased appetite and weight changes have been reported. Any use of Serotal in a child or adolescent should be closely supervised by a physician, with regular follow-up visits.