AVESTALO Tablet

For the treatment of:

- Major depressive disorder

- Panic disorder with or without agoraphobia

- Social anxiety disorder (social phobia)

- Generalized anxiety disorder

- Obsessive-compulsive disorder

Dosage and administration

As a single daily dose and may be taken with or without food.

Major depressive disorder

Adolescents (12-17 years of age): 10mg once daily. If the dose is increased to 20mg, this should occur after a minimum of 3 weeks.

Adults: 10mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20mg daily. If the dose is increased to 20mg, this should occur after a minimum of 1 week. Usually 2-4 weeks are necessary to obtain antidepressant response. After the symptoms resolve, treatment for at least 6 months is required or consolidation of the response.

Panic disorder with or without agoraphobia

An initial dose of 5mg is recommended for the first week before increasing the dose to 10mg daily. The dose may be further increased, up to a maximum of 20mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment tests several months.

Social anxiety disorder

The usual dosage is 10mg once daily. Usually 2-4 weeks are necessary to obtain symptom relief. The dose may be subsequently, depending on individual patient response, be decreased to 5mg or increased to a maximum of 20mg daily. Social anxiety disorder is a disease with a chronic course and treatment for 12 weeks is recommended to consolidate response. Long term treatment for 6 months can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals.

Generalised anxiety disorder

Initial dosage is 10mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20mg daily.

Obsessive-compulsive disorder

Initial dose is 10mg once daily. Depending on individual patient response, the dose may be increased to 20mg daily. As OCD is a chronic disease, patients should be treated for sufficient period to ensure that they are symptom free. Treatment benefits and dose should be re-evaluated at regular intervals.

Special Populations

See the package insert about the details below:

- Elderly Patients (>65 years of age)

- Patients with renal impairment

- Patients with hepatic impairment

- Poor metabolisers of CYP2C19

- Discontinuation

- In patients with hypersensitivity to escitalopram or to any of the excipients,

- To use concomitantly with non-selective, irreversible monoamine, oxidase inhibitors (MAO-inhibitors),

- To use concomitantly with reversible MAO-A inhibitors (e.g. Moclobemide) or the reversible non-selective MAO-inhibitor linezolid,

- In patient with known QT interval prolongation or congenital long QT syndrome,

- To use concomitantly with drugs that are known to prolong the QT interval,

- To use concomitantly with pimozide.

Very Common

Nausea

Common

Decreased appetite, increased appetite, weight increased, anxiety, restlessness, abnormal dreams, libido decreased, anorgasmia, insomnia, somnolence, dizziness, paraesthesia, tremor, sinusitis, yawning, diarrhea, constipation, vomiting, dry mouth, sweating increased, arthralgia, myalgia, ejaculation disorder, impotence, fatigue and pyrexia.

Uncommon

Weight decreased bruxism, agitation, nervousness, panic attack, confusional state, taste disturbance, sleep disorder, syncope, mydriasis, visual disturbance, tinnitus, tachycardia, epistaxis, gastrointestinal hemorrhages (including rectal hemorrhage), urticaria, alopecia, rash, pruritis, metrorrhagia, menorrhagia and oedema.

Rare

Anaphylactic reaction, serotonin syndrome, aggression, depersonalization, hallucination and bradycardia.

Withdrawal symptoms

Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and visual disturbances.

See the package insert about the details below:

- Drugs affecting platelet function

- Serotonergic drugs

- Products lowering the seizure threshold

- Lithium/Tryptophan

- Centrally acting drugs

- St John’s Wort

- Cimetidine/ CYP2C19 inhibitors

- CYP2D6 enzyme

- Alcohol

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Therefore, escitalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Escitalopram is excreted in human breast milk. Therefore, breast-feeding is not recommended during treatment.

See the package insert about the details below:

- Paradoxical anxiety

- Seizures

- Mania

- Diabetes

- Suicide/suicidal thoughts or clinical worsening

- Akathisia/psychomotor restlessness

- Hyponatremia

- ECT (electroconvulsive therapy)

- Serotonin syndrome

- Coronary heart disease

- QT interval prolongation

The antidepressant action of escitalopram is presumed to be linked to the potentiation of serotonergic activity i the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).

Escitalopram has high affinity for the primary binding site and an allosteric modulating effect on the secretion transporter. Allosteric modulation of the serotonin transporter enhances binding of escitalopram to the primary binding site, resulting in more complete serotonin reuptake inhibition.