COMPOSITION

Questa 10mg: Each film coated tablet contains Escitalopram
Oxalate eq. to Escitalopram U.S.P………10mg.

Indications

1. Treatment of major depressive episodes.
2. Treatment of panic disorder with or without agoraphobia.
3. Treatment of social anxiety disorder (social phobia).
4. Treatment of generalised anxiety disorder.

Dosage and method of administration
Safety of daily doses above 20 mg has not been demonstrated.
Questa is administered as a single daily dose and may be taken with or without food.

Major depressive episodes
Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain antidepressant response.

After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response.

Panic disorder with or without agoraphobia
An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily. The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months.

Social anxiety disorder
Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually, 2-4 weeks are necessary to obtain symptom relief. Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals.

Generalised anxiety disorder
Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Treatment for 3 months is recommended to consolidate response.

Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals Elderly patients (> 65 years of age) Initial treatment with half the usually recommended dose and a lower maximum dose should be considered.

Children and adolescents (<18 years) Not recommended, since safety and effectiveness in this population have not been established.

Reduced renal function
Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min).

Reduced hepatic function
An initial dose of 5 mg daily for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily.

Discontinuation symptoms
When stopping treatment with Questa the dose should be gradually reduced over a period of one or two weeks in order to avoid possible discontinuations symptoms.

Contra-indications
Hypersensitivity to escitalopram or to any of the excipients.
Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors)

Precautions
Questa should not be used in the treatment of children and adolescents under age of 18 years. An increase in suicide-related behaviors (suicide attempt and suicidal thoughts), and hostility were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for the appearance of suicidal symptoms.

The following special warnings and precautions apply to the therapeutic class of SSRIs (Selective Serotonin Re-uptake Inhibitors).

Paradoxical anxiety
Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. This paradoxical reaction usually subsides within the first two weeks of treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect.

Seizures
The medicinal product should be discontinued in any patient who develops seizures. SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. SSRIs should be discontinued if there is an increase in seizure frequency.

Mania
SSRIs should be used with caution in patients with a history of mania/hypomania. SSRIs should be discontinued in any patient entering a manic phase.

Diabetes
In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycemic dosage may need to be adjusted.

Suicide
The possibility of suicide attempt is inherent in depression and may persist until significant improvement occurs, either spontaneously or following treatment.

Patients being treated with antidepressants should be monitored carefully especially at the beginning of treatment for clinical worsening and/or the emergence of suicidality (suicidal ideation and behaviour).

This precaution should also be observed when treating other psychiatric disorders because of the possibility of co-morbidity with major depressive disorder.

Hyponatraemia
Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. Caution should be exercised in patients at risk, such as elderly, cirrhotic patients or patients concomitantly treated with medications known to cause hyponatraemia.

Haemorrhage
There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRIs. Caution is advised in patients taking SSRIs, particularly with concomitant use of oral\ anticoagulants; medicinal products known to affect platelet function (e.g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products (NSAIDs), ticlopidine and dipyridamole); and in patients with known bleeding tendencies ECT (electroconvulsive therapy) .There is limited clinical experience of concurrent administration of SSRIs and ECT; therefore caution is advisable. Reversible, selective MAO-A inhibitors The combination of escitalopram with MAO-A inhibitors is generally not recommended due to the risk of onset of a serotonin syndrome.

Serotonin syndrome
Caution is advisable if escitalopram is used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol and tryptophan.

In rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products. A combination of symptoms, such as agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition. If this occurs treatment with the SSRI and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated.

St. John’s Wort
Concomitant use of SSRIs and herbal remedies containing St. John’s Wort (Hypericum perforatum) may result in an increased incidence of adverse reactions.

Discontinuations symptoms
When stopping therapy with Questa, the dose should be gradually reduced over a period of one or two weeks in order to avoid possible discontinuations symptoms.

Pregnancy and lactation

Pregnancy
In reproductive toxicity studies performed in rats with escitalopram, embryo-fetotoxic effects were observed, but no increased incidence of malformations.

For escitalopram only limited clinical data are available regarding exposure in pregnancy.

Questa should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit ratio.

Using SSRIs in the third trimester may result in effects, including neurobehavioral disturbances, in the newborn infant. The following effects were reported in neonates with SSRIs administered to pregnant women until date of birth: irritability, tremor, hypertonia, increased muscle tone, constant crying, and difficulty in suckling or in sleeping. They may either indicate serotonergic effects or withdrawal syndrome. If used during pregnancy SSRIs should never be stopped abruptly.

Lactation
It is expected that escitalopram will be excreted into human milk and, breast-feeding is not recommended during the treatment.

Effects on ability to drive and use machines Although Questa has been shown not to affect intellectual function or psychomotor performance, any psychoactive medicinal product may impair judgment or skills. Patients should be cautioned about the potential risk of an influence on their ability to drive a car and operate machinery.

Overdose
Toxicity
Clinical data on escitalopram overdose are limited. However, it has been observed that doses of 600 mg of escitalopram have been taken without any serious symptoms being reported.

Symptoms
Symptoms of overdose with racemic citalopram (>600 mg): Dizziness, tremor, agitation, somnolence, unconsciousness, seizures, tachycardia, changes in the ECG with ST-T changes, broadening of the QRS complex, prolonged QT interval, arrhythmias, respiratory depression, vomiting, rhabdomyolysis, metabolic acidosis, hypokalaemia. It is anticipated that overdoses with escitalopram would result in similar symptoms.

Treatment
There is no specific antidote. Establish and maintain an airway, ensure adequate oxygenation and respiratory function. Gastric lavage should be carried out as soon as possible after oral ingestion.

The use of activated charcoal should be considered. Cardiac and vital signs monitoring are recommended along with general symptomatic supportive measures.

Presentation
Questa 10mg: Cold Form & Cold Seal Pack of 14’s Tablet.

Storage
Protect from light & moisture, store below 30 o C.
Keep out of the reach of children.

WARNING:
To be sold on the prescription of registered medical practitioner only.